diff --git a/.github/workflows/claude-comment-review.yml b/.github/workflows/claude-comment-review.yml new file mode 100644 index 0000000..70d96fc --- /dev/null +++ b/.github/workflows/claude-comment-review.yml @@ -0,0 +1,32 @@ +name: Claude PR Comment Review + +on: + issue_comment: + types: [created] + pull_request_review_comment: + types: [created] + +permissions: + contents: read + pull-requests: write + +jobs: + review: + if: >- + ${{ contains(github.event.comment.body, '@claude') + && (github.event.issue.pull_request != null || + github.event.pull_request != null) }} + runs-on: ubuntu-latest + steps: + - name: Checkout + uses: actions/checkout@v4 + + - name: Run Claude Code Action (comment-triggered) + uses: anthropics/claude-code-action@v1 + with: + anthropic_api_key: ${{ secrets.ANTHROPIC_API_KEY}} + prompt: | + You are reviewing a GitHub Pull Request. Focus on security, correctness, clarity. + - Only comment on files that changed in this PR. + - Prioritize actionable fixes and cite specific lines. + - Keep comments concise; avoid restating code. diff --git a/.gitmodules b/.gitmodules index 64dddfd..f71abca 100644 --- a/.gitmodules +++ b/.gitmodules @@ -1,3 +1,6 @@ [submodule "cdisc-json-validation"] path = cdisc-json-validation url = https://github.com/pendingintent/cdisc-json-validation.git +[submodule "cdisc-biomedical-concept-groupings"] + path = cdisc-biomedical-concept-groupings + url = https://github.com/pendingintent/cdisc-biomedical-concept-groupings.git diff --git a/cdisc-biomedical-concept-groupings b/cdisc-biomedical-concept-groupings new file mode 160000 index 0000000..854d5fc --- /dev/null +++ b/cdisc-biomedical-concept-groupings @@ -0,0 +1 @@ +Subproject commit 854d5fc18d5d1a3bee7063a5f6408dc10ebc2a8c diff --git a/config.env b/config.env index e792af1..1148075 100644 --- a/config.env +++ b/config.env @@ -56,6 +56,13 @@ CDISC_BC_API_BASE_URL=https://api.library.cdisc.org/api/cosmos/v2 # Base URL for the CDISC Library CRF Specializations API. # Falls back to CDISC_BC_API_BASE_URL when not set. CDISC_CRF_API_BASE_URL=http://localhost:8000/api/cosmos/v2 +#CDISC_CRF_API_BASE_URL=https://apidev.cdisclibrary.org/api/cosmos/v2 + +# The CDISC Library CRF Specializations API uses a separate +# api-key/subscription-key from the main CDISC Library API. +# Set CDISC_CRF_API_KEY / CDISC_CRF_SUBSCRIPTION_KEY in your +# shell environment (do NOT add them here). Falls back to +# CDISC_API_KEY / CDISC_SUBSCRIPTION_KEY when not set. # Set to 1 to skip all remote CDISC Library API calls. # Useful for offline development or testing. @@ -92,6 +99,28 @@ SOA_BUILDER_CACHE_TTL=3600 CDISC_REQUEST_TIMEOUT=15 +# ------------------------------------------------------------ +# Biomedical Concept Grouping Service +# ------------------------------------------------------------ + +# Base URL for the cdisc-biomedical-concept-groupings service +# (BC classification schemes/values/assignments powering the +# BC Grouping Explorer on the Concept Groups page). Run it via +# `python run.py` from the cdisc-biomedical-concept-groupings +# submodule directory. +BC_GROUPING_SERVICE_URL=http://127.0.0.1:8901 + +# Timeout (in seconds) for outbound HTTP requests to the +# BC Grouping service. Kept short since this is expected to be +# a local service — fail fast rather than hang the page load. +BC_GROUPING_REQUEST_TIMEOUT=3 + +# Time-to-live (in seconds) for the BC Grouping data cache. +# Default is 300 (5 minutes). Use the "Refresh" button on the +# BC Grouping Explorer to force an immediate refresh. +BC_GROUPING_CACHE_TTL=300 + + # ------------------------------------------------------------ # Biomedical Concept Property Population # ------------------------------------------------------------ diff --git a/output/fhir/NCT12345678-vulcan-soa-latest.json b/output/fhir/NCT12345678-vulcan-soa-latest.json new file mode 100644 index 0000000..7d56da7 --- /dev/null +++ b/output/fhir/NCT12345678-vulcan-soa-latest.json @@ -0,0 +1,2649 @@ +{ + "resourceType": "Bundle", + "type": "collection", + "entry": [ + { + "fullUrl": "http://hl7.org/fhir/uv/vulcan-schedule/PlanDefinition/H2Q-MC-LZZT-ProtocolDesign", + "resource": { + "resourceType": "PlanDefinition", + "id": "H2Q-MC-LZZT-ProtocolDesign", + "meta": { + "profile": [ + "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/StudyProtocolSoa" + ] + }, + "url": "http://hl7.org/fhir/uv/vulcan-schedule/PlanDefinition/H2Q-MC-LZZT-ProtocolDesign", + "identifier": [ + { + "use": "usual", + "value": "H2Q-MC-LZZT-ProtocolDesign-1" + } + ], + "version": "1.0.0", + "title": "H2Q-MC-LZZT CDISC Pilot LZZT Protocol Schedule of Activities", + "type": { + "coding": [ + { + "system": "http://terminology.hl7.org/CodeSystem/plan-definition-type", + "code": "clinical-protocol" + } + ] + }, + "status": "active", + "purpose": "The purpose of this PlanDefinition is to illustrate the planned study encounters.", + "action": [ + { + "id": "Study-Visit-SCREEN1", + "title": "Screen 1", + "description": "Planned Visit [Screen 1]", + "definitionUri": "PlanDefinition/H2Q-MC-LZZT-Study-Visit-SCREEN1", + "relatedAction": [ + { + "actionId": "Study-Visit-DOSE", + "relationship": "before", + "offsetDuration": { + "value": 14.0, + "system": "http://unitsofmeasure.org", + "code": "d" + } + } + ] + }, + { + "id": "Study-Visit-SCREEN2", + "title": "Screen 2", + "description": "Planned Visit [Screen 2]", + "definitionUri": "PlanDefinition/H2Q-MC-LZZT-Study-Visit-SCREEN2", + "relatedAction": [ + { + "actionId": "Study-Visit-DOSE", + "relationship": "before", + "offsetDuration": { + "value": 2.0, + "system": "http://unitsofmeasure.org", + "code": "d" + }, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/AcceptableOffsetRangeSoa", + "valueRange": { + "low": { + "value": 1.833, + "system": "http://unitsofmeasure.org", + "code": "d" + }, + "high": { + "value": 2.0, + "system": "http://unitsofmeasure.org", + "code": "d" + } + } + } + ] + } + ] + }, + { + "id": "Study-Visit-DOSE", + "title": "Dose", + "description": "Planned Visit [Dose]", + "definitionUri": "PlanDefinition/H2Q-MC-LZZT-Study-Visit-DOSE" + }, + { + "id": "Study-Visit-WEEK2", + "title": "Week 2", + "description": "Planned Visit [Week 2]", + "definitionUri": "PlanDefinition/H2Q-MC-LZZT-Study-Visit-WEEK2", + "relatedAction": [ + { + "actionId": "Study-Visit-DOSE", + "relationship": "after", + "offsetDuration": { + "value": 14.0, + "system": "http://unitsofmeasure.org", + "code": "d" + }, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/AcceptableOffsetRangeSoa", + "valueRange": { + "low": { + "value": 11.0, + "system": "http://unitsofmeasure.org", + "code": "d" + }, + "high": { + "value": 17.0, + "system": "http://unitsofmeasure.org", + "code": "d" + } + } + } + ] + } + ] + }, + { + "id": "Study-Visit-WEEK4", + "title": "Week 4", + "description": "Planned Visit [Week 4]", + "definitionUri": "PlanDefinition/H2Q-MC-LZZT-Study-Visit-WEEK4", + "relatedAction": [ + { + "actionId": "Study-Visit-DOSE", + "relationship": "after", + "offsetDuration": { + "value": 28.0, + "system": "http://unitsofmeasure.org", + "code": "d" + }, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/AcceptableOffsetRangeSoa", + "valueRange": { + "low": { + "value": 25.0, + "system": "http://unitsofmeasure.org", + "code": "d" + }, + "high": { + "value": 31.0, + "system": "http://unitsofmeasure.org", + "code": "d" + } + } + } + ] + } + ] + }, + { + "id": "Study-Visit-WEEK6", + "title": "Week 6", + "description": "Planned Visit [Week 6]", + "definitionUri": "PlanDefinition/H2Q-MC-LZZT-Study-Visit-WEEK6", + "relatedAction": [ + { + "actionId": "Study-Visit-DOSE", + "relationship": "after", + "offsetDuration": { + "value": 42.0, + "system": "http://unitsofmeasure.org", + "code": "d" + }, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/AcceptableOffsetRangeSoa", + "valueRange": { + "low": { + "value": 39.0, + "system": "http://unitsofmeasure.org", + "code": "d" + }, + "high": { + "value": 45.0, + "system": "http://unitsofmeasure.org", + "code": "d" + } + } + } + ] + } + ] + }, + { + "id": "Study-Visit-WEEK8", + "title": "Week 8", + "description": "Planned Visit [Week 8]", + "definitionUri": "PlanDefinition/H2Q-MC-LZZT-Study-Visit-WEEK8", + "relatedAction": [ + { + "actionId": "Study-Visit-DOSE", + "relationship": "after", + "offsetDuration": { + "value": 56.0, + "system": "http://unitsofmeasure.org", + "code": "d" + }, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/AcceptableOffsetRangeSoa", + "valueRange": { + "low": { + "value": 53.0, + "system": "http://unitsofmeasure.org", + "code": "d" + }, + "high": { + "value": 59.0, + "system": "http://unitsofmeasure.org", + "code": "d" + } + } + } + ] + } + ] + }, + { + "id": "Study-Visit-WEEK8N", + "title": "Week 8 NPI", + "description": "Planned Visit [Week 8 NPI]", + "definitionUri": "PlanDefinition/H2Q-MC-LZZT-Study-Visit-WEEK8N", + "relatedAction": [ + { + "actionId": "Study-Visit-WEEK8", + "relationship": "after", + "offsetDuration": { + "value": 14.0, + "system": "http://unitsofmeasure.org", + "code": "d" + } + } + ] + }, + { + "id": "Study-Visit-WEEK12", + "title": "Week 12", + "description": "Planned Visit [Week 12]", + "definitionUri": "PlanDefinition/H2Q-MC-LZZT-Study-Visit-WEEK12", + "relatedAction": [ + { + "actionId": "Study-Visit-DOSE", + "relationship": "after", + "offsetDuration": { + "value": 84.0, + "system": "http://unitsofmeasure.org", + "code": "d" + }, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/AcceptableOffsetRangeSoa", + "valueRange": { + "low": { + "value": 80.0, + "system": "http://unitsofmeasure.org", + "code": "d" + }, + "high": { + "value": 88.0, + "system": "http://unitsofmeasure.org", + "code": "d" + } + } + } + ] + } + ] + }, + { + "id": "Study-Visit-WEEK12N", + "title": "Week 12 NPI", + "description": "Planned Visit [Week 12 NPI]", + "definitionUri": "PlanDefinition/H2Q-MC-LZZT-Study-Visit-WEEK12N", + "relatedAction": [ + { + "actionId": "Study-Visit-WEEK12", + "relationship": "after", + "offsetDuration": { + "value": 14.0, + "system": "http://unitsofmeasure.org", + "code": "d" + } + } + ] + }, + { + "id": "Study-Visit-WEEK16", + "title": "Week 16", + "description": "Planned Visit [Week 16]", + "definitionUri": "PlanDefinition/H2Q-MC-LZZT-Study-Visit-WEEK16", + "relatedAction": [ + { + "actionId": "Study-Visit-DOSE", + "relationship": "after", + "offsetDuration": { + "value": 112.0, + "system": "http://unitsofmeasure.org", + "code": "d" + }, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/AcceptableOffsetRangeSoa", + "valueRange": { + "low": { + "value": 108.0, + "system": "http://unitsofmeasure.org", + "code": "d" + }, + "high": { + "value": 116.0, + "system": "http://unitsofmeasure.org", + "code": "d" + } + } + } + ] + } + ] + }, + { + "id": "Study-Visit-WEEK16N", + "title": "Week 16 NPI", + "description": "Planned Visit [Week 16 NPI]", + "definitionUri": "PlanDefinition/H2Q-MC-LZZT-Study-Visit-WEEK16N", + "relatedAction": [ + { + "actionId": "Study-Visit-WEEK16", + "relationship": "after", + "offsetDuration": { + "value": 14.0, + "system": "http://unitsofmeasure.org", + "code": "d" + } + } + ] + }, + { + "id": "Study-Visit-WEEK20", + "title": "Week 20", + "description": "Planned Visit [Week 20]", + "definitionUri": "PlanDefinition/H2Q-MC-LZZT-Study-Visit-WEEK20", + "relatedAction": [ + { + "actionId": "Study-Visit-DOSE", + "relationship": "after", + "offsetDuration": { + "value": 140.0, + "system": "http://unitsofmeasure.org", + "code": "d" + }, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/AcceptableOffsetRangeSoa", + "valueRange": { + "low": { + "value": 136.0, + "system": "http://unitsofmeasure.org", + "code": "d" + }, + "high": { + "value": 144.0, + "system": "http://unitsofmeasure.org", + "code": "d" + } + } + } + ] + } + ] + }, + { + "id": "Study-Visit-WEEK20N", + "title": "Week 20 NPI", + "description": "Planned Visit [Week 20 NPI]", + "definitionUri": "PlanDefinition/H2Q-MC-LZZT-Study-Visit-WEEK20N", + "relatedAction": [ + { + "actionId": "Study-Visit-WEEK20", + "relationship": "after", + "offsetDuration": { + "value": 14.0, + "system": "http://unitsofmeasure.org", + "code": "d" + } + } + ] + }, + { + "id": "Study-Visit-WEEK24", + "title": "Week 24", + "description": "Planned Visit [Week 24]", + "definitionUri": "PlanDefinition/H2Q-MC-LZZT-Study-Visit-WEEK24", + "relatedAction": [ + { + "actionId": "Study-Visit-DOSE", + "relationship": "after", + "offsetDuration": { + "value": 168.0, + "system": "http://unitsofmeasure.org", + "code": "d" + }, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/AcceptableOffsetRangeSoa", + "valueRange": { + "low": { + "value": 164.0, + "system": "http://unitsofmeasure.org", + "code": "d" + }, + "high": { + "value": 172.0, + "system": "http://unitsofmeasure.org", + "code": "d" + } + } + } + ] + } + ] + }, + { + "id": "Study-Visit-WEEK26", + "title": "Week 26", + "description": "Planned Visit [Week 26]", + "definitionUri": "PlanDefinition/H2Q-MC-LZZT-Study-Visit-WEEK26", + "relatedAction": [ + { + "actionId": "Study-Visit-DOSE", + "relationship": "after", + "offsetDuration": { + "value": 182.0, + "system": "http://unitsofmeasure.org", + "code": "d" + }, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/AcceptableOffsetRangeSoa", + "valueRange": { + "low": { + "value": 179.0, + "system": "http://unitsofmeasure.org", + "code": "d" + }, + "high": { + "value": 185.0, + "system": "http://unitsofmeasure.org", + "code": "d" + } + } + } + ] + } + ] + } + ] + } + }, + { + "fullUrl": "http://hl7.org/fhir/uv/vulcan-schedule/PlanDefinition/H2Q-MC-LZZT-Study-Visit-SCREEN1", + "resource": { + "resourceType": "PlanDefinition", + "id": "H2Q-MC-LZZT-Study-Visit-SCREEN1", + "meta": { + "profile": [ + "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/StudyVisitSoa" + ] + }, + "url": "http://hl7.org/fhir/uv/vulcan-schedule/PlanDefinition/H2Q-MC-LZZT-Study-Visit-SCREEN1", + "identifier": [ + { + "use": "usual", + "value": "H2Q-MC-LZZT-Study-Visit-SCREEN1" + } + ], + "version": "1.0.0", + "title": "H2Q-MC-LZZT Screen 1", + "type": { + "coding": [ + { + "system": "http://terminology.hl7.org/CodeSystem/plan-definition-type", + "code": "clinical-protocol" + } + ] + }, + "status": "active", + "description": "Screen 1 Activity Instance", + "action": [ + { + "title": "Informed Consent", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Informed-Consent" + }, + { + "title": "Inclusion/Exclusion Criteria", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Inclusion-Exclusion-Criteria" + }, + { + "title": "Patient Number assigned", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Patient-number-assigned" + }, + { + "title": "Demographics", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Demographics" + }, + { + "title": "Education", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Education" + }, + { + "title": "Hachinski", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Hachinski" + }, + { + "title": "MMSE", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-MMSE" + }, + { + "title": "Physical examination", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Physical-examination" + }, + { + "title": "Medical History", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Medical-History" + }, + { + "title": "Habits", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Habits" + }, + { + "title": "Chest X-ray", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Chest-X-ray" + }, + { + "title": "Vital Signs", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Vital-Signs" + }, + { + "title": "ECG", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-ECG" + }, + { + "title": "Placebo TTS Test", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Placebo-TTS-Test" + }, + { + "title": "CT Scan", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-CT-Scan" + }, + { + "title": "MRI", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-MRI" + }, + { + "title": "MRI, CT Scan", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-MRI-CT-Scan" + }, + { + "title": "Concomitant medications", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Concomitant-medications" + }, + { + "title": "Hematology", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Hematology" + }, + { + "title": "Chemistry", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Chemistry" + }, + { + "title": "Urinalysis", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Urinalysis" + }, + { + "title": "Hemoglobin A1C", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Hemoglobin-A1C" + }, + { + "title": "CIBIC+", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-CIBIC" + }, + { + "title": "DAD", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-DAD" + }, + { + "title": "ADAS-Cog", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-ADAS-Cog" + }, + { + "title": "NPI-X", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-NPI-X" + } + ] + } + }, + { + "fullUrl": "http://hl7.org/fhir/uv/vulcan-schedule/PlanDefinition/H2Q-MC-LZZT-Study-Visit-SCREEN2", + "resource": { + "resourceType": "PlanDefinition", + "id": "H2Q-MC-LZZT-Study-Visit-SCREEN2", + "meta": { + "profile": [ + "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/StudyVisitSoa" + ] + }, + "url": "http://hl7.org/fhir/uv/vulcan-schedule/PlanDefinition/H2Q-MC-LZZT-Study-Visit-SCREEN2", + "identifier": [ + { + "use": "usual", + "value": "H2Q-MC-LZZT-Study-Visit-SCREEN2" + } + ], + "version": "1.0.0", + "title": "H2Q-MC-LZZT Screen 2", + "type": { + "coding": [ + { + "system": "http://terminology.hl7.org/CodeSystem/plan-definition-type", + "code": "clinical-protocol" + } + ] + }, + "status": "active", + "description": "Screen 2 Activity Instance", + "action": [ + { + "title": "Vital Signs", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Vital-Signs" + }, + { + "title": "Ambulatory ECG placed", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Ambulatory-ECG-placed" + }, + { + "title": "NPI-X", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-NPI-X" + } + ] + } + }, + { + "fullUrl": "http://hl7.org/fhir/uv/vulcan-schedule/PlanDefinition/H2Q-MC-LZZT-Study-Visit-DOSE", + "resource": { + "resourceType": "PlanDefinition", + "id": "H2Q-MC-LZZT-Study-Visit-DOSE", + "meta": { + "profile": [ + "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/StudyVisitSoa" + ] + }, + "url": "http://hl7.org/fhir/uv/vulcan-schedule/PlanDefinition/H2Q-MC-LZZT-Study-Visit-DOSE", + "identifier": [ + { + "use": "usual", + "value": "H2Q-MC-LZZT-Study-Visit-DOSE" + } + ], + "version": "1.0.0", + "title": "H2Q-MC-LZZT Dose", + "type": { + "coding": [ + { + "system": "http://terminology.hl7.org/CodeSystem/plan-definition-type", + "code": "clinical-protocol" + } + ] + }, + "status": "active", + "description": "Dose Activity Instance", + "action": [ + { + "title": "Patient randomized", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Patient-randomised" + }, + { + "title": "Vital Signs", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Vital-Signs" + }, + { + "title": "Ambulatory ECG removed", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Ambulatory-ECG-removed" + }, + { + "title": "Concomitant medications", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Concomitant-medications" + }, + { + "title": "Study Drug", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Study-Drug" + }, + { + "title": "Plasma Specimen (Xanomeline)", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-Plasma-Specimen-Xanomeline" + }, + { + "title": "ADAS-Cog", + "definitionUri": "ActivityDefinition/H2Q-MC-LZZT-Activity-ADAS-Cog" + }, + { + "title": "CIBIC+", + "definitionUri": 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"http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-TTS-Acceptability-Survey", + "identifier": [ + { + "use": "usual", + "value": "TTS Acceptability Survey" + } + ], + "name": "TTS_Acceptability_Survey", + "title": "TTS Acceptability Survey", + "status": "active", + "description": "TTS Acceptability Survey results", + "code": { + "coding": [ + { + "system": "https://ncithesaurus.nci.nih.gov", + "code": "NEW_LZZT", + "display": "TTS Acceptability Survey" + } + ], + "text": "TTS Acceptability Survey" + } + } + }, + { + "fullUrl": "http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-Patient-randomised", + "resource": { + "resourceType": "ActivityDefinition", + "id": "H2Q-MC-LZZT-Activity-Patient-randomised", + "meta": { + "profile": [ + "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/StudyActivitySoa" + ] + }, + "url": "http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-Patient-randomised", + "identifier": [ + { + "use": "usual", + "value": "Patient randomised" + } + ], + "name": "Patient_randomised", + "title": "Patient randomized", + "status": "active", + "description": "Patient randomized activity", + "code": { + "coding": [ + { + "system": "https://ncithesaurus.nci.nih.gov", + "code": "C114209", + "display": "Subject is Randomized" + } + ], + "text": "Subject is Randomized" + } + } + }, + { + "fullUrl": "http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-Plasma-Specimen-Xanomeline", + "resource": { + "resourceType": "ActivityDefinition", + "id": "H2Q-MC-LZZT-Activity-Plasma-Specimen-Xanomeline", + "meta": { + "profile": [ + "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/StudyActivitySoa" + ] + }, + "url": "http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-Plasma-Specimen-Xanomeline", + "identifier": [ + { + "use": "usual", + "value": "Plasma Specimen (Xanomeline)" + } + ], + "name": "Plasma_Specimen_Xanomeline", + "title": "Plasma Specimen (Xanomeline)", + "status": "active", + "description": "Plasma Specimen (Xanomeline) results" + } + }, + { + "fullUrl": "http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-Inclusion-Exclusion-Criteria", + "resource": { + "resourceType": "ActivityDefinition", + "id": "H2Q-MC-LZZT-Activity-Inclusion-Exclusion-Criteria", + "meta": { + "profile": [ + "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/StudyActivitySoa" + ] + }, + "url": "http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-Inclusion-Exclusion-Criteria", + "identifier": [ + { + "use": "usual", + "value": "Inclusion/Exclusion Criteria" + } + ], + "name": "Inclusion_Exclusion_Criteria", + "title": "Inclusion/Exclusion Criteria", + "status": "active", + "description": "Inclusion/Exclusion Criteria activity", + "code": { + "coding": [ + { + "system": "https://ncithesaurus.nci.nih.gov", + "code": "C25532", + "display": "Inclusion Criteria" + } + ], + "text": "Inclusion Criteria" + } + } + }, + { + "fullUrl": "http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-Chemistry", + "resource": { + "resourceType": "ActivityDefinition", + "id": "H2Q-MC-LZZT-Activity-Chemistry", + "meta": { + "profile": [ + "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/StudyActivitySoa" + ] + }, + "url": "http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-Chemistry", + "identifier": [ + { + "use": "usual", + "value": "Chemistry" + } + ], + "name": "Chemistry", + "title": "Chemistry", + "status": "active", + "description": "Chemistry test results", + "code": { + "coding": [ + { + "system": "https://ncithesaurus.nci.nih.gov", + "code": "C64433", + "display": "Alanine Aminotransferase Measurement" + } + ], + "text": "Alanine Aminotransferase Measurement" + } + } + }, + { + "fullUrl": "http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-MRI-CT-Scan", + "resource": { + "resourceType": "ActivityDefinition", + "id": "H2Q-MC-LZZT-Activity-MRI-CT-Scan", + "meta": { + "profile": [ + "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/StudyActivitySoa" + ] + }, + "url": "http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-MRI-CT-Scan", + "identifier": [ + { + "use": "usual", + "value": "MRI, CT Scan" + } + ], + "name": "MRI_CT_Scan", + "title": "MRI, CT Scan", + "status": "active", + "description": "MRI, CT Scan results", + "code": { + "coding": [ + { + "system": "https://ncithesaurus.nci.nih.gov", + "code": "C16809", + "display": "Magnetic Resonance Imaging" + } + ], + "text": "Magnetic Resonance Imaging" + } + } + }, + { + "fullUrl": "http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-Hemoglobin-A1C", + "resource": { + "resourceType": "ActivityDefinition", + "id": "H2Q-MC-LZZT-Activity-Hemoglobin-A1C", + "meta": { + "profile": [ + "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/StudyActivitySoa" + ] + }, + "url": "http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-Hemoglobin-A1C", + "identifier": [ + { + "use": "usual", + "value": "Hemoglobin A1C" + } + ], + "name": "Hemoglobin_A1C", + "title": "Hemoglobin A1C", + "status": "active", + "description": "Hemoglobin A1C results", + "code": { + "coding": [ + { + "system": "https://ncithesaurus.nci.nih.gov", + "code": "C64849", + "display": "Hemoglobin A1C Measurement" + } + ], + "text": "Hemoglobin A1C Measurement" + } + } + }, + { + "fullUrl": "http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-Patient-number-assigned", + "resource": { + "resourceType": "ActivityDefinition", + "id": "H2Q-MC-LZZT-Activity-Patient-number-assigned", + "meta": { + "profile": [ + "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/StudyActivitySoa" + ] + }, + "url": "http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-Patient-number-assigned", + "identifier": [ + { + "use": "usual", + "value": "Patient number assigned" + } + ], + "name": "Patient_number_assigned", + "title": "Patient Number assigned", + "status": "active", + "description": "Patient Number assigned activity", + "code": { + "coding": [ + { + "system": "https://ncithesaurus.nci.nih.gov", + "code": "C114209", + "display": "Subject is Randomized" + } + ], + "text": "Subject is Randomized" + } + } + }, + { + "fullUrl": "http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-Chest-X-ray", + "resource": { + "resourceType": "ActivityDefinition", + "id": "H2Q-MC-LZZT-Activity-Chest-X-ray", + "meta": { + "profile": [ + "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/StudyActivitySoa" + ] + }, + "url": "http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-Chest-X-ray", + "identifier": [ + { + "use": "usual", + "value": "Chest X-ray" + } + ], + "name": "Chest_X_ray", + "title": "Chest X-ray", + "status": "active", + "description": "Chest X-ray result", + "code": { + "coding": [ + { + "system": "https://ncithesaurus.nci.nih.gov", + "code": "C38101", + "display": "X-Ray Imaging" + } + ], + "text": "X-Ray Imaging" + } + } + }, + { + "fullUrl": "http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-Informed-Consent", + "resource": { + "resourceType": "ActivityDefinition", + "id": "H2Q-MC-LZZT-Activity-Informed-Consent", + "meta": { + "profile": [ + "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/StudyActivitySoa" + ] + }, + "url": "http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-Informed-Consent", + "identifier": [ + { + "use": "usual", + "value": "Informed Consent" + } + ], + "name": "Informed_Consent", + "title": "Informed Consent", + "status": "active", + "description": "Informed consent activity", + "code": { + "coding": [ + { + "system": "https://ncithesaurus.nci.nih.gov", + "code": "C16735", + "display": "Informed Consent" + } + ], + "text": "Informed Consent" + } + } + }, + { + "fullUrl": "http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-ADAS-Cog", + "resource": { + "resourceType": "ActivityDefinition", + "id": "H2Q-MC-LZZT-Activity-ADAS-Cog", + "meta": { + "profile": [ + "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/StudyActivitySoa" + ] + }, + "url": "http://hl7.org/fhir/uv/vulcan-schedule/ActivityDefinition/H2Q-MC-LZZT-Activity-ADAS-Cog", + "identifier": [ + { + "use": "usual", + "value": "ADAS-Cog" + } + ], + "name": "ADAS_Cog", + "title": "ADAS-Cog", + "status": "active", + "description": "ADAS-Cog results", + "code": { + "coding": [ + { + "system": "https://ncithesaurus.nci.nih.gov", + "code": "C100177", + "display": "CDISC ADAS-Cog - Word Recall Average Score" + } + ], + "text": "CDISC ADAS-Cog - Word Recall Average Score" + } + } + } + ] +} \ No newline at end of file diff --git a/output/fhir/usdm_to_vulcan_fhir.py b/output/fhir/usdm_to_vulcan_fhir.py new file mode 100644 index 0000000..e189ef6 --- /dev/null +++ b/output/fhir/usdm_to_vulcan_fhir.py @@ -0,0 +1,396 @@ +"""One-off USDM -> FHIR mapper following the HL7 Vulcan Schedule of +Activities Implementation Guide (StudyProtocolSoa / StudyVisitSoa / +StudyActivitySoa profiles), grounded against the IG's own published +H2Q-MC-LZZT example resources at +http://hl7.org/fhir/uv/vulcan-schedule/. + +Reads a USDM v4 JSON export from soa-workbench and emits a FHIR Bundle +containing: + - one top-level PlanDefinition (StudyProtocolSoa) with one action per + planned visit, carrying day offsets (action.relatedAction.offsetDuration) + and acceptable visit windows (AcceptableOffsetRangeSoa extension) + - one per-visit PlanDefinition (StudyVisitSoa) with one action per + activity performed at that visit + - one ActivityDefinition (StudyActivitySoa) per unique activity + referenced by the main schedule timeline + +Scope: main schedule timeline only. Branch timelines (adverse event, +early termination, vital-sign sub-profiles) are not represented -- see +the summary printed at the end of the run. +""" + +import json +import re +import sys +from pathlib import Path + +IG_BASE = "http://hl7.org/fhir/uv/vulcan-schedule" +OFFSET_RANGE_EXT_URL = f"{IG_BASE}/StructureDefinition/AcceptableOffsetRangeSoa" + +ISO_DURATION_RE = re.compile( + r"^(?P-)?P" + r"(?:(?P\d+(?:\.\d+)?)W)?" + r"(?:(?P\d+(?:\.\d+)?)D)?" + r"(?:T" + r"(?:(?P\d+(?:\.\d+)?)H)?" + r"(?:(?P\d+(?:\.\d+)?)M)?" + r")?$" +) + + +def parse_iso_duration_to_days(value): + """Parse an ISO 8601 duration (e.g. '-P2W', 'P2D', 'PT4H') into a + single signed value in days. The Vulcan IG's own example + (AcceptableOffsetRangeSoa, action.relatedAction.offsetDuration) + always expresses offsets/windows in UCUM 'd', so we normalize to + days here rather than carrying mixed units through the mapping. + """ + if not value: + return 0.0 + m = ISO_DURATION_RE.match(value) + if not m: + raise ValueError(f"Unrecognized ISO 8601 duration: {value!r}") + sign = -1 if m.group("sign") else 1 + weeks = float(m.group("weeks") or 0) + days = float(m.group("days") or 0) + hours = float(m.group("hours") or 0) + minutes = float(m.group("minutes") or 0) + total_days = weeks * 7 + days + hours / 24.0 + minutes / 1440.0 + return sign * total_days + + +def quantity(value, unit): + return {"value": value, "system": "http://unitsofmeasure.org", "code": unit} + + +def slugify(text): + text = re.sub(r"[^A-Za-z0-9]+", "-", text.strip()) + return re.sub(r"-+", "-", text).strip("-") + + +def load_usdm(path): + with open(path) as f: + return json.load(f) + + +def get_study_design(usdm): + version = usdm["study"]["versions"][0] + return version, version["studyDesigns"][0] + + +def index_by_id(items): + return {item["id"]: item for item in items} + + +def find_main_timeline(study_design): + for tl in study_design["scheduleTimelines"]: + if tl.get("mainTimeline"): + return tl + raise ValueError("No main schedule timeline found") + + +def walk_instance_order(timeline, instances_by_id): + """Follow entryId -> defaultConditionId to get true visit order, + skipping ScheduledDecisionInstance nodes (no encounterId).""" + order = [] + seen = set() + current_id = timeline["entryId"] + while current_id and current_id not in seen: + seen.add(current_id) + inst = instances_by_id.get(current_id) + if inst is None: + break + if inst.get("instanceType") == "ScheduledActivityInstance" and inst.get( + "encounterId" + ): + order.append(inst) + current_id = inst.get("defaultConditionId") + return order + + +def build_offset_range_extension(offset_days, window_lower, window_upper): + if window_lower is None and window_upper is None: + return None + lower_days = abs(parse_iso_duration_to_days(window_lower)) if window_lower else 0.0 + upper_days = abs(parse_iso_duration_to_days(window_upper)) if window_upper else 0.0 + low = offset_days - lower_days + high = offset_days + upper_days + return { + "url": OFFSET_RANGE_EXT_URL, + "valueRange": { + "low": quantity(round(low, 3), "d"), + "high": quantity(round(high, 3), "d"), + }, + } + + +def build_related_action(anchor_action_id, timing): + """Build PlanDefinition.action.relatedAction for a visit relative + to its anchor, or return None if this visit IS the anchor + (Timing.type == 'Fixed Reference', matching the IG's + Index-Activity-Event pattern where the anchor visit has no + relatedAction at all).""" + type_decode = timing["type"]["decode"] + if type_decode == "Fixed Reference": + return None + + relationship = {"Before": "before", "After": "after"}.get(type_decode) + if relationship is None: + raise ValueError(f"Unrecognized timing type: {type_decode!r}") + + offset_days = abs(parse_iso_duration_to_days(timing["value"])) + + related_action = { + "actionId": anchor_action_id, + "relationship": relationship, + "offsetDuration": quantity(round(offset_days, 3), "d"), + } + ext = build_offset_range_extension( + offset_days, timing.get("windowLower"), timing.get("windowUpper") + ) + if ext: + related_action["extension"] = [ext] + return related_action + + +def build_activity_definition(protocol_slug, activity, bc_by_id): + slug = f"{protocol_slug}-Activity-{slugify(activity['name'])}" + resource = { + "resourceType": "ActivityDefinition", + "id": slug, + "meta": {"profile": [f"{IG_BASE}/StructureDefinition/StudyActivitySoa"]}, + "url": f"{IG_BASE}/ActivityDefinition/{slug}", + "identifier": [{"use": "usual", "value": activity["name"]}], + "name": slugify(activity["name"]).replace("-", "_"), + "title": activity.get("label") or activity["name"], + "status": "active", + "description": activity.get("description") + or activity.get("label") + or activity["name"], + } + + bc_ids = activity.get("biomedicalConceptIds") or [] + if bc_ids: + bc = bc_by_id.get(bc_ids[0]) + if bc and bc.get("reference"): + code_value = bc["reference"].rsplit("/", 1)[-1] + resource["code"] = { + "coding": [ + { + "system": "https://ncithesaurus.nci.nih.gov", + "code": code_value, + "display": bc.get("name") or activity["name"], + } + ], + "text": bc.get("name") or activity["name"], + } + return resource + + +def build_visit_plan_definition( + protocol_slug, instance, encounter, activities_by_id, activity_def_ids +): + action_slug = f"{protocol_slug}-Study-Visit-{slugify(instance['name'])}" + display_label = instance.get("label") or encounter.get("label") or instance["name"] + display_description = ( + instance.get("description") or encounter.get("description") or display_label + ) + + actions = [] + seen_activity_ids = set() + duplicate_count = 0 + for activity_id in instance.get("activityIds", []): + if activity_id in seen_activity_ids: + duplicate_count += 1 + continue + seen_activity_ids.add(activity_id) + activity = activities_by_id.get(activity_id) + if activity is None: + continue + activity_def_id = activity_def_ids[activity_id] + actions.append( + { + "title": activity.get("label") or activity["name"], + "definitionUri": f"ActivityDefinition/{activity_def_id}", + } + ) + + return ( + { + "resourceType": "PlanDefinition", + "id": action_slug, + "meta": {"profile": [f"{IG_BASE}/StructureDefinition/StudyVisitSoa"]}, + "url": f"{IG_BASE}/PlanDefinition/{action_slug}", + "identifier": [{"use": "usual", "value": action_slug}], + "version": "1.0.0", + "title": f"{protocol_slug} {display_label}", + "type": { + "coding": [ + { + "system": "http://terminology.hl7.org/CodeSystem/plan-definition-type", + "code": "clinical-protocol", + } + ] + }, + "status": "active", + "description": display_description, + "action": actions, + }, + action_slug, + duplicate_count, + ) + + +def main(usdm_path, output_path): + usdm = load_usdm(usdm_path) + version, study_design = get_study_design(usdm) + protocol_slug = study_design["name"] + study_name = f"{protocol_slug} {usdm['study'].get('label') or ''}".strip() + + encounters_by_id = index_by_id(study_design["encounters"]) + activities_by_id = index_by_id(study_design["activities"]) + bc_by_id = index_by_id(version.get("biomedicalConcepts", [])) + + main_timeline = find_main_timeline(study_design) + instances_by_id = index_by_id(main_timeline["instances"]) + timings_by_from_id = { + t["relativeFromScheduledInstanceId"]: t for t in main_timeline["timings"] + } + + ordered_visits = walk_instance_order(main_timeline, instances_by_id) + + # Pass 1: assign each visit its FHIR action id, so relatedAction + # references (which point at another visit's action id) resolve + # regardless of iteration order. + visit_action_ids = {} + for inst in ordered_visits: + visit_action_ids[inst["id"]] = f"Study-Visit-{slugify(inst['name'])}" + + # Pass 2: build the top-level protocol actions with relatedAction + # offsets/windows, and the per-visit PlanDefinitions. + protocol_actions = [] + visit_plan_definitions = [] + activity_def_ids = { + activity_id: f"{protocol_slug}-Activity-{slugify(activities_by_id[activity_id]['name'])}" + for activity_id in { + aid for inst in ordered_visits for aid in inst.get("activityIds", []) + } + } + + total_duplicate_activities = 0 + for inst in ordered_visits: + encounter = encounters_by_id[inst["encounterId"]] + action_id = visit_action_ids[inst["id"]] + visit_pd, visit_pd_id, dup_count = build_visit_plan_definition( + protocol_slug, inst, encounter, activities_by_id, activity_def_ids + ) + visit_plan_definitions.append(visit_pd) + total_duplicate_activities += dup_count + + display_label = inst.get("label") or encounter.get("label") or inst["name"] + protocol_action = { + "id": action_id, + "title": display_label, + "description": f"Planned Visit [{display_label}]", + "definitionUri": f"PlanDefinition/{visit_pd_id}", + } + + timing = timings_by_from_id.get(inst["id"]) + if timing is not None: + anchor_inst_id = timing["relativeToScheduledInstanceId"] + anchor_action_id = visit_action_ids.get(anchor_inst_id) + if anchor_action_id and anchor_action_id != action_id: + related_action = build_related_action(anchor_action_id, timing) + if related_action is not None: + protocol_action["relatedAction"] = [related_action] + protocol_actions.append(protocol_action) + + protocol_plan_definition = { + "resourceType": "PlanDefinition", + "id": f"{protocol_slug}-ProtocolDesign", + "meta": {"profile": [f"{IG_BASE}/StructureDefinition/StudyProtocolSoa"]}, + "url": f"{IG_BASE}/PlanDefinition/{protocol_slug}-ProtocolDesign", + "identifier": [{"use": "usual", "value": f"{protocol_slug}-ProtocolDesign-1"}], + "version": "1.0.0", + "title": f"{study_name} Protocol Schedule of Activities", + "type": { + "coding": [ + { + "system": "http://terminology.hl7.org/CodeSystem/plan-definition-type", + "code": "clinical-protocol", + } + ] + }, + "status": "active", + "purpose": "The purpose of this PlanDefinition is to illustrate the planned study encounters.", + "action": protocol_actions, + } + + activity_definitions = [ + build_activity_definition(protocol_slug, activities_by_id[aid], bc_by_id) + for aid in activity_def_ids + ] + + all_resources = ( + [protocol_plan_definition] + visit_plan_definitions + activity_definitions + ) + bundle = { + "resourceType": "Bundle", + "type": "collection", + "entry": [{"fullUrl": r["url"], "resource": r} for r in all_resources], + } + + Path(output_path).parent.mkdir(parents=True, exist_ok=True) + with open(output_path, "w") as f: + json.dump(bundle, f, indent=2) + + print(f"Study: {study_name}") + print(f"Protocol slug: {protocol_slug}") + print( + f"Main timeline: {main_timeline['name']} ({len(ordered_visits)} visits walked)" + ) + print(f"Generated {len(all_resources)} resources:") + print( + f" - 1 top-level PlanDefinition (StudyProtocolSoa): {protocol_plan_definition['id']}" + ) + print( + f" - {len(visit_plan_definitions)} per-visit PlanDefinitions (StudyVisitSoa)" + ) + print(f" - {len(activity_definitions)} ActivityDefinitions (StudyActivitySoa)") + coded = sum(1 for a in activity_definitions if "code" in a) + print( + f" ({coded}/{len(activity_definitions)} carry a code, from linked BiomedicalConcepts)" + ) + if total_duplicate_activities: + print( + f"NOTE: skipped {total_duplicate_activities} duplicate activity " + f"references found in the source USDM data (several instances " + f"list every activityId twice) -- deduplicated per visit so " + f"each activity appears once in its PlanDefinition" + ) + other_timelines = [ + tl["name"] + for tl in study_design["scheduleTimelines"] + if not tl.get("mainTimeline") + ] + if other_timelines: + print(f"NOT mapped (out of scope): {', '.join(other_timelines)}") + print(f"\nWrote: {output_path}") + + +if __name__ == "__main__": + usdm_path = ( + sys.argv[1] + if len(sys.argv) > 1 + else ( + "/Users/dmoreland/projects/soa-workbench/output/json/NCT12345678-latest.json" + ) + ) + output_path = ( + sys.argv[2] + if len(sys.argv) > 2 + else ( + "/Users/dmoreland/projects/soa-workbench/output/fhir/NCT12345678-vulcan-soa-latest.json" + ) + ) + main(usdm_path, output_path) diff --git a/output/json/NCT01797120-dds-latest.json b/output/json/NCT01797120-dds-latest.json new file mode 100644 index 0000000..4ae61aa --- /dev/null +++ b/output/json/NCT01797120-dds-latest.json @@ -0,0 +1,18466 @@ +{ + "OID": "MDV.None.Version1.Design1", + "name": "MDV None", + "description": "Data Definitions for None", + "fileOID": "ODM.DEFINE-JSON.None.Version1.Design1", + "creationDateTime": "2026-08-06T13:27:49.607773+00:00", + "odmVersion": "1.3.2", + "fileType": "Snapshot", + "originator": "Define-JSON Processor", + "context": "Other", + "defineVersion": "2.1.0", + "studyOID": "ODM.None.Version1.Design1", + "studyName": null, + "studyDescription": "Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus Everolimus in Post-Menopausal Patients with Hormone-Receptor Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy", + "protocolName": null, + "itemGroups": [ + { + "OID": "IG.DS", + "name": "DS", + "description": "Disposition", + "domain": "DS", + "purpose": "Tabulation", + "structure": "One record per disposition status or protocol milestone per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "DSSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "EVENTS" + }, + "items": [ + { + "OID": "IT.DS.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.DS.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.DS.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.DS.DSSEQ", + "mandatory": true, + "name": "DSSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.DS.DSTERM", + "mandatory": true, + "name": "DSTERM", + "description": "Reported Term for the Disposition Event", + "role": "Topic", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_228", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.DS.DSDECOD", + "mandatory": true, + "name": "DSDECOD", + "description": "Standardized Disposition Term", + "role": "Synonym Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_227", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.NCOMPLT" + }, + { + "OID": "IT.DS.DSCAT", + "mandatory": false, + "name": "DSCAT", + "description": "Category for Disposition Event", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.DSCAT" + }, + { + "OID": "IT.DS.DSSTDTC", + "mandatory": false, + "name": "DSSTDTC", + "description": "Start Date/Time of Disposition Event", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_229", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.DS.DSSTDY", + "mandatory": false, + "name": "DSSTDY", + "description": "Study Day of Start of Disposition Event", + "role": "Timing", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_1" + }, + { + "OID": "IG.RS", + "name": "RS", + "description": "Disease Response and Clin Classification", + "domain": "RS", + "purpose": "Tabulation", + "structure": "One record per response assessment or clinical classification assessment per time point per visit per subject per assessor per medical evaluator", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "RSSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "FINDINGS" + }, + "items": [ + { + "OID": "IT.RS.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.RS.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.RS.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.RS.RSSEQ", + "mandatory": true, + "name": "RSSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.RS.RSLNKGRP", + "mandatory": false, + "name": "RSLNKGRP", + "description": "Link Group ID", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.RS.RSTESTCD", + "mandatory": true, + "name": "RSTESTCD", + "description": "Assessment Short Name", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ONCRTSCD" + }, + { + "OID": "IT.RS.RSTEST", + "mandatory": true, + "name": "RSTEST", + "description": "Assessment Name", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ONCRTS" + }, + { + "OID": "IT.RS.RSCAT", + "mandatory": false, + "name": "RSCAT", + "description": "Category for Assessment", + "role": "Grouping Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ONCRSCAT" + }, + { + "OID": "IT.RS.RSORRES", + "mandatory": false, + "name": "RSORRES", + "description": "Result or Finding in Original Units", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_250", + "dataType": "text", + "length": 20, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.RS.RSSTRESC", + "mandatory": false, + "name": "RSSTRESC", + "description": "Character Result/Finding in Std Format", + "role": "Result Qualifier", + "dataType": "integer", + "length": 1, + "origin": { + "type": "Derived", + "source": "Sponsor" + }, + "codeList": "CL.ONCRSR" + }, + { + "OID": "IT.RS.RSSTRESN", + "mandatory": false, + "name": "RSSTRESN", + "description": "Numeric Result/Finding in Standard Units", + "role": "Result Qualifier", + "dataType": "integer", + "length": 1, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.RS.RSEVAL", + "mandatory": false, + "name": "RSEVAL", + "description": "Evaluator", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.EVAL" + }, + { + "OID": "IT.RS.RSEVALID", + "mandatory": false, + "name": "RSEVALID", + "description": "Evaluator Identifier", + "role": "Variable Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Vendor" + }, + "codeList": "CL.MEDEVAL" + }, + { + "OID": "IT.RS.VISITNUM", + "mandatory": false, + "name": "VISITNUM", + "description": "Visit Number", + "role": "Timing", + "dataType": "integer", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.RS.RSDTC", + "mandatory": false, + "name": "RSDTC", + "description": "Date/Time of Assessment", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_251", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_5" + }, + { + "OID": "IG.VS", + "name": "VS", + "description": "Vital Signs", + "domain": "VS", + "purpose": "Tabulation", + "structure": "One record per vital sign measurement per time point per visit per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "VSSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "FINDINGS" + }, + "items": [ + { + "OID": "IT.VS.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.VS.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.VS.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.VS.VSSEQ", + "mandatory": true, + "name": "VSSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.VS.VSTESTCD", + "mandatory": true, + "name": "VSTESTCD", + "description": "Vital Signs Test Short Name", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.VSTESTCD" + }, + { + "OID": "IT.VS.VSTEST", + "mandatory": true, + "name": "VSTEST", + "description": "Vital Signs Test Name", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.VSTEST" + }, + { + "OID": "IT.VS.VSPOS", + "mandatory": false, + "name": "VSPOS", + "description": "Vital Signs Position of Subject", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_254", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.POSITION" + }, + { + "OID": "IT.VS.VSORRES", + "mandatory": false, + "name": "VSORRES", + "description": "Result or Finding in Original Units", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_252", + "dataType": "integer", + "length": 3, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.VS.VSORRESU", + "mandatory": false, + "name": "VSORRESU", + "description": "Original Units", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_253", + "dataType": "text", + "length": 20, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.VSRESU" + }, + { + "OID": "IT.VS.VSSTRESC", + "mandatory": false, + "name": "VSSTRESC", + "description": "Character Result/Finding in Std Format", + "role": "Result Qualifier", + "dataType": "integer", + "length": 3, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.VS.VSSTRESN", + "mandatory": false, + "name": "VSSTRESN", + "description": "Numeric Result/Finding in Standard Units", + "role": "Result Qualifier", + "dataType": "integer", + "length": 3, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.VS.VSSTRESU", + "mandatory": false, + "name": "VSSTRESU", + "description": "Standard Units", + "role": "Variable Qualifier", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.VSRESU" + }, + { + "OID": "IT.VS.VSLOC", + "mandatory": false, + "name": "VSLOC", + "description": "Location of Vital Signs Measurement", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_255", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.LOC" + }, + { + "OID": "IT.VS.VSLAT", + "mandatory": false, + "name": "VSLAT", + "description": "Laterality", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_256", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.LAT" + }, + { + "OID": "IT.VS.VSLOBXFL", + "mandatory": false, + "name": "VSLOBXFL", + "description": "Last Observation Before Exposure Flag", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.VS.VISITNUM", + "mandatory": false, + "name": "VISITNUM", + "description": "Visit Number", + "role": "Timing", + "dataType": "integer", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.VS.VSDTC", + "mandatory": false, + "name": "VSDTC", + "description": "Date/Time of Measurements", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_257", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_7" + }, + { + "OID": "IG.CM", + "name": "CM", + "description": "Concomitant/Prior Medications", + "domain": "CM", + "purpose": "Tabulation", + "structure": "One record per recorded intervention occurrence or constant-dosing interval per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "CMSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "INTERVENTIONS" + }, + "items": [ + { + "OID": "IT.CM.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMSEQ", + "mandatory": true, + "name": "CMSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMTRT", + "mandatory": true, + "name": "CMTRT", + "description": "Reported Name of Drug, Med, or Therapy", + "role": "Topic", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_317", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.CM.CMDECOD", + "mandatory": false, + "name": "CMDECOD", + "description": "Standardized Medication Name", + "role": "Synonym Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_318", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMCAT", + "mandatory": false, + "name": "CMCAT", + "description": "Category for Medication", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMSCAT", + "mandatory": false, + "name": "CMSCAT", + "description": "Subcategory for Medication", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMPRESP", + "mandatory": false, + "name": "CMPRESP", + "description": "CM Pre-specified", + "role": "Variable Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.CM.CMOCCUR", + "mandatory": false, + "name": "CMOCCUR", + "description": "CM Occurrence", + "role": "Record Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.CM.CMINDC", + "mandatory": false, + "name": "CMINDC", + "description": "Indication", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_320", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.CM.CMCLAS", + "mandatory": false, + "name": "CMCLAS", + "description": "Medication Class", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_319", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMCLASCD", + "mandatory": false, + "name": "CMCLASCD", + "description": "Medication Class Code", + "role": "Variable Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMDOSE", + "mandatory": false, + "name": "CMDOSE", + "description": "Dose per Administration", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_321", + "dataType": "float", + "length": 8, + "displayFormat": "8.3", + "significantDigits": 3, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.CM.CMDOSTXT", + "mandatory": false, + "name": "CMDOSTXT", + "description": "Dose Description", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_322", + "dataType": "text", + "length": 40, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.CM.CMDOSU", + "mandatory": false, + "name": "CMDOSU", + "description": "Dose Units", + "role": "Variable Qualifier", + 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}, + { + "OID": "CONCPROP.BiomedicalConceptProperty_434", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64432", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Alkaline Phosphatase Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_72", + "name": "Urate Measurement", + "label": "Urate Measurement", + "aliases": [ + "Urate", + "Uric Acid" + ], + "href": "/mdr/bc/biomedicalconcepts/C64814", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_435", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": 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"code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64814", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Urate Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_78", + "name": "Solicited Medical History", + "label": "Solicited Medical History", + "aliases": [ + "Medical History", + "Medical History Collection" + ], + "href": "/mdr/bc/biomedicalconcepts/C200145", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_552", + "name": "MHTERM", + "label": "MHTERM", + "mandatory": true, + "coding": [ + { + "code": "C83118", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Reported Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_553", + "name": "MHDECOD", + "label": "MHDECOD", + "mandatory": false, + "coding": [ + { + "code": "C83346", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Dictionary Derived Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_554", + "name": "MHSTDTC", + "label": "MHSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83338", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Event Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_555", + "name": "MHENDTC", + "label": "MHENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Event End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_556", + "name": "MHENRF", + "label": "MHENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_557", + "name": "MHENRTPT", + "label": "MHENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_558", + "name": "MHENTPT", + "label": "MHENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Reference End Time Point End" + } + ] + } + ], + "coding": [ + { + "code": "C200145", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Solicited Medical History" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_79", + "name": "Unsolicited Adverse Event", + "label": "Unsolicited Adverse Event", + "aliases": [ + "Adverse Event" + ], + "href": 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"codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_562", + "name": "Adverse Event Subcategory", + "label": "Adverse Event Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C83212", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_563", + "name": "Adverse Event Location", + "label": "Adverse Event Location", + "mandatory": true, + "coding": [ + { + "code": "C83205", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Location" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_564", + "name": "Severity of Adverse Event", + "label": "Severity of Adverse Event", + "mandatory": true, + "coding": [ + { + "code": "C53253", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Severity of Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_565", + "name": "Seriousness of Adverse Event", + "label": "Seriousness of Adverse Event", + "mandatory": true, + "coding": [ + { + "code": "C53252", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Seriousness of Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_566", + "name": "Adverse Event Toxicity Grade", + "label": "Adverse Event Toxicity Grade", + "mandatory": true, + "coding": [ + { + "code": "C78605", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Toxicity Grade" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_567", + "name": "Adverse Event Action Taken with Study Treatment", + "label": "Adverse Event Action Taken with Study Treatment", + "mandatory": true, + "coding": [ + { + "code": "C83013", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Action Taken with Study Treatment" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_568", + "name": "Other Actions taken in Response to Adverse Event", + "label": "Other Actions taken in Response to Adverse Event", + "mandatory": true, + "coding": [ + { + "code": "C83109", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Other Actions taken in Response to Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_569", + "name": "Adverse Event Attribution to Product or Procedure", + "label": "Adverse Event Attribution to Product or Procedure", + "mandatory": true, + "coding": [ + { + "code": "C41358", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Attribution to Product or Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_570", + "name": "Adverse Event Relationship to Non 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"code": "C83199", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Concomitant Treatment" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_582", + "name": "Adverse Event Start Date Time", + "label": "Adverse Event Start Date Time", + "mandatory": true, + "coding": [ + { + "code": "C83215", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_583", + "name": "Adverse Event End Date Time", + "label": "Adverse Event End Date Time", + "mandatory": true, + "coding": [ + { + "code": "C83201", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event End Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C179176", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Unsolicited Adverse Event" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_80", + "name": "Physical Examination Finding", + "label": "Physical Examination Finding", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C83119", + "properties": [], + "coding": [ + { + "code": "C83119", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-04-02", + "decode": "Physical Examination Finding" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_81", + "name": "Physical Examination Finding", + "label": "Physical Examination Finding", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C83119", + "properties": [], + "coding": [ + { + "code": "C83119", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-04-02", + "decode": "Physical Examination Finding" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_82", + "name": "New Lesion Progression", + "label": "New Lesion Progression", + "aliases": [ + "NEWLPROG" + ], + "href": "/mdr/bc/biomedicalconcepts/C103420", + "properties": [ + { + "OID": 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"decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_263", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_264", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_265", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute" + } + ], + "codeList": "CL.20024ecd" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_266", + "name": "VSPOS", + "label": "VSPOS", 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"codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_330", + "name": "CMSTRTPT", + "label": "CMSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_331", + "name": "CMSTTPT", + "label": "CMSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_332", + "name": "CMENRF", + "label": "CMENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference 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"codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_405", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_406", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_407", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.af8f8a19" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_408", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_409", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_410", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_411", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_412", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.af8f8a19" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_413", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_414", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_415", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_416", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_417", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.af8f8a19" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_418", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_419", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_420", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_421", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_422", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.9e69169e" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_423", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_424", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_425", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_426", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_427", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.9e69169e" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_428", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_429", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_430", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_431", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_432", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.9e69169e" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_433", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_434", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_435", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_436", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_437", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.9e69169e" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_438", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_439", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_552", + "name": "MHTERM", + "label": "MHTERM", + "mandatory": true, + "coding": [ + { + "code": "C83118", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Reported Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_553", + "name": "MHDECOD", + "label": "MHDECOD", + "mandatory": false, + "coding": [ + { + "code": "C83346", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Dictionary Derived Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_554", + "name": "MHSTDTC", + "label": "MHSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83338", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Event Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_555", + "name": "MHENDTC", + "label": "MHENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Event End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_556", + "name": "MHENRF", + "label": "MHENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_557", + "name": "MHENRTPT", + "label": "MHENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_558", + "name": "MHENTPT", + "label": "MHENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Reference End Time Point End" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_559", + "name": "Adverse Event Verbatim Description", + "label": "Adverse Event Verbatim Description", + "mandatory": true, + "coding": [ + { + "code": "C78541", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Verbatim Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_560", + "name": "Adverse Event Dictionary Derived Term", + "label": "Adverse Event Dictionary Derived Term", + "mandatory": true, + "coding": [ + { + "code": "C83344", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Dictionary Derived Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_561", + "name": "Adverse Event Category", + "label": "Adverse Event Category", + "mandatory": true, + "coding": [ + { + "code": "C83198", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_562", + "name": "Adverse Event Subcategory", + "label": "Adverse Event Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C83212", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_563", + "name": "Adverse Event Location", + "label": "Adverse Event Location", + "mandatory": true, + "coding": [ + { + "code": "C83205", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Location" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_564", + "name": "Severity of Adverse Event", + "label": "Severity of Adverse Event", + "mandatory": true, + "coding": [ + { + "code": "C53253", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Severity of Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_565", + "name": "Seriousness of Adverse Event", + "label": "Seriousness of Adverse Event", + "mandatory": true, + "coding": [ + { + "code": "C53252", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Seriousness of Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_566", + "name": "Adverse Event Toxicity Grade", + "label": "Adverse Event Toxicity Grade", + "mandatory": true, + "coding": [ + { + "code": "C78605", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Toxicity Grade" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_567", + "name": "Adverse Event Action Taken with Study Treatment", + "label": "Adverse Event Action Taken with Study Treatment", + "mandatory": true, + "coding": [ + { + "code": "C83013", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Action Taken with Study Treatment" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_568", + "name": "Other Actions taken in Response to Adverse Event", + "label": "Other Actions taken in Response to Adverse Event", + "mandatory": true, + "coding": [ + { + "code": "C83109", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Other Actions taken in Response to Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_569", + "name": "Adverse Event Attribution to Product or Procedure", + "label": "Adverse Event Attribution to Product or Procedure", + "mandatory": true, + "coding": [ + { + "code": "C41358", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Attribution to Product or Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_570", + "name": "Adverse Event Relationship to Non Study Treatment", + "label": "Adverse Event Relationship to Non Study Treatment", + "mandatory": true, + "coding": [ + { + "code": "C83210", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Relationship to Non Study Treatment" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_571", + "name": "Adverse Event Pattern", + "label": "Adverse Event Pattern", + "mandatory": true, + "coding": [ + { + "code": "C83208", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Pattern" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_572", + "name": "Adverse Event Outcome", + "label": "Adverse Event Outcome", + "mandatory": true, + "coding": [ + { + "code": "C49489", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Outcome" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_573", + "name": "Adverse Event Involves Cancer", + "label": "Adverse Event Involves Cancer", + "mandatory": true, + "coding": [ + { + "code": "C83211", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Involves Cancer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_574", + "name": "Adverse Event Seriousness Due to Congenital Anomaly", + "label": "Adverse Event Seriousness Due to Congenital Anomaly", + "mandatory": true, + "coding": [ + { + "code": "C83117", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Seriousness Due to Congenital Anomaly" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_575", + "name": "Disabling Adverse Event", + "label": "Disabling Adverse Event", + "mandatory": true, + "coding": [ + { + "code": "C113380", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Disabling Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_576", + "name": "Death Related to Adverse Event", + "label": "Death Related to Adverse Event", + "mandatory": true, + "coding": [ + { + "code": "C48275", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Death Related to Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_577", + "name": "Adverse Event associated with Hospitalization", + "label": "Adverse Event associated with Hospitalization", + "mandatory": true, + "coding": [ + { + "code": "C83052", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event associated with Hospitalization" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_578", + "name": "Life Threatening Adverse Event", + "label": "Life Threatening Adverse Event", + "mandatory": true, + "coding": [ + { + "code": "C84266", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Life Threatening Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_579", + "name": "Adverse Event Occurred with Overdose", + "label": "Adverse Event Occurred with Overdose", + "mandatory": true, + "coding": [ + { + "code": "C83214", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Occurred with Overdose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_580", + "name": "Adverse Event Associated with Serious Medical Event", + "label": "Adverse Event Associated with Serious Medical Event", + "mandatory": true, + "coding": [ + { + "code": "C83053", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Associated with Serious Medical Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_581", + "name": "Adverse Event Concomitant Treatment", + "label": "Adverse Event Concomitant Treatment", + "mandatory": true, + "coding": [ + { + "code": "C83199", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Concomitant Treatment" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_582", + "name": "Adverse Event Start Date Time", + "label": "Adverse Event Start Date Time", + "mandatory": true, + "coding": [ + { + "code": "C83215", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_583", + "name": "Adverse Event End Date Time", + "label": "Adverse Event End Date Time", + "mandatory": true, + "coding": [ + { + "code": "C83201", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Adverse Event End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_440", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-06-27", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_441", + "name": "Observation Result", + "label": "Observation Result", + "mandatory": true, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-06-27", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_442", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-06-27", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_443", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", 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"codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_447", + "name": "Test Method", + "label": "Test Method", + "mandatory": true, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_448", + "name": "Observation Result", + "label": "Observation Result", + "mandatory": true, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_449", + "name": "Tumor Results Reference Identifier", + "label": "Tumor Results Reference Identifier", + "mandatory": true, + "coding": [ + { + "code": "C117419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Results Reference Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_450", + "name": "Tumor Results Group Identifier", + "label": "Tumor Results Group Identifier", + "mandatory": true, + "coding": [ + { + "code": "C117411", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Results Group Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_451", + "name": "Tumor Results Link Group", + "label": "Tumor Results Link Group", + "mandatory": true, + "coding": [ + { + "code": "C117412", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Results Link Group" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_452", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "mandatory": true, + "coding": [ + { + "code": "C117043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator 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"label": "Evaluator Identifier", + "mandatory": true, + "coding": [ + { + "code": "C117043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_457", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_458", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_459", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "mandatory": true, + "coding": [ + { + "code": "C117043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_460", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_461", + "name": "Observation Result", + "label": "Observation Result", + "mandatory": true, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_462", + "name": "Result Anatomical Location", + "label": "Result Anatomical Location", + "mandatory": true, + "coding": [ + { + "code": "C170500", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Result Anatomical Location" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_463", + "name": "Tumor Identifier Reference Identifier", + "label": "Tumor Identifier Reference Identifier", + "mandatory": true, + "coding": [ + { + "code": "C117442", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Identifier Reference Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_464", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_465", + "name": "Directionality", + "label": "Directionality", + "mandatory": true, + "coding": [ + { + "code": "C54215", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Directionality" + } 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"name": "Tumor Identifier Reference Identifier", + "label": "Tumor Identifier Reference Identifier", + "mandatory": true, + "coding": [ + { + "code": "C117442", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Identifier Reference Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_480", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_481", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "mandatory": true, + "coding": [ + { + "code": "C117043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_482", + "name": "TUORRES", + 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"codeSystemVersion": "2026-05-26", + "decode": "Directionality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_486", + "name": "TUMETHOD", + "label": "TUMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_487", + "name": "TUEVAL", + "label": "TUEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_488", + "name": "TUEVALID", + "label": "TUEVALID", + "mandatory": false, + "coding": [ + { + "code": "C117043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_489", + "name": "TUREFID", + "label": 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"codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_493", + "name": "RSEVAL", + "label": "RSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_494", + "name": "RSEVALID", + "label": "RSEVALID", + "mandatory": false, + "coding": [ + { + "code": "C117043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_495", + "name": "RSDTC", + "label": "RSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_496", + "name": "RSORRES", + "label": "RSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_497", + "name": "RSEVAL", + "label": "RSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_498", + "name": "RSEVALID", + "label": "RSEVALID", + "mandatory": false, + "coding": [ + { + "code": "C117043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_499", + "name": "RSDTC", + "label": "RSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + 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"CONCPROP.BiomedicalConceptProperty_664", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_665", + "name": "Observation Result", + "label": "Observation Result", + "mandatory": true, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_666", + "name": "Unit of Concentration", + "label": "Unit of Concentration", + "mandatory": true, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_667", + "name": "Measurement, Test or Examination Detail", + "label": "Measurement, Test or Examination Detail", + "mandatory": true, + "coding": [ + { + "code": "C117062", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Measurement, Test or Examination Detail" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_668", + "name": "Test Method", + "label": "Test Method", + "mandatory": true, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_669", + "name": "Biospecimen Type", + "label": "Biospecimen Type", + "mandatory": true, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Biospecimen Type" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_670", + "name": "MBTSTDTL", + "label": "MBTSTDTL", + "mandatory": false, + "coding": [ + { + "code": "C117062", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Measurement, Test or Examination Detail" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_671", + "name": "MBORRES", + "label": "MBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_672", + "name": "MBORRESU", + "label": "MBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_673", + "name": "MBSPEC", + "label": "MBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.9e69169e" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_674", + "name": "MBMETHOD", + "label": "MBMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_675", + "name": "MBDTC", + "label": "MBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_676", + "name": "MBTSTDTL", + "label": "MBTSTDTL", + "mandatory": false, + "coding": [ + { + "code": "C117062", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Measurement, Test or Examination Detail" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_677", + "name": "MBORRES", + "label": "MBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_678", + "name": "MBORRESU", + "label": "MBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_679", + "name": "MBSPEC", + "label": "MBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.9e69169e" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_680", + "name": "MBMETHOD", + "label": "MBMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_681", + "name": "MBDTC", + "label": "MBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_682", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_683", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C44279", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Volume" + } + ], + "codeList": "CL.a00fe0a9" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_684", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1aeb2034" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_685", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_686", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ] +} diff --git a/output/json/NCT01797120-latest.json b/output/json/NCT01797120-latest.json index ac0703c..94da8b8 100644 --- a/output/json/NCT01797120-latest.json +++ b/output/json/NCT01797120-latest.json @@ -25,13 +25,13 @@ { "id": "ExtensionAttribute_46", "url": "tool-version", - "valueString": "pi-fix-bc-props-specs-in-usdm", + "valueString": "1.6.0", "instanceType": "ExtensionAttribute" }, { "id": "ExtensionAttribute_47", "url": "usdm-creation-date", - "valueString": "20260716T11:34", + "valueString": "20260806T13:12", "instanceType": "ExtensionAttribute" } ], @@ -87,7 +87,7 @@ "id": "Code_486", "extensionAttributes": [], "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-09-26", "decode": "CLINIC", "instanceType": "Code" @@ -98,7 +98,7 @@ "id": "Code_487", "extensionAttributes": [], "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-09-26", "decode": "IN PERSON", "instanceType": "Code" @@ -140,7 +140,7 @@ "id": "Code_489", "extensionAttributes": [], "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-09-26", "decode": "CLINIC", "instanceType": "Code" @@ -151,7 +151,7 @@ "id": "Code_490", "extensionAttributes": [], "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-09-26", "decode": "IN PERSON", "instanceType": "Code" @@ -193,7 +193,7 @@ "id": "Code_492", "extensionAttributes": [], "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-09-26", "decode": "CLINIC", "instanceType": "Code" @@ -204,7 +204,7 @@ "id": "Code_493", "extensionAttributes": [], "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-09-26", "decode": "IN PERSON", "instanceType": "Code" @@ -238,7 +238,7 @@ "id": "Code_10039", "extensionAttributes": [], "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "CLINIC", "instanceType": "Code" @@ -249,7 +249,7 @@ "id": "Code_10040", "extensionAttributes": [], "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "IN PERSON", "instanceType": "Code" @@ -283,7 +283,7 @@ "id": "Code_10042", "extensionAttributes": [], "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "CLINIC", "instanceType": "Code" @@ -294,7 +294,7 @@ "id": "Code_10043", "extensionAttributes": [], "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "IN PERSON", "instanceType": "Code" @@ -328,7 +328,7 @@ "id": "Code_10045", "extensionAttributes": [], "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "CLINIC", "instanceType": "Code" @@ -339,7 +339,7 @@ "id": "Code_10046", "extensionAttributes": [], "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "IN PERSON", "instanceType": "Code" @@ -373,7 +373,7 @@ "id": "Code_10048", "extensionAttributes": [], "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "CLINIC", "instanceType": "Code" @@ -384,7 +384,7 @@ "id": "Code_10049", "extensionAttributes": [], "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "IN PERSON", "instanceType": "Code" @@ -418,7 +418,7 @@ "id": "Code_10051", "extensionAttributes": [], "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "CLINIC", "instanceType": "Code" @@ -429,7 +429,7 @@ "id": "Code_10052", "extensionAttributes": [], "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "IN PERSON", "instanceType": "Code" @@ -463,7 +463,7 @@ "id": "Code_10054", "extensionAttributes": [], "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "CLINIC", "instanceType": "Code" @@ -474,7 +474,7 @@ "id": "Code_10055", "extensionAttributes": [], "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "IN PERSON", "instanceType": "Code" @@ -508,7 +508,7 @@ "id": "Code_10057", "extensionAttributes": [], "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "CLINIC", "instanceType": "Code" @@ -519,7 +519,7 @@ "id": "Code_10058", "extensionAttributes": [], "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "IN PERSON", "instanceType": "Code" @@ -553,7 +553,7 @@ "id": "Code_10060", "extensionAttributes": [], "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "CLINIC", "instanceType": "Code" @@ -564,7 +564,7 @@ "id": "Code_10061", "extensionAttributes": [], "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "IN PERSON", "instanceType": "Code" @@ -598,7 +598,7 @@ "id": "Code_10063", "extensionAttributes": [], "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "CLINIC", "instanceType": "Code" @@ -609,7 +609,7 @@ "id": "Code_10064", "extensionAttributes": [], "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "IN PERSON", "instanceType": "Code" @@ -643,7 +643,7 @@ "id": "Code_10069", "extensionAttributes": [], "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "CLINIC", "instanceType": "Code" @@ -654,7 +654,7 @@ "id": "Code_10070", "extensionAttributes": [], "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "IN PERSON", "instanceType": "Code" @@ -688,7 +688,7 @@ "id": "Code_10067", "extensionAttributes": [], "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "CLINIC", "instanceType": "Code" @@ -699,7 +699,7 @@ "id": "Code_10068", "extensionAttributes": [], "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "IN PERSON", "instanceType": "Code" @@ -733,7 +733,7 @@ "id": "Code_10072", "extensionAttributes": [], "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "CLINIC", "instanceType": "Code" @@ -744,7 +744,7 @@ "id": "Code_10073", "extensionAttributes": [], "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "IN PERSON", "instanceType": "Code" @@ -786,7 +786,7 @@ "id": "Code_10075", "extensionAttributes": [], "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "CLINIC", "instanceType": "Code" @@ -797,7 +797,7 @@ "id": "Code_10076", "extensionAttributes": [], "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "IN PERSON", "instanceType": "Code" @@ -847,7 +847,7 @@ "id": "Code_10078", "extensionAttributes": [], "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "CLINIC", "instanceType": "Code" @@ -858,7 +858,7 @@ "id": "Code_10079", "extensionAttributes": [], "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-03-27", "decode": "IN PERSON", "instanceType": "Code" @@ -955,8 +955,8 @@ "childIds": [], "definedProcedures": [], "biomedicalConceptIds": [ - "BiomedicalConcept_3", - "BiomedicalConcept_4" + "BiomedicalConcept_78", + "BiomedicalConcept_80" ], "bcCategoryIds": [], "bcSurrogateIds": [], @@ -994,7 +994,6 @@ "childIds": [], "definedProcedures": [], "biomedicalConceptIds": [ - "BiomedicalConcept_49", "BiomedicalConcept_50" ], "bcCategoryIds": [], @@ -1057,8 +1056,8 @@ "childIds": [], "definedProcedures": [], "biomedicalConceptIds": [ - "BiomedicalConcept_47", - "BiomedicalConcept_48" + "BiomedicalConcept_79", + "BiomedicalConcept_81" ], "bcCategoryIds": [], "bcSurrogateIds": [], @@ -1068,7 +1067,32 @@ }, { "id": "Activity_22", - "extensionAttributes": [], + "extensionAttributes": [ + { + "id": "ExtensionAttribute_88", + "url": "http://www.cdisc.org/usdm/extensions/biomedicalConceptGrouping", + "valueExtensionClass": { + "id": "ExtensionClass_3", + "url": "http://www.cdisc.org/usdm/extensions/BiomedicalConceptGrouping", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_89", + "url": "classification-scheme-id", + "valueString": "concept_group", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_90", + "url": "classification-value-id", + "valueString": "cg_recist_1_1", + "instanceType": "ExtensionAttribute" + } + ], + "instanceType": "ExtensionClass" + }, + "instanceType": "ExtensionAttribute" + } + ], "name": "IMAGING SCANS", "label": "Imaging Scans", "description": "Tumor imaging scans", @@ -1077,11 +1101,20 @@ "childIds": [], "definedProcedures": [], "biomedicalConceptIds": [ - "BiomedicalConcept_73", - "BiomedicalConcept_74", - "BiomedicalConcept_75", - "BiomedicalConcept_76", - "BiomedicalConcept_77" + "BiomedicalConcept_82", + "BiomedicalConcept_83", + "BiomedicalConcept_84", + "BiomedicalConcept_85", + "BiomedicalConcept_86", + "BiomedicalConcept_87", + "BiomedicalConcept_88", + "BiomedicalConcept_89", + "BiomedicalConcept_90", + "BiomedicalConcept_91", + "BiomedicalConcept_92", + "BiomedicalConcept_93", + "BiomedicalConcept_94", + "BiomedicalConcept_95" ], "bcCategoryIds": [], "bcSurrogateIds": [], @@ -1112,7 +1145,32 @@ }, { "id": "Activity_10", - "extensionAttributes": [], + "extensionAttributes": [ + { + "id": "ExtensionAttribute_85", + "url": "http://www.cdisc.org/usdm/extensions/biomedicalConceptGrouping", + "valueExtensionClass": { + "id": "ExtensionClass_2", + "url": "http://www.cdisc.org/usdm/extensions/BiomedicalConceptGrouping", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_86", + "url": "classification-scheme-id", + "valueString": "concept_group", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_87", + "url": "classification-value-id", + "valueString": "cg_urinalysis", + "instanceType": "ExtensionAttribute" + } + ], + "instanceType": "ExtensionClass" + }, + "instanceType": "ExtensionAttribute" + } + ], "name": "URINALYSIS", "label": "Urinalysis Labs", "description": "Urinalysis Labs", @@ -1121,9 +1179,9 @@ "childIds": [], "definedProcedures": [], "biomedicalConceptIds": [ - "BiomedicalConcept_26", - "BiomedicalConcept_27", - "BiomedicalConcept_28" + "BiomedicalConcept_96", + "BiomedicalConcept_97", + "BiomedicalConcept_98" ], "bcCategoryIds": [], "bcSurrogateIds": [], @@ -1144,7 +1202,17 @@ "biomedicalConceptIds": [ "BiomedicalConcept_61", "BiomedicalConcept_62", - "BiomedicalConcept_63" + "BiomedicalConcept_63", + "BiomedicalConcept_99", + "BiomedicalConcept_100", + "BiomedicalConcept_101", + "BiomedicalConcept_102", + "BiomedicalConcept_103", + "BiomedicalConcept_104", + "BiomedicalConcept_105", + "BiomedicalConcept_106", + "BiomedicalConcept_107", + "BiomedicalConcept_122" ], "bcCategoryIds": [], "bcSurrogateIds": [], @@ -1176,12 +1244,12 @@ "BiomedicalConcept_69", "BiomedicalConcept_70", "BiomedicalConcept_71", - "BiomedicalConcept_72" + "BiomedicalConcept_72", + "BiomedicalConcept_118" ], "bcCategoryIds": [], "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_1", - "BiomedicalConceptSurrogate_8" + "BiomedicalConceptSurrogate_1" ], "timelineId": null, "notes": [], @@ -1238,15 +1306,11 @@ "nextId": "Activity_28", "childIds": [], "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_2", - "BiomedicalConceptSurrogate_3", - "BiomedicalConceptSurrogate_4", - "BiomedicalConceptSurrogate_5", - "BiomedicalConceptSurrogate_6" + "biomedicalConceptIds": [ + "BiomedicalConcept_119" ], + "bcCategoryIds": [], + "bcSurrogateIds": [], "timelineId": null, "notes": [], "instanceType": "Activity" @@ -1261,11 +1325,11 @@ "nextId": "Activity_29", "childIds": [], "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_2" + "biomedicalConceptIds": [ + "BiomedicalConcept_121" ], + "bcCategoryIds": [], + "bcSurrogateIds": [], "timelineId": null, "notes": [], "instanceType": "Activity" @@ -1280,11 +1344,11 @@ "nextId": "Activity_30", "childIds": [], "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_6" + "biomedicalConceptIds": [ + "BiomedicalConcept_120" ], + "bcCategoryIds": [], + "bcSurrogateIds": [], "timelineId": null, "notes": [], "instanceType": "Activity" @@ -1318,15 +1382,27 @@ "extensionAttributes": [], "name": "PFTS", "label": "PFTs with DLCO as medically indicatedn", - "description": "PFTs with DLCO as medically indicatedn", + "description": "PFTs with DLCO as medically indicated", "previousId": "Activity_30", "nextId": null, "childIds": [], "definedProcedures": [], - "biomedicalConceptIds": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_108", + "BiomedicalConcept_109", + "BiomedicalConcept_110", + "BiomedicalConcept_111", + "BiomedicalConcept_112", + "BiomedicalConcept_113", + "BiomedicalConcept_114", + "BiomedicalConcept_115", + "BiomedicalConcept_116", + "BiomedicalConcept_117", + "BiomedicalConcept_123" + ], "bcCategoryIds": [], "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_7" + "BiomedicalConceptSurrogate_25" ], "timelineId": null, "notes": [], @@ -1487,8 +1563,8 @@ "id": "Code_1", "extensionAttributes": [], "code": "C202487", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", "decode": "SCREENING", "instanceType": "Code" }, @@ -1507,8 +1583,8 @@ "id": "Code_2", "extensionAttributes": [], "code": "C101526", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", "decode": "TREATMENT", "instanceType": "Code" }, @@ -1527,8 +1603,8 @@ "id": "Code_813", "extensionAttributes": [], "code": "C123452", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", "decode": "CONTINUATION TREATMENT", "instanceType": "Code" }, @@ -1547,8 +1623,8 @@ "id": "Code_3", "extensionAttributes": [], "code": "C202578", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", "decode": "FOLLOW-UP", "instanceType": "Code" }, @@ -4184,33 +4260,42 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_3", - "extensionAttributes": [], - "name": "Medical History Yes No Indicator", - "label": "Medical History Yes No Indicator", + "id": "BiomedicalConcept_5", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_3", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/ECOG101", + "instanceType": "ExtensionAttribute" + } + ], + "name": "ECOG - Performance Status", + "label": "ECOG - Performance Status", "synonyms": [ - "MHYN" + "ECOG1-Performance Status", + "ECOG101", + "ECOG - Performance Status" ], - "reference": "/mdr/bc/biomedicalconcepts/C85522", + "reference": "/mdr/bc/biomedicalconcepts/C102408", "properties": [ { - "id": "BiomedicalConceptProperty_242", + "id": "BiomedicalConceptProperty_250", "extensionAttributes": [], - "name": "Medical History Yes No Indicator", - "label": "Medical History Yes No Indicator", - "isRequired": true, + "name": "RSORRES", + "label": "RSORRES", + "isRequired": false, "isEnabled": true, - "datatype": "string", + "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9640", + "id": "AliasCode_9648", "standardCode": { - "id": "Code_10396", + "id": "Code_10404", "extensionAttributes": [], - "code": "C85522", + "code": "C91106", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Medical History Yes No Indicator", + "codeSystemVersion": "2026-05-26", + "decode": "Clinical or Research Assessment Answer", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -4219,22 +4304,22 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_243", + "id": "BiomedicalConceptProperty_251", "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, + "name": "RSDTC", + "label": "RSDTC", + "isRequired": false, "isEnabled": true, "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9641", + "id": "AliasCode_9649", "standardCode": { - "id": "Code_10397", + "id": "Code_10405", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", + "codeSystemVersion": "2026-05-26", "decode": "Collection Date Time", "instanceType": "Code" }, @@ -4245,15 +4330,15 @@ } ], "code": { - "id": "AliasCode_11", + "id": "AliasCode_13", "extensionAttributes": [], "standardCode": { - "id": "Code_18", + "id": "Code_20", "extensionAttributes": [], - "code": "C85522", + "code": "C102408", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Medical History Yes No Indicator", + "codeSystemVersion": "2025-09-23", + "decode": "ECOG - Performance Status", "instanceType": "Code" }, "standardCodeAliases": [], @@ -4263,34 +4348,72 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_4", + "id": "BiomedicalConcept_6", "extensionAttributes": [], - "name": "Medical History Reported Term [RETIRED]", - "label": "Medical History Reported Term [RETIRED]", + "name": "Physical Examination Finding", + "label": "Physical Examination Finding", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C83119", + "properties": [], + "code": { + "id": "AliasCode_21", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28", + "extensionAttributes": [], + "code": "C83119", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-04-02", + "decode": "Physical Examination Finding", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_7", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_4", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/SYSBP", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_85", + "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", + "valueString": "/mdr/specializations/crf/specializations/SYSBP_DENORMALIZED", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Systolic Blood Pressure", + "label": "Systolic Blood Pressure", "synonyms": [ - "Medical History", - "MHTERM" + "SYSBP" ], - "reference": "/mdr/bc/biomedicalconcepts/C83118", + "reference": "/mdr/bc/biomedicalconcepts/C25298", "properties": [ { - "id": "BiomedicalConceptProperty_244", + "id": "BiomedicalConceptProperty_252", "extensionAttributes": [], - "name": "Medical History Dictionary Derived Term", - "label": "Medical History Dictionary Derived Term", - "isRequired": true, + "name": "VSORRES", + "label": "VSORRES", + "isRequired": false, "isEnabled": true, - "datatype": "string", + "datatype": "integer", "responseCodes": [], "code": { - "id": "AliasCode_9642", + "id": "AliasCode_9650", "standardCode": { - "id": "Code_10398", + "id": "Code_10406", "extensionAttributes": [], - "code": "C83346", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Dictionary Derived Term", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -4299,23 +4422,40 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_245", + "id": "BiomedicalConceptProperty_253", "extensionAttributes": [], - "name": "Medical History Occurrence", - "label": "Medical History Occurrence", - "isRequired": true, + "name": "VSORRESU", + "label": "VSORRESU", + "isRequired": false, "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], + "datatype": "text", + "responseCodes": [ + { + "id": "ResponseCode_42", + "instanceType": "ResponseCode", + "name": "mmHg", + "label": "mmHg", + "isEnabled": true, + "code": { + "id": "Code_10408", + "extensionAttributes": [], + "code": "C49670", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "mmHg", + "instanceType": "Code" + } + } + ], "code": { - "id": "AliasCode_9643", + "id": "AliasCode_9651", "standardCode": { - "id": "Code_10399", + "id": "Code_10407", "extensionAttributes": [], - "code": "C83067", + "code": "C49669", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Occurrence", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -4324,23 +4464,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_246", + "id": "BiomedicalConceptProperty_254", "extensionAttributes": [], - "name": "Medical History Pre-specified", - "label": "Medical History Pre-specified", - "isRequired": true, + "name": "VSPOS", + "label": "VSPOS", + "isRequired": false, "isEnabled": true, - "datatype": "boolean", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9644", + "id": "AliasCode_9653", "standardCode": { - "id": "Code_10400", + "id": "Code_10409", "extensionAttributes": [], - "code": "C87897", + "code": "C62164", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Pre-specified", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -4349,23 +4489,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_247", + "id": "BiomedicalConceptProperty_255", "extensionAttributes": [], - "name": "Medical History Reported Term", - "label": "Medical History Reported Term", - "isRequired": true, + "name": "VSLOC", + "label": "VSLOC", + "isRequired": false, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9645", + "id": "AliasCode_9654", "standardCode": { - "id": "Code_10401", + "id": "Code_10410", "extensionAttributes": [], - "code": "C83118", + "code": "C13717", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -4374,23 +4514,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_248", + "id": "BiomedicalConceptProperty_256", "extensionAttributes": [], - "name": "Medical History Category", - "label": "Medical History Category", - "isRequired": true, + "name": "VSLAT", + "label": "VSLAT", + "isRequired": false, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9646", + "id": "AliasCode_9655", "standardCode": { - "id": "Code_10402", + "id": "Code_10411", "extensionAttributes": [], - "code": "C83018", + "code": "C25185", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Category", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -4399,23 +4539,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_249", + "id": "BiomedicalConceptProperty_257", "extensionAttributes": [], - "name": "Medical History Subcategory", - "label": "Medical History Subcategory", - "isRequired": true, + "name": "VSDTC", + "label": "VSDTC", + "isRequired": false, "isEnabled": true, - "datatype": "string", + "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9647", + "id": "AliasCode_9656", "standardCode": { - "id": "Code_10403", + "id": "Code_10412", "extensionAttributes": [], - "code": "C83143", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Subcategory", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -4425,15 +4565,15 @@ } ], "code": { - "id": "AliasCode_12", + "id": "AliasCode_22", "extensionAttributes": [], "standardCode": { - "id": "Code_19", + "id": "Code_29", "extensionAttributes": [], - "code": "C83118", + "code": "C25298", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term [RETIRED]", + "decode": "Systolic Blood Pressure", "instanceType": "Code" }, "standardCodeAliases": [], @@ -4443,138 +4583,30 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_5", + "id": "BiomedicalConcept_8", "extensionAttributes": [ { - "id": "ExtensionAttribute_3", + "id": "ExtensionAttribute_5", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ECOG101", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/DIABP", "instanceType": "ExtensionAttribute" - } - ], - "name": "ECOG - Performance Status", - "label": "ECOG - Performance Status", - "synonyms": [ - "ECOG1-Performance Status", - "ECOG101", - "ECOG - Performance Status" - ], - "reference": "/mdr/bc/biomedicalconcepts/C102408", - "properties": [ - { - "id": "BiomedicalConceptProperty_250", - "extensionAttributes": [], - "name": "RSORRES", - "label": "RSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9648", - "standardCode": { - "id": "Code_10404", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_251", - "extensionAttributes": [], - "name": "RSDTC", - "label": "RSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9649", - "standardCode": { - "id": "Code_10405", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_13", - "extensionAttributes": [], - "standardCode": { - "id": "Code_20", - "extensionAttributes": [], - "code": "C102408", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "ECOG - Performance Status", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_6", - "extensionAttributes": [], - "name": "Physical Examination Finding", - "label": "Physical Examination Finding", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C83119", - "properties": [], - "code": { - "id": "AliasCode_21", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28", - "extensionAttributes": [], - "code": "C83119", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-04-02", - "decode": "Physical Examination Finding", - "instanceType": "Code" }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_7", - "extensionAttributes": [ { - "id": "ExtensionAttribute_4", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SYSBP", + "id": "ExtensionAttribute_86", + "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", + "valueString": "/mdr/specializations/crf/specializations/DIABP_DENORMALIZED", "instanceType": "ExtensionAttribute" } ], - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", + "name": "Diastolic Blood Pressure", + "label": "Diastolic Blood Pressure", "synonyms": [ - "SYSBP" + "DIABP" ], - "reference": "/mdr/bc/biomedicalconcepts/C25298", + "reference": "/mdr/bc/biomedicalconcepts/C25299", "properties": [ { - "id": "BiomedicalConceptProperty_252", + "id": "BiomedicalConceptProperty_258", "extensionAttributes": [], "name": "VSORRES", "label": "VSORRES", @@ -4583,9 +4615,9 @@ "datatype": "integer", "responseCodes": [], "code": { - "id": "AliasCode_9650", + "id": "AliasCode_9657", "standardCode": { - "id": "Code_10406", + "id": "Code_10413", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -4599,7 +4631,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_253", + "id": "BiomedicalConceptProperty_259", "extensionAttributes": [], "name": "VSORRESU", "label": "VSORRESU", @@ -4608,13 +4640,13 @@ "datatype": "text", "responseCodes": [ { - "id": "ResponseCode_42", + "id": "ResponseCode_43", "instanceType": "ResponseCode", "name": "mmHg", "label": "mmHg", "isEnabled": true, "code": { - "id": "Code_10408", + "id": "Code_10415", "extensionAttributes": [], "code": "C49670", "codeSystem": "http://www.cdisc.org", @@ -4625,9 +4657,9 @@ } ], "code": { - "id": "AliasCode_9651", + "id": "AliasCode_9658", "standardCode": { - "id": "Code_10407", + "id": "Code_10414", "extensionAttributes": [], "code": "C49669", "codeSystem": "http://www.cdisc.org", @@ -4641,7 +4673,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_254", + "id": "BiomedicalConceptProperty_260", "extensionAttributes": [], "name": "VSPOS", "label": "VSPOS", @@ -4650,9 +4682,9 @@ "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9653", + "id": "AliasCode_9660", "standardCode": { - "id": "Code_10409", + "id": "Code_10416", "extensionAttributes": [], "code": "C62164", "codeSystem": "http://www.cdisc.org", @@ -4666,7 +4698,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_255", + "id": "BiomedicalConceptProperty_261", "extensionAttributes": [], "name": "VSLOC", "label": "VSLOC", @@ -4675,9 +4707,9 @@ "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9654", + "id": "AliasCode_9661", "standardCode": { - "id": "Code_10410", + "id": "Code_10417", "extensionAttributes": [], "code": "C13717", "codeSystem": "http://www.cdisc.org", @@ -4691,7 +4723,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_256", + "id": "BiomedicalConceptProperty_262", "extensionAttributes": [], "name": "VSLAT", "label": "VSLAT", @@ -4700,9 +4732,9 @@ "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9655", + "id": "AliasCode_9662", "standardCode": { - "id": "Code_10411", + "id": "Code_10418", "extensionAttributes": [], "code": "C25185", "codeSystem": "http://www.cdisc.org", @@ -4716,7 +4748,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_257", + "id": "BiomedicalConceptProperty_263", "extensionAttributes": [], "name": "VSDTC", "label": "VSDTC", @@ -4725,9 +4757,9 @@ "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9656", + "id": "AliasCode_9663", "standardCode": { - "id": "Code_10412", + "id": "Code_10419", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", @@ -4742,15 +4774,15 @@ } ], "code": { - "id": "AliasCode_22", + "id": "AliasCode_34", "extensionAttributes": [], "standardCode": { - "id": "Code_29", + "id": "Code_41", "extensionAttributes": [], - "code": "C25298", + "code": "C25299", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure", + "decode": "Diastolic Blood Pressure", "instanceType": "Code" }, "standardCodeAliases": [], @@ -4760,24 +4792,30 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_8", + "id": "BiomedicalConcept_9", "extensionAttributes": [ { - "id": "ExtensionAttribute_5", + "id": "ExtensionAttribute_6", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/DIABP", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/HR", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_87", + "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", + "valueString": "/mdr/specializations/crf/specializations/HR_DENORMALIZED", "instanceType": "ExtensionAttribute" } ], - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", + "name": "Heart Rate", + "label": "Heart Rate", "synonyms": [ - "DIABP" + "HR" ], - "reference": "/mdr/bc/biomedicalconcepts/C25299", + "reference": "/mdr/bc/biomedicalconcepts/C49677", "properties": [ { - "id": "BiomedicalConceptProperty_258", + "id": "BiomedicalConceptProperty_264", "extensionAttributes": [], "name": "VSORRES", "label": "VSORRES", @@ -4786,9 +4824,9 @@ "datatype": "integer", "responseCodes": [], "code": { - "id": "AliasCode_9657", + "id": "AliasCode_9664", "standardCode": { - "id": "Code_10413", + "id": "Code_10420", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -4802,7 +4840,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_259", + "id": "BiomedicalConceptProperty_265", "extensionAttributes": [], "name": "VSORRESU", "label": "VSORRESU", @@ -4811,31 +4849,31 @@ "datatype": "text", "responseCodes": [ { - "id": "ResponseCode_43", + "id": "ResponseCode_44", "instanceType": "ResponseCode", - "name": "mmHg", - "label": "mmHg", + "name": "beats/min", + "label": "beats/min", "isEnabled": true, "code": { - "id": "Code_10415", + "id": "Code_10422", "extensionAttributes": [], - "code": "C49670", + "code": "C49673", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "mmHg", + "decode": "beats/min", "instanceType": "Code" } } ], "code": { - "id": "AliasCode_9658", + "id": "AliasCode_9665", "standardCode": { - "id": "Code_10414", + "id": "Code_10421", "extensionAttributes": [], - "code": "C49669", + "code": "C73688", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure", + "decode": "Count per Minute", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -4844,7 +4882,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_260", + "id": "BiomedicalConceptProperty_266", "extensionAttributes": [], "name": "VSPOS", "label": "VSPOS", @@ -4853,9 +4891,9 @@ "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9660", + "id": "AliasCode_9667", "standardCode": { - "id": "Code_10416", + "id": "Code_10423", "extensionAttributes": [], "code": "C62164", "codeSystem": "http://www.cdisc.org", @@ -4869,7 +4907,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_261", + "id": "BiomedicalConceptProperty_267", "extensionAttributes": [], "name": "VSLOC", "label": "VSLOC", @@ -4878,9 +4916,9 @@ "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9661", + "id": "AliasCode_9668", "standardCode": { - "id": "Code_10417", + "id": "Code_10424", "extensionAttributes": [], "code": "C13717", "codeSystem": "http://www.cdisc.org", @@ -4894,7 +4932,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_262", + "id": "BiomedicalConceptProperty_268", "extensionAttributes": [], "name": "VSLAT", "label": "VSLAT", @@ -4903,9 +4941,9 @@ "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9662", + "id": "AliasCode_9669", "standardCode": { - "id": "Code_10418", + "id": "Code_10425", "extensionAttributes": [], "code": "C25185", "codeSystem": "http://www.cdisc.org", @@ -4919,7 +4957,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_263", + "id": "BiomedicalConceptProperty_269", "extensionAttributes": [], "name": "VSDTC", "label": "VSDTC", @@ -4928,9 +4966,9 @@ "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9663", + "id": "AliasCode_9670", "standardCode": { - "id": "Code_10419", + "id": "Code_10426", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", @@ -4945,218 +4983,15 @@ } ], "code": { - "id": "AliasCode_34", + "id": "AliasCode_46", "extensionAttributes": [], "standardCode": { - "id": "Code_41", + "id": "Code_53", "extensionAttributes": [], - "code": "C25299", + "code": "C49677", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_9", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_6", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HR", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Heart Rate", - "label": "Heart Rate", - "synonyms": [ - "HR" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [ - { - "id": "BiomedicalConceptProperty_264", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_9664", - "standardCode": { - "id": "Code_10420", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_265", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_44", - "instanceType": "ResponseCode", - "name": "beats/min", - "label": "beats/min", - "isEnabled": true, - "code": { - "id": "Code_10422", - "extensionAttributes": [], - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9665", - "standardCode": { - "id": "Code_10421", - "extensionAttributes": [], - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_266", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9667", - "standardCode": { - "id": "Code_10423", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_267", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9668", - "standardCode": { - "id": "Code_10424", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_268", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9669", - "standardCode": { - "id": "Code_10425", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_269", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9670", - "standardCode": { - "id": "Code_10426", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_46", - "extensionAttributes": [], - "standardCode": { - "id": "Code_53", - "extensionAttributes": [], - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate", + "decode": "Heart Rate", "instanceType": "Code" }, "standardCodeAliases": [], @@ -5173,6 +5008,12 @@ "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", "valueString": "/mdr/specializations/sdtm/datasetspecializations/TEMP", "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_88", + "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", + "valueString": "/mdr/specializations/crf/specializations/TEMP_DENORMALIZED", + "instanceType": "ExtensionAttribute" } ], "name": "Body Temperature", @@ -5309,6 +5150,12 @@ "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", "valueString": "/mdr/specializations/sdtm/datasetspecializations/WEIGHT", "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_89", + "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", + "valueString": "/mdr/specializations/crf/specializations/WEIGHT_DENORMALIZED", + "instanceType": "ExtensionAttribute" } ], "name": "Body Weight", @@ -6306,41 +6153,58 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_26", + "id": "BiomedicalConcept_50", "extensionAttributes": [ { - "id": "ExtensionAttribute_14", + "id": "ExtensionAttribute_44", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PHURIN", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CMPRESP", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_45", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CMPRIORBREASTCANCER", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_46", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CMPRIORCANCER", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_47", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CMFREE", "instanceType": "ExtensionAttribute" } ], - "name": "pH", - "label": "pH", + "name": "Concomitant Therapy", + "label": "Concomitant Therapy", "synonyms": [ - "PH", - "potential of Hydrogen" + "Concomitant Medication" ], - "reference": "/mdr/bc/biomedicalconcepts/C45997", + "reference": "/mdr/bc/biomedicalconcepts/C53630", "properties": [ { - "id": "BiomedicalConceptProperty_302", + "id": "BiomedicalConceptProperty_317", "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, + "name": "CMTRT", + "label": "CMTRT", + "isRequired": true, "isEnabled": true, - "datatype": "float", + "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9708", + "id": "AliasCode_9726", "standardCode": { - "id": "Code_10464", + "id": "Code_10482", "extensionAttributes": [], - "code": "C70856", + "code": "C70902", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Agent", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -6349,40 +6213,6398 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_303", + "id": "BiomedicalConceptProperty_318", "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", + "name": "CMDECOD", + "label": "CMDECOD", "isRequired": false, "isEnabled": true, + "datatype": "text", + "responseCodes": [], + "code": { + "id": "AliasCode_9727", + "standardCode": { + "id": "Code_10483", + "extensionAttributes": [], + "code": "C83345", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dictionary Derived Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_319", + "extensionAttributes": [], + "name": "CMCLAS", + "label": "CMCLAS", + "isRequired": false, + "isEnabled": true, + "datatype": "text", + "responseCodes": [], + "code": { + "id": "AliasCode_9728", + "standardCode": { + "id": "Code_10484", + "extensionAttributes": [], + "code": "C83219", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Class", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_320", + "extensionAttributes": [], + "name": "CMINDC", + "label": "CMINDC", + "isRequired": false, + "isEnabled": true, + "datatype": "text", + "responseCodes": [], + "code": { + "id": "AliasCode_9729", + "standardCode": { + "id": "Code_10485", + "extensionAttributes": [], + "code": "C83085", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Indication", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_321", + "extensionAttributes": [], + "name": "CMDOSE", + "label": "CMDOSE", + "isRequired": false, + "isEnabled": true, + "datatype": "float", + "responseCodes": [], + "code": { + "id": "AliasCode_9730", + "standardCode": { + "id": "Code_10486", + "extensionAttributes": [], + "code": "C83221", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_322", + "extensionAttributes": [], + "name": "CMDOSTXT", + "label": "CMDOSTXT", + "isRequired": false, + "isEnabled": true, + "datatype": "text", + "responseCodes": [], + "code": { + "id": "AliasCode_9731", + "standardCode": { + "id": "Code_10487", + "extensionAttributes": [], + "code": "C83221", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_323", + "extensionAttributes": [], + "name": "CMDOSU", + "label": "CMDOSU", + "isRequired": false, + "isEnabled": true, + "datatype": "text", + "responseCodes": [], + "code": { + "id": "AliasCode_9732", + "standardCode": { + "id": "Code_10488", + "extensionAttributes": [], + "code": "C83034", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Unit", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_324", + "extensionAttributes": [], + "name": "CMDOSFRM", + "label": "CMDOSFRM", + "isRequired": false, + "isEnabled": true, + "datatype": "text", + "responseCodes": [], + "code": { + "id": "AliasCode_9733", + "standardCode": { + "id": "Code_10489", + "extensionAttributes": [], + "code": "C83110", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Form", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_325", + "extensionAttributes": [], + "name": "CMDOSFRQ", + "label": "CMDOSFRQ", + "isRequired": false, + "isEnabled": true, + "datatype": "text", + "responseCodes": [], + "code": { + "id": "AliasCode_9734", + "standardCode": { + "id": "Code_10490", + "extensionAttributes": [], + "code": "C83042", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Frequency", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_326", + "extensionAttributes": [], + "name": "CMROUTE", + "label": "CMROUTE", + "isRequired": false, + "isEnabled": true, + "datatype": "text", + "responseCodes": [], + "code": { + "id": "AliasCode_9735", + "standardCode": { + "id": "Code_10491", + "extensionAttributes": [], + "code": "C83120", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Route of Administration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": 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[], + "name": "Test Method", + "label": "Test Method", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9969", + "standardCode": { + "id": "Code_10725", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_478", + "extensionAttributes": [], + "name": "Tumor Identifier Link Identifier", + "label": "Tumor Identifier Link Identifier", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], "code": { - "id": "AliasCode_9709", + "id": "AliasCode_9970", "standardCode": { - "id": "Code_10465", + "id": "Code_10726", "extensionAttributes": [], - "code": "C70713", + "code": "C117436", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", + "decode": "Tumor Identifier Link Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -6391,23 +12613,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_304", + "id": "BiomedicalConceptProperty_479", "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, + "name": "Tumor Identifier Reference Identifier", + "label": "Tumor Identifier Reference Identifier", + "isRequired": true, "isEnabled": true, - "datatype": "boolean", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9711", + "id": "AliasCode_9971", "standardCode": { - "id": "Code_10467", + "id": "Code_10727", "extensionAttributes": [], - "code": "C93566", + "code": "C117442", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", + "decode": "Tumor Identifier Reference Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -6416,18 +12638,18 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_305", + "id": "BiomedicalConceptProperty_480", "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, "isEnabled": true, "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9712", + "id": "AliasCode_9972", "standardCode": { - "id": "Code_10468", + "id": "Code_10728", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", @@ -6439,18 +12661,43 @@ }, "notes": [], "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_481", + "extensionAttributes": [], + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9973", + "standardCode": { + "id": "Code_10729", + "extensionAttributes": [], + "code": "C117043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" } ], "code": { - "id": "AliasCode_5691", + "id": "AliasCode_9923", "extensionAttributes": [], "standardCode": { - "id": "Code_5770", + "id": "Code_10679", "extensionAttributes": [], - "code": "C45997", + "code": "C225438", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "pH", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Fragmentation Assessment", "instanceType": "Code" }, "standardCodeAliases": [], @@ -6460,36 +12707,52 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_27", + "id": "BiomedicalConcept_88", "extensionAttributes": [ { - "id": "ExtensionAttribute_15", + "id": "ExtensionAttribute_54", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/COLORURIN", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/TUMIDENT_RECIST1_1", "instanceType": "ExtensionAttribute" } ], - "name": "Color Assessment", - "label": "Color Assessment", + "name": "Tumor Identification", + "label": "Tumor Identification", "synonyms": [ - "COLOR", - "Color" + "TUMIDENT" ], - "reference": "/mdr/bc/biomedicalconcepts/C64546", + "reference": "/mdr/bc/biomedicalconcepts/C94523", "properties": [ { - "id": "BiomedicalConceptProperty_306", + "id": "BiomedicalConceptProperty_482", "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", + "name": "TUORRES", + "label": "TUORRES", "isRequired": false, "isEnabled": true, "datatype": "text", - "responseCodes": [], + "responseCodes": [ + { + "id": "ResponseCode_78", + "instanceType": "ResponseCode", + "name": "TARGET", + "label": "TARGET", + "isEnabled": true, + "code": { + "id": "Code_10731", + "extensionAttributes": [], + "code": "C94520", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "TARGET", + "instanceType": "Code" + } + } + ], "code": { - "id": "AliasCode_9713", + "id": "AliasCode_9974", "standardCode": { - "id": "Code_10469", + "id": "Code_10730", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -6503,40 +12766,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_307", + "id": "BiomedicalConceptProperty_483", "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", + "name": "TULOC", + "label": "TULOC", "isRequired": false, "isEnabled": true, "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_51", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_10471", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], + "responseCodes": [], "code": { - "id": "AliasCode_9714", + "id": "AliasCode_9976", "standardCode": { - "id": "Code_10470", + "id": "Code_10732", "extensionAttributes": [], - "code": "C70713", + "code": "C170500", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", + "decode": "Result Anatomical Location", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -6545,84 +12791,48 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_308", + "id": "BiomedicalConceptProperty_484", "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", + "name": "TULAT", + "label": "TULAT", "isRequired": false, "isEnabled": true, - "datatype": "datetime", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9716", + "id": "AliasCode_9977", "standardCode": { - "id": "Code_10472", + "id": "Code_10733", "extensionAttributes": [], - "code": "C82515", + "code": "C25185", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", + "decode": "Laterality", "instanceType": "Code" }, "instanceType": "AliasCode" }, "notes": [], "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_9356", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10031", - "extensionAttributes": [], - "code": "C64546", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Color Assessment", - "instanceType": "Code" }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_28", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_16", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SPGRAVURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Specific Gravity", - "label": "Specific Gravity", - "synonyms": [ - "SPGRAV" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64832", - "properties": [ { - "id": "BiomedicalConceptProperty_309", + "id": "BiomedicalConceptProperty_485", "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", + "name": "TUDIR", + "label": "TUDIR", "isRequired": false, "isEnabled": true, - "datatype": "float", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9717", + "id": "AliasCode_9978", "standardCode": { - "id": "Code_10473", + "id": "Code_10734", "extensionAttributes": [], - "code": "C70856", + "code": "C54215", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", + "decode": "Directionality", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -6631,40 +12841,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_310", + "id": "BiomedicalConceptProperty_486", "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", + "name": "TUMETHOD", + "label": "TUMETHOD", "isRequired": false, "isEnabled": true, "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_52", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_10475", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], + "responseCodes": [], "code": { - "id": "AliasCode_9718", + "id": "AliasCode_9979", "standardCode": { - "id": "Code_10474", + "id": "Code_10735", "extensionAttributes": [], - "code": "C70713", + "code": "C82535", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", + "decode": "Test Method", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -6673,23 +12866,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_311", + "id": "BiomedicalConceptProperty_487", "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", + "name": "TUEVAL", + "label": "TUEVAL", "isRequired": false, "isEnabled": true, - "datatype": "boolean", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9720", + "id": "AliasCode_9980", "standardCode": { - "id": "Code_10476", + "id": "Code_10736", "extensionAttributes": [], - "code": "C93566", + "code": "C51824", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", + "decode": "Evaluator", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -6698,77 +12891,73 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_312", + "id": "BiomedicalConceptProperty_488", "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", + "name": "TUEVALID", + "label": "TUEVALID", "isRequired": false, "isEnabled": true, - "datatype": "datetime", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9721", + "id": "AliasCode_9981", "standardCode": { - "id": "Code_10477", + "id": "Code_10737", "extensionAttributes": [], - "code": "C82515", + "code": "C117043", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", + "decode": "Evaluator Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" }, "notes": [], "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5692", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5771", + }, + { + "id": "BiomedicalConceptProperty_489", "extensionAttributes": [], - "code": "C64832", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Specific Gravity", - "instanceType": "Code" + "name": "TUREFID", + "label": "TUREFID", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9982", + "standardCode": { + "id": "Code_10738", + "extensionAttributes": [], + "code": "C117442", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Identifier Reference Identifier", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_47", - "extensionAttributes": [], - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "synonyms": [ - "AEYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83347", - "properties": [ { - "id": "BiomedicalConceptProperty_313", + "id": "BiomedicalConceptProperty_490", "extensionAttributes": [], - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "isRequired": true, + "name": "TULNKID", + "label": "TULNKID", + "isRequired": false, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9722", + "id": "AliasCode_9983", "standardCode": { - "id": "Code_10478", + "id": "Code_10739", "extensionAttributes": [], - "code": "C83347", + "code": "C117436", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Identifier Link Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -6777,22 +12966,22 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_314", + "id": "BiomedicalConceptProperty_491", "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, + "name": "TUDTC", + "label": "TUDTC", + "isRequired": false, "isEnabled": true, "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9723", + "id": "AliasCode_9984", "standardCode": { - "id": "Code_10479", + "id": "Code_10740", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", + "codeSystemVersion": "2026-05-26", "decode": "Collection Date Time", "instanceType": "Code" }, @@ -6803,15 +12992,15 @@ } ], "code": { - "id": "AliasCode_5693", + "id": "AliasCode_9924", "extensionAttributes": [], "standardCode": { - "id": "Code_5772", + "id": "Code_10680", "extensionAttributes": [], - "code": "C83347", + "code": "C94523", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Identification", "instanceType": "Code" }, "standardCodeAliases": [], @@ -6821,66 +13010,41 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_48", + "id": "BiomedicalConcept_89", "extensionAttributes": [ { - "id": "ExtensionAttribute_17", + "id": "ExtensionAttribute_42", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ADVEVENT", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/TRGRESP", "instanceType": "ExtensionAttribute" } ], - "name": "Adverse Event", - "label": "Adverse Event", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C41331", - "properties": [], - "code": { - "id": "AliasCode_9907", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10663", - "extensionAttributes": [], - "code": "C41331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Adverse Event [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_49", - "extensionAttributes": [], - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", + "name": "Response in Target Lesion", + "label": "Response in Target Lesion", "synonyms": [ - "CMYN" + "TRGRESP", + "Target Response" ], - "reference": "/mdr/bc/biomedicalconcepts/C83056", + "reference": "/mdr/bc/biomedicalconcepts/C94534", "properties": [ { - "id": "BiomedicalConceptProperty_315", + "id": "BiomedicalConceptProperty_492", "extensionAttributes": [], - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "isRequired": true, + "name": "RSORRES", + "label": "RSORRES", + "isRequired": false, "isEnabled": true, - "datatype": "string", + "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9724", + "id": "AliasCode_9985", "standardCode": { - "id": "Code_10480", + "id": "Code_10741", "extensionAttributes": [], - "code": "C83056", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -6889,84 +13053,48 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_316", + "id": "BiomedicalConceptProperty_493", "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, + "name": "RSEVAL", + "label": "RSEVAL", + "isRequired": false, "isEnabled": true, - "datatype": "datetime", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9725", + "id": "AliasCode_9986", "standardCode": { - "id": "Code_10481", + "id": "Code_10742", "extensionAttributes": [], - "code": "C82515", + "code": "C51824", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", "instanceType": "Code" }, "instanceType": "AliasCode" }, "notes": [], "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5694", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5773", - "extensionAttributes": [], - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator", - "instanceType": "Code" }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_50", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_18", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CMFREE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Concomitant Therapy", - "label": "Concomitant Therapy", - "synonyms": [ - "Concomitant Medication" - ], - "reference": "/mdr/bc/biomedicalconcepts/C53630", - "properties": [ { - "id": "BiomedicalConceptProperty_317", + "id": "BiomedicalConceptProperty_494", "extensionAttributes": [], - "name": "CMTRT", - "label": "CMTRT", - "isRequired": true, + "name": "RSEVALID", + "label": "RSEVALID", + "isRequired": false, "isEnabled": true, - "datatype": "text", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9726", + "id": "AliasCode_9987", "standardCode": { - "id": "Code_10482", + "id": "Code_10743", "extensionAttributes": [], - "code": "C70902", + "code": "C117043", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Agent", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -6975,48 +13103,85 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_318", + "id": "BiomedicalConceptProperty_495", "extensionAttributes": [], - "name": "CMDECOD", - "label": "CMDECOD", + "name": "RSDTC", + "label": "RSDTC", "isRequired": false, "isEnabled": true, - "datatype": "text", + "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9727", + "id": "AliasCode_9988", "standardCode": { - "id": "Code_10483", + "id": "Code_10744", "extensionAttributes": [], - "code": "C83345", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", "instanceType": "Code" }, "instanceType": "AliasCode" }, "notes": [], "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_9925", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10681", + "extensionAttributes": [], + "code": "C94534", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-06-27", + "decode": "Response in Target Lesion", + "instanceType": "Code" }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_90", + "extensionAttributes": [ { - "id": "BiomedicalConceptProperty_319", + "id": "ExtensionAttribute_41", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/NTRGRESP", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Response in Non-Target Lesion", + "label": "Response in Non-Target Lesion", + "synonyms": [ + "NTRGRESP", + "Non-Target Response" + ], + "reference": "/mdr/bc/biomedicalconcepts/C94535", + "properties": [ + { + "id": "BiomedicalConceptProperty_496", "extensionAttributes": [], - "name": "CMCLAS", - "label": "CMCLAS", + "name": "RSORRES", + "label": "RSORRES", "isRequired": false, "isEnabled": true, "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9728", + "id": "AliasCode_9989", "standardCode": { - "id": "Code_10484", + "id": "Code_10745", "extensionAttributes": [], - "code": "C83219", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Class", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7025,23 +13190,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_320", + "id": "BiomedicalConceptProperty_497", "extensionAttributes": [], - "name": "CMINDC", - "label": "CMINDC", + "name": "RSEVAL", + "label": "RSEVAL", "isRequired": false, "isEnabled": true, - "datatype": "text", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9729", + "id": "AliasCode_9990", "standardCode": { - "id": "Code_10485", + "id": "Code_10746", "extensionAttributes": [], - "code": "C83085", + "code": "C51824", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Indication", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7050,23 +13215,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_321", + "id": "BiomedicalConceptProperty_498", "extensionAttributes": [], - "name": "CMDOSE", - "label": "CMDOSE", + "name": "RSEVALID", + "label": "RSEVALID", "isRequired": false, "isEnabled": true, - "datatype": "float", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9730", + "id": "AliasCode_9991", "standardCode": { - "id": "Code_10486", + "id": "Code_10747", "extensionAttributes": [], - "code": "C83221", + "code": "C117043", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7075,48 +13240,84 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_322", + "id": "BiomedicalConceptProperty_499", "extensionAttributes": [], - "name": "CMDOSTXT", - "label": "CMDOSTXT", + "name": "RSDTC", + "label": "RSDTC", "isRequired": false, "isEnabled": true, - "datatype": "text", + "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9731", + "id": "AliasCode_9992", "standardCode": { - "id": "Code_10487", + "id": "Code_10748", "extensionAttributes": [], - "code": "C83221", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", "instanceType": "Code" }, "instanceType": "AliasCode" }, "notes": [], "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_9926", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10682", + "extensionAttributes": [], + "code": "C94535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-06-27", + "decode": "Response in Non-Target Lesion", + "instanceType": "Code" }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_91", + "extensionAttributes": [ { - "id": "BiomedicalConceptProperty_323", + "id": "ExtensionAttribute_55", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/BESTRESP", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Best Overall Response", + "label": "Best Overall Response", + "synonyms": [ + "BESTRESP" + ], + "reference": "/mdr/bc/biomedicalconcepts/C94536", + "properties": [ + { + "id": "BiomedicalConceptProperty_500", "extensionAttributes": [], - "name": "CMDOSU", - "label": "CMDOSU", - "isRequired": false, + "name": "Disease Response Link Group", + "label": "Disease Response Link Group", + "isRequired": true, "isEnabled": true, - "datatype": "text", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9732", + "id": "AliasCode_9993", "standardCode": { - "id": "Code_10488", + "id": "Code_10749", "extensionAttributes": [], - "code": "C83034", + "code": "C117394", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Unit", + "codeSystemVersion": "2024-06-27", + "decode": "Disease Response Link Group", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7125,23 +13326,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_324", + "id": "BiomedicalConceptProperty_501", "extensionAttributes": [], - "name": "CMDOSFRM", - "label": "CMDOSFRM", - "isRequired": false, + "name": "Category", + "label": "Category", + "isRequired": true, "isEnabled": true, - "datatype": "text", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9733", + "id": "AliasCode_9994", "standardCode": { - "id": "Code_10489", + "id": "Code_10750", "extensionAttributes": [], - "code": "C83110", + "code": "C25372", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Form", + "codeSystemVersion": "2024-06-27", + "decode": "Category", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7150,23 +13351,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_325", + "id": "BiomedicalConceptProperty_502", "extensionAttributes": [], - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", - "isRequired": false, + "name": "Observation Result", + "label": "Observation Result", + "isRequired": true, "isEnabled": true, - "datatype": "text", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9734", + "id": "AliasCode_9995", "standardCode": { - "id": "Code_10490", + "id": "Code_10751", "extensionAttributes": [], - "code": "C83042", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency", + "codeSystemVersion": "2024-06-27", + "decode": "Observation Result", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7175,23 +13376,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_326", + "id": "BiomedicalConceptProperty_503", "extensionAttributes": [], - "name": "CMROUTE", - "label": "CMROUTE", - "isRequired": false, + "name": "Evaluator", + "label": "Evaluator", + "isRequired": true, "isEnabled": true, - "datatype": "text", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9735", + "id": "AliasCode_9996", "standardCode": { - "id": "Code_10491", + "id": "Code_10752", "extensionAttributes": [], - "code": "C83120", + "code": "C51824", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Route of Administration", + "codeSystemVersion": "2024-06-27", + "decode": "Evaluator", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7200,23 +13401,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_327", + "id": "BiomedicalConceptProperty_504", "extensionAttributes": [], - "name": "CMSTDTC", - "label": "CMSTDTC", - "isRequired": false, + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "isRequired": true, "isEnabled": true, - "datatype": "datetime", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9736", + "id": "AliasCode_9997", "standardCode": { - "id": "Code_10492", + "id": "Code_10753", "extensionAttributes": [], - "code": "C83235", + "code": "C117043", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time", + "codeSystemVersion": "2024-06-27", + "decode": "Evaluator Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7225,23 +13426,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_328", + "id": "BiomedicalConceptProperty_505", "extensionAttributes": [], - "name": "CMENDTC", - "label": "CMENDTC", - "isRequired": false, + "name": "Clinical Trial Epoch", + "label": "Clinical Trial Epoch", + "isRequired": true, "isEnabled": true, - "datatype": "datetime", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9737", + "id": "AliasCode_9998", "standardCode": { - "id": "Code_10493", + "id": "Code_10754", "extensionAttributes": [], - "code": "C83225", + "code": "C71738", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time", + "codeSystemVersion": "2024-06-27", + "decode": "Clinical Trial Epoch", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7250,48 +13451,84 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_329", + "id": "BiomedicalConceptProperty_506", "extensionAttributes": [], - "name": "CMSTRF", - "label": "CMSTRF", - "isRequired": false, + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, "isEnabled": true, - "datatype": "text", + "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9738", + "id": "AliasCode_9999", "standardCode": { - "id": "Code_10494", + "id": "Code_10755", "extensionAttributes": [], - "code": "C82559", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period", + "codeSystemVersion": "2024-06-27", + "decode": "Collection Date Time", "instanceType": "Code" }, "instanceType": "AliasCode" }, "notes": [], "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_9927", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10683", + "extensionAttributes": [], + "code": "C94536", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-06-27", + "decode": "Best Overall Response", + "instanceType": "Code" }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_92", + "extensionAttributes": [ { - "id": "BiomedicalConceptProperty_330", + "id": "ExtensionAttribute_56", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/BESTRESP", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Overall Response", + "label": "Overall Response", + "synonyms": [ + "OVRLRESP" + ], + "reference": "/mdr/bc/biomedicalconcepts/C96613", + "properties": [ + { + "id": "BiomedicalConceptProperty_507", "extensionAttributes": [], - "name": "CMSTRTPT", - "label": "CMSTRTPT", + "name": "RSLNKGRP", + "label": "RSLNKGRP", "isRequired": false, "isEnabled": true, - "datatype": "text", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9739", + "id": "AliasCode_10000", "standardCode": { - "id": "Code_10495", + "id": "Code_10756", "extensionAttributes": [], - "code": "C82560", + "code": "C117394", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point", + "codeSystemVersion": "2026-05-26", + "decode": "Disease Response Link Group", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7300,23 +13537,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_331", + "id": "BiomedicalConceptProperty_508", "extensionAttributes": [], - "name": "CMSTTPT", - "label": "CMSTTPT", + "name": "RSORRES", + "label": "RSORRES", "isRequired": false, "isEnabled": true, "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9740", + "id": "AliasCode_10001", "standardCode": { - "id": "Code_10496", + "id": "Code_10757", "extensionAttributes": [], - "code": "C82575", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7325,23 +13562,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_332", + "id": "BiomedicalConceptProperty_509", "extensionAttributes": [], - "name": "CMENRF", - "label": "CMENRF", + "name": "RSEVAL", + "label": "RSEVAL", "isRequired": false, "isEnabled": true, - "datatype": "text", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9741", + "id": "AliasCode_10002", "standardCode": { - "id": "Code_10497", + "id": "Code_10758", "extensionAttributes": [], - "code": "C82557", + "code": "C51824", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7350,23 +13587,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_333", + "id": "BiomedicalConceptProperty_510", "extensionAttributes": [], - "name": "CMENRTPT", - "label": "CMENRTPT", + "name": "RSEVALID", + "label": "RSEVALID", "isRequired": false, "isEnabled": true, - "datatype": "text", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9742", + "id": "AliasCode_10003", "standardCode": { - "id": "Code_10498", + "id": "Code_10759", "extensionAttributes": [], - "code": "C82558", + "code": "C117043", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7375,23 +13612,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_334", + "id": "BiomedicalConceptProperty_511", "extensionAttributes": [], - "name": "CMENTPT", - "label": "CMENTPT", + "name": "RSDTC", + "label": "RSDTC", "isRequired": false, "isEnabled": true, - "datatype": "text", + "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9743", + "id": "AliasCode_10004", "standardCode": { - "id": "Code_10499", + "id": "Code_10760", "extensionAttributes": [], - "code": "C82574", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7401,15 +13638,15 @@ } ], "code": { - "id": "AliasCode_9908", + "id": "AliasCode_9928", "extensionAttributes": [], "standardCode": { - "id": "Code_10664", + "id": "Code_10684", "extensionAttributes": [], - "code": "C53630", + "code": "C96613", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Therapy", + "codeSystemVersion": "2024-06-27", + "decode": "Overall Response", "instanceType": "Code" }, "standardCodeAliases": [], @@ -7419,61 +13656,116 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_51", + "id": "BiomedicalConcept_93", "extensionAttributes": [ { - "id": "ExtensionAttribute_19", + "id": "ExtensionAttribute_57", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RANDOM", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/NEW_TUMSTATE_RECIST1_1", "instanceType": "ExtensionAttribute" } ], - "name": "Randomization", - "label": "Randomization", + "name": "Tumor Status", + "label": "Tumor Status", "synonyms": [ - "randomization", - "RANDOM", - "Randomized", - "Trial is Randomized", - "randomized" + "TUMSTATE", + "Tumor State" ], - "reference": "/mdr/bc/biomedicalconcepts/C25196", + "reference": "/mdr/bc/biomedicalconcepts/C96643", "properties": [ { - "id": "BiomedicalConceptProperty_335", + "id": "BiomedicalConceptProperty_512", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_10005", + "standardCode": { + "id": "Code_10761", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_513", + "extensionAttributes": [], + "name": "Tumor Results Group Identifier", + "label": "Tumor Results Group Identifier", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_10006", + "standardCode": { + "id": "Code_10762", + "extensionAttributes": [], + "code": "C117411", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Results Group Identifier", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_514", + "extensionAttributes": [], + "name": "Tumor Results Reference Identifier", + "label": "Tumor Results Reference Identifier", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_10007", + "standardCode": { + "id": "Code_10763", + "extensionAttributes": [], + "code": "C117419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Results Reference Identifier", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_515", "extensionAttributes": [], - "name": "TSPARMCD", - "label": "TSPARMCD", - "isRequired": false, + "name": "Tumor Results Link Group", + "label": "Tumor Results Link Group", + "isRequired": true, "isEnabled": true, "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_53", - "instanceType": "ResponseCode", - "name": "RANDOM", - "label": "RANDOM", - "isEnabled": true, - "code": { - "id": "Code_10501", - "extensionAttributes": [], - "code": "C25196", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "RANDOM", - "instanceType": "Code" - } - } - ], + "responseCodes": [], "code": { - "id": "AliasCode_9744", + "id": "AliasCode_10008", "standardCode": { - "id": "Code_10500", + "id": "Code_10764", "extensionAttributes": [], - "code": "C83445", + "code": "C117412", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Results Link Group", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7482,40 +13774,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_336", + "id": "BiomedicalConceptProperty_516", "extensionAttributes": [], - "name": "TSPARM", - "label": "TSPARM", - "isRequired": false, + "name": "Tumor Results Link Identifier", + "label": "Tumor Results Link Identifier", + "isRequired": true, "isEnabled": true, "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_54", - "instanceType": "ResponseCode", - "name": "Trial is Randomized", - "label": "Trial is Randomized", - "isEnabled": true, - "code": { - "id": "Code_10503", - "extensionAttributes": [], - "code": "C25196", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial is Randomized", - "instanceType": "Code" - } - } - ], + "responseCodes": [], "code": { - "id": "AliasCode_9746", + "id": "AliasCode_10009", "standardCode": { - "id": "Code_10502", + "id": "Code_10765", "extensionAttributes": [], - "code": "C49691", + "code": "C117413", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Results Link Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7524,23 +13799,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_337", + "id": "BiomedicalConceptProperty_517", "extensionAttributes": [], - "name": "TSVAL", - "label": "TSVAL", - "isRequired": false, + "name": "Observation Result", + "label": "Observation Result", + "isRequired": true, "isEnabled": true, - "datatype": "boolean", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9748", + "id": "AliasCode_10010", "standardCode": { - "id": "Code_10504", + "id": "Code_10766", "extensionAttributes": [], - "code": "C83447", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7549,23 +13824,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_338", + "id": "BiomedicalConceptProperty_518", "extensionAttributes": [], - "name": "TSVALCD", - "label": "TSVALCD", - "isRequired": false, + "name": "Test Method", + "label": "Test Method", + "isRequired": true, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9749", + "id": "AliasCode_10011", "standardCode": { - "id": "Code_10505", + "id": "Code_10767", "extensionAttributes": [], - "code": "C117458", + "code": "C82535", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7574,23 +13849,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_339", + "id": "BiomedicalConceptProperty_519", "extensionAttributes": [], - "name": "TSVCDREF", - "label": "TSVCDREF", - "isRequired": false, + "name": "Evaluator", + "label": "Evaluator", + "isRequired": true, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9750", + "id": "AliasCode_10012", "standardCode": { - "id": "Code_10506", + "id": "Code_10768", "extensionAttributes": [], - "code": "C117460", + "code": "C51824", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7599,23 +13874,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_340", + "id": "BiomedicalConceptProperty_520", "extensionAttributes": [], - "name": "TSVCDVER", - "label": "TSVCDVER", - "isRequired": false, + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "isRequired": true, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9751", + "id": "AliasCode_10013", "standardCode": { - "id": "Code_10507", + "id": "Code_10769", "extensionAttributes": [], - "code": "C117461", + "code": "C117043", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7625,15 +13900,15 @@ } ], "code": { - "id": "AliasCode_9357", + "id": "AliasCode_9929", "extensionAttributes": [], "standardCode": { - "id": "Code_10032", + "id": "Code_10685", "extensionAttributes": [], - "code": "C25196", + "code": "C96643", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Randomization", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Status", "instanceType": "Code" }, "standardCodeAliases": [], @@ -7643,35 +13918,35 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_52", + "id": "BiomedicalConcept_94", "extensionAttributes": [ { - "id": "ExtensionAttribute_20", + "id": "ExtensionAttribute_58", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PTBLD", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/LDIAM_RECIST1_1", "instanceType": "ExtensionAttribute" } ], - "name": "Prothrombin Time", - "label": "Prothrombin Time", + "name": "Longest Diameter", + "label": "Longest Diameter", "synonyms": [ - "PT" + "LDIAM" ], - "reference": "/mdr/bc/biomedicalconcepts/C62656", + "reference": "/mdr/bc/biomedicalconcepts/C96684", "properties": [ { - "id": "BiomedicalConceptProperty_341", + "id": "BiomedicalConceptProperty_521", "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, + "name": "Observation Result", + "label": "Observation Result", + "isRequired": true, "isEnabled": true, - "datatype": "float", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9752", + "id": "AliasCode_10014", "standardCode": { - "id": "Code_10508", + "id": "Code_10770", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -7685,40 +13960,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_342", + "id": "BiomedicalConceptProperty_522", "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, + "name": "Tumor Results Group Identifier", + "label": "Tumor Results Group Identifier", + "isRequired": true, "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_55", - "instanceType": "ResponseCode", - "name": "s", - "label": "s", - "isEnabled": true, - "code": { - "id": "Code_10510", - "extensionAttributes": [], - "code": "C42535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "s", - "instanceType": "Code" - } - } - ], + "datatype": "string", + "responseCodes": [], "code": { - "id": "AliasCode_9753", + "id": "AliasCode_10015", "standardCode": { - "id": "Code_10509", + "id": "Code_10771", "extensionAttributes": [], - "code": "C42574", + "code": "C117411", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", + "decode": "Tumor Results Group Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7727,40 +13985,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_343", + "id": "BiomedicalConceptProperty_523", "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, + "name": "Tumor Results Reference Identifier", + "label": "Tumor Results Reference Identifier", + "isRequired": true, "isEnabled": true, "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_56", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_10512", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], + "responseCodes": [], "code": { - "id": "AliasCode_9755", + "id": "AliasCode_10016", "standardCode": { - "id": "Code_10511", + "id": "Code_10772", "extensionAttributes": [], - "code": "C70713", + "code": "C117419", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", + "decode": "Tumor Results Reference Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7769,23 +14010,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_344", + "id": "BiomedicalConceptProperty_524", "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, + "name": "Tumor Results Link Group", + "label": "Tumor Results Link Group", + "isRequired": true, "isEnabled": true, - "datatype": "boolean", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9757", + "id": "AliasCode_10017", "standardCode": { - "id": "Code_10513", + "id": "Code_10773", "extensionAttributes": [], - "code": "C93566", + "code": "C117412", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", + "decode": "Tumor Results Link Group", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7794,85 +14035,73 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_345", + "id": "BiomedicalConceptProperty_525", "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, + "name": "Tumor Results Link Identifier", + "label": "Tumor Results Link Identifier", + "isRequired": true, "isEnabled": true, - "datatype": "datetime", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9758", + "id": "AliasCode_10018", "standardCode": { - "id": "Code_10514", + "id": "Code_10774", "extensionAttributes": [], - "code": "C82515", + "code": "C117413", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", + "decode": "Tumor Results Link Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" }, "notes": [], "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5695", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5774", + }, + { + "id": "BiomedicalConceptProperty_526", "extensionAttributes": [], - "code": "C62656", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Prothrombin Time", - "instanceType": "Code" + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_10019", + "standardCode": { + "id": "Code_10775", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_53", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_21", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/INRBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "International Normalized Ratio of Prothrombin Time", - "label": "International Normalized Ratio of Prothrombin Time", - "synonyms": [ - "INR", - "Prothrombin Intl. Normalized Ratio" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64805", - "properties": [ { - "id": "BiomedicalConceptProperty_346", + "id": "BiomedicalConceptProperty_527", "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "isRequired": true, "isEnabled": true, - "datatype": "integer", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9759", + "id": "AliasCode_10020", "standardCode": { - "id": "Code_10515", + "id": "Code_10776", "extensionAttributes": [], - "code": "C70856", + "code": "C117043", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", + "decode": "Evaluator Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7881,40 +14110,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_347", + "id": "BiomedicalConceptProperty_528", "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, + "name": "Evaluator", + "label": "Evaluator", + "isRequired": true, "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_57", - "instanceType": "ResponseCode", - "name": "RATIO", - "label": "RATIO", - "isEnabled": true, - "code": { - "id": "Code_10517", - "extensionAttributes": [], - "code": "C44256", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "RATIO", - "instanceType": "Code" - } - } - ], + "datatype": "string", + "responseCodes": [], "code": { - "id": "AliasCode_9760", + "id": "AliasCode_10021", "standardCode": { - "id": "Code_10516", + "id": "Code_10777", "extensionAttributes": [], - "code": "C42574", + "code": "C51824", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", + "decode": "Evaluator", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7923,40 +14135,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_348", + "id": "BiomedicalConceptProperty_529", "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, + "name": "Test Method", + "label": "Test Method", + "isRequired": true, "isEnabled": true, "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_58", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_10519", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], + "responseCodes": [], "code": { - "id": "AliasCode_9762", + "id": "AliasCode_10022", "standardCode": { - "id": "Code_10518", + "id": "Code_10778", "extensionAttributes": [], - "code": "C70713", + "code": "C82535", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", + "decode": "Test Method", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7965,23 +14160,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_349", + "id": "BiomedicalConceptProperty_530", "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, + "name": "Unit of Length", + "label": "Unit of Length", + "isRequired": true, "isEnabled": true, - "datatype": "datetime", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9764", + "id": "AliasCode_10023", "standardCode": { - "id": "Code_10520", + "id": "Code_10779", "extensionAttributes": [], - "code": "C82515", + "code": "C42578", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", + "decode": "Unit of Length", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -7991,15 +14186,15 @@ } ], "code": { - "id": "AliasCode_5696", + "id": "AliasCode_9930", "extensionAttributes": [], "standardCode": { - "id": "Code_5775", + "id": "Code_10686", "extensionAttributes": [], - "code": "C64805", + "code": "C96684", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "International Normalized Ratio of Prothrombin Time", + "codeSystemVersion": "2026-05-26", + "decode": "Longest Diameter", "instanceType": "Code" }, "standardCodeAliases": [], @@ -8009,40 +14204,41 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_54", + "id": "BiomedicalConcept_95", "extensionAttributes": [ { - "id": "ExtensionAttribute_22", + "id": "ExtensionAttribute_59", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/APTTBLD", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/LPERP_RECIST1_1", "instanceType": "ExtensionAttribute" } ], - "name": "Activated Partial Thromboplastin Time", - "label": "Activated Partial Thromboplastin Time", + "name": "Longest Perpendicular", + "label": "Longest Perpendicular", "synonyms": [ - "APTT" + "LPERP", + "Short Axis Diameter" ], - "reference": "/mdr/bc/biomedicalconcepts/C38462", + "reference": "/mdr/bc/biomedicalconcepts/C96685", "properties": [ { - "id": "BiomedicalConceptProperty_350", + "id": "BiomedicalConceptProperty_531", "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "isRequired": true, "isEnabled": true, - "datatype": "integer", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9765", + "id": "AliasCode_10024", "standardCode": { - "id": "Code_10521", + "id": "Code_10780", "extensionAttributes": [], - "code": "C70856", + "code": "C117043", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", + "decode": "Evaluator Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -8051,40 +14247,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_351", + "id": "BiomedicalConceptProperty_532", "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, + "name": "Evaluator", + "label": "Evaluator", + "isRequired": true, "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_59", - "instanceType": "ResponseCode", - "name": "s", - "label": "s", - "isEnabled": true, - "code": { - "id": "Code_10523", - "extensionAttributes": [], - "code": "C42535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "s", - "instanceType": "Code" - } - } - ], + "datatype": "string", + "responseCodes": [], "code": { - "id": "AliasCode_9766", + "id": "AliasCode_10025", "standardCode": { - "id": "Code_10522", + "id": "Code_10781", "extensionAttributes": [], - "code": "C42574", + "code": "C51824", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", + "decode": "Evaluator", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -8093,40 +14272,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_352", + "id": "BiomedicalConceptProperty_533", "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, + "name": "Tumor Results Reference Identifier", + "label": "Tumor Results Reference Identifier", + "isRequired": true, "isEnabled": true, "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_60", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_10525", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], + "responseCodes": [], "code": { - "id": "AliasCode_9768", + "id": "AliasCode_10026", "standardCode": { - "id": "Code_10524", + "id": "Code_10782", "extensionAttributes": [], - "code": "C70713", + "code": "C117419", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", + "decode": "Tumor Results Reference Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -8135,84 +14297,48 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_353", + "id": "BiomedicalConceptProperty_534", "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, + "name": "Tumor Results Link Group", + "label": "Tumor Results Link Group", + "isRequired": true, "isEnabled": true, - "datatype": "datetime", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9770", + "id": "AliasCode_10027", "standardCode": { - "id": "Code_10526", + "id": "Code_10783", "extensionAttributes": [], - "code": "C82515", + "code": "C117412", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", + "decode": "Tumor Results Link Group", "instanceType": "Code" }, "instanceType": "AliasCode" }, "notes": [], "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_9909", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10665", - "extensionAttributes": [], - "code": "C38462", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Activated Partial Thromboplastin Time", - "instanceType": "Code" }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_55", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_23", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/GLUCBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Glucose Measurement", - "label": "Glucose Measurement", - "synonyms": [ - "Glucose" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105585", - "properties": [ { - "id": "BiomedicalConceptProperty_354", + "id": "BiomedicalConceptProperty_535", "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, + "name": "Tumor Results Link Identifier", + "label": "Tumor Results Link Identifier", + "isRequired": true, "isEnabled": true, - "datatype": "float", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9771", + "id": "AliasCode_10028", "standardCode": { - "id": "Code_10527", + "id": "Code_10784", "extensionAttributes": [], - "code": "C70856", + "code": "C117413", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", + "decode": "Tumor Results Link Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -8221,23 +14347,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_355", + "id": "BiomedicalConceptProperty_536", "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, + "name": "Observation Result", + "label": "Observation Result", + "isRequired": true, "isEnabled": true, - "datatype": "text", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9772", + "id": "AliasCode_10029", "standardCode": { - "id": "Code_10528", + "id": "Code_10785", "extensionAttributes": [], - "code": "C48207", + "code": "C70856", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", + "decode": "Observation Result", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -8246,40 +14372,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_356", + "id": "BiomedicalConceptProperty_537", "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, + "name": "Unit of Length", + "label": "Unit of Length", + "isRequired": true, "isEnabled": true, "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_61", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_10530", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], + "responseCodes": [], "code": { - "id": "AliasCode_9773", + "id": "AliasCode_10030", "standardCode": { - "id": "Code_10529", + "id": "Code_10786", "extensionAttributes": [], - "code": "C70713", + "code": "C42578", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", + "decode": "Unit of Length", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -8288,23 +14397,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_357", + "id": "BiomedicalConceptProperty_538", "extensionAttributes": [], - "name": "LBMETHOD", - "label": "LBMETHOD", - "isRequired": false, + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, "isEnabled": true, - "datatype": "string", + "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9775", + "id": "AliasCode_10031", "standardCode": { - "id": "Code_10531", + "id": "Code_10787", "extensionAttributes": [], - "code": "C82535", + "code": "C82515", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Test Method", + "decode": "Collection Date Time", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -8313,23 +14422,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_358", + "id": "BiomedicalConceptProperty_539", "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, + "name": "Tumor Results Group Identifier", + "label": "Tumor Results Group Identifier", + "isRequired": true, "isEnabled": true, - "datatype": "boolean", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9776", + "id": "AliasCode_10032", "standardCode": { - "id": "Code_10532", + "id": "Code_10788", "extensionAttributes": [], - "code": "C93566", + "code": "C117411", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", + "decode": "Tumor Results Group Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -8338,23 +14447,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_359", + "id": "BiomedicalConceptProperty_540", "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, + "name": "Test Method", + "label": "Test Method", + "isRequired": true, "isEnabled": true, - "datatype": "datetime", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9777", + "id": "AliasCode_10033", "standardCode": { - "id": "Code_10533", + "id": "Code_10789", "extensionAttributes": [], - "code": "C82515", + "code": "C82535", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", + "decode": "Test Method", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -8364,15 +14473,15 @@ } ], "code": { - "id": "AliasCode_9910", + "id": "AliasCode_9931", "extensionAttributes": [], "standardCode": { - "id": "Code_10666", + "id": "Code_10687", "extensionAttributes": [], - "code": "C105585", + "code": "C96685", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement", + "codeSystemVersion": "2026-05-26", + "decode": "Longest Perpendicular", "instanceType": "Code" }, "standardCodeAliases": [], @@ -8382,25 +14491,25 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_56", + "id": "BiomedicalConcept_96", "extensionAttributes": [ { - "id": "ExtensionAttribute_24", + "id": "ExtensionAttribute_14", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TRIGSERPL", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PHURIN", "instanceType": "ExtensionAttribute" } ], - "name": "Triglyceride Measurement", - "label": "Triglyceride Measurement", + "name": "pH", + "label": "pH", "synonyms": [ - "TRIG", - "Triglycerides" + "PH", + "potential of Hydrogen" ], - "reference": "/mdr/bc/biomedicalconcepts/C64812", + "reference": "/mdr/bc/biomedicalconcepts/C45997", "properties": [ { - "id": "BiomedicalConceptProperty_360", + "id": "BiomedicalConceptProperty_541", "extensionAttributes": [], "name": "LBORRES", "label": "LBORRES", @@ -8409,9 +14518,9 @@ "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9778", + "id": "AliasCode_10037", "standardCode": { - "id": "Code_10534", + "id": "Code_10793", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -8425,32 +14534,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_361", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9779", - "standardCode": { - "id": "Code_10535", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_362", + "id": "BiomedicalConceptProperty_542", "extensionAttributes": [], "name": "LBSPEC", "label": "LBSPEC", @@ -8459,26 +14543,26 @@ "datatype": "string", "responseCodes": [ { - "id": "ResponseCode_62", + "id": "ResponseCode_79", "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", + "name": "URINE", + "label": "URINE", "isEnabled": true, "code": { - "id": "Code_10537", + "id": "Code_10795", "extensionAttributes": [], - "code": "C105706", + "code": "C13283", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", + "decode": "URINE", "instanceType": "Code" } } ], "code": { - "id": "AliasCode_9780", + "id": "AliasCode_10038", "standardCode": { - "id": "Code_10536", + "id": "Code_10794", "extensionAttributes": [], "code": "C70713", "codeSystem": "http://www.cdisc.org", @@ -8492,7 +14576,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_363", + "id": "BiomedicalConceptProperty_543", "extensionAttributes": [], "name": "LBFAST", "label": "LBFAST", @@ -8501,9 +14585,9 @@ "datatype": "boolean", "responseCodes": [], "code": { - "id": "AliasCode_9782", + "id": "AliasCode_10040", "standardCode": { - "id": "Code_10538", + "id": "Code_10796", "extensionAttributes": [], "code": "C93566", "codeSystem": "http://www.cdisc.org", @@ -8517,7 +14601,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_364", + "id": "BiomedicalConceptProperty_544", "extensionAttributes": [], "name": "LBDTC", "label": "LBDTC", @@ -8526,9 +14610,9 @@ "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9783", + "id": "AliasCode_10041", "standardCode": { - "id": "Code_10539", + "id": "Code_10797", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", @@ -8543,15 +14627,15 @@ } ], "code": { - "id": "AliasCode_9911", + "id": "AliasCode_10034", "extensionAttributes": [], "standardCode": { - "id": "Code_10667", + "id": "Code_10790", "extensionAttributes": [], - "code": "C64812", + "code": "C45997", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Triglyceride Measurement", + "decode": "pH", "instanceType": "Code" }, "standardCodeAliases": [], @@ -8561,37 +14645,36 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_57", + "id": "BiomedicalConcept_97", "extensionAttributes": [ { - "id": "ExtensionAttribute_25", + "id": "ExtensionAttribute_15", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CHOLSERPL", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/COLORURIN", "instanceType": "ExtensionAttribute" } ], - "name": "Cholesterol Measurement", - "label": "Cholesterol Measurement", + "name": "Color Assessment", + "label": "Color Assessment", "synonyms": [ - "CHOL", - "Cholesterol", - "Total Cholesterol" + "COLOR", + "Color" ], - "reference": "/mdr/bc/biomedicalconcepts/C105586", + "reference": "/mdr/bc/biomedicalconcepts/C64546", "properties": [ { - "id": "BiomedicalConceptProperty_365", + "id": "BiomedicalConceptProperty_545", "extensionAttributes": [], "name": "LBORRES", "label": "LBORRES", "isRequired": false, "isEnabled": true, - "datatype": "float", + "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9784", + "id": "AliasCode_10042", "standardCode": { - "id": "Code_10540", + "id": "Code_10798", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -8605,32 +14688,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_366", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9785", - "standardCode": { - "id": "Code_10541", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_367", + "id": "BiomedicalConceptProperty_546", "extensionAttributes": [], "name": "LBSPEC", "label": "LBSPEC", @@ -8639,56 +14697,31 @@ "datatype": "string", "responseCodes": [ { - "id": "ResponseCode_63", + "id": "ResponseCode_80", "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", + "name": "URINE", + "label": "URINE", "isEnabled": true, "code": { - "id": "Code_10543", + "id": "Code_10800", "extensionAttributes": [], - "code": "C105706", + "code": "C13283", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9786", - "standardCode": { - "id": "Code_10542", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_368", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], + "codeSystemVersion": "2026-05-26", + "decode": "URINE", + "instanceType": "Code" + } + } + ], "code": { - "id": "AliasCode_9788", + "id": "AliasCode_10043", "standardCode": { - "id": "Code_10544", + "id": "Code_10799", "extensionAttributes": [], - "code": "C93566", + "code": "C70713", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", + "decode": "Biospecimen Type", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -8697,7 +14730,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_369", + "id": "BiomedicalConceptProperty_547", "extensionAttributes": [], "name": "LBDTC", "label": "LBDTC", @@ -8706,9 +14739,9 @@ "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9789", + "id": "AliasCode_10045", "standardCode": { - "id": "Code_10545", + "id": "Code_10801", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", @@ -8723,15 +14756,15 @@ } ], "code": { - "id": "AliasCode_534", + "id": "AliasCode_10035", "extensionAttributes": [], "standardCode": { - "id": "Code_574", + "id": "Code_10791", "extensionAttributes": [], - "code": "C105586", + "code": "C64546", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Cholesterol Measurement", + "codeSystemVersion": "2025-11-18", + "decode": "Color Assessment", "instanceType": "Code" }, "standardCodeAliases": [], @@ -8741,25 +14774,24 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_58", + "id": "BiomedicalConcept_98", "extensionAttributes": [ { - "id": "ExtensionAttribute_26", + "id": "ExtensionAttribute_16", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HDLSERPL", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/SPGRAVURIN", "instanceType": "ExtensionAttribute" } ], - "name": "High Density Lipoprotein Cholesterol Measurement", - "label": "High Density Lipoprotein Cholesterol Measurement", + "name": "Specific Gravity", + "label": "Specific Gravity", "synonyms": [ - "HDL", - "HDL Cholesterol" + "SPGRAV" ], - "reference": "/mdr/bc/biomedicalconcepts/C105587", + "reference": "/mdr/bc/biomedicalconcepts/C64832", "properties": [ { - "id": "BiomedicalConceptProperty_370", + "id": "BiomedicalConceptProperty_548", "extensionAttributes": [], "name": "LBORRES", "label": "LBORRES", @@ -8768,9 +14800,9 @@ "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9790", + "id": "AliasCode_10046", "standardCode": { - "id": "Code_10546", + "id": "Code_10802", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -8784,32 +14816,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_371", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9791", - "standardCode": { - "id": "Code_10547", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_372", + "id": "BiomedicalConceptProperty_549", "extensionAttributes": [], "name": "LBSPEC", "label": "LBSPEC", @@ -8818,26 +14825,26 @@ "datatype": "string", "responseCodes": [ { - "id": "ResponseCode_64", + "id": "ResponseCode_81", "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", + "name": "URINE", + "label": "URINE", "isEnabled": true, "code": { - "id": "Code_10549", + "id": "Code_10804", "extensionAttributes": [], - "code": "C105706", + "code": "C13283", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", + "decode": "URINE", "instanceType": "Code" } } ], "code": { - "id": "AliasCode_9792", + "id": "AliasCode_10047", "standardCode": { - "id": "Code_10548", + "id": "Code_10803", "extensionAttributes": [], "code": "C70713", "codeSystem": "http://www.cdisc.org", @@ -8851,7 +14858,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_373", + "id": "BiomedicalConceptProperty_550", "extensionAttributes": [], "name": "LBFAST", "label": "LBFAST", @@ -8860,9 +14867,9 @@ "datatype": "boolean", "responseCodes": [], "code": { - "id": "AliasCode_9794", + "id": "AliasCode_10049", "standardCode": { - "id": "Code_10550", + "id": "Code_10805", "extensionAttributes": [], "code": "C93566", "codeSystem": "http://www.cdisc.org", @@ -8876,7 +14883,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_374", + "id": "BiomedicalConceptProperty_551", "extensionAttributes": [], "name": "LBDTC", "label": "LBDTC", @@ -8885,9 +14892,9 @@ "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9795", + "id": "AliasCode_10050", "standardCode": { - "id": "Code_10551", + "id": "Code_10806", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", @@ -8902,15 +14909,15 @@ } ], "code": { - "id": "AliasCode_5697", + "id": "AliasCode_10036", "extensionAttributes": [], "standardCode": { - "id": "Code_5776", + "id": "Code_10792", "extensionAttributes": [], - "code": "C105587", + "code": "C64832", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "High Density Lipoprotein Cholesterol Measurement", + "decode": "Specific Gravity", "instanceType": "Code" }, "standardCodeAliases": [], @@ -8920,25 +14927,28 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_59", + "id": "BiomedicalConcept_99", "extensionAttributes": [ { - "id": "ExtensionAttribute_27", + "id": "ExtensionAttribute_62", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/LDLSERPL", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/HCTBLD", "instanceType": "ExtensionAttribute" } ], - "name": "Low Density Lipoprotein Cholesterol Measurement", - "label": "Low Density Lipoprotein Cholesterol Measurement", + "name": "Hematocrit Measurement", + "label": "Hematocrit Measurement", "synonyms": [ - "LDL", - "LDL Cholesterol" + "Hematocrit", + "Packed Cell Volume", + "PCV", + "Erythrocyte Volume Fraction", + "EVF" ], - "reference": "/mdr/bc/biomedicalconcepts/C105588", + "reference": "/mdr/bc/biomedicalconcepts/C64796", "properties": [ { - "id": "BiomedicalConceptProperty_375", + "id": "BiomedicalConceptProperty_584", "extensionAttributes": [], "name": "LBORRES", "label": "LBORRES", @@ -8947,9 +14957,9 @@ "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9796", + "id": "AliasCode_10107", "standardCode": { - "id": "Code_10552", + "id": "Code_10863", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -8963,7 +14973,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_376", + "id": "BiomedicalConceptProperty_585", "extensionAttributes": [], "name": "LBORRESU", "label": "LBORRESU", @@ -8972,14 +14982,14 @@ "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9797", + "id": "AliasCode_10108", "standardCode": { - "id": "Code_10553", + "id": "Code_10864", "extensionAttributes": [], - "code": "C48207", + "code": "C69174", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", + "decode": "Unit of Volume Fraction", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -8988,7 +14998,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_377", + "id": "BiomedicalConceptProperty_586", "extensionAttributes": [], "name": "LBSPEC", "label": "LBSPEC", @@ -8997,26 +15007,26 @@ "datatype": "string", "responseCodes": [ { - "id": "ResponseCode_65", + "id": "ResponseCode_82", "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", + "name": "BLOOD", + "label": "BLOOD", "isEnabled": true, "code": { - "id": "Code_10555", + "id": "Code_10866", "extensionAttributes": [], - "code": "C105706", + "code": "C12434", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", + "decode": "BLOOD", "instanceType": "Code" } } ], "code": { - "id": "AliasCode_9798", + "id": "AliasCode_10109", "standardCode": { - "id": "Code_10554", + "id": "Code_10865", "extensionAttributes": [], "code": "C70713", "codeSystem": "http://www.cdisc.org", @@ -9030,7 +15040,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_378", + "id": "BiomedicalConceptProperty_587", "extensionAttributes": [], "name": "LBFAST", "label": "LBFAST", @@ -9039,9 +15049,9 @@ "datatype": "boolean", "responseCodes": [], "code": { - "id": "AliasCode_9800", + "id": "AliasCode_10111", "standardCode": { - "id": "Code_10556", + "id": "Code_10867", "extensionAttributes": [], "code": "C93566", "codeSystem": "http://www.cdisc.org", @@ -9055,7 +15065,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_379", + "id": "BiomedicalConceptProperty_588", "extensionAttributes": [], "name": "LBDTC", "label": "LBDTC", @@ -9064,9 +15074,9 @@ "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9801", + "id": "AliasCode_10112", "standardCode": { - "id": "Code_10557", + "id": "Code_10868", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", @@ -9081,41 +15091,15 @@ } ], "code": { - "id": "AliasCode_7397", + "id": "AliasCode_10051", "extensionAttributes": [], "standardCode": { - "id": "Code_7476", + "id": "Code_10807", "extensionAttributes": [], - "code": "C105588", + "code": "C64796", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Low Density Lipoprotein Cholesterol Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_60", - "extensionAttributes": [], - "name": "ECOG Clinical Classification Question", - "label": "ECOG Clinical Classification Question", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C101874", - "properties": [], - "code": { - "id": "AliasCode_9912", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10668", - "extensionAttributes": [], - "code": "C101874", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "ECOG Clinical Classification Question", + "decode": "Hematocrit Measurement", "instanceType": "Code" }, "standardCodeAliases": [], @@ -9125,25 +15109,25 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_61", + "id": "BiomedicalConcept_100", "extensionAttributes": [ { - "id": "ExtensionAttribute_28", + "id": "ExtensionAttribute_63", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/WBCBLD", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/HGBBLD", "instanceType": "ExtensionAttribute" } ], - "name": "Leukocyte Count", - "label": "Leukocyte Count", + "name": "Hemoglobin Measurement", + "label": "Hemoglobin Measurement", "synonyms": [ - "WBC", - "White Blood Cells" + "Hemoglobin", + "HGB" ], - "reference": "/mdr/bc/biomedicalconcepts/C51948", + "reference": "/mdr/bc/biomedicalconcepts/C64848", "properties": [ { - "id": "BiomedicalConceptProperty_380", + "id": "BiomedicalConceptProperty_589", "extensionAttributes": [], "name": "LBORRES", "label": "LBORRES", @@ -9152,9 +15136,9 @@ "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9802", + "id": "AliasCode_10113", "standardCode": { - "id": "Code_10558", + "id": "Code_10869", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -9168,7 +15152,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_381", + "id": "BiomedicalConceptProperty_590", "extensionAttributes": [], "name": "LBORRESU", "label": "LBORRESU", @@ -9177,14 +15161,14 @@ "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9803", + "id": "AliasCode_10114", "standardCode": { - "id": "Code_10559", + "id": "Code_10870", "extensionAttributes": [], - "code": "C67391", + "code": "C64571", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", + "decode": "Unit of Mass Concentration", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -9193,7 +15177,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_382", + "id": "BiomedicalConceptProperty_591", "extensionAttributes": [], "name": "LBSPEC", "label": "LBSPEC", @@ -9202,13 +15186,13 @@ "datatype": "string", "responseCodes": [ { - "id": "ResponseCode_66", + "id": "ResponseCode_83", "instanceType": "ResponseCode", "name": "BLOOD", "label": "BLOOD", "isEnabled": true, "code": { - "id": "Code_10561", + "id": "Code_10872", "extensionAttributes": [], "code": "C12434", "codeSystem": "http://www.cdisc.org", @@ -9219,9 +15203,9 @@ } ], "code": { - "id": "AliasCode_9804", + "id": "AliasCode_10115", "standardCode": { - "id": "Code_10560", + "id": "Code_10871", "extensionAttributes": [], "code": "C70713", "codeSystem": "http://www.cdisc.org", @@ -9235,7 +15219,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_383", + "id": "BiomedicalConceptProperty_592", "extensionAttributes": [], "name": "LBFAST", "label": "LBFAST", @@ -9244,9 +15228,9 @@ "datatype": "boolean", "responseCodes": [], "code": { - "id": "AliasCode_9806", + "id": "AliasCode_10117", "standardCode": { - "id": "Code_10562", + "id": "Code_10873", "extensionAttributes": [], "code": "C93566", "codeSystem": "http://www.cdisc.org", @@ -9260,7 +15244,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_384", + "id": "BiomedicalConceptProperty_593", "extensionAttributes": [], "name": "LBDTC", "label": "LBDTC", @@ -9269,9 +15253,9 @@ "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9807", + "id": "AliasCode_10118", "standardCode": { - "id": "Code_10563", + "id": "Code_10874", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", @@ -9286,15 +15270,15 @@ } ], "code": { - "id": "AliasCode_5698", + "id": "AliasCode_10052", "extensionAttributes": [], "standardCode": { - "id": "Code_5777", + "id": "Code_10808", "extensionAttributes": [], - "code": "C51948", + "code": "C64848", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Leukocyte Count", + "codeSystemVersion": "2025-07-01", + "decode": "Hemoglobin Measurement", "instanceType": "Code" }, "standardCodeAliases": [], @@ -9304,25 +15288,25 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_62", + "id": "BiomedicalConcept_101", "extensionAttributes": [ { - "id": "ExtensionAttribute_29", + "id": "ExtensionAttribute_64", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RBCBLD", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/MCH", "instanceType": "ExtensionAttribute" } ], - "name": "Erythrocyte Count", - "label": "Erythrocyte Count", + "name": "Erythrocyte Mean Corpuscular Hemoglobin", + "label": "Erythrocyte Mean Corpuscular Hemoglobin", "synonyms": [ - "RBC", - "Red Blood Cells" + "RBC Mean Corpuscular Hemoglobin", + "MCH" ], - "reference": "/mdr/bc/biomedicalconcepts/C51946", + "reference": "/mdr/bc/biomedicalconcepts/C64797", "properties": [ { - "id": "BiomedicalConceptProperty_385", + "id": "BiomedicalConceptProperty_594", "extensionAttributes": [], "name": "LBORRES", "label": "LBORRES", @@ -9331,9 +15315,9 @@ "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9808", + "id": "AliasCode_10119", "standardCode": { - "id": "Code_10564", + "id": "Code_10875", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -9347,7 +15331,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_386", + "id": "BiomedicalConceptProperty_595", "extensionAttributes": [], "name": "LBORRESU", "label": "LBORRESU", @@ -9356,14 +15340,14 @@ "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9809", + "id": "AliasCode_10120", "standardCode": { - "id": "Code_10565", + "id": "Code_10876", "extensionAttributes": [], - "code": "C67391", + "code": "C25709", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", + "decode": "Unit of Measure", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -9372,7 +15356,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_387", + "id": "BiomedicalConceptProperty_596", "extensionAttributes": [], "name": "LBSPEC", "label": "LBSPEC", @@ -9381,26 +15365,26 @@ "datatype": "string", "responseCodes": [ { - "id": "ResponseCode_67", + "id": "ResponseCode_84", "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", + "name": "ERYTHROCYTES", + "label": "ERYTHROCYTES", "isEnabled": true, "code": { - "id": "Code_10567", + "id": "Code_10878", "extensionAttributes": [], - "code": "C12434", + "code": "C12521", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", + "decode": "ERYTHROCYTES", "instanceType": "Code" } } ], "code": { - "id": "AliasCode_9810", + "id": "AliasCode_10121", "standardCode": { - "id": "Code_10566", + "id": "Code_10877", "extensionAttributes": [], "code": "C70713", "codeSystem": "http://www.cdisc.org", @@ -9414,7 +15398,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_388", + "id": "BiomedicalConceptProperty_597", "extensionAttributes": [], "name": "LBFAST", "label": "LBFAST", @@ -9423,9 +15407,9 @@ "datatype": "boolean", "responseCodes": [], "code": { - "id": "AliasCode_9812", + "id": "AliasCode_10123", "standardCode": { - "id": "Code_10568", + "id": "Code_10879", "extensionAttributes": [], "code": "C93566", "codeSystem": "http://www.cdisc.org", @@ -9439,7 +15423,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_389", + "id": "BiomedicalConceptProperty_598", "extensionAttributes": [], "name": "LBDTC", "label": "LBDTC", @@ -9448,9 +15432,9 @@ "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9813", + "id": "AliasCode_10124", "standardCode": { - "id": "Code_10569", + "id": "Code_10880", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", @@ -9465,15 +15449,15 @@ } ], "code": { - "id": "AliasCode_9913", + "id": "AliasCode_10053", "extensionAttributes": [], "standardCode": { - "id": "Code_10669", + "id": "Code_10809", "extensionAttributes": [], - "code": "C51946", + "code": "C64797", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Erythrocyte Count", + "codeSystemVersion": "2025-07-01", + "decode": "Erythrocyte Mean Corpuscular Hemoglobin", "instanceType": "Code" }, "standardCodeAliases": [], @@ -9483,26 +15467,24 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_63", + "id": "BiomedicalConcept_102", "extensionAttributes": [ { - "id": "ExtensionAttribute_30", + "id": "ExtensionAttribute_65", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PLATBLD", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/LYMPHBLD", "instanceType": "ExtensionAttribute" } ], - "name": "Platelet Count", - "label": "Platelet Count", + "name": "Lymphocyte Count", + "label": "Lymphocyte Count", "synonyms": [ - "Thrombocytes", - "Platelets", - "Anucleated Thrombocytes" + "Lymphocytes" ], - "reference": "/mdr/bc/biomedicalconcepts/C51951", + "reference": "/mdr/bc/biomedicalconcepts/C51949", "properties": [ { - "id": "BiomedicalConceptProperty_390", + "id": "BiomedicalConceptProperty_599", "extensionAttributes": [], "name": "LBORRES", "label": "LBORRES", @@ -9511,9 +15493,9 @@ "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9814", + "id": "AliasCode_10125", "standardCode": { - "id": "Code_10570", + "id": "Code_10881", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -9527,7 +15509,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_391", + "id": "BiomedicalConceptProperty_600", "extensionAttributes": [], "name": "LBORRESU", "label": "LBORRESU", @@ -9536,9 +15518,9 @@ "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9815", + "id": "AliasCode_10126", "standardCode": { - "id": "Code_10571", + "id": "Code_10882", "extensionAttributes": [], "code": "C67391", "codeSystem": "http://www.cdisc.org", @@ -9552,7 +15534,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_392", + "id": "BiomedicalConceptProperty_601", "extensionAttributes": [], "name": "LBSPEC", "label": "LBSPEC", @@ -9561,13 +15543,13 @@ "datatype": "string", "responseCodes": [ { - "id": "ResponseCode_68", + "id": "ResponseCode_85", "instanceType": "ResponseCode", "name": "BLOOD", "label": "BLOOD", "isEnabled": true, "code": { - "id": "Code_10573", + "id": "Code_10884", "extensionAttributes": [], "code": "C12434", "codeSystem": "http://www.cdisc.org", @@ -9578,9 +15560,9 @@ } ], "code": { - "id": "AliasCode_9816", + "id": "AliasCode_10127", "standardCode": { - "id": "Code_10572", + "id": "Code_10883", "extensionAttributes": [], "code": "C70713", "codeSystem": "http://www.cdisc.org", @@ -9594,7 +15576,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_393", + "id": "BiomedicalConceptProperty_602", "extensionAttributes": [], "name": "LBFAST", "label": "LBFAST", @@ -9603,9 +15585,9 @@ "datatype": "boolean", "responseCodes": [], "code": { - "id": "AliasCode_9818", + "id": "AliasCode_10129", "standardCode": { - "id": "Code_10574", + "id": "Code_10885", "extensionAttributes": [], "code": "C93566", "codeSystem": "http://www.cdisc.org", @@ -9619,7 +15601,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_394", + "id": "BiomedicalConceptProperty_603", "extensionAttributes": [], "name": "LBDTC", "label": "LBDTC", @@ -9628,9 +15610,9 @@ "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9819", + "id": "AliasCode_10130", "standardCode": { - "id": "Code_10575", + "id": "Code_10886", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", @@ -9645,15 +15627,15 @@ } ], "code": { - "id": "AliasCode_5699", + "id": "AliasCode_10054", "extensionAttributes": [], "standardCode": { - "id": "Code_5778", + "id": "Code_10810", "extensionAttributes": [], - "code": "C51951", + "code": "C51949", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Platelet Count", + "decode": "Lymphocyte Count", "instanceType": "Code" }, "standardCodeAliases": [], @@ -9663,25 +15645,24 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_64", + "id": "BiomedicalConcept_103", "extensionAttributes": [ { - "id": "ExtensionAttribute_31", + "id": "ExtensionAttribute_66", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/KBLD", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/MONOBLD", "instanceType": "ExtensionAttribute" } ], - "name": "Potassium Measurement", - "label": "Potassium Measurement", + "name": "Monocyte Count", + "label": "Monocyte Count", "synonyms": [ - "Potassium", - "K" + "Monocytes" ], - "reference": "/mdr/bc/biomedicalconcepts/C64853", + "reference": "/mdr/bc/biomedicalconcepts/C64823", "properties": [ { - "id": "BiomedicalConceptProperty_395", + "id": "BiomedicalConceptProperty_604", "extensionAttributes": [], "name": "LBORRES", "label": "LBORRES", @@ -9690,9 +15671,9 @@ "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9820", + "id": "AliasCode_10131", "standardCode": { - "id": "Code_10576", + "id": "Code_10887", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -9706,7 +15687,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_396", + "id": "BiomedicalConceptProperty_605", "extensionAttributes": [], "name": "LBORRESU", "label": "LBORRESU", @@ -9715,14 +15696,14 @@ "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9821", + "id": "AliasCode_10132", "standardCode": { - "id": "Code_10577", + "id": "Code_10888", "extensionAttributes": [], - "code": "C64567", + "code": "C67391", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", + "decode": "Unit of Number Concentration", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -9731,7 +15712,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_397", + "id": "BiomedicalConceptProperty_606", "extensionAttributes": [], "name": "LBSPEC", "label": "LBSPEC", @@ -9740,13 +15721,13 @@ "datatype": "string", "responseCodes": [ { - "id": "ResponseCode_69", + "id": "ResponseCode_86", "instanceType": "ResponseCode", "name": "BLOOD", "label": "BLOOD", "isEnabled": true, "code": { - "id": "Code_10579", + "id": "Code_10890", "extensionAttributes": [], "code": "C12434", "codeSystem": "http://www.cdisc.org", @@ -9757,9 +15738,9 @@ } ], "code": { - "id": "AliasCode_9822", + "id": "AliasCode_10133", "standardCode": { - "id": "Code_10578", + "id": "Code_10889", "extensionAttributes": [], "code": "C70713", "codeSystem": "http://www.cdisc.org", @@ -9773,7 +15754,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_398", + "id": "BiomedicalConceptProperty_607", "extensionAttributes": [], "name": "LBFAST", "label": "LBFAST", @@ -9782,9 +15763,9 @@ "datatype": "boolean", "responseCodes": [], "code": { - "id": "AliasCode_9824", + "id": "AliasCode_10135", "standardCode": { - "id": "Code_10580", + "id": "Code_10891", "extensionAttributes": [], "code": "C93566", "codeSystem": "http://www.cdisc.org", @@ -9798,7 +15779,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_399", + "id": "BiomedicalConceptProperty_608", "extensionAttributes": [], "name": "LBDTC", "label": "LBDTC", @@ -9807,9 +15788,9 @@ "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9825", + "id": "AliasCode_10136", "standardCode": { - "id": "Code_10581", + "id": "Code_10892", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", @@ -9824,15 +15805,15 @@ } ], "code": { - "id": "AliasCode_5700", + "id": "AliasCode_10055", "extensionAttributes": [], "standardCode": { - "id": "Code_5779", + "id": "Code_10811", "extensionAttributes": [], - "code": "C64853", + "code": "C64823", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Potassium Measurement", + "decode": "Monocyte Count", "instanceType": "Code" }, "standardCodeAliases": [], @@ -9842,25 +15823,26 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_65", + "id": "BiomedicalConcept_104", "extensionAttributes": [ { - "id": "ExtensionAttribute_32", + "id": "ExtensionAttribute_67", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SODIUMBLD", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/NEUTBLD", "instanceType": "ExtensionAttribute" } ], - "name": "Sodium Measurement", - "label": "Sodium Measurement", + "name": "Absolute Neutrophil Count", + "label": "Absolute Neutrophil Count", "synonyms": [ - "Sodium", - "NA" + "Neutrophils", + "Total Neutrophil Count", + "NEUT" ], - "reference": "/mdr/bc/biomedicalconcepts/C64809", + "reference": "/mdr/bc/biomedicalconcepts/C63321", "properties": [ { - "id": "BiomedicalConceptProperty_400", + "id": "BiomedicalConceptProperty_609", "extensionAttributes": [], "name": "LBORRES", "label": "LBORRES", @@ -9869,9 +15851,9 @@ "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9826", + "id": "AliasCode_10137", "standardCode": { - "id": "Code_10582", + "id": "Code_10893", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -9885,23 +15867,40 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_401", + "id": "BiomedicalConceptProperty_610", "extensionAttributes": [], "name": "LBORRESU", "label": "LBORRESU", "isRequired": false, "isEnabled": true, "datatype": "text", - "responseCodes": [], + "responseCodes": [ + { + "id": "ResponseCode_87", + "instanceType": "ResponseCode", + "name": "10^9/L", + "label": "10^9/L", + "isEnabled": true, + "code": { + "id": "Code_10895", + "extensionAttributes": [], + "code": "C67255", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "10^9/L", + "instanceType": "Code" + } + } + ], "code": { - "id": "AliasCode_9827", + "id": "AliasCode_10138", "standardCode": { - "id": "Code_10583", + "id": "Code_10894", "extensionAttributes": [], - "code": "C64567", + "code": "C67391", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", + "decode": "Unit of Number Concentration", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -9910,7 +15909,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_402", + "id": "BiomedicalConceptProperty_611", "extensionAttributes": [], "name": "LBSPEC", "label": "LBSPEC", @@ -9919,13 +15918,13 @@ "datatype": "string", "responseCodes": [ { - "id": "ResponseCode_70", + "id": "ResponseCode_88", "instanceType": "ResponseCode", "name": "BLOOD", "label": "BLOOD", "isEnabled": true, "code": { - "id": "Code_10585", + "id": "Code_10897", "extensionAttributes": [], "code": "C12434", "codeSystem": "http://www.cdisc.org", @@ -9936,9 +15935,9 @@ } ], "code": { - "id": "AliasCode_9828", + "id": "AliasCode_10140", "standardCode": { - "id": "Code_10584", + "id": "Code_10896", "extensionAttributes": [], "code": "C70713", "codeSystem": "http://www.cdisc.org", @@ -9952,7 +15951,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_403", + "id": "BiomedicalConceptProperty_612", "extensionAttributes": [], "name": "LBFAST", "label": "LBFAST", @@ -9961,9 +15960,9 @@ "datatype": "boolean", "responseCodes": [], "code": { - "id": "AliasCode_9830", + "id": "AliasCode_10142", "standardCode": { - "id": "Code_10586", + "id": "Code_10898", "extensionAttributes": [], "code": "C93566", "codeSystem": "http://www.cdisc.org", @@ -9977,7 +15976,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_404", + "id": "BiomedicalConceptProperty_613", "extensionAttributes": [], "name": "LBDTC", "label": "LBDTC", @@ -9986,9 +15985,9 @@ "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9831", + "id": "AliasCode_10143", "standardCode": { - "id": "Code_10587", + "id": "Code_10899", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", @@ -10003,15 +16002,15 @@ } ], "code": { - "id": "AliasCode_5701", + "id": "AliasCode_10056", "extensionAttributes": [], "standardCode": { - "id": "Code_5780", + "id": "Code_10812", "extensionAttributes": [], - "code": "C64809", + "code": "C63321", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Sodium Measurement", + "decode": "Absolute Neutrophil Count", "instanceType": "Code" }, "standardCodeAliases": [], @@ -10021,25 +16020,25 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_66", + "id": "BiomedicalConcept_105", "extensionAttributes": [ { - "id": "ExtensionAttribute_33", + "id": "ExtensionAttribute_68", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CLBLD", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/BASOBLD", "instanceType": "ExtensionAttribute" } ], - "name": "Chloride Measurement", - "label": "Chloride Measurement", + "name": "Absolute Basophil Count", + "label": "Absolute Basophil Count", "synonyms": [ - "Chloride", - "CL" + "Basophils", + "Total Basophil Count" ], - "reference": "/mdr/bc/biomedicalconcepts/C64495", + "reference": "/mdr/bc/biomedicalconcepts/C64470", "properties": [ { - "id": "BiomedicalConceptProperty_405", + "id": "BiomedicalConceptProperty_614", "extensionAttributes": [], "name": "LBORRES", "label": "LBORRES", @@ -10048,9 +16047,9 @@ "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9832", + "id": "AliasCode_10144", "standardCode": { - "id": "Code_10588", + "id": "Code_10900", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -10064,7 +16063,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_406", + "id": "BiomedicalConceptProperty_615", "extensionAttributes": [], "name": "LBORRESU", "label": "LBORRESU", @@ -10073,14 +16072,14 @@ "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9833", + "id": "AliasCode_10145", "standardCode": { - "id": "Code_10589", + "id": "Code_10901", "extensionAttributes": [], - "code": "C64567", + "code": "C67391", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", + "decode": "Unit of Number Concentration", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -10089,7 +16088,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_407", + "id": "BiomedicalConceptProperty_616", "extensionAttributes": [], "name": "LBSPEC", "label": "LBSPEC", @@ -10098,13 +16097,13 @@ "datatype": "string", "responseCodes": [ { - "id": "ResponseCode_71", + "id": "ResponseCode_89", "instanceType": "ResponseCode", "name": "BLOOD", "label": "BLOOD", "isEnabled": true, "code": { - "id": "Code_10591", + "id": "Code_10903", "extensionAttributes": [], "code": "C12434", "codeSystem": "http://www.cdisc.org", @@ -10115,9 +16114,9 @@ } ], "code": { - "id": "AliasCode_9834", + "id": "AliasCode_10146", "standardCode": { - "id": "Code_10590", + "id": "Code_10902", "extensionAttributes": [], "code": "C70713", "codeSystem": "http://www.cdisc.org", @@ -10131,7 +16130,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_408", + "id": "BiomedicalConceptProperty_617", "extensionAttributes": [], "name": "LBFAST", "label": "LBFAST", @@ -10140,9 +16139,9 @@ "datatype": "boolean", "responseCodes": [], "code": { - "id": "AliasCode_9836", + "id": "AliasCode_10148", "standardCode": { - "id": "Code_10592", + "id": "Code_10904", "extensionAttributes": [], "code": "C93566", "codeSystem": "http://www.cdisc.org", @@ -10156,7 +16155,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_409", + "id": "BiomedicalConceptProperty_618", "extensionAttributes": [], "name": "LBDTC", "label": "LBDTC", @@ -10165,9 +16164,9 @@ "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9837", + "id": "AliasCode_10149", "standardCode": { - "id": "Code_10593", + "id": "Code_10905", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", @@ -10182,15 +16181,15 @@ } ], "code": { - "id": "AliasCode_5702", + "id": "AliasCode_10057", "extensionAttributes": [], "standardCode": { - "id": "Code_5781", + "id": "Code_10813", "extensionAttributes": [], - "code": "C64495", + "code": "C64470", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Chloride Measurement", + "decode": "Absolute Basophil Count", "instanceType": "Code" }, "standardCodeAliases": [], @@ -10200,25 +16199,24 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_67", + "id": "BiomedicalConcept_106", "extensionAttributes": [ { - "id": "ExtensionAttribute_34", + "id": "ExtensionAttribute_69", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CO2BLD", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/EOSBLD", "instanceType": "ExtensionAttribute" } ], - "name": "Carbon Dioxide Measurement", - "label": "Carbon Dioxide Measurement", + "name": "Eosinophil Count", + "label": "Eosinophil Count", "synonyms": [ - "Carbon Dioxide", - "CO2" + "Eosinophils" ], - "reference": "/mdr/bc/biomedicalconcepts/C64545", + "reference": "/mdr/bc/biomedicalconcepts/C64550", "properties": [ { - "id": "BiomedicalConceptProperty_410", + "id": "BiomedicalConceptProperty_619", "extensionAttributes": [], "name": "LBORRES", "label": "LBORRES", @@ -10227,9 +16225,9 @@ "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9838", + "id": "AliasCode_10150", "standardCode": { - "id": "Code_10594", + "id": "Code_10906", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -10243,7 +16241,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_411", + "id": "BiomedicalConceptProperty_620", "extensionAttributes": [], "name": "LBORRESU", "label": "LBORRESU", @@ -10252,14 +16250,14 @@ "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9839", + "id": "AliasCode_10151", "standardCode": { - "id": "Code_10595", + "id": "Code_10907", "extensionAttributes": [], - "code": "C64567", + "code": "C67391", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", + "decode": "Unit of Number Concentration", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -10268,7 +16266,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_412", + "id": "BiomedicalConceptProperty_621", "extensionAttributes": [], "name": "LBSPEC", "label": "LBSPEC", @@ -10277,13 +16275,13 @@ "datatype": "string", "responseCodes": [ { - "id": "ResponseCode_72", + "id": "ResponseCode_90", "instanceType": "ResponseCode", "name": "BLOOD", "label": "BLOOD", "isEnabled": true, "code": { - "id": "Code_10597", + "id": "Code_10909", "extensionAttributes": [], "code": "C12434", "codeSystem": "http://www.cdisc.org", @@ -10294,9 +16292,9 @@ } ], "code": { - "id": "AliasCode_9840", + "id": "AliasCode_10152", "standardCode": { - "id": "Code_10596", + "id": "Code_10908", "extensionAttributes": [], "code": "C70713", "codeSystem": "http://www.cdisc.org", @@ -10310,7 +16308,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_413", + "id": "BiomedicalConceptProperty_622", "extensionAttributes": [], "name": "LBFAST", "label": "LBFAST", @@ -10319,9 +16317,9 @@ "datatype": "boolean", "responseCodes": [], "code": { - "id": "AliasCode_9842", + "id": "AliasCode_10154", "standardCode": { - "id": "Code_10598", + "id": "Code_10910", "extensionAttributes": [], "code": "C93566", "codeSystem": "http://www.cdisc.org", @@ -10335,7 +16333,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_414", + "id": "BiomedicalConceptProperty_623", "extensionAttributes": [], "name": "LBDTC", "label": "LBDTC", @@ -10344,9 +16342,9 @@ "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9843", + "id": "AliasCode_10155", "standardCode": { - "id": "Code_10599", + "id": "Code_10911", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", @@ -10361,15 +16359,15 @@ } ], "code": { - "id": "AliasCode_5703", + "id": "AliasCode_10058", "extensionAttributes": [], "standardCode": { - "id": "Code_5782", + "id": "Code_10814", "extensionAttributes": [], - "code": "C64545", + "code": "C64550", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Carbon Dioxide Measurement", + "decode": "Eosinophil Count", "instanceType": "Code" }, "standardCodeAliases": [], @@ -10379,25 +16377,26 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_68", + "id": "BiomedicalConcept_107", "extensionAttributes": [ { - "id": "ExtensionAttribute_35", + "id": "ExtensionAttribute_70", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CABLD", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/NEUTBBLD", "instanceType": "ExtensionAttribute" } ], - "name": "Calcium Measurement", - "label": "Calcium Measurement", + "name": "Neutrophil Band Form Count", + "label": "Neutrophil Band Form Count", "synonyms": [ - "Calcium", - "CA" + "Neutrophil Bands", + "Bands", + "NEUTB" ], - "reference": "/mdr/bc/biomedicalconcepts/C64488", + "reference": "/mdr/bc/biomedicalconcepts/C64830", "properties": [ { - "id": "BiomedicalConceptProperty_415", + "id": "BiomedicalConceptProperty_624", "extensionAttributes": [], "name": "LBORRES", "label": "LBORRES", @@ -10406,9 +16405,9 @@ "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9844", + "id": "AliasCode_10156", "standardCode": { - "id": "Code_10600", + "id": "Code_10912", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -10422,23 +16421,40 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_416", + "id": "BiomedicalConceptProperty_625", "extensionAttributes": [], "name": "LBORRESU", "label": "LBORRESU", "isRequired": false, "isEnabled": true, "datatype": "text", - "responseCodes": [], + "responseCodes": [ + { + "id": "ResponseCode_91", + "instanceType": "ResponseCode", + "name": "10^6/L", + "label": "10^6/L", + "isEnabled": true, + "code": { + "id": "Code_10914", + "extensionAttributes": [], + "code": "C67452", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "10^6/L", + "instanceType": "Code" + } + } + ], "code": { - "id": "AliasCode_9845", + "id": "AliasCode_10157", "standardCode": { - "id": "Code_10601", + "id": "Code_10913", "extensionAttributes": [], - "code": "C48207", + "code": "C67391", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", + "decode": "Unit of Number Concentration", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -10447,7 +16463,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_417", + "id": "BiomedicalConceptProperty_626", "extensionAttributes": [], "name": "LBSPEC", "label": "LBSPEC", @@ -10456,13 +16472,13 @@ "datatype": "string", "responseCodes": [ { - "id": "ResponseCode_73", + "id": "ResponseCode_92", "instanceType": "ResponseCode", "name": "BLOOD", "label": "BLOOD", "isEnabled": true, "code": { - "id": "Code_10603", + "id": "Code_10916", "extensionAttributes": [], "code": "C12434", "codeSystem": "http://www.cdisc.org", @@ -10473,9 +16489,9 @@ } ], "code": { - "id": "AliasCode_9846", + "id": "AliasCode_10159", "standardCode": { - "id": "Code_10602", + "id": "Code_10915", "extensionAttributes": [], "code": "C70713", "codeSystem": "http://www.cdisc.org", @@ -10489,7 +16505,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_418", + "id": "BiomedicalConceptProperty_627", "extensionAttributes": [], "name": "LBFAST", "label": "LBFAST", @@ -10498,9 +16514,9 @@ "datatype": "boolean", "responseCodes": [], "code": { - "id": "AliasCode_9848", + "id": "AliasCode_10161", "standardCode": { - "id": "Code_10604", + "id": "Code_10917", "extensionAttributes": [], "code": "C93566", "codeSystem": "http://www.cdisc.org", @@ -10514,7 +16530,7 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_419", + "id": "BiomedicalConceptProperty_628", "extensionAttributes": [], "name": "LBDTC", "label": "LBDTC", @@ -10523,9 +16539,9 @@ "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9849", + "id": "AliasCode_10162", "standardCode": { - "id": "Code_10605", + "id": "Code_10918", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", @@ -10540,15 +16556,15 @@ } ], "code": { - "id": "AliasCode_5704", + "id": "AliasCode_10059", "extensionAttributes": [], "standardCode": { - "id": "Code_5783", + "id": "Code_10815", "extensionAttributes": [], - "code": "C64488", + "code": "C64830", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Calcium Measurement", + "decode": "Neutrophil Band Form Count", "instanceType": "Code" }, "standardCodeAliases": [], @@ -10558,35 +16574,35 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_69", + "id": "BiomedicalConcept_108", "extensionAttributes": [ { - "id": "ExtensionAttribute_36", + "id": "ExtensionAttribute_75", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/UREANSERPL", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/FVC_RE", "instanceType": "ExtensionAttribute" } ], - "name": "Urea Nitrogen Measurement", - "label": "Urea Nitrogen Measurement", + "name": "Forced Vital Capacity", + "label": "Forced Vital Capacity", "synonyms": [ - "Urea Nitrogen" + "FVC" ], - "reference": "/mdr/bc/biomedicalconcepts/C125949", + "reference": "/mdr/bc/biomedicalconcepts/C111361", "properties": [ { - "id": "BiomedicalConceptProperty_420", + "id": "BiomedicalConceptProperty_629", "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", + "name": "REORRES", + "label": "REORRES", "isRequired": false, "isEnabled": true, "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9850", + "id": "AliasCode_10163", "standardCode": { - "id": "Code_10606", + "id": "Code_10919", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -10600,23 +16616,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_421", + "id": "BiomedicalConceptProperty_630", "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", + "name": "REORRESU", + "label": "REORRESU", "isRequired": false, "isEnabled": true, "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9851", + "id": "AliasCode_10164", "standardCode": { - "id": "Code_10607", + "id": "Code_10920", "extensionAttributes": [], - "code": "C48207", + "code": "C44279", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", + "decode": "Unit of Volume", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -10625,40 +16641,88 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_422", + "id": "BiomedicalConceptProperty_631", "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", + "name": "REDTC", + "label": "REDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_10165", + "standardCode": { + "id": "Code_10921", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_10060", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10816", + "extensionAttributes": [], + "code": "C111361", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Forced Vital Capacity", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_109", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_76", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/FEV1_RE", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Forced Expiratory Volume in 1 Second", + "label": "Forced Expiratory Volume in 1 Second", + "synonyms": [ + "FEV1", + "FEV1%VC", + "Forced Expiratory Volume 1 Test", + "PFT/FEV1", + "Pulmonary Function Test/Forced Expiratory Volume 1" + ], + "reference": "/mdr/bc/biomedicalconcepts/C38084", + "properties": [ + { + "id": "BiomedicalConceptProperty_632", + "extensionAttributes": [], + "name": "REORRES", + "label": "REORRES", "isRequired": false, "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_74", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_10609", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], + "datatype": "float", + "responseCodes": [], "code": { - "id": "AliasCode_9852", + "id": "AliasCode_10166", "standardCode": { - "id": "Code_10608", + "id": "Code_10922", "extensionAttributes": [], - "code": "C70713", + "code": "C70856", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", + "decode": "Observation Result", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -10667,23 +16731,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_423", + "id": "BiomedicalConceptProperty_633", "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", + "name": "REORRESU", + "label": "REORRESU", "isRequired": false, "isEnabled": true, - "datatype": "boolean", + "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9854", + "id": "AliasCode_10167", "standardCode": { - "id": "Code_10610", + "id": "Code_10923", "extensionAttributes": [], - "code": "C93566", + "code": "C44279", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", + "decode": "Unit of Volume", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -10692,18 +16756,18 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_424", + "id": "BiomedicalConceptProperty_634", "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", + "name": "REDTC", + "label": "REDTC", "isRequired": false, "isEnabled": true, "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9855", + "id": "AliasCode_10168", "standardCode": { - "id": "Code_10611", + "id": "Code_10924", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", @@ -10718,15 +16782,15 @@ } ], "code": { - "id": "AliasCode_5705", + "id": "AliasCode_10061", "extensionAttributes": [], "standardCode": { - "id": "Code_5784", + "id": "Code_10817", "extensionAttributes": [], - "code": "C125949", + "code": "C38084", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urea Nitrogen Measurement", + "codeSystemVersion": "2026-05-26", + "decode": "Forced Expiratory Volume in 1 Second", "instanceType": "Code" }, "standardCodeAliases": [], @@ -10736,35 +16800,37 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_70", + "id": "BiomedicalConcept_110", "extensionAttributes": [ { - "id": "ExtensionAttribute_37", + "id": "ExtensionAttribute_77", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTSERPL", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/FEV6_RE", "instanceType": "ExtensionAttribute" } ], - "name": "Total Protein Measurement", - "label": "Total Protein Measurement", + "name": "Forced Expiratory Volume in 6 Seconds", + "label": "Forced Expiratory Volume in 6 Seconds", "synonyms": [ - "Protein" + "FEV6", + "Forced Expiratory Volume 6", + "Forced Expiratory Volume 6 Test" ], - "reference": "/mdr/bc/biomedicalconcepts/C64858", + "reference": "/mdr/bc/biomedicalconcepts/C47843", "properties": [ { - "id": "BiomedicalConceptProperty_425", + "id": "BiomedicalConceptProperty_635", "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", + "name": "REORRES", + "label": "REORRES", "isRequired": false, "isEnabled": true, "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9856", + "id": "AliasCode_10169", "standardCode": { - "id": "Code_10612", + "id": "Code_10925", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -10778,23 +16844,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_426", + "id": "BiomedicalConceptProperty_636", "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", + "name": "REORRESU", + "label": "REORRESU", "isRequired": false, "isEnabled": true, "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9857", + "id": "AliasCode_10170", "standardCode": { - "id": "Code_10613", + "id": "Code_10926", "extensionAttributes": [], - "code": "C48207", + "code": "C44279", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", + "decode": "Unit of Volume", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -10803,65 +16869,84 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_427", + "id": "BiomedicalConceptProperty_637", "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", + "name": "REDTC", + "label": "REDTC", "isRequired": false, "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_75", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_10615", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], + "datatype": "datetime", + "responseCodes": [], "code": { - "id": "AliasCode_9858", + "id": "AliasCode_10171", "standardCode": { - "id": "Code_10614", + "id": "Code_10927", "extensionAttributes": [], - "code": "C70713", + "code": "C82515", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", + "decode": "Collection Date Time", "instanceType": "Code" }, "instanceType": "AliasCode" }, "notes": [], "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_10062", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10818", + "extensionAttributes": [], + "code": "C47843", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Forced Expiratory Volume in 6 Seconds", + "instanceType": "Code" }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_111", + "extensionAttributes": [ { - "id": "BiomedicalConceptProperty_428", + "id": "ExtensionAttribute_78", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PEF_RE", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Peak Expiratory Flow", + "label": "Peak Expiratory Flow", + "synonyms": [ + "PEF" + ], + "reference": "/mdr/bc/biomedicalconcepts/C41372", + "properties": [ + { + "id": "BiomedicalConceptProperty_638", "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", + "name": "REORRES", + "label": "REORRES", "isRequired": false, "isEnabled": true, - "datatype": "boolean", + "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9860", + "id": "AliasCode_10172", "standardCode": { - "id": "Code_10616", + "id": "Code_10928", "extensionAttributes": [], - "code": "C93566", + "code": "C70856", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", + "decode": "Observation Result", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -10870,18 +16955,43 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_429", + "id": "BiomedicalConceptProperty_639", "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", + "name": "REORRESU", + "label": "REORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "text", + "responseCodes": [], + "code": { + "id": "AliasCode_10173", + "standardCode": { + "id": "Code_10929", + "extensionAttributes": [], + "code": "C48568", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Volumetric Flow Rate", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_640", + "extensionAttributes": [], + "name": "REDTC", + "label": "REDTC", "isRequired": false, "isEnabled": true, "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9861", + "id": "AliasCode_10174", "standardCode": { - "id": "Code_10617", + "id": "Code_10930", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", @@ -10896,15 +17006,15 @@ } ], "code": { - "id": "AliasCode_5706", + "id": "AliasCode_10063", "extensionAttributes": [], "standardCode": { - "id": "Code_5785", + "id": "Code_10819", "extensionAttributes": [], - "code": "C64858", + "code": "C41372", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement", + "codeSystemVersion": "2026-03-31", + "decode": "Peak Expiratory Flow", "instanceType": "Code" }, "standardCodeAliases": [], @@ -10914,35 +17024,36 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_71", + "id": "BiomedicalConcept_112", "extensionAttributes": [ { - "id": "ExtensionAttribute_38", + "id": "ExtensionAttribute_79", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALPSERPL", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/TV_RE", "instanceType": "ExtensionAttribute" } ], - "name": "Alkaline Phosphatase Measurement", - "label": "Alkaline Phosphatase Measurement", + "name": "Tidal Volume", + "label": "Tidal Volume", "synonyms": [ - "Alkaline Phosphatase" + "TIDALVOL", + "TV" ], - "reference": "/mdr/bc/biomedicalconcepts/C64432", + "reference": "/mdr/bc/biomedicalconcepts/C111324", "properties": [ { - "id": "BiomedicalConceptProperty_430", + "id": "BiomedicalConceptProperty_641", "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", + "name": "REORRES", + "label": "REORRES", "isRequired": false, "isEnabled": true, "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9862", + "id": "AliasCode_10175", "standardCode": { - "id": "Code_10618", + "id": "Code_10931", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -10956,23 +17067,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_431", + "id": "BiomedicalConceptProperty_642", "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", + "name": "REORRESU", + "label": "REORRESU", "isRequired": false, "isEnabled": true, "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9863", + "id": "AliasCode_10176", "standardCode": { - "id": "Code_10619", + "id": "Code_10932", "extensionAttributes": [], - "code": "C67365", + "code": "C44279", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", + "decode": "Unit of Volume", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -10981,40 +17092,84 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_432", + "id": "BiomedicalConceptProperty_643", "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", + "name": "REDTC", + "label": "REDTC", "isRequired": false, "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_76", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_10621", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], + "datatype": "datetime", + "responseCodes": [], "code": { - "id": "AliasCode_9864", + "id": "AliasCode_10177", "standardCode": { - "id": "Code_10620", + "id": "Code_10933", "extensionAttributes": [], - "code": "C70713", + "code": "C82515", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_10064", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10820", + "extensionAttributes": [], + "code": "C111324", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Tidal Volume", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_113", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_80", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/IC_RE", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Inspiratory Capacity", + "label": "Inspiratory Capacity", + "synonyms": [ + "IC" + ], + "reference": "/mdr/bc/biomedicalconcepts/C111362", + "properties": [ + { + "id": "BiomedicalConceptProperty_644", + "extensionAttributes": [], + "name": "REORRES", + "label": "REORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "float", + "responseCodes": [], + "code": { + "id": "AliasCode_10178", + "standardCode": { + "id": "Code_10934", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -11023,23 +17178,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_433", + "id": "BiomedicalConceptProperty_645", "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", + "name": "REORRESU", + "label": "REORRESU", "isRequired": false, "isEnabled": true, - "datatype": "boolean", + "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9866", + "id": "AliasCode_10179", "standardCode": { - "id": "Code_10622", + "id": "Code_10935", "extensionAttributes": [], - "code": "C93566", + "code": "C44279", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", + "decode": "Unit of Volume", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -11048,18 +17203,18 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_434", + "id": "BiomedicalConceptProperty_646", "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", + "name": "REDTC", + "label": "REDTC", "isRequired": false, "isEnabled": true, "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9867", + "id": "AliasCode_10180", "standardCode": { - "id": "Code_10623", + "id": "Code_10936", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", @@ -11074,15 +17229,15 @@ } ], "code": { - "id": "AliasCode_5707", + "id": "AliasCode_10065", "extensionAttributes": [], "standardCode": { - "id": "Code_5786", + "id": "Code_10821", "extensionAttributes": [], - "code": "C64432", + "code": "C111362", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alkaline Phosphatase Measurement", + "codeSystemVersion": "2026-03-31", + "decode": "Inspiratory Capacity", "instanceType": "Code" }, "standardCodeAliases": [], @@ -11092,36 +17247,35 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_72", + "id": "BiomedicalConcept_114", "extensionAttributes": [ { - "id": "ExtensionAttribute_39", + "id": "ExtensionAttribute_81", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/URATESERPL", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/ERV_RE", "instanceType": "ExtensionAttribute" } ], - "name": "Urate Measurement", - "label": "Urate Measurement", + "name": "Expiratory Reserve Volume", + "label": "Expiratory Reserve Volume", "synonyms": [ - "Urate", - "Uric Acid" + "ERV" ], - "reference": "/mdr/bc/biomedicalconcepts/C64814", + "reference": "/mdr/bc/biomedicalconcepts/C111200", "properties": [ { - "id": "BiomedicalConceptProperty_435", + "id": "BiomedicalConceptProperty_647", "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", + "name": "REORRES", + "label": "REORRES", "isRequired": false, "isEnabled": true, "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9868", + "id": "AliasCode_10181", "standardCode": { - "id": "Code_10624", + "id": "Code_10937", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -11135,23 +17289,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_436", + "id": "BiomedicalConceptProperty_648", "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", + "name": "REORRESU", + "label": "REORRESU", "isRequired": false, "isEnabled": true, "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9869", + "id": "AliasCode_10182", "standardCode": { - "id": "Code_10625", + "id": "Code_10938", "extensionAttributes": [], - "code": "C48207", + "code": "C44279", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", + "decode": "Unit of Volume", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -11160,65 +17314,84 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_437", + "id": "BiomedicalConceptProperty_649", "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", + "name": "REDTC", + "label": "REDTC", "isRequired": false, "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_77", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_10627", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], + "datatype": "datetime", + "responseCodes": [], "code": { - "id": "AliasCode_9870", + "id": "AliasCode_10183", "standardCode": { - "id": "Code_10626", + "id": "Code_10939", "extensionAttributes": [], - "code": "C70713", + "code": "C82515", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", + "decode": "Collection Date Time", "instanceType": "Code" }, "instanceType": "AliasCode" }, "notes": [], "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_10066", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10822", + "extensionAttributes": [], + "code": "C111200", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Expiratory Reserve Volume", + "instanceType": "Code" }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_115", + "extensionAttributes": [ { - "id": "BiomedicalConceptProperty_438", + "id": "ExtensionAttribute_82", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/IRV_RE", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Inspiratory Reserve Volume", + "label": "Inspiratory Reserve Volume", + "synonyms": [ + "IRV" + ], + "reference": "/mdr/bc/biomedicalconcepts/C111237", + "properties": [ + { + "id": "BiomedicalConceptProperty_650", "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", + "name": "REORRES", + "label": "REORRES", "isRequired": false, "isEnabled": true, - "datatype": "boolean", + "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9872", + "id": "AliasCode_10184", "standardCode": { - "id": "Code_10628", + "id": "Code_10940", "extensionAttributes": [], - "code": "C93566", + "code": "C70856", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", + "decode": "Observation Result", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -11227,18 +17400,43 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_439", + "id": "BiomedicalConceptProperty_651", "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", + "name": "REORRESU", + "label": "REORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "text", + "responseCodes": [], + "code": { + "id": "AliasCode_10185", + "standardCode": { + "id": "Code_10941", + "extensionAttributes": [], + "code": "C44279", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Volume", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_652", + "extensionAttributes": [], + "name": "REDTC", + "label": "REDTC", "isRequired": false, "isEnabled": true, "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9873", + "id": "AliasCode_10186", "standardCode": { - "id": "Code_10629", + "id": "Code_10942", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", @@ -11253,15 +17451,15 @@ } ], "code": { - "id": "AliasCode_717", + "id": "AliasCode_10067", "extensionAttributes": [], "standardCode": { - "id": "Code_757", + "id": "Code_10823", "extensionAttributes": [], - "code": "C64814", + "code": "C111237", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urate Measurement", + "codeSystemVersion": "2026-03-31", + "decode": "Inspiratory Reserve Volume", "instanceType": "Code" }, "standardCodeAliases": [], @@ -11271,55 +17469,39 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_73", - "extensionAttributes": [], - "name": "Tumor Size Measurement", - "label": "Tumor Size Measurement", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C106303", - "properties": [ + "id": "BiomedicalConcept_116", + "extensionAttributes": [ { - "id": "BiomedicalConceptProperty_440", - "extensionAttributes": [], - "name": "Anatomic Site", - "label": "Anatomic Site", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9874", - "standardCode": { - "id": "Code_10630", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, + "id": "ExtensionAttribute_83", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/SVC_RE", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Slow Vital Capacity", + "label": "Slow Vital Capacity", + "synonyms": [ + "SVC" + ], + "reference": "/mdr/bc/biomedicalconcepts/C111315", + "properties": [ { - "id": "BiomedicalConceptProperty_441", + "id": "BiomedicalConceptProperty_653", "extensionAttributes": [], - "name": "Observation Result", - "label": "Observation Result", - "isRequired": true, + "name": "REORRES", + "label": "REORRES", + "isRequired": false, "isEnabled": true, - "datatype": "decimal", + "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9875", + "id": "AliasCode_10187", "standardCode": { - "id": "Code_10631", + "id": "Code_10943", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", + "codeSystemVersion": "2026-05-26", "decode": "Observation Result", "instanceType": "Code" }, @@ -11329,48 +17511,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_442", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9876", - "standardCode": { - "id": "Code_10632", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_443", + "id": "BiomedicalConceptProperty_654", "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, + "name": "REORRESU", + "label": "REORRESU", + "isRequired": false, "isEnabled": true, - "datatype": "string", + "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9877", + "id": "AliasCode_10188", "standardCode": { - "id": "Code_10633", + "id": "Code_10944", "extensionAttributes": [], - "code": "C25692", + "code": "C44279", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Subcategory", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Volume", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -11379,22 +17536,22 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_444", + "id": "BiomedicalConceptProperty_655", "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, + "name": "REDTC", + "label": "REDTC", + "isRequired": false, "isEnabled": true, "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9878", + "id": "AliasCode_10189", "standardCode": { - "id": "Code_10634", + "id": "Code_10945", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", + "codeSystemVersion": "2026-05-26", "decode": "Collection Date Time", "instanceType": "Code" }, @@ -11402,25 +17559,62 @@ }, "notes": [], "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_10068", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10824", + "extensionAttributes": [], + "code": "C111315", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Slow Vital Capacity", + "instanceType": "Code" }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_117", + "extensionAttributes": [ { - "id": "BiomedicalConceptProperty_445", + "id": "ExtensionAttribute_84", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/DLCOVA_RE", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Diffusion Capacity of the Lung for Carbon Monoxide/Alveolar Volume Ratio", + "label": "Diffusion Capacity of the Lung for Carbon Monoxide/Alveolar Volume Ratio", + "synonyms": [ + "DLCO/VA", + "DLCOVA" + ], + "reference": "/mdr/bc/biomedicalconcepts/C120830", + "properties": [ + { + "id": "BiomedicalConceptProperty_656", "extensionAttributes": [], - "name": "Specimen Anatomic Site", - "label": "Specimen Anatomic Site", - "isRequired": true, + "name": "REORRES", + "label": "REORRES", + "isRequired": false, "isEnabled": true, - "datatype": "string", + "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9879", + "id": "AliasCode_10190", "standardCode": { - "id": "Code_10635", + "id": "Code_10946", "extensionAttributes": [], - "code": "C171435", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Specimen Anatomic Site", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -11429,23 +17623,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_446", + "id": "BiomedicalConceptProperty_657", "extensionAttributes": [], - "name": "Biospecimen Type", - "label": "Biospecimen Type", - "isRequired": true, + "name": "REORRESU", + "label": "REORRESU", + "isRequired": false, "isEnabled": true, - "datatype": "string", + "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9880", + "id": "AliasCode_10191", "standardCode": { - "id": "Code_10636", + "id": "Code_10947", "extensionAttributes": [], - "code": "C70713", + "code": "C48570", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Biospecimen Type", + "codeSystemVersion": "2026-05-26", + "decode": "Percent Unit", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -11454,23 +17648,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_447", + "id": "BiomedicalConceptProperty_658", "extensionAttributes": [], - "name": "Unit of Length", - "label": "Unit of Length", - "isRequired": true, + "name": "REDTC", + "label": "REDTC", + "isRequired": false, "isEnabled": true, - "datatype": "string", + "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9881", + "id": "AliasCode_10192", "standardCode": { - "id": "Code_10637", + "id": "Code_10948", "extensionAttributes": [], - "code": "C42578", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Unit of Length", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -11480,15 +17674,15 @@ } ], "code": { - "id": "AliasCode_5708", + "id": "AliasCode_10069", "extensionAttributes": [], "standardCode": { - "id": "Code_5787", + "id": "Code_10825", "extensionAttributes": [], - "code": "C106303", + "code": "C120830", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Tumor Size Measurement", + "codeSystemVersion": "2026-03-31", + "decode": "Diffusion Capacity of the Lung for Carbon Monoxide/Alveolar Volume Ratio", "instanceType": "Code" }, "standardCodeAliases": [], @@ -11498,52 +17692,36 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_74", + "id": "BiomedicalConcept_118", "extensionAttributes": [ { - "id": "ExtensionAttribute_40", + "id": "ExtensionAttribute_72", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TUMERGE", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PHOSSERPL", "instanceType": "ExtensionAttribute" } ], - "name": "Tumor Identification", - "label": "Tumor Identification", + "name": "Phosphate Measurement", + "label": "Phosphate Measurement", "synonyms": [ - "TUMIDENT" + "Phosphorus", + "Phosphate" ], - "reference": "/mdr/bc/biomedicalconcepts/C94523", + "reference": "/mdr/bc/biomedicalconcepts/C64857", "properties": [ { - "id": "BiomedicalConceptProperty_448", + "id": "BiomedicalConceptProperty_659", "extensionAttributes": [], - "name": "TUORRES", - "label": "TUORRES", + "name": "LBORRES", + "label": "LBORRES", "isRequired": false, "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_78", - "instanceType": "ResponseCode", - "name": "TARGET", - "label": "TARGET", - "isEnabled": true, - "code": { - "id": "Code_10639", - "extensionAttributes": [], - "code": "C94520", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "TARGET", - "instanceType": "Code" - } - } - ], + "datatype": "float", + "responseCodes": [], "code": { - "id": "AliasCode_9882", + "id": "AliasCode_10193", "standardCode": { - "id": "Code_10638", + "id": "Code_10949", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", @@ -11557,23 +17735,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_449", + "id": "BiomedicalConceptProperty_660", "extensionAttributes": [], - "name": "TULOC", - "label": "TULOC", + "name": "LBORRESU", + "label": "LBORRESU", "isRequired": false, "isEnabled": true, - "datatype": "string", + "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9884", + "id": "AliasCode_10194", "standardCode": { - "id": "Code_10640", + "id": "Code_10950", "extensionAttributes": [], - "code": "C170500", + "code": "C48207", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Result Anatomical Location", + "decode": "Unit of Concentration", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -11582,23 +17760,40 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_450", + "id": "BiomedicalConceptProperty_661", "extensionAttributes": [], - "name": "TULAT", - "label": "TULAT", + "name": "LBSPEC", + "label": "LBSPEC", "isRequired": false, "isEnabled": true, "datatype": "string", - "responseCodes": [], + "responseCodes": [ + { + "id": "ResponseCode_93", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_10952", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], "code": { - "id": "AliasCode_9885", + "id": "AliasCode_10195", "standardCode": { - "id": "Code_10641", + "id": "Code_10951", "extensionAttributes": [], - "code": "C25185", + "code": "C70713", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Laterality", + "decode": "Biospecimen Type", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -11607,23 +17802,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_451", + "id": "BiomedicalConceptProperty_662", "extensionAttributes": [], - "name": "TUDIR", - "label": "TUDIR", + "name": "LBFAST", + "label": "LBFAST", "isRequired": false, "isEnabled": true, - "datatype": "string", + "datatype": "boolean", "responseCodes": [], "code": { - "id": "AliasCode_9886", + "id": "AliasCode_10197", "standardCode": { - "id": "Code_10642", + "id": "Code_10953", "extensionAttributes": [], - "code": "C54215", + "code": "C93566", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Directionality", + "decode": "Fasting Status Indicator", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -11632,48 +17827,103 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_452", + "id": "BiomedicalConceptProperty_663", "extensionAttributes": [], - "name": "TUMETHOD", - "label": "TUMETHOD", + "name": "LBDTC", + "label": "LBDTC", "isRequired": false, "isEnabled": true, - "datatype": "string", + "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9887", + "id": "AliasCode_10198", "standardCode": { - "id": "Code_10643", + "id": "Code_10954", "extensionAttributes": [], - "code": "C82535", + "code": "C82515", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Test Method", + "decode": "Collection Date Time", "instanceType": "Code" }, "instanceType": "AliasCode" }, "notes": [], "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_10070", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10826", + "extensionAttributes": [], + "code": "C64857", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Phosphate Measurement", + "instanceType": "Code" }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_119", + "extensionAttributes": [], + "name": "Hepatitis B Surface Antibody Measurement", + "label": "Hepatitis B Surface Antibody Measurement", + "synonyms": [ + "HBV Surface Antibody", + "HBV Surface Antibody Measurement" + ], + "reference": "/mdr/bc/biomedicalconcepts/C74711", + "properties": [ { - "id": "BiomedicalConceptProperty_453", + "id": "BiomedicalConceptProperty_664", "extensionAttributes": [], - "name": "TUEVAL", - "label": "TUEVAL", - "isRequired": false, + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_10199", + "standardCode": { + "id": "Code_10955", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_665", + "extensionAttributes": [], + "name": "Observation Result", + "label": "Observation Result", + "isRequired": true, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9888", + "id": "AliasCode_10200", "standardCode": { - "id": "Code_10644", + "id": "Code_10956", "extensionAttributes": [], - "code": "C51824", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", + "codeSystemVersion": "2026-07-14", + "decode": "Observation Result", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -11682,23 +17932,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_454", + "id": "BiomedicalConceptProperty_666", "extensionAttributes": [], - "name": "TUEVALID", - "label": "TUEVALID", - "isRequired": false, + "name": "Unit of Concentration", + "label": "Unit of Concentration", + "isRequired": true, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9889", + "id": "AliasCode_10201", "standardCode": { - "id": "Code_10645", + "id": "Code_10957", "extensionAttributes": [], - "code": "C117043", + "code": "C48207", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier", + "codeSystemVersion": "2026-07-14", + "decode": "Unit of Concentration", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -11707,23 +17957,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_455", + "id": "BiomedicalConceptProperty_667", "extensionAttributes": [], - "name": "TUREFID", - "label": "TUREFID", - "isRequired": false, + "name": "Measurement, Test or Examination Detail", + "label": "Measurement, Test or Examination Detail", + "isRequired": true, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9890", + "id": "AliasCode_10202", "standardCode": { - "id": "Code_10646", + "id": "Code_10958", "extensionAttributes": [], - "code": "C117442", + "code": "C117062", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Reference Identifier", + "codeSystemVersion": "2026-07-14", + "decode": "Measurement, Test or Examination Detail", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -11732,23 +17982,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_456", + "id": "BiomedicalConceptProperty_668", "extensionAttributes": [], - "name": "TULNKID", - "label": "TULNKID", - "isRequired": false, + "name": "Test Method", + "label": "Test Method", + "isRequired": true, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9891", + "id": "AliasCode_10203", "standardCode": { - "id": "Code_10647", + "id": "Code_10959", "extensionAttributes": [], - "code": "C117436", + "code": "C82535", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Link Identifier", + "codeSystemVersion": "2026-07-14", + "decode": "Test Method", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -11757,23 +18007,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_457", + "id": "BiomedicalConceptProperty_669", "extensionAttributes": [], - "name": "TUDTC", - "label": "TUDTC", - "isRequired": false, + "name": "Biospecimen Type", + "label": "Biospecimen Type", + "isRequired": true, "isEnabled": true, - "datatype": "datetime", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9892", + "id": "AliasCode_10204", "standardCode": { - "id": "Code_10648", + "id": "Code_10960", "extensionAttributes": [], - "code": "C82515", + "code": "C70713", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", + "codeSystemVersion": "2026-07-14", + "decode": "Biospecimen Type", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -11783,15 +18033,15 @@ } ], "code": { - "id": "AliasCode_5709", + "id": "AliasCode_10071", "extensionAttributes": [], "standardCode": { - "id": "Code_5788", + "id": "Code_10827", "extensionAttributes": [], - "code": "C94523", + "code": "C74711", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identification", + "codeSystemVersion": "2026-07-14", + "decode": "Hepatitis B Surface Antibody Measurement", "instanceType": "Code" }, "standardCodeAliases": [], @@ -11801,40 +18051,65 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_75", + "id": "BiomedicalConcept_120", "extensionAttributes": [ { - "id": "ExtensionAttribute_41", + "id": "ExtensionAttribute_74", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/NTRGRESP", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/HCRNASERPL", "instanceType": "ExtensionAttribute" } ], - "name": "Response in Non-Target Lesion", - "label": "Response in Non-Target Lesion", + "name": "Hepatitis C Virus RNA Measurement", + "label": "Hepatitis C Virus RNA Measurement", "synonyms": [ - "NTRGRESP", - "Non-Target Response" + "HCRNA", + "Hepatitis C RNA" ], - "reference": "/mdr/bc/biomedicalconcepts/C94535", + "reference": "/mdr/bc/biomedicalconcepts/C142330", "properties": [ { - "id": "BiomedicalConceptProperty_458", + "id": "BiomedicalConceptProperty_670", "extensionAttributes": [], - "name": "RSORRES", - "label": "RSORRES", + "name": "MBTSTDTL", + "label": "MBTSTDTL", "isRequired": false, "isEnabled": true, - "datatype": "text", + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_10205", + "standardCode": { + "id": "Code_10961", + "extensionAttributes": [], + "code": "C117062", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Measurement, Test or Examination Detail", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_671", + "extensionAttributes": [], + "name": "MBORRES", + "label": "MBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9893", + "id": "AliasCode_10206", "standardCode": { - "id": "Code_10649", + "id": "Code_10962", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", + "codeSystemVersion": "2026-07-14", "decode": "Observation Result", "instanceType": "Code" }, @@ -11844,23 +18119,65 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_459", + "id": "BiomedicalConceptProperty_672", "extensionAttributes": [], - "name": "RSEVAL", - "label": "RSEVAL", + "name": "MBORRESU", + "label": "MBORRESU", "isRequired": false, "isEnabled": true, - "datatype": "string", + "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9894", + "id": "AliasCode_10207", + "standardCode": { + "id": "Code_10963", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_673", + "extensionAttributes": [], + "name": "MBSPEC", + "label": "MBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_94", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_10965", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_10208", "standardCode": { - "id": "Code_10650", + "id": "Code_10964", "extensionAttributes": [], - "code": "C51824", + "code": "C70713", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", + "codeSystemVersion": "2026-07-14", + "decode": "Biospecimen Type", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -11869,23 +18186,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_460", + "id": "BiomedicalConceptProperty_674", "extensionAttributes": [], - "name": "RSEVALID", - "label": "RSEVALID", + "name": "MBMETHOD", + "label": "MBMETHOD", "isRequired": false, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9895", + "id": "AliasCode_10210", "standardCode": { - "id": "Code_10651", + "id": "Code_10966", "extensionAttributes": [], - "code": "C117043", + "code": "C82535", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier", + "codeSystemVersion": "2026-07-14", + "decode": "Test Method", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -11894,22 +18211,22 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_461", + "id": "BiomedicalConceptProperty_675", "extensionAttributes": [], - "name": "RSDTC", - "label": "RSDTC", + "name": "MBDTC", + "label": "MBDTC", "isRequired": false, "isEnabled": true, "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9896", + "id": "AliasCode_10211", "standardCode": { - "id": "Code_10652", + "id": "Code_10967", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", + "codeSystemVersion": "2026-07-14", "decode": "Collection Date Time", "instanceType": "Code" }, @@ -11920,15 +18237,15 @@ } ], "code": { - "id": "AliasCode_5710", + "id": "AliasCode_10072", "extensionAttributes": [], "standardCode": { - "id": "Code_5789", + "id": "Code_10828", "extensionAttributes": [], - "code": "C94535", + "code": "C142330", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Response in Non-Target Lesion", + "codeSystemVersion": "2026-07-14", + "decode": "Hepatitis C Virus RNA Measurement", "instanceType": "Code" }, "standardCodeAliases": [], @@ -11938,40 +18255,66 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_76", + "id": "BiomedicalConcept_121", "extensionAttributes": [ { - "id": "ExtensionAttribute_42", + "id": "ExtensionAttribute_73", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TRGRESP", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/HBDNASERPL", "instanceType": "ExtensionAttribute" } ], - "name": "Response in Target Lesion", - "label": "Response in Target Lesion", + "name": "Hepatitis B DNA Measurement", + "label": "Hepatitis B DNA Measurement", "synonyms": [ - "TRGRESP", - "Target Response" + "HBDNA", + "HBV DNA", + "HBV DNA Measurement" ], - "reference": "/mdr/bc/biomedicalconcepts/C94534", + "reference": "/mdr/bc/biomedicalconcepts/C103404", "properties": [ { - "id": "BiomedicalConceptProperty_462", + "id": "BiomedicalConceptProperty_676", "extensionAttributes": [], - "name": "RSORRES", - "label": "RSORRES", + "name": "MBTSTDTL", + "label": "MBTSTDTL", "isRequired": false, "isEnabled": true, - "datatype": "text", + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_10212", + "standardCode": { + "id": "Code_10968", + "extensionAttributes": [], + "code": "C117062", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Measurement, Test or Examination Detail", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_677", + "extensionAttributes": [], + "name": "MBORRES", + "label": "MBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9897", + "id": "AliasCode_10213", "standardCode": { - "id": "Code_10653", + "id": "Code_10969", "extensionAttributes": [], "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", + "codeSystemVersion": "2026-07-14", "decode": "Observation Result", "instanceType": "Code" }, @@ -11981,23 +18324,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_463", + "id": "BiomedicalConceptProperty_678", "extensionAttributes": [], - "name": "RSEVAL", - "label": "RSEVAL", + "name": "MBORRESU", + "label": "MBORRESU", "isRequired": false, "isEnabled": true, - "datatype": "string", + "datatype": "text", "responseCodes": [], "code": { - "id": "AliasCode_9898", + "id": "AliasCode_10214", "standardCode": { - "id": "Code_10654", + "id": "Code_10970", "extensionAttributes": [], - "code": "C51824", + "code": "C48207", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", + "codeSystemVersion": "2026-07-14", + "decode": "Unit of Concentration", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -12006,23 +18349,65 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_464", + "id": "BiomedicalConceptProperty_679", "extensionAttributes": [], - "name": "RSEVALID", - "label": "RSEVALID", + "name": "MBSPEC", + "label": "MBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_95", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_10972", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_10215", + "standardCode": { + "id": "Code_10971", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_680", + "extensionAttributes": [], + "name": "MBMETHOD", + "label": "MBMETHOD", "isRequired": false, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_9899", + "id": "AliasCode_10217", "standardCode": { - "id": "Code_10655", + "id": "Code_10973", "extensionAttributes": [], - "code": "C117043", + "code": "C82535", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier", + "codeSystemVersion": "2026-07-14", + "decode": "Test Method", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -12031,22 +18416,22 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_465", + "id": "BiomedicalConceptProperty_681", "extensionAttributes": [], - "name": "RSDTC", - "label": "RSDTC", + "name": "MBDTC", + "label": "MBDTC", "isRequired": false, "isEnabled": true, "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9900", + "id": "AliasCode_10218", "standardCode": { - "id": "Code_10656", + "id": "Code_10974", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", + "codeSystemVersion": "2026-07-14", "decode": "Collection Date Time", "instanceType": "Code" }, @@ -12057,15 +18442,15 @@ } ], "code": { - "id": "AliasCode_5711", + "id": "AliasCode_10073", "extensionAttributes": [], "standardCode": { - "id": "Code_5790", + "id": "Code_10829", "extensionAttributes": [], - "code": "C94534", + "code": "C103404", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Response in Target Lesion", + "codeSystemVersion": "2026-07-14", + "decode": "Hepatitis B DNA Measurement", "instanceType": "Code" }, "standardCodeAliases": [], @@ -12075,40 +18460,41 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_77", + "id": "BiomedicalConcept_122", "extensionAttributes": [ { - "id": "ExtensionAttribute_43", + "id": "ExtensionAttribute_71", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/OVRLRESP", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/MCV", "instanceType": "ExtensionAttribute" } ], - "name": "Overall Response", - "label": "Overall Response", + "name": "Erythrocyte Mean Corpuscular Volume", + "label": "Erythrocyte Mean Corpuscular Volume", "synonyms": [ - "OVRLRESP" + "RBC Mean Corpuscular Volume", + "MCV" ], - "reference": "/mdr/bc/biomedicalconcepts/C96613", + "reference": "/mdr/bc/biomedicalconcepts/C64799", "properties": [ { - "id": "BiomedicalConceptProperty_466", + "id": "BiomedicalConceptProperty_682", "extensionAttributes": [], - "name": "RSLNKGRP", - "label": "RSLNKGRP", + "name": "LBORRES", + "label": "LBORRES", "isRequired": false, "isEnabled": true, - "datatype": "string", + "datatype": "float", "responseCodes": [], "code": { - "id": "AliasCode_9901", + "id": "AliasCode_10219", "standardCode": { - "id": "Code_10657", + "id": "Code_10975", "extensionAttributes": [], - "code": "C117394", + "code": "C70856", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Disease Response Link Group", + "decode": "Observation Result", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -12117,23 +18503,40 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_467", + "id": "BiomedicalConceptProperty_683", "extensionAttributes": [], - "name": "RSORRES", - "label": "RSORRES", + "name": "LBORRESU", + "label": "LBORRESU", "isRequired": false, "isEnabled": true, "datatype": "text", - "responseCodes": [], + "responseCodes": [ + { + "id": "ResponseCode_96", + "instanceType": "ResponseCode", + "name": "fL", + "label": "fL", + "isEnabled": true, + "code": { + "id": "Code_10977", + "extensionAttributes": [], + "code": "C64780", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "fL", + "instanceType": "Code" + } + } + ], "code": { - "id": "AliasCode_9902", + "id": "AliasCode_10220", "standardCode": { - "id": "Code_10658", + "id": "Code_10976", "extensionAttributes": [], - "code": "C70856", + "code": "C44279", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", + "decode": "Unit of Volume", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -12142,23 +18545,40 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_468", + "id": "BiomedicalConceptProperty_684", "extensionAttributes": [], - "name": "RSEVAL", - "label": "RSEVAL", + "name": "LBSPEC", + "label": "LBSPEC", "isRequired": false, "isEnabled": true, "datatype": "string", - "responseCodes": [], + "responseCodes": [ + { + "id": "ResponseCode_97", + "instanceType": "ResponseCode", + "name": "ERYTHROCYTES", + "label": "ERYTHROCYTES", + "isEnabled": true, + "code": { + "id": "Code_10979", + "extensionAttributes": [], + "code": "C12521", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "ERYTHROCYTES", + "instanceType": "Code" + } + } + ], "code": { - "id": "AliasCode_9903", + "id": "AliasCode_10222", "standardCode": { - "id": "Code_10659", + "id": "Code_10978", "extensionAttributes": [], - "code": "C51824", + "code": "C70713", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", + "decode": "Biospecimen Type", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -12167,23 +18587,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_469", + "id": "BiomedicalConceptProperty_685", "extensionAttributes": [], - "name": "RSEVALID", - "label": "RSEVALID", + "name": "LBFAST", + "label": "LBFAST", "isRequired": false, "isEnabled": true, - "datatype": "string", + "datatype": "boolean", "responseCodes": [], "code": { - "id": "AliasCode_9904", + "id": "AliasCode_10224", "standardCode": { - "id": "Code_10660", + "id": "Code_10980", "extensionAttributes": [], - "code": "C117043", + "code": "C93566", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier", + "decode": "Fasting Status Indicator", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -12192,18 +18612,18 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_470", + "id": "BiomedicalConceptProperty_686", "extensionAttributes": [], - "name": "RSDTC", - "label": "RSDTC", + "name": "LBDTC", + "label": "LBDTC", "isRequired": false, "isEnabled": true, "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_9905", + "id": "AliasCode_10225", "standardCode": { - "id": "Code_10661", + "id": "Code_10981", "extensionAttributes": [], "code": "C82515", "codeSystem": "http://www.cdisc.org", @@ -12218,15 +18638,46 @@ } ], "code": { - "id": "AliasCode_763", + "id": "AliasCode_10074", "extensionAttributes": [], "standardCode": { - "id": "Code_803", + "id": "Code_10830", "extensionAttributes": [], - "code": "C96613", + "code": "C64799", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Overall Response", + "codeSystemVersion": "2025-07-01", + "decode": "Erythrocyte Mean Corpuscular Volume", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_123", + "extensionAttributes": [], + "name": "Pulmonary Function Test", + "label": "Pulmonary Function Test", + "synonyms": [ + "Pulmonary Function Test", + "lung function test", + "PFT", + "Pulmonary Function Testing" + ], + "reference": "/mdr/bc/biomedicalconcepts/C38081", + "properties": [], + "code": { + "id": "AliasCode_10226", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10982", + "extensionAttributes": [], + "code": "C38081", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Pulmonary Function Test", "instanceType": "Code" }, "standardCodeAliases": [], @@ -12247,76 +18698,6 @@ "notes": [], "instanceType": "BiomedicalConceptSurrogate" }, - { - "id": "BiomedicalConceptSurrogate_2", - "extensionAttributes": [], - "name": "Hepatitis B DNA Measurement", - "label": "Hepatitis B DNA Measurement (C103404)", - "description": "A measurement of the Hepatitis B virus DNA in a biological specimen", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103404", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_3", - "extensionAttributes": [], - "name": "Hepatitis B Surface Antigen", - "label": "Hepatitis B Virus Surface Antigen Measurement (C64850)", - "description": "A measurement of the surface antigen reaction of a biological specimen to the Hepatitis B virus.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C64850", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_4", - "extensionAttributes": [], - "name": "HBsAb+", - "label": "Hepatitis B Surface Antibody Positive (C153243)", - "description": "An indication that antibodies that recognize a hepatitis B virus surface protein have been detected in a sample.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C153243", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_5", - "extensionAttributes": [], - "name": "HBsAb-", - "label": "Hepatitis B Surface Antibody Negative (C153244)", - "description": "An indication that antibodies that recognize a hepatitis B virus surface protein have not been detected in a sample.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C153244", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_6", - "extensionAttributes": [], - "name": "HCV RNA Positive", - "label": "HCV RNA Positive (C162042)", - "description": "An indication that hepatitis C RNA has been detected in a sample.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C162042", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_7", - "extensionAttributes": [], - "name": "PFTs with DLCO", - "label": "Pulmonary function tests (PFTs) that include DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide) (C38081)", - "description": "A broad range of tests that are performed to assess how well lungs inhale and exhale air and how efficiently they transfer oxygen into the blood.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C38081", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_8", - "extensionAttributes": [], - "name": "Dietary Phosphorus Measurement", - "label": "Dietary Phosphorus Measurement (C184481)", - "description": "A determination of the phosphorus in a nutritional product or meal, or a portion thereof.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C184481", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, { "id": "BiomedicalConceptSurrogate_19", "extensionAttributes": [], @@ -12376,6 +18757,16 @@ "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C142734", "notes": [], "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_25", + "extensionAttributes": [], + "name": "DLCO", + "label": "DLCO (C38083)", + "description": "The volume of the carbon monoxide that is transferred from inspired air into the pulmonary capillary blood.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C38083", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" } ], "bcCategories": [], @@ -13022,7 +19413,7 @@ "extensionAttributes": [], "code": "C70817", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", + "codeSystemVersion": "2026-03-27", "decode": "Protocol", "instanceType": "Code" }, @@ -13037,7 +19428,7 @@ "extensionAttributes": [], "code": "C25508", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", + "codeSystemVersion": "2026-03-27", "decode": "Final", "instanceType": "Code" }, @@ -13053,7 +19444,7 @@ "extensionAttributes": [], "code": "C215663", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", + "codeSystemVersion": "2026-03-27", "decode": "Effective Date", "instanceType": "Code" }, @@ -14381,5 +20772,5 @@ }, "usdmVersion": "4.0", "systemName": "SOA Workbench", - "systemVersion": "pi-fix-bc-props-specs-in-usdm" + "systemVersion": "1.6.0" } diff --git a/pytest.ini b/pytest.ini index 7ea3dd3..8d24ed6 100644 --- a/pytest.ini +++ b/pytest.ini @@ -1,4 +1,4 @@ [pytest] pythonpath = src addopts = -q -norecursedirs = old-tests +norecursedirs = old-tests cdisc-biomedical-concept-groupings diff --git a/schema/dataStructure.yml b/schema/dataStructure.yml new file mode 100644 index 0000000..9e074cf --- /dev/null +++ b/schema/dataStructure.yml @@ -0,0 +1,8244 @@ +Abbreviation: + NCI C-Code: C42610 + Preferred Term: Abbreviation + Definition: A set of letters that are drawn from a word or from a sequence of words + and that are used for brevity in place of the full word or phrase. (CDISC Glossary) + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + abbreviatedText: + Type: + - $ref: '#/string' + NCI C-Code: C215487 + Preferred Term: Text Abbreviation Value + Definition: The literal value of an instance of unstructured text that is used + as the abbreviation. + Cardinality: '1' + Relationship Type: Value + Model Name: abbreviatedText + Model Representation: Attribute + expandedText: + Type: + - $ref: '#/string' + NCI C-Code: C215569 + Preferred Term: Abbreviation Long Name + Definition: The full literal representation of the abbreviation. + Cardinality: '1' + Relationship Type: Value + Model Name: expandedText + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215570 + Preferred Term: Abbreviation Notes + Definition: A brief written record relevant to the abbreviation. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +Activity: + NCI C-Code: C71473 + Preferred Term: Study Activity + Definition: An action, undertaking, or event, which is anticipated to be performed + or observed, or was performed or observed, according to the study protocol during + the execution of the study. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C188842 + Preferred Term: Study Activity Name + Definition: The literal identifier (i.e., distinctive designation) of the study + activity. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207458 + Preferred Term: Study Activity Label + Definition: The short descriptive designation for the study activity. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C70960 + Preferred Term: Study Activity Description + Definition: A narrative representation of the study activity. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215519 + Preferred Term: Activity Notes + Definition: A brief written record relevant to the activity. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + definedProcedures: + Type: + - $ref: '#/Procedure' + Definition: A USDM relationship between the Activity and Procedure classes which + identifies the set of defined procedures associated with the activity. + Cardinality: 0..* + Relationship Type: Value + Model Name: definedProcedures + Model Representation: Relationship + biomedicalConceptIds: + Type: + - $ref: '#/BiomedicalConcept' + Definition: A USDM relationship between the Activity and BiomedicalConcept classes + which identifies the set of biomedical concepts associated with the activity. + Cardinality: 0..* + Relationship Type: Ref + Model Name: biomedicalConcepts + Model Representation: Relationship + nextId: + Type: + - $ref: '#/Activity' + Definition: A USDM relationship within the Activity class which identifies the + activity that follows the current activity in the display order. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: next + Model Representation: Relationship + timelineId: + Type: + - $ref: '#/ScheduleTimeline' + Definition: A USDM relationship between the Activity and ScheduleTimeline classes + which provides the details associated with an instance of the scheduled timeline + related to the activity. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: timeline + Model Representation: Relationship + childIds: + Type: + - $ref: '#/Activity' + Definition: A USDM relationship within the Activity class which identifies the + set of child activities associated with an activity. + Cardinality: 0..* + Relationship Type: Ref + Model Name: children + Model Representation: Relationship + previousId: + Type: + - $ref: '#/Activity' + Definition: A USDM relationship within the Activity class which identifies the + activity that precedes the current activity in the display order. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: previous + Model Representation: Relationship + bcSurrogateIds: + Type: + - $ref: '#/BiomedicalConceptSurrogate' + Definition: A USDM relationship between the Activity and BiomedicalConceptSurrogate + classes which identifies the set of biomedical concept surrogates associated + with the activity. + Cardinality: 0..* + Relationship Type: Ref + Model Name: bcSurrogates + Model Representation: Relationship + bcCategoryIds: + Type: + - $ref: '#/BiomedicalConceptCategory' + Definition: A USDM relationship between the Activity and BiomedicalConceptCategory + classes which identifies the set of biomedical concept categories associated + with the activity. + Cardinality: 0..* + Relationship Type: Ref + Model Name: bcCategories + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +Address: + NCI C-Code: C25407 + Preferred Term: Address + Definition: A standardized representation of the location of a person, business, + building, or organization. (NCI) + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + text: + Type: + - $ref: '#/string' + NCI C-Code: C201311 + Preferred Term: Address Full Text + Definition: A standardized representation of the complete set of components + denoting the physical address of the person, business, building, or organization. + Cardinality: 0..1 + Relationship Type: Value + Model Name: text + Model Representation: Attribute + lines: + Type: + - $ref: '#/string' + NCI C-Code: C25690 + Preferred Term: Address Line + Definition: The street name and number, building number, apartment or unit number, + or post office box number where an entity is physically located. + Cardinality: 0..* + Relationship Type: Value + Model Name: lines + Model Representation: Attribute + district: + Type: + - $ref: '#/string' + NCI C-Code: C176229 + Preferred Term: District + Definition: An administrative or territorial division of a city, town, county, + parish, state, country, or other locality based on a shared characteristic. + Cardinality: 0..1 + Relationship Type: Value + Model Name: district + Model Representation: Attribute + city: + Type: + - $ref: '#/string' + NCI C-Code: C25160 + Preferred Term: City + Definition: A relatively large and/or densely populated area of human habitation + with administrative or legal status that may be specified as a component of + a postal address. + Cardinality: 0..1 + Relationship Type: Value + Model Name: city + Model Representation: Attribute + postalCode: + Type: + - $ref: '#/string' + NCI C-Code: C25621 + Preferred Term: Postal Code + Definition: An alphanumeric code assigned to a mail delivery area. + Cardinality: 0..1 + Relationship Type: Value + Model Name: postalCode + Model Representation: Attribute + state: + Type: + - $ref: '#/string' + NCI C-Code: C87194 + Preferred Term: State + Definition: A sub-division of a country that forms part of a federal union. + States are usually, but not always, more autonomous than provinces and may + have different laws from the central government. + Cardinality: 0..1 + Relationship Type: Value + Model Name: state + Model Representation: Attribute + country: + Type: + - $ref: '#/Code' + NCI C-Code: C25464 + Preferred Term: Country + Definition: A sovereign nation occupying a distinct territory and ruled by an + autonomous government. + Cardinality: 0..1 + Relationship Type: Value + Model Name: country + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +AdministrableProduct: + NCI C-Code: C215492 + Preferred Term: Administrable Product + Definition: Any study product that is formulated and presented in the form that + is suitable for administration to a study participant. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C215573 + Preferred Term: Administrable Product Definition Name + Definition: The literal identifier (i.e., distinctive designation) of the administrable + product. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C215575 + Preferred Term: Administrable Product Definition Label + Definition: The short descriptive designation for the administrable product. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C215574 + Preferred Term: Administrable Product Definition Description + Definition: A narrative representation of the administrable product. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + administrableDoseForm: + Type: + - $ref: '#/AliasCode' + NCI C-Code: C215576 + Preferred Term: Administrable Product Dose Form + Definition: The physical form in which formulated ingredient(s) are presented + in the administrable product. + Cardinality: '1' + Relationship Type: Value + Model Name: administrableDoseForm + Model Representation: Attribute + sourcing: + Type: + - $ref: '#/Code' + NCI C-Code: C215578 + Preferred Term: Administrable Product Sourcing + Definition: An indication as to whether the administrable product is obtained + from a local or central source. + Cardinality: 0..1 + Relationship Type: Value + Model Name: sourcing + Model Representation: Attribute + productDesignation: + Type: + - $ref: '#/Code' + NCI C-Code: C215579 + Preferred Term: Administrable Product Product Designation + Definition: An indication as to whether the administrable product is an investigational + medicinal product or an auxiliary medicinal product. + Cardinality: '1' + Relationship Type: Value + Model Name: productDesignation + Model Representation: Attribute + pharmacologicClass: + Type: + - $ref: '#/Code' + NCI C-Code: C215577 + Preferred Term: Administrable Product Pharmacologic Class + Definition: The pharmacological class of the administrable product. + Cardinality: 0..1 + Relationship Type: Value + Model Name: pharmacologicClass + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215580 + Preferred Term: Administrable Product Notes + Definition: A brief written record relevant to the administrable product. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + identifiers: + Type: + - $ref: '#/AdministrableProductIdentifier' + Definition: A USDM relationship between the AdministrableProduct and AdministrableProductIdentifier + classes which provides the set of identifiers related to the administrable + product. + Cardinality: 0..* + Relationship Type: Value + Model Name: identifiers + Model Representation: Relationship + properties: + Type: + - $ref: '#/AdministrableProductProperty' + Definition: A USDM relationship between the AdministrableProduct and AdministrableProductProperty + classes which provides the set of properties related to the administrable + product. + Cardinality: 0..* + Relationship Type: Value + Model Name: properties + Model Representation: Relationship + ingredients: + Type: + - $ref: '#/Ingredient' + Definition: A USDM relationship between the AdministrableProduct and Ingredient + classes which provides the set of ingredients related to the administrable + product. + Cardinality: 0..* + Relationship Type: Value + Model Name: ingredients + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +AdministrableProductIdentifier: + NCI C-Code: C215493 + Preferred Term: Administrable Product Identifier + Definition: A sequence of characters used to identify, name, or characterize the + administrable product. + Modifier: Concrete + Super Classes: + - $ref: '#/Identifier' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + Inherited From: + - $ref: '#/Identifier' + text: + Type: + - $ref: '#/string' + NCI C-Code: C215581 + Preferred Term: Administrable Product Identifier Text + Definition: An instance of structured text that represents the administrable + product. + Cardinality: '1' + Relationship Type: Value + Model Name: text + Model Representation: Attribute + Inherited From: + - $ref: '#/Identifier' + scopeId: + Type: + - $ref: '#/Organization' + Definition: A USDM relationship between the AdministrableProductIdentifier and + Organization class which provides the details associated with which provides + the details associated with each organization that has assigned the administrable + product identifier. + Cardinality: '1' + Relationship Type: Ref + Model Name: scope + Model Representation: Relationship + Inherited From: + - $ref: '#/Identifier' + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +AdministrableProductProperty: + NCI C-Code: C215494 + Preferred Term: Administrable Product Property + Definition: A characteristic from a set of characteristics used to define an administrable + product. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C215582 + Preferred Term: Administrable Product Property Name + Definition: The literal identifier (i.e., distinctive designation) of the administrable + product property. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + type: + Type: + - $ref: '#/Code' + NCI C-Code: C215585 + Preferred Term: Administrable Product Property Type + Definition: A characterization or classification of the administrable product + property. + Cardinality: '1' + Relationship Type: Value + Model Name: type + Model Representation: Attribute + text: + Type: + - $ref: '#/string' + NCI C-Code: C215583 + Preferred Term: Administrable Product Property Text + Definition: An instance of structured text that represents the administrable + product property. + Cardinality: '1' + Relationship Type: Value + Model Name: text + Model Representation: Attribute + quantity: + Type: + - $ref: '#/Quantity' + NCI C-Code: C215584 + Preferred Term: Administrable Product Property Quantity Value + Definition: The numeric value associated with an administrable product property. + Cardinality: 0..1 + Relationship Type: Value + Model Name: quantity + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +Administration: + NCI C-Code: C25409 + Preferred Term: Administration + Definition: The act of dispensing, applying, or tendering a product, agent, or therapy. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C207465 + Preferred Term: Administration Name + Definition: The literal identifier (i.e., distinctive designation) for the administration + of a product, agent, or therapy. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207464 + Preferred Term: Administration Label + Definition: The short descriptive designation for the administration of a product, + agent, or therapy. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C207463 + Preferred Term: Administration Description + Definition: A narrative representation for the administration of a product, + agent, or therapy. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + dose: + Type: + - $ref: '#/Quantity' + NCI C-Code: C167190 + Preferred Term: Administration Dose + Definition: The value representing the amount of an agent given to an individual + at one time. + Cardinality: 0..1 + Relationship Type: Value + Model Name: dose + Model Representation: Attribute + frequency: + Type: + - $ref: '#/AliasCode' + NCI C-Code: C89081 + Preferred Term: Dosing Frequency + Definition: The number of doses administered per a specific interval. + Cardinality: 0..1 + Relationship Type: Value + Model Name: frequency + Model Representation: Attribute + route: + Type: + - $ref: '#/AliasCode' + NCI C-Code: C38114 + Preferred Term: Route of Administration + Definition: The pathway by which a substance is administered in order to reach + the site of action in the body. + Cardinality: 0..1 + Relationship Type: Value + Model Name: route + Model Representation: Attribute + duration: + Type: + - $ref: '#/Duration' + NCI C-Code: C69282 + Preferred Term: Administration Duration + Definition: The amount of time elapsed during the administration of an agent. + Cardinality: '1' + Relationship Type: Value + Model Name: duration + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215544 + Preferred Term: Administration Notes + Definition: A brief written record relevant to the administration of the product, + agent, or therapy. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + administrableProductId: + Type: + - $ref: '#/AdministrableProduct' + Definition: A USDM relationship between the Administration and AdministrableProductDefinition + classes which identifies the administrable product associated with the administration + of the product, agent, or therapy. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: administrableProduct + Model Representation: Relationship + medicalDeviceId: + Type: + - $ref: '#/MedicalDevice' + Definition: A USDM relationship between the Administration and MedicalDevice + classes which identifies the medical device associated with an instance of + product, agent, or therapy administration. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: medicalDevice + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +AliasCode: + NCI C-Code: C201344 + Preferred Term: Alias Code + Definition: An alternative symbol or combination of symbols which is assigned to + the members of a collection. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + standardCode: + Type: + - $ref: '#/Code' + NCI C-Code: C215528 + Preferred Term: Standard Code + Definition: A combination of symbols that is used to represent the standard + code. + Cardinality: '1' + Relationship Type: Value + Model Name: standardCode + Model Representation: Attribute + standardCodeAliases: + Type: + - $ref: '#/Code' + NCI C-Code: C215529 + Preferred Term: Standard Code Aliases + Definition: Alternative combinations of symbols used to represent aliases or + alternatives to the standard code. + Cardinality: 0..* + Relationship Type: Value + Model Name: standardCodeAliases + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +AnalysisPopulation: + NCI C-Code: C188814 + Preferred Term: Analysis Population + Definition: A target study population on which an analysis is performed. These may + be represented by the entire study population, a subgroup defined by a particular + characteristic measured at baseline, or a principal stratum defined by the occurrence + (or non-occurrence, depending on context) of a specific intercurrent event. (ICH + E9 R1 Addendum) + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + text: + Type: + - $ref: '#/string' + NCI C-Code: C207468 + Preferred Term: Analysis Population Text + Definition: An instance of unstructured text that represents the analysis population. + Cardinality: '1' + Relationship Type: Value + Model Name: text + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C207467 + Preferred Term: Analysis Population Name + Definition: The literal identifier (i.e., distinctive designation) of the analysis + population. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207466 + Preferred Term: Analysis Population Label + Definition: The short descriptive designation for the analysis population. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C188854 + Preferred Term: Analysis Population Description + Definition: A narrative representation of the analysis population. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215525 + Preferred Term: Analysis Population Notes + Definition: A brief written record relevant to the analysis population. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + subsetOfIds: + Type: + - $ref: '#/PopulationDefinition' + Definition: A USDM relationship between the AnalysisPopulation and PopulationDefinition + classes which identifies the population definition of which the analysis population + is a subset. + Cardinality: 0..* + Relationship Type: Ref + Model Name: subsetOf + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +AssignedPerson: + NCI C-Code: C215496 + Preferred Term: Assigned Person + Definition: An individual person who is allotted or appointed to a particular role, + function, or other entity. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C215596 + Preferred Term: Assigned Person Name + Definition: The literal identifier (i.e., distinctive designation) of the assigned + person. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C215598 + Preferred Term: Assigned Person Label + Definition: The short descriptive designation for the assigned person. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C215597 + Preferred Term: Assigned Person Description + Definition: A narrative representation of the assigned person. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + personName: + Type: + - $ref: '#/PersonName' + NCI C-Code: C216993 + Preferred Term: Assigned Person Person Name + Definition: A word or group of words indicating the identity of an assigned + person usually consisting of a first (personal) name and a last (family) name + with an optional middle name. In some cultural traditions the family name + comes first. + Cardinality: '1' + Relationship Type: Value + Model Name: personName + Model Representation: Attribute + jobTitle: + Type: + - $ref: '#/string' + NCI C-Code: C215599 + Preferred Term: Assigned Person Job Title + Definition: An identifying designation related to the assigned person's occupation. + Cardinality: '1' + Relationship Type: Value + Model Name: jobTitle + Model Representation: Attribute + organizationId: + Type: + - $ref: '#/Organization' + Definition: A USDM relationship between the AssignedPerson and Organization + classes that identifies that organization to which the assigned person belongs. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: organization + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +BiomedicalConcept: + NCI C-Code: C201345 + Preferred Term: Biomedical Concept + Definition: A unit of biomedical knowledge created from a unique combination of + characteristics that include implementation details like variables and terminologies, + used as building blocks for standardized, hierarchically structured clinical research + information. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C201312 + Preferred Term: Biomedical Concept Name + Definition: The literal identifier (i.e., distinctive designation) of the biomedical + concept. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207470 + Preferred Term: Biomedical Concept Label + Definition: The short descriptive designation for the biomedical concept. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + synonyms: + Type: + - $ref: '#/string' + NCI C-Code: C201314 + Preferred Term: Biomedical Concept Synonym + Definition: A word or an expression that serves as a figurative, symbolic, or + exact substitute for a biomedical concept, and which has the same meaning. + Cardinality: 0..* + Relationship Type: Value + Model Name: synonyms + Model Representation: Attribute + reference: + Type: + - $ref: '#/string' + NCI C-Code: C201313 + Preferred Term: Biomedical Concept Reference + Definition: A citation to an authoritative source for a biomedical concept. + Cardinality: '1' + Relationship Type: Value + Model Name: reference + Model Representation: Attribute + code: + Type: + - $ref: '#/AliasCode' + NCI C-Code: C207469 + Preferred Term: Biomedical Concept Concept Code + Definition: A concept unique identifier assigned to a biomedical concept that + points to the meaning of that biomedical concept. + Cardinality: '1' + Relationship Type: Value + Model Name: code + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215530 + Preferred Term: Biomedical Concept Notes + Definition: A brief written record relevant to the biomedical concept. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + properties: + Type: + - $ref: '#/BiomedicalConceptProperty' + Definition: A USDM relationship between the BiomedicalConcept and BiomedicalConceptProperty + classes which identifies the set of properties associated with the biomedical + concept. + Cardinality: 0..* + Relationship Type: Value + Model Name: properties + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +BiomedicalConceptCategory: + NCI C-Code: C201346 + Preferred Term: Biomedical Concept Category + Definition: A grouping of biomedical concepts based on some commonality or by user + defined characteristics. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C201317 + Preferred Term: Biomedical Concept Category Name + Definition: The literal identifier (i.e., distinctive designation) of the biomedical + concept category. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207471 + Preferred Term: Biomedical Concept Category Label + Definition: The short descriptive designation for the biomedical concept category. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C201316 + Preferred Term: Biomedical Concept Category Description + Definition: A narrative representation of the biomedical concept category. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + code: + Type: + - $ref: '#/AliasCode' + NCI C-Code: C201315 + Preferred Term: Biomedical Concept Category Code + Definition: A symbol or combination of symbols which is assigned to the biomedical + concept category. + Cardinality: 0..1 + Relationship Type: Value + Model Name: code + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215533 + Preferred Term: Biomedical Concept Category Notes + Definition: A brief written record relevant to the biomedical concept category. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + memberIds: + Type: + - $ref: '#/BiomedicalConcept' + Definition: A USDM relationship between the BiomedicalConceptCategory and BiomedicalConcept + classes which identifies the set of biomedical concept members associated + with the biomedical concept category. + Cardinality: 0..* + Relationship Type: Ref + Model Name: members + Model Representation: Relationship + childIds: + Type: + - $ref: '#/BiomedicalConceptCategory' + Definition: A USDM relationship within the BiomedicalConceptCategory class which + identifies the set of child categories of a biomedical concept. + Cardinality: 0..* + Relationship Type: Ref + Model Name: children + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +BiomedicalConceptProperty: + NCI C-Code: C202493 + Preferred Term: Biomedical Concept Property + Definition: A characteristic from a set of characteristics used to define a biomedical + concept. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C202494 + Preferred Term: Biomedical Concept Property Name + Definition: The literal identifier (i.e., distinctive designation) of the biomedical + concept property. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207472 + Preferred Term: Biomedical Concept Property Label + Definition: The short descriptive designation for the biomedical concept property. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + isRequired: + Type: + - $ref: '#/boolean' + NCI C-Code: C202495 + Preferred Term: Biomedical Concept Property Required Indicator + Definition: An indication as to whether the biomedical concept property is required. + Cardinality: '1' + Relationship Type: Value + Model Name: isRequired + Model Representation: Attribute + isEnabled: + Type: + - $ref: '#/boolean' + NCI C-Code: C202496 + Preferred Term: Biomedical Concept Property Enabled Indicator + Definition: An indication as to whether the biomedical concept property is activated + for use within a given usage context for a biomedical concept. + Cardinality: '1' + Relationship Type: Value + Model Name: isEnabled + Model Representation: Attribute + datatype: + Type: + - $ref: '#/string' + NCI C-Code: C201319 + Preferred Term: Biomedical Concept Property Response Data Type + Definition: The structural format of the biomedical concept property response + value. The datatype is carried in the attribute and influences the set of + allowable values the attribute may assume. (After HL7) + Cardinality: '1' + Relationship Type: Value + Model Name: datatype + Model Representation: Attribute + code: + Type: + - $ref: '#/AliasCode' + NCI C-Code: C201318 + Preferred Term: Biomedical Concept Property Concept Code + Definition: A concept unique identifier assigned to a biomedical concept property + that points to the meaning of that biomedical concept property. + Cardinality: '1' + Relationship Type: Value + Model Name: code + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215531 + Preferred Term: Biomedical Concept Property Notes + Definition: A brief written record relevant to the biomedical concept property. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + responseCodes: + Type: + - $ref: '#/ResponseCode' + Definition: A USDM relationship between the BiomedicalConceptProperty and ResponseCode + classes which identifies the set of response codes associated with the biomedical + concept property. + Cardinality: 0..* + Relationship Type: Value + Model Name: responseCodes + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +BiomedicalConceptSurrogate: + NCI C-Code: C207590 + Preferred Term: Biomedical Concept Surrogate + Definition: A concept that substitutes for a standard biomedical concept from the + designated source. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C207474 + Preferred Term: Biomedical Concept Surrogate Name + Definition: The literal identifier (i.e., distinctive designation) of the biomedical + concept surrogate. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207473 + Preferred Term: Biomedical Concept Surrogate Label + Definition: The short descriptive designation for the biomedical concept surrogate. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C201320 + Preferred Term: Biomedical Concept Surrogate Description + Definition: A narrative representation of the biomedical concept surrogate. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + reference: + Type: + - $ref: '#/string' + NCI C-Code: C201321 + Preferred Term: Biomedical Concept Surrogate Reference + Definition: A citation to an authoritative source for a biomedical concept surrogate. + Cardinality: 0..1 + Relationship Type: Value + Model Name: reference + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215532 + Preferred Term: Biomedical Concept Surrogate Notes + Definition: A brief written record relevant to the biomedical concept surrogate. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +BiospecimenRetention: + NCI C-Code: C215505 + Preferred Term: Biospecimen Retention + Definition: The continued possession, cataloging, and storage of collected biological + specimens beyond their initial use. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C215645 + Preferred Term: Biospecimen Retention Name + Definition: The literal identifier (i.e., distinctive designation) of the biospecimen + retention. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C215646 + Preferred Term: Biospecimen Retention Label + Definition: The short descriptive designation for the biospecimen retention. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C181231 + Preferred Term: Biospecimen Retention Description + Definition: A narrative representation of the biospecimen retention. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + isRetained: + Type: + - $ref: '#/boolean' + NCI C-Code: C164620 + Preferred Term: Biospecimen Retention Indicator + Definition: An indication as to whether biospecimens were retained. + Cardinality: '1' + Relationship Type: Value + Model Name: isRetained + Model Representation: Attribute + includesDNA: + Type: + - $ref: '#/boolean' + NCI C-Code: C127777 + Preferred Term: Biospecimen Retention Includes DNA Indicator + Definition: An indication as to whether retained biospecimens contain DNA. + Cardinality: 0..1 + Relationship Type: Value + Model Name: includesDNA + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +Characteristic: + NCI C-Code: C25447 + Preferred Term: Characteristic + Definition: The distinguishing qualities or prominent aspects of an entity. + Modifier: Concrete + Super Classes: + - $ref: '#/SyntaxTemplate' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + name: + Type: + - $ref: '#/string' + NCI C-Code: C207477 + Preferred Term: Characteristic Name + Definition: The literal identifier (i.e., distinctive designation) of the characteristic. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + label: + Type: + - $ref: '#/string' + NCI C-Code: C207476 + Preferred Term: Characteristic Label + Definition: The short descriptive designation for the characteristic. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + description: + Type: + - $ref: '#/string' + NCI C-Code: C207475 + Preferred Term: Characteristic Description + Definition: A narrative representation of the characteristic. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + text: + Type: + - $ref: '#/string' + NCI C-Code: C207478 + Preferred Term: Characteristic Text + Definition: An instance of structured text that represents the characteristic. + Cardinality: '1' + Relationship Type: Value + Model Name: text + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215548 + Preferred Term: Characteristic Notes + Definition: A brief written record relevant to the characteristic. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + dictionaryId: + Type: + - $ref: '#/SyntaxTemplateDictionary' + Definition: A USDM relationship between the Characteristic and SyntaxTemplateDictionary + classes which provides the set of dictionary entries related to characteristics. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: dictionary + Model Representation: Relationship + Inherited From: + - $ref: '#/SyntaxTemplate' + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +Code: + NCI C-Code: C25162 + Preferred Term: Code + Definition: A symbol or combination of symbols which is assigned to the members + of a collection. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + code: + Type: + - $ref: '#/string' + NCI C-Code: C188858 + Preferred Term: Code Value + Definition: The literal value of a code. + Cardinality: '1' + Relationship Type: Value + Model Name: code + Model Representation: Attribute + codeSystem: + Type: + - $ref: '#/string' + NCI C-Code: C188859 + Preferred Term: Code System Name + Definition: The literal identifier (i.e., distinctive designation) of the system + used to assign and/or manage codes. + Cardinality: '1' + Relationship Type: Value + Model Name: codeSystem + Model Representation: Attribute + codeSystemVersion: + Type: + - $ref: '#/string' + NCI C-Code: C188868 + Preferred Term: Code System Version + Definition: The version of the code system. + Cardinality: '1' + Relationship Type: Value + Model Name: codeSystemVersion + Model Representation: Attribute + decode: + Type: + - $ref: '#/string' + NCI C-Code: C188861 + Preferred Term: Decode + Definition: Standardized or dictionary-derived human readable text associated + with a code. + Cardinality: '1' + Relationship Type: Value + Model Name: decode + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +CommentAnnotation: + NCI C-Code: C44272 + Preferred Term: Comment Annotation + Definition: An explanatory or critical comment, or other in-context information + (e.g., pattern, motif, link), that has been associated with data or other types + of information. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + text: + Type: + - $ref: '#/string' + NCI C-Code: C215555 + Preferred Term: Comment Annotation Text + Definition: An instance of unstructured text that represents the comment annotation. + Cardinality: '1' + Relationship Type: Value + Model Name: text + Model Representation: Attribute + codes: + Type: + - $ref: '#/Code' + NCI C-Code: C215556 + Preferred Term: Comment Annotation Code + Definition: A symbol or combination of symbols which is assigned to the comment + annotation. + Cardinality: 0..* + Relationship Type: Value + Model Name: codes + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +Condition: + NCI C-Code: C25457 + Preferred Term: Condition + Definition: A state of being. + Modifier: Concrete + Super Classes: + - $ref: '#/SyntaxTemplate' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + name: + Type: + - $ref: '#/string' + NCI C-Code: C207483 + Preferred Term: Condition Name + Definition: The literal identifier (i.e., distinctive designation) of the condition. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + label: + Type: + - $ref: '#/string' + NCI C-Code: C207482 + Preferred Term: Condition Label + Definition: The short descriptive designation for the condition. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + description: + Type: + - $ref: '#/string' + NCI C-Code: C207481 + Preferred Term: Condition Description + Definition: A narrative representation of the condition. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + text: + Type: + - $ref: '#/string' + NCI C-Code: C207484 + Preferred Term: Condition Text + Definition: An instance of structured text that represents the condition. + Cardinality: '1' + Relationship Type: Value + Model Name: text + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215552 + Preferred Term: Condition Notes + Definition: A brief written record relevant to the condition. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + dictionaryId: + Type: + - $ref: '#/SyntaxTemplateDictionary' + Definition: A USDM relationship between the Condition and SyntaxTemplateDictionary + classes which provides the set of dictionary entries related to conditions. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: dictionary + Model Representation: Relationship + Inherited From: + - $ref: '#/SyntaxTemplate' + contextIds: + Type: + - $ref: '#/Activity' + - $ref: '#/ScheduledActivityInstance' + Definition: A USDM relationship between the Condition and the ScheduledActivityInstance + or Activity classes which identifies the scheduled activity instance or activity + to which the condition belongs. + Cardinality: 0..* + Relationship Type: Ref + Model Name: context + Model Representation: Relationship + appliesToIds: + Type: + - $ref: '#/BiomedicalConceptCategory' + - $ref: '#/Procedure' + - $ref: '#/Activity' + - $ref: '#/BiomedicalConcept' + - $ref: '#/BiomedicalConceptSurrogate' + Definition: A USDM relationship between the Condition and the Activity, Procedure, + BiomedicalConcept, BiomedicalConceptSurrogate, or BiomedicalConceptCategory + classes which identifies the procedure, activity, biomedical concept, biomedical + concept surrogate, or biomedical concept category that applies to the condition. + Cardinality: 0..* + Relationship Type: Ref + Model Name: appliesTo + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +ConditionAssignment: + NCI C-Code: C201335 + Preferred Term: Condition Assignment + Definition: An allotting or appointment to a condition or set of conditions that + are to be met in order to make a logical decision. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + condition: + Type: + - $ref: '#/string' + NCI C-Code: C47953 + Preferred Term: Logical Condition + Definition: An assumption on which rests the validity or effect of something + else. + Cardinality: '1' + Relationship Type: Value + Model Name: condition + Model Representation: Attribute + conditionTargetId: + Type: + - $ref: '#/ScheduledInstance' + Definition: A USDM relationship between the ConditionAssignment and ScheduledInstance + classes which identifies the scheduled instance associated with the condition + assignment. + Cardinality: '1' + Relationship Type: Ref + Model Name: conditionTarget + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +DocumentContentReference: + NCI C-Code: C215499 + Preferred Term: Document Content Reference + Definition: A citation pointing to the location of specific content within a document. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + sectionNumber: + Type: + - $ref: '#/string' + NCI C-Code: C215609 + Preferred Term: Document Content Reference Section Number + Definition: The numeric identifier of a particular section for the document + content reference. + Cardinality: '1' + Relationship Type: Value + Model Name: sectionNumber + Model Representation: Attribute + sectionTitle: + Type: + - $ref: '#/string' + NCI C-Code: C215610 + Preferred Term: Document Content Reference Section Title + Definition: An identifying designation for a particular section for the document + content reference. + Cardinality: '1' + Relationship Type: Value + Model Name: sectionTitle + Model Representation: Attribute + appliesToId: + Type: + - $ref: '#/StudyDefinitionDocument' + Definition: A USDM relationship between the DocumentContentReference and StudyDefinitionDocument + classes which identifies the study definition document to which the document + content reference applies. + Cardinality: '1' + Relationship Type: Ref + Model Name: appliesTo + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +Duration: + NCI C-Code: C25330 + Preferred Term: Duration + Definition: The length of time during which something continues. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + text: + Type: + - $ref: '#/string' + NCI C-Code: C217008 + Preferred Term: Duration Text + Definition: An instance of unstructured text that represents the event duration. + Cardinality: 0..1 + Relationship Type: Value + Model Name: text + Model Representation: Attribute + quantity: + Type: + - $ref: '#/QuantityRange' + NCI C-Code: C217011 + Preferred Term: Duration Quantity Value + Definition: The value representing the amount of time over which the event occurs. + Cardinality: 0..1 + Relationship Type: Value + Model Name: quantity + Model Representation: Attribute + durationWillVary: + Type: + - $ref: '#/boolean' + NCI C-Code: C217009 + Preferred Term: Duration Will Vary Indicator + Definition: An indication as to whether the event duration is planned to vary + within and/or across subjects. + Cardinality: '1' + Relationship Type: Value + Model Name: durationWillVary + Model Representation: Attribute + reasonDurationWillVary: + Type: + - $ref: '#/string' + NCI C-Code: C217010 + Preferred Term: Reason Duration Will Vary + Definition: The explanation for why the event duration will vary within and/or + across subjects. + Cardinality: 0..1 + Relationship Type: Value + Model Name: reasonDurationWillVary + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +EligibilityCriterion: + NCI C-Code: C16112 + Preferred Term: Study Eligibility Criterion + Definition: Characteristics which are necessary to allow a subject to participate + in a clinical study, as outlined in the study protocol. The concept covers inclusion + and exclusion criteria. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C207488 + Preferred Term: Study Eligibility Criterion Name + Definition: The literal identifier (i.e., distinctive designation) of the study + eligibility criterion. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207487 + Preferred Term: Study Eligibility Criterion Label + Definition: The short descriptive designation for the study eligibility criterion. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C207486 + Preferred Term: Study Eligibility Criterion Description + Definition: A narrative representation of the study eligibility criterion. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + identifier: + Type: + - $ref: '#/string' + NCI C-Code: C207489 + Preferred Term: Study Eligibility Criterion Identifier + Definition: A sequence of characters used to identify, name, or characterize + the inclusion or exclusion criterion. + Cardinality: '1' + Relationship Type: Value + Model Name: identifier + Model Representation: Attribute + category: + Type: + - $ref: '#/Code' + NCI C-Code: C83016 + Preferred Term: Study Eligibility Criterion Category + Definition: A classification of the inclusion exclusion criterion. + Cardinality: '1' + Relationship Type: Value + Model Name: category + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215537 + Preferred Term: Eligibility Criterion Notes + Definition: A brief written record relevant to the eligibility criterion. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + criterionItemId: + Type: + - $ref: '#/EligibilityCriterionItem' + Definition: A USDM relationship between the EligibilityCriterion and EligibilityCriterionItem + classes which identifies the item belonging to the eligibility criterion. + Cardinality: '1' + Relationship Type: Ref + Model Name: criterionItem + Model Representation: Relationship + nextId: + Type: + - $ref: '#/EligibilityCriterion' + Definition: A USDM relationship within the EligibilityCriterion class which + identifies the eligibility criterion that follows the current eligibility + criterion in the display order. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: next + Model Representation: Relationship + previousId: + Type: + - $ref: '#/EligibilityCriterion' + Definition: A USDM relationship within the EligibilityCriterion class which + identifies the eligibility criterion that precedes the current eligibility + criterion in the display order. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: previous + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +EligibilityCriterionItem: + NCI C-Code: C215506 + Preferred Term: Eligibility Criterion Item + Definition: An individual item within the container that holds an instance of an + eligibility criterion. + Modifier: Concrete + Super Classes: + - $ref: '#/SyntaxTemplate' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + name: + Type: + - $ref: '#/string' + NCI C-Code: C215647 + Preferred Term: Eligibility Criterion Item Name + Definition: The literal identifier (i.e., distinctive designation) of the eligibility + criterion item. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + label: + Type: + - $ref: '#/string' + NCI C-Code: C215650 + Preferred Term: Eligibility Criterion Item Label + Definition: The short descriptive designation for the eligibility criterion + item. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + description: + Type: + - $ref: '#/string' + NCI C-Code: C215649 + Preferred Term: Eligibility Criterion Item Description + Definition: A narrative representation of the eligibility criterion item. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + text: + Type: + - $ref: '#/string' + NCI C-Code: C215648 + Preferred Term: Eligibility Criterion Item Text + Definition: An instance of structured text that represents the eligibility criterion + item. + Cardinality: '1' + Relationship Type: Value + Model Name: text + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215651 + Preferred Term: Eligibility Criterion Item Notes + Definition: A brief written record relevant to the eligibility criterion item. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + dictionaryId: + Type: + - $ref: '#/SyntaxTemplateDictionary' + Definition: 'A USDM relationship between the EligibilityCriterionItem and SyntaxTemplateDictionary + classes which provides the dictionary entry associated with a eligibility + criterion item. ' + Cardinality: 0..1 + Relationship Type: Ref + Model Name: dictionary + Model Representation: Relationship + Inherited From: + - $ref: '#/SyntaxTemplate' + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +Encounter: + NCI C-Code: C215488 + Preferred Term: Study Encounter + Definition: Any physical or virtual contact between two or more parties involved + in a study, at which an assessment or activity takes place. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C171010 + Preferred Term: Study Encounter Name + Definition: The literal identifier (i.e., distinctive designation) for a protocol-defined + study encounter. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207490 + Preferred Term: Study Encounter Label + Definition: The short descriptive designation for the study encounter. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C188836 + Preferred Term: Study Encounter Description + Definition: A narrative representation of the protocol-defined study encounter. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + type: + Type: + - $ref: '#/Code' + NCI C-Code: C188839 + Preferred Term: Study Encounter Type + Definition: A characterization or classification of the study encounter. + Cardinality: '1' + Relationship Type: Value + Model Name: type + Model Representation: Attribute + environmentalSettings: + Type: + - $ref: '#/Code' + NCI C-Code: C188840 + Preferred Term: Environmental Setting + Definition: The environment/setting where the event, intervention, or finding + occurred. + Cardinality: 0..* + Relationship Type: Value + Model Name: environmentalSettings + Model Representation: Attribute + contactModes: + Type: + - $ref: '#/Code' + NCI C-Code: C188841 + Preferred Term: Contact Mode + Definition: The means by which an interaction occurs between the subject/participant + and person or entity (e.g., a device). + Cardinality: 0..* + Relationship Type: Value + Model Name: contactModes + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215518 + Preferred Term: Encounter Notes + Definition: A brief written record relevant to the study encounter. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + transitionEndRule: + Type: + - $ref: '#/TransitionRule' + Definition: A USDM relationship between the Encounter and TransitionRule classes + which provides the details associated with a transition rule used to trigger + the end of an encounter. + Cardinality: 0..1 + Relationship Type: Value + Model Name: transitionEndRule + Model Representation: Relationship + nextId: + Type: + - $ref: '#/Encounter' + Definition: A USDM relationship within the Encounter class which identifies + the encounter that chronologically follows the current encounter. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: next + Model Representation: Relationship + transitionStartRule: + Type: + - $ref: '#/TransitionRule' + Definition: A USDM relationship between the Encounter and TransitionRule classes + which provides the details associated with a transition rule used to trigger + the start of an encounter. + Cardinality: 0..1 + Relationship Type: Value + Model Name: transitionStartRule + Model Representation: Relationship + scheduledAtId: + Type: + - $ref: '#/Timing' + Definition: A USDM relationship between the Encounter and Timing classes which + provides information related to the scheduled timing of an encounter. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: scheduledAt + Model Representation: Relationship + previousId: + Type: + - $ref: '#/Encounter' + Definition: A USDM relationship within the Encounter class which identifies + the encounter that chronologically precedes the current encounter. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: previous + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +Endpoint: + NCI C-Code: C25212 + Preferred Term: Study Endpoint + Definition: 'A defined variable intended to reflect an outcome of interest that + is statistically analyzed to address a particular research question. NOTE: A precise + definition of an endpoint typically specifies the type of assessments made, the + timing of those assessments, the assessment tools used, and possibly other details, + as applicable, such as how multiple assessments within an individual are to be + combined. [After BEST Resource] (CDISC Glossary)' + Modifier: Concrete + Super Classes: + - $ref: '#/SyntaxTemplate' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + name: + Type: + - $ref: '#/string' + NCI C-Code: C207492 + Preferred Term: Study Endpoint Name + Definition: The literal identifier (i.e., distinctive designation) of the study + endpoint. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + label: + Type: + - $ref: '#/string' + NCI C-Code: C207491 + Preferred Term: Study Endpoint Label + Definition: The short descriptive designation for the study endpoint. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + description: + Type: + - $ref: '#/string' + NCI C-Code: C188824 + Preferred Term: Study Endpoint Description + Definition: A narrative representation of the study endpoint. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + text: + Type: + - $ref: '#/string' + NCI C-Code: C207493 + Preferred Term: Study Endpoint Text + Definition: An instance of structured text that represents the study endpoint. + Cardinality: '1' + Relationship Type: Value + Model Name: text + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215514 + Preferred Term: Endpoint Notes + Definition: A brief written record relevant to the study endpoint. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + dictionaryId: + Type: + - $ref: '#/SyntaxTemplateDictionary' + Definition: A USDM relationship between the Endpoint and SyntaxTemplateDictionary + classes which provides the set of dictionary entries related to study endpoints. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: dictionary + Model Representation: Relationship + Inherited From: + - $ref: '#/SyntaxTemplate' + level: + Type: + - $ref: '#/Code' + NCI C-Code: C188826 + Preferred Term: Study Endpoint Level + Definition: A characterization or classification of the study endpoint that + determines its category of importance relative to other study endpoints. + Cardinality: '1' + Relationship Type: Value + Model Name: level + Model Representation: Attribute + purpose: + Type: + - $ref: '#/string' + NCI C-Code: C188825 + Preferred Term: Study Endpoint Purpose Description + Definition: The textual representation of the study endpoint purpose. + Cardinality: '1' + Relationship Type: Value + Model Name: purpose + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +Estimand: + NCI C-Code: C188813 + Preferred Term: Estimand + Definition: A precise description of the treatment effect reflecting the clinical + question posed by a given clinical trial objective. It summarises at a population + level what the outcomes would be in the same patients under different treatment + conditions being compared. (ICH E9 R1 Addendum) + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + populationSummary: + Type: + - $ref: '#/string' + NCI C-Code: C188853 + Preferred Term: Population-Level Summary + Definition: A synopsis of the clinical endpoint of interest within the analysis + target study population. + Cardinality: '1' + Relationship Type: Value + Model Name: populationSummary + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C215522 + Preferred Term: Estimand Name + Definition: The literal identifier (i.e., distinctive designation) of the estimand. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C215524 + Preferred Term: Estimand Label + Definition: The short descriptive designation for the estimand. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C215523 + Preferred Term: Estimand Description + Definition: A narrative representation of the estimand. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215521 + Preferred Term: Estimand Notes + Definition: A brief written record relevant to the study estimand. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + analysisPopulationId: + Type: + - $ref: '#/AnalysisPopulation' + Definition: A USDM relationship between the Estimand and AnalysisPopulation + classes which provides the details associated with an instance of the analysis + population used to partially define a study estimand. + Cardinality: '1' + Relationship Type: Ref + Model Name: analysisPopulation + Model Representation: Relationship + variableOfInterestId: + Type: + - $ref: '#/Endpoint' + Definition: A USDM relationship between the Estimand and Endpoint classes which + provides the details associated with an instance of the variable of interest + within a study endpoint used to partially define a study estimand. + Cardinality: '1' + Relationship Type: Ref + Model Name: variableOfInterest + Model Representation: Relationship + intercurrentEvents: + Type: + - $ref: '#/IntercurrentEvent' + Definition: A USDM relationship between the Estimand and IntercurrentEvent classes + which identifies the set of intercurrent events associated with a study estimand. + Cardinality: 1..* + Relationship Type: Value + Model Name: intercurrentEvents + Model Representation: Relationship + interventionIds: + Type: + - $ref: '#/StudyIntervention' + Definition: A USDM relationship between the Estimand and StudyIntervention classes + which identifies the set of study interventions associated with the Estimand. + Cardinality: 1..* + Relationship Type: Ref + Model Name: interventions + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +ExtensionAttribute: + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + url: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + valueString: + Type: + - $ref: '#/string' + Cardinality: 0..1 + Relationship Type: Value + valueBoolean: + Type: + - $ref: '#/boolean' + Cardinality: 0..1 + Relationship Type: Value + valueInteger: + Type: + - $ref: '#/integer' + Cardinality: 0..1 + Relationship Type: Value + valueId: + Type: + - $ref: '#/string' + Cardinality: 0..1 + Relationship Type: Value + valueQuantity: + Type: + - $ref: '#/Quantity' + Cardinality: 0..1 + Relationship Type: Value + valueRange: + Type: + - $ref: '#/Range' + Cardinality: 0..1 + Relationship Type: Value + valueCode: + Type: + - $ref: '#/Code' + Cardinality: 0..1 + Relationship Type: Value + valueAliasCode: + Type: + - $ref: '#/AliasCode' + Cardinality: 0..1 + Relationship Type: Value + valueExtensionClass: + Type: + - $ref: '#/ExtensionClass' + Cardinality: 0..1 + Relationship Type: Value + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +ExtensionClass: + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + url: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 1..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +GeographicScope: + NCI C-Code: C207591 + Preferred Term: Geographic Scope + Definition: The extent or range related to the physical location of an entity. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + type: + Type: + - $ref: '#/Code' + NCI C-Code: C207495 + Preferred Term: Geographic Scope Type + Definition: A characterization or classification of the geographic scope. + Cardinality: '1' + Relationship Type: Value + Model Name: type + Model Representation: Attribute + code: + Type: + - $ref: '#/AliasCode' + NCI C-Code: C207494 + Preferred Term: Geographic Scope Code + Definition: A symbol or combination of symbols which is assigned to the geographic + scope. + Cardinality: 0..1 + Relationship Type: Value + Model Name: code + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +GovernanceDate: + NCI C-Code: C207595 + Preferred Term: Study Governance Date + Definition: Any of the dates associated with event milestones within a clinical + study's oversight and management framework. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C207499 + Preferred Term: Study Governance Date Name + Definition: The literal identifier (i.e., distinctive designation) of the study + governance date + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207498 + Preferred Term: Study Governance Date Label + Definition: The short descriptive designation for the study governance date. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C207497 + Preferred Term: Study Governance Date Description + Definition: A narrative representation of the study governance date. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + type: + Type: + - $ref: '#/Code' + NCI C-Code: C207496 + Preferred Term: Study Governance Date Type + Definition: A characterization or classification of the study governance date. + Cardinality: '1' + Relationship Type: Value + Model Name: type + Model Representation: Attribute + dateValue: + Type: + - $ref: '#/date' + NCI C-Code: C207500 + Preferred Term: Study Governance Date Value + Definition: The information contained in the date field. + Cardinality: '1' + Relationship Type: Value + Model Name: dateValue + Model Representation: Attribute + geographicScopes: + Type: + - $ref: '#/GeographicScope' + Definition: A USDM relationship between the GovernanceDate and GeographicScope + classes which identifies the set of geographic scopes associated with the + governance date. + Cardinality: 1..* + Relationship Type: Value + Model Name: geographicScopes + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +Identifier: + NCI C-Code: C25364 + Preferred Term: Identifier + Definition: One or more characters used to identify, name, or characterize the nature, + properties, or contents of a thing. + Modifier: Abstract + Sub Classes: + - $ref: '#/AdministrableProductIdentifier' + - $ref: '#/MedicalDeviceIdentifier' + - $ref: '#/ReferenceIdentifier' + - $ref: '#/StudyIdentifier' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + text: + Type: + - $ref: '#/string' + NCI C-Code: C215581 + Preferred Term: Administrable Product Identifier Text + Definition: An instance of structured text that represents the administrable + product. + Cardinality: '1' + Relationship Type: Value + Model Name: text + Model Representation: Attribute + scopeId: + Type: + - $ref: '#/Organization' + Definition: A USDM relationship between the AdministrableProductIdentifier and + Organization class which provides the details associated with which provides + the details associated with each organization that has assigned the administrable + product identifier. + Cardinality: '1' + Relationship Type: Ref + Model Name: scope + Model Representation: Relationship +Indication: + NCI C-Code: C41184 + Preferred Term: Disease/Condition Indication + Definition: The disease or condition the intervention will diagnose, treat, prevent, + cure, or mitigate. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C207503 + Preferred Term: Disease/Condition Indication Name + Definition: The literal identifier (i.e., distinctive designation) of the disease/condition + indication. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207502 + Preferred Term: Disease/Condition Indication Label + Definition: The short descriptive designation for the disease/condition indication. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C112038 + Preferred Term: Disease/Condition Indication Description + Definition: A narrative representation of the condition, disease or disorder + that the clinical trial is intended to investigate or address. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + isRareDisease: + Type: + - $ref: '#/boolean' + NCI C-Code: C207501 + Preferred Term: Disease/Condition Indication Is Rare Disease Indicator + Definition: An indication as to whether the disease/condition indication under + study is considered a rare disease. + Cardinality: '1' + Relationship Type: Value + Model Name: isRareDisease + Model Representation: Attribute + codes: + Type: + - $ref: '#/Code' + NCI C-Code: C188822 + Preferred Term: Disease/Condition Indication Code + Definition: A short sequence of characters that represents the disease/condition + indication. + Cardinality: 0..* + Relationship Type: Value + Model Name: codes + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215509 + Preferred Term: Indication Notes + Definition: A brief written record relevant to the disease/condition indication. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +Ingredient: + NCI C-Code: C51981 + Preferred Term: Ingredient + Definition: Any component that constitutes a part of a compounded substance or mixture. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + role: + Type: + - $ref: '#/Code' + NCI C-Code: C215595 + Preferred Term: Ingredient Role + Definition: The intended use of the ingredient within the context of the compounded + substance or mixture. + Cardinality: '1' + Relationship Type: Value + Model Name: role + Model Representation: Attribute + substance: + Type: + - $ref: '#/Substance' + Definition: A USDM relationship between the Ingredient and Substance classes + that identifies the substance associated with the ingredient. + Cardinality: '1' + Relationship Type: Value + Model Name: substance + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +IntercurrentEvent: + NCI C-Code: C188815 + Preferred Term: Intercurrent Event + Definition: An event(s) occurring after treatment initiation that affects either + the interpretation or the existence of the measurements associated with the clinical + question of interest. (ICH E9 Addendum on Estimands) + Modifier: Concrete + Super Classes: + - $ref: '#/SyntaxTemplate' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + name: + Type: + - $ref: '#/string' + NCI C-Code: C188855 + Preferred Term: Intercurrent Event Name + Definition: The literal identifier (i.e., distinctive designation) of the intercurrent + event. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + label: + Type: + - $ref: '#/string' + NCI C-Code: C207504 + Preferred Term: Intercurrent Event Label + Definition: The short descriptive designation for the intercurrent event. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + description: + Type: + - $ref: '#/string' + NCI C-Code: C188856 + Preferred Term: Intercurrent Event Description + Definition: A narrative representation of the intercurrent event. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + text: + Type: + - $ref: '#/string' + NCI C-Code: C215526 + Preferred Term: Intercurrent Event Text + Definition: An instance of structured text that represents the intercurrent + event. + Cardinality: '1' + Relationship Type: Value + Model Name: text + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215527 + Preferred Term: Intercurrent Event Notes + Definition: A brief written record relevant to the intercurrent event. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + dictionaryId: + Type: + - $ref: '#/SyntaxTemplateDictionary' + Definition: 'A USDM relationship between the IntercurrentEvent and SyntaxTemplateDictionary + classes which provides the set of dictionary entries related to the intercurrent + event. ' + Cardinality: 0..1 + Relationship Type: Ref + Model Name: dictionary + Model Representation: Relationship + Inherited From: + - $ref: '#/SyntaxTemplate' + strategy: + Type: + - $ref: '#/string' + NCI C-Code: C188857 + Preferred Term: Intercurrent Event Strategy + Definition: A textual description of the planned strategy to manage and/or mitigate + intercurrent events. + Cardinality: '1' + Relationship Type: Value + Model Name: strategy + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +InterventionalStudyDesign: + NCI C-Code: C215503 + Preferred Term: Interventional Study Design + Definition: The strategy that specifies the structure of an interventional trial + in terms of the planned activities (including timing) and statistical analysis + approach intended to meet the objectives of the study. + Modifier: Concrete + Super Classes: + - $ref: '#/StudyDesign' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + Inherited From: + - $ref: '#/StudyDesign' + name: + Type: + - $ref: '#/string' + NCI C-Code: C215626 + Preferred Term: Interventional Study Design Name + Definition: The literal identifier (i.e., distinctive designation) of the interventional + study design. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + Inherited From: + - $ref: '#/StudyDesign' + label: + Type: + - $ref: '#/string' + NCI C-Code: C215628 + Preferred Term: Interventional Study Design Label + Definition: The short descriptive designation for the interventional study design. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + Inherited From: + - $ref: '#/StudyDesign' + description: + Type: + - $ref: '#/string' + NCI C-Code: C215627 + Preferred Term: Interventional Study Design Description + Definition: A narrative representation of the interventional study design. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + Inherited From: + - $ref: '#/StudyDesign' + rationale: + Type: + - $ref: '#/string' + NCI C-Code: C215629 + Preferred Term: Interventional Study Design Rationale + Definition: Reason(s) for choosing the interventional study design. This may + include reasons for the choice of control or comparator, as well as the scientific + rationale for the study design. + Cardinality: '1' + Relationship Type: Value + Model Name: rationale + Model Representation: Attribute + Inherited From: + - $ref: '#/StudyDesign' + therapeuticAreas: + Type: + - $ref: '#/Code' + NCI C-Code: C215633 + Preferred Term: Interventional Study Design Therapeutic Areas + Definition: A categorization of a disease, disorder, or other condition based + on common characteristics and often associated with a medical specialty focusing + on research and development of specific therapeutic interventions for the + purpose of treatment and prevention, which is associated with the interventional + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: therapeuticAreas + Model Representation: Attribute + Inherited From: + - $ref: '#/StudyDesign' + studyType: + Type: + - $ref: '#/Code' + NCI C-Code: C215631 + Preferred Term: Interventional Study Design Study Type + Definition: The study type associated with the interventional study design. + Cardinality: 0..1 + Relationship Type: Value + Model Name: studyType + Model Representation: Attribute + Inherited From: + - $ref: '#/StudyDesign' + characteristics: + Type: + - $ref: '#/Code' + NCI C-Code: C215632 + Preferred Term: Interventional Study Design Characteristics + Definition: The distinguishing qualities or prominent aspects of an interventional + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: characteristics + Model Representation: Attribute + Inherited From: + - $ref: '#/StudyDesign' + studyPhase: + Type: + - $ref: '#/AliasCode' + NCI C-Code: C215630 + Preferred Term: Interventional Study Design Study Phase + Definition: The study phase associated with the interventional study design. + Cardinality: 0..1 + Relationship Type: Value + Model Name: studyPhase + Model Representation: Attribute + Inherited From: + - $ref: '#/StudyDesign' + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215634 + Preferred Term: Interventional Study Design Notes + Definition: A brief written record relevant to the interventional study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + Inherited From: + - $ref: '#/StudyDesign' + activities: + Type: + - $ref: '#/Activity' + Definition: A USDM relationship between the InterventionalStudyDesign and Activity + classes which identifies the set of activities associated with the interventional + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: activities + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + biospecimenRetentions: + Type: + - $ref: '#/BiospecimenRetention' + Definition: A USDM relationship between the InterventionalStudyDesign and BiospecimenRetention + classes which identifies the status of biospecimen retentions related to the + interventional study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: biospecimenRetentions + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + eligibilityCriteria: + Type: + - $ref: '#/EligibilityCriterion' + Definition: A USDM relationship between the InterventionalStudyDesign and EligibilityCriterion + classes which identifies the set of eligibility criterion associated with + the interventional study design. + Cardinality: 1..* + Relationship Type: Value + Model Name: eligibilityCriteria + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + encounters: + Type: + - $ref: '#/Encounter' + Definition: A USDM relationship between the InterventionalStudyDesign and Encounter + classes which identifies the set of encounters associated with the interventional + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: encounters + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + estimands: + Type: + - $ref: '#/Estimand' + Definition: A USDM relationship between the InterventionalStudyDesign and Estimand + classes which identifies the set of estimands associated with the interventional + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: estimands + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + indications: + Type: + - $ref: '#/Indication' + Definition: A USDM relationship between the InterventionalStudyDesign and Indication + classes which identifies the set of indications associated with the interventional + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: indications + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + objectives: + Type: + - $ref: '#/Objective' + Definition: A USDM relationship between the InterventionalStudyDesign and Objective + classes which identifies the set of objectives associated with the interventional + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: objectives + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + scheduleTimelines: + Type: + - $ref: '#/ScheduleTimeline' + Definition: A USDM relationship between the InterventionalStudyDesign and ScheduleTimeline + classes which identifies the set of scheduled timelines associated with the + interventional study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: scheduleTimelines + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + arms: + Type: + - $ref: '#/StudyArm' + Definition: A USDM relationship between the InterventionalStudyDesign and StudyArm + classes which identifies the set of study arms associated with the interventional + study design. + Cardinality: 1..* + Relationship Type: Value + Model Name: arms + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + studyCells: + Type: + - $ref: '#/StudyCell' + Definition: 'A USDM relationship between the InterventionalStudyDesign and StudyCell + classes which identifies the set of study cells associated with the interventional + study design. ' + Cardinality: 1..* + Relationship Type: Value + Model Name: studyCells + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + documentVersionIds: + Type: + - $ref: '#/StudyDefinitionDocumentVersion' + Definition: A USDM relationship between the InterventionalStudyDesign and StudyDefinitionDocumentVersion + classes which identifies the version of the study definition documents associated + with the interventional study design. + Cardinality: 0..* + Relationship Type: Ref + Model Name: documentVersions + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + elements: + Type: + - $ref: '#/StudyElement' + Definition: A USDM relationship between the InterventionalStudyDesign and StudyElement + classes which identifies the set of study elements associated with the interventional + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: elements + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + studyInterventionIds: + Type: + - $ref: '#/StudyIntervention' + Definition: A USDM relationship between the InterventionalStudyDesign and StudyIntervention + classes which identifies the set of study interventions associated with interventional + study design. + Cardinality: 0..* + Relationship Type: Ref + Model Name: studyInterventions + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + epochs: + Type: + - $ref: '#/StudyEpoch' + Definition: A USDM relationship between the InterventionalStudyDesign and StudyEpoch + classes which identifies the set of study epochs associated with the interventional + study design. + Cardinality: 1..* + Relationship Type: Value + Model Name: epochs + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + population: + Type: + - $ref: '#/StudyDesignPopulation' + Definition: A USDM relationship between the InterventionalStudyDesign and StudyDesignPopulation + classes which identifies the population associated with the interventional + study design. + Cardinality: '1' + Relationship Type: Value + Model Name: population + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + model: + Type: + - $ref: '#/Code' + NCI C-Code: C98746 + Preferred Term: Intervention Model Type + Definition: The general design of the strategy for assigning interventions to + subjects in a clinical study. (clinicaltrials.gov) + Cardinality: '1' + Relationship Type: Value + Model Name: model + Model Representation: Attribute + subTypes: + Type: + - $ref: '#/Code' + NCI C-Code: C49660 + Preferred Term: Trial Type + Definition: The nature of the interventional study for which information is + being collected. + Cardinality: 0..* + Relationship Type: Value + Model Name: subTypes + Model Representation: Attribute + blindingSchema: + Type: + - $ref: '#/AliasCode' + NCI C-Code: C49658 + Preferred Term: Trial Blinding Schema + Definition: The type of experimental design used to describe the level of awareness + of the study subjects and/ or study personnel as it relates to the respective + intervention(s) or assessments being observed, received or administered. + Cardinality: 0..1 + Relationship Type: Value + Model Name: blindingSchema + Model Representation: Attribute + intentTypes: + Type: + - $ref: '#/Code' + NCI C-Code: C49652 + Preferred Term: Trial Intent Type + Definition: The planned purpose of the therapy, device, or agent under study + in the clinical trial. + Cardinality: 0..* + Relationship Type: Value + Model Name: intentTypes + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + analysisPopulations: + Type: + - $ref: '#/AnalysisPopulation' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +Masking: + NCI C-Code: C191278 + Preferred Term: Masking + Definition: The mechanism used to obscure the distinctive characteristics of the + study intervention or procedure to make it indistinguishable from a comparator. + (CDISC Glossary) + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + text: + Type: + - $ref: '#/string' + NCI C-Code: C215553 + Preferred Term: Masking Text + Definition: An instance of unstructured text that represents how the masking + is performed and maintained. + Cardinality: '1' + Relationship Type: Value + Model Name: text + Model Representation: Attribute + isMasked: + Type: + - $ref: '#/boolean' + NCI C-Code: C215554 + Preferred Term: Masked Indicator + Definition: An indication as to whether the study role is masked. + Cardinality: '1' + Relationship Type: Value + Model Name: isMasked + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +MedicalDevice: + NCI C-Code: C16830 + Preferred Term: Medical Device + Definition: Any instrument, apparatus, implement, machine, appliance, implant, reagent + for in vitro use, software, material or other similar or related article, intended + by the manufacturer to be used, alone or in combination for, one or more specific + medical purpose(s). [After REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT + AND OF THE COUNCIL of 5 April 2017 on medical devices] + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C215614 + Preferred Term: Medical Device Name + Definition: The literal identifier (i.e., distinctive designation) of the medical + device. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C215616 + Preferred Term: Medical Device Label + Definition: The short descriptive designation for the medical device. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C215615 + Preferred Term: Medical Device Description + Definition: A narrative representation of the medical device. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + hardwareVersion: + Type: + - $ref: '#/string' + NCI C-Code: C215617 + Preferred Term: Hardware Version + Definition: A form or variant of hardware; one of a sequence of copies of the + physical components from which a computer is constructed, each incorporating + new modifications. + Cardinality: 0..1 + Relationship Type: Value + Model Name: hardwareVersion + Model Representation: Attribute + softwareVersion: + Type: + - $ref: '#/string' + NCI C-Code: C111093 + Preferred Term: Software Version + Definition: A form or variant of software; one of a sequence of copies of a + software program, each incorporating new modifications. (NCI) + Cardinality: 0..1 + Relationship Type: Value + Model Name: softwareVersion + Model Representation: Attribute + sourcing: + Type: + - $ref: '#/Code' + NCI C-Code: C215619 + Preferred Term: Medical Device Sourcing + Definition: An indication as to whether the medical device is obtained from + a local or central source. + Cardinality: 0..1 + Relationship Type: Value + Model Name: sourcing + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215618 + Preferred Term: Medical Device Notes + Definition: A brief written record relevant to the medical device. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + embeddedProductId: + Type: + - $ref: '#/AdministrableProduct' + Definition: A USDM relationship between the MedicalDevice and AdministrableProduct + classes which identifies the administrable product that is an integral component + of the medical device. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: embeddedProduct + Model Representation: Relationship + identifiers: + Type: + - $ref: '#/MedicalDeviceIdentifier' + Definition: A USDM relationship between the MedicalDevice and MedicalDeviceIdentifier + classes which provides the set of identifiers related to the medical device. + Cardinality: 0..* + Relationship Type: Value + Model Name: identifiers + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +MedicalDeviceIdentifier: + NCI C-Code: C215501 + Preferred Term: Medical Device Identifier + Definition: A sequence of characters used to identify, name, or characterize the + medical device. + Modifier: Concrete + Super Classes: + - $ref: '#/Identifier' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + Inherited From: + - $ref: '#/Identifier' + text: + Type: + - $ref: '#/string' + NCI C-Code: C215620 + Preferred Term: Medical Device Identifier Text + Definition: An instance of structured text that represents the medical device + identifier. + Cardinality: '1' + Relationship Type: Value + Model Name: text + Model Representation: Attribute + Inherited From: + - $ref: '#/Identifier' + scopeId: + Type: + - $ref: '#/Organization' + Definition: A USDM relationship between the MedicalDeviceIdentifier and Organization + classes which provides the details associated with each organization that + has assigned the identifier. + Cardinality: '1' + Relationship Type: Ref + Model Name: scope + Model Representation: Relationship + Inherited From: + - $ref: '#/Identifier' + type: + Type: + - $ref: '#/Code' + NCI C-Code: C215621 + Preferred Term: Medical Device Identifier Type + Definition: A characterization or classification of the medical device identifier. + Cardinality: '1' + Relationship Type: Value + Model Name: type + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +NarrativeContent: + NCI C-Code: C207592 + Preferred Term: Narrative Content + Definition: The container that holds an instance of unstructured text and which + may include objects such as tables, figures, and images. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C207507 + Preferred Term: Narrative Content Name + Definition: The literal identifier (i.e., distinctive designation) of the narrative + content. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + sectionNumber: + Type: + - $ref: '#/string' + NCI C-Code: C207509 + Preferred Term: Narrative Content Section Number + Definition: The numeric identifier assigned to a particular document section + containing narrative content. + Cardinality: 0..1 + Relationship Type: Value + Model Name: sectionNumber + Model Representation: Attribute + sectionTitle: + Type: + - $ref: '#/string' + NCI C-Code: C207510 + Preferred Term: Narrative Content Section Title + Definition: An identifying designation for the document section containing narrative + content. + Cardinality: 0..1 + Relationship Type: Value + Model Name: sectionTitle + Model Representation: Attribute + displaySectionTitle: + Type: + - $ref: '#/boolean' + NCI C-Code: C215534 + Preferred Term: Narrative Content Section Title Display Indicator + Definition: An indication as to whether the section title is to be displayed + in the document containing narrative content. + Cardinality: '1' + Relationship Type: Value + Model Name: displaySectionTitle + Model Representation: Attribute + displaySectionNumber: + Type: + - $ref: '#/boolean' + NCI C-Code: C215535 + Preferred Term: Narrative Content Section Number Display Indicator + Definition: An indication as to whether the section number is to be displayed + in the document containing narrative content. + Cardinality: '1' + Relationship Type: Value + Model Name: displaySectionNumber + Model Representation: Attribute + contentItemId: + Type: + - $ref: '#/NarrativeContentItem' + Definition: A USDM relationship between the NarrativeContent and NarrativeContentItem + classes which identifies the content item associated with the narrative content. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: contentItem + Model Representation: Relationship + previousId: + Type: + - $ref: '#/NarrativeContent' + Definition: A USDM relationship within the NarrativeContent class which identifies + the narrative content that precedes the current narrative content in the display + order. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: previous + Model Representation: Relationship + nextId: + Type: + - $ref: '#/NarrativeContent' + Definition: A USDM relationship within the NarrativeContent class which identifies + the narrative content that follows the current narrative content in the display + order. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: next + Model Representation: Relationship + childIds: + Type: + - $ref: '#/NarrativeContent' + Definition: A USDM relationship within the NarrativeContent class which identifies + the set of child content associated with an instance of narrative content. + Cardinality: 0..* + Relationship Type: Ref + Model Name: children + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +NarrativeContentItem: + NCI C-Code: C215489 + Preferred Term: Narrative Content Item + Definition: An individual item within the container that holds an instance of unstructured + text and which may include objects such as tables, figures, and images. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C215557 + Preferred Term: Narrative Content Item Name + Definition: The literal identifier (i.e., distinctive designation) of the narrative + content item. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + text: + Type: + - $ref: '#/string' + NCI C-Code: C215558 + Preferred Term: Narrative Content Item Text + Definition: An instance of unstructured text that represents the narrative content + item. + Cardinality: '1' + Relationship Type: Value + Model Name: text + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +Objective: + NCI C-Code: C142450 + Preferred Term: Study Objective + Definition: The reason for performing a study in terms of the scientific questions + to be answered by the analysis of data collected during the study. + Modifier: Concrete + Super Classes: + - $ref: '#/SyntaxTemplate' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + name: + Type: + - $ref: '#/string' + NCI C-Code: C207512 + Preferred Term: Study Objective Name + Definition: The literal identifier (i.e., distinctive designation) of the study + objective. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + label: + Type: + - $ref: '#/string' + NCI C-Code: C207511 + Preferred Term: Study Objective Label + Definition: The short descriptive designation for the study objective. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + description: + Type: + - $ref: '#/string' + NCI C-Code: C94090 + Preferred Term: Study Objective Description + Definition: A narrative representation of the study objective. (BRIDG) + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + text: + Type: + - $ref: '#/string' + NCI C-Code: C207513 + Preferred Term: Study Objective Text + Definition: An instance of structured text that represents the study objective. + Cardinality: '1' + Relationship Type: Value + Model Name: text + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215513 + Preferred Term: Objective Notes + Definition: A brief written record relevant to the study objective. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + Inherited From: + - $ref: '#/SyntaxTemplate' + dictionaryId: + Type: + - $ref: '#/SyntaxTemplateDictionary' + Definition: A USDM relationship between the Objective and SyntaxTemplateDictionary + classes which provides the set of dictionary entries related to study objectives. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: dictionary + Model Representation: Relationship + Inherited From: + - $ref: '#/SyntaxTemplate' + level: + Type: + - $ref: '#/Code' + NCI C-Code: C188823 + Preferred Term: Study Objective Level + Definition: A characterization or classification of the study objective that + determines its category of importance relative to other study objectives. + Cardinality: '1' + Relationship Type: Value + Model Name: level + Model Representation: Attribute + endpoints: + Type: + - $ref: '#/Endpoint' + Definition: A USDM relationship between the Objective and Endpoint classes which + identifies the set of endpoints associated with the study objective. + Cardinality: 0..* + Relationship Type: Value + Model Name: endpoints + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +ObservationalStudyDesign: + NCI C-Code: C215504 + Preferred Term: Observational Study Design + Definition: The strategy that specifies the structure of an observational study + in terms of the planned activities (including timing) and statistical analysis + approach intended to meet the objectives of the study. + Modifier: Concrete + Super Classes: + - $ref: '#/StudyDesign' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + Inherited From: + - $ref: '#/StudyDesign' + name: + Type: + - $ref: '#/string' + NCI C-Code: C215636 + Preferred Term: Observational Study Design Name + Definition: The literal identifier (i.e., distinctive designation) of the observational + study design. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + Inherited From: + - $ref: '#/StudyDesign' + label: + Type: + - $ref: '#/string' + NCI C-Code: C215638 + Preferred Term: Observational Study Design Label + Definition: The short descriptive designation for the observational study design. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + Inherited From: + - $ref: '#/StudyDesign' + description: + Type: + - $ref: '#/string' + NCI C-Code: C215637 + Preferred Term: Observational Study Design Description + Definition: A narrative representation of the observational study design. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + Inherited From: + - $ref: '#/StudyDesign' + rationale: + Type: + - $ref: '#/string' + NCI C-Code: C215639 + Preferred Term: Observational Study Design Rationale + Definition: Reason(s) for choosing the observational study design. This may + include reasons for the choice of control or comparator, as well as the scientific + rationale for the study design. + Cardinality: '1' + Relationship Type: Value + Model Name: rationale + Model Representation: Attribute + Inherited From: + - $ref: '#/StudyDesign' + therapeuticAreas: + Type: + - $ref: '#/Code' + NCI C-Code: C215643 + Preferred Term: Observational Study Design Therapeutic Areas + Definition: A categorization of a disease, disorder, or other condition based + on common characteristics and often associated with a medical specialty focusing + on research and development of specific therapeutic interventions for the + purpose of treatment and prevention, which is associated with the observational + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: therapeuticAreas + Model Representation: Attribute + Inherited From: + - $ref: '#/StudyDesign' + studyType: + Type: + - $ref: '#/Code' + NCI C-Code: C215641 + Preferred Term: Observational Study Design Study Type + Definition: The study type associated with the observational study design. + Cardinality: 0..1 + Relationship Type: Value + Model Name: studyType + Model Representation: Attribute + Inherited From: + - $ref: '#/StudyDesign' + characteristics: + Type: + - $ref: '#/Code' + NCI C-Code: C215642 + Preferred Term: Observational Study Design Characteristics + Definition: The distinguishing qualities or prominent aspects of an observational + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: characteristics + Model Representation: Attribute + Inherited From: + - $ref: '#/StudyDesign' + studyPhase: + Type: + - $ref: '#/AliasCode' + NCI C-Code: C215640 + Preferred Term: Observational Study Design Study Phase + Definition: The study phase associated with the observational study design. + Cardinality: 0..1 + Relationship Type: Value + Model Name: studyPhase + Model Representation: Attribute + Inherited From: + - $ref: '#/StudyDesign' + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215644 + Preferred Term: Observational Study Design Notes + Definition: A brief written record relevant to the observational study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + Inherited From: + - $ref: '#/StudyDesign' + activities: + Type: + - $ref: '#/Activity' + Definition: A USDM relationship between the ObservationalStudyDesign and Activity + classes which identifies the set of activities associated with the observational + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: activities + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + biospecimenRetentions: + Type: + - $ref: '#/BiospecimenRetention' + Definition: A USDM relationship between the ObservationalStudyDesign and BiospecimenRetention + classes which identifies the status of biospecimen retentions related to the + observational study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: biospecimenRetentions + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + eligibilityCriteria: + Type: + - $ref: '#/EligibilityCriterion' + Definition: A USDM relationship between the ObservationalStudyDesign and EligibilityCriterion + classes which identifies the set of eligibility criterion associated with + the observational study design. + Cardinality: 1..* + Relationship Type: Value + Model Name: eligibilityCriteria + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + encounters: + Type: + - $ref: '#/Encounter' + Definition: A USDM relationship between the ObservationalStudyDesign and Encounter + classes which identifies the set of encounters associated with the observational + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: encounters + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + estimands: + Type: + - $ref: '#/Estimand' + Definition: A USDM relationship between the ObservationalStudyDesign and Estimand + classes which identifies the set of estimands associated with the observational + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: estimands + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + indications: + Type: + - $ref: '#/Indication' + Definition: A USDM relationship between the ObservationalStudyDesign and Indication + classes which identifies the set of indications associated with the observational + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: indications + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + objectives: + Type: + - $ref: '#/Objective' + Definition: A USDM relationship between the ObservationalStudyDesign and Objective + classes which identifies the set of objectives associated with the observational + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: objectives + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + scheduleTimelines: + Type: + - $ref: '#/ScheduleTimeline' + Definition: A USDM relationship between the ObservationalStudyDesign and ScheduleTimeline + classes which identifies the set of scheduled timelines associated with the + observational study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: scheduleTimelines + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + arms: + Type: + - $ref: '#/StudyArm' + Definition: A USDM relationship between the ObservationalStudyDesign and StudyArm + classes which identifies the set of study arms associated with the observational + study design. + Cardinality: 1..* + Relationship Type: Value + Model Name: arms + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + studyCells: + Type: + - $ref: '#/StudyCell' + Definition: 'A USDM relationship between the ObservationalStudyDesign and StudyCell + classes which identifies the set of study cells associated with the observational + study design. ' + Cardinality: 1..* + Relationship Type: Value + Model Name: studyCells + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + documentVersionIds: + Type: + - $ref: '#/StudyDefinitionDocumentVersion' + Definition: A USDM relationship between the ObservationalStudyDesign and StudyDefinitionDocumentVersion + classes which identifies the version of the study definition documents associated + with the observational study design. + Cardinality: 0..* + Relationship Type: Ref + Model Name: documentVersions + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + elements: + Type: + - $ref: '#/StudyElement' + Definition: A USDM relationship between the ObservationalStudyDesign and StudyElement + classes which identifies the set of study elements associated with the observational + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: elements + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + studyInterventionIds: + Type: + - $ref: '#/StudyIntervention' + Definition: A USDM relationship between the ObservationalStudyDesign and StudyIntervention + classes which identifies the set of study interventions associated with observational + study design. + Cardinality: 0..* + Relationship Type: Ref + Model Name: studyInterventions + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + epochs: + Type: + - $ref: '#/StudyEpoch' + Definition: A USDM relationship between the ObservationalStudyDesign and StudyEpoch + classes which identifies the set of study epochs associated with the observational + study design. + Cardinality: 1..* + Relationship Type: Value + Model Name: epochs + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + population: + Type: + - $ref: '#/StudyDesignPopulation' + Definition: A USDM relationship between the ObservationalStudyDesign and StudyDesignPopulation + classes which identifies the population associated with the observational + study design. + Cardinality: '1' + Relationship Type: Value + Model Name: population + Model Representation: Relationship + Inherited From: + - $ref: '#/StudyDesign' + model: + Type: + - $ref: '#/Code' + NCI C-Code: C147138 + Preferred Term: Observation Study Design Model Type + Definition: The general design of the strategy for identifying and following + up with participants during observational studies. (clinicaltrials.gov) + Cardinality: '1' + Relationship Type: Value + Model Name: model + Model Representation: Attribute + subTypes: + Type: + - $ref: '#/Code' + NCI C-Code: C215635 + Preferred Term: Observational Study Type + Definition: The nature of the observational study for which information is being + collected. + Cardinality: 0..* + Relationship Type: Value + Model Name: subTypes + Model Representation: Attribute + timePerspective: + Type: + - $ref: '#/Code' + NCI C-Code: C126065 + Preferred Term: Observational Time Perspective + Definition: The temporal relationship between the observation period and time + of subject enrollment. (ClinicalTrials.gov) + Cardinality: '1' + Relationship Type: Value + Model Name: timePerspective + Model Representation: Attribute + samplingMethod: + Type: + - $ref: '#/Code' + NCI C-Code: C126067 + Preferred Term: Observational Study Sampling Method + Definition: The sampling method used to assign study participants into groups + or cohorts within an observational study. + Cardinality: 0..1 + Relationship Type: Value + Model Name: samplingMethod + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + analysisPopulations: + Type: + - $ref: '#/AnalysisPopulation' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +Organization: + NCI C-Code: C19711 + Preferred Term: Organization + Definition: A formalized group of persons or other organizations collected together + for a common purpose (such as administrative, legal, political) and the infrastructure + to carry out that purpose. (BRIDG) + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C93874 + Preferred Term: Organization Name + Definition: The literal identifier (i.e., distinctive designation) of the organization. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207514 + Preferred Term: Organization Label + Definition: The short descriptive designation for the organization. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + identifier: + Type: + - $ref: '#/string' + NCI C-Code: C93401 + Preferred Term: Organization Identifier + Definition: A unique symbol that establishes identity of the organization. (BRIDG) + Cardinality: '1' + Relationship Type: Value + Model Name: identifier + Model Representation: Attribute + identifierScheme: + Type: + - $ref: '#/string' + NCI C-Code: C188819 + Preferred Term: Identifier Provider Organization Name + Definition: The name of the organization that provides the identifier for the + entity. + Cardinality: '1' + Relationship Type: Value + Model Name: identifierScheme + Model Representation: Attribute + type: + Type: + - $ref: '#/Code' + NCI C-Code: C188820 + Preferred Term: Organization Type + Definition: A characterization or classification of the formalized group of + persons or other organizations collected together for a common purpose (such + as administrative, legal, political) and the infrastructure to carry out that + purpose. + Cardinality: '1' + Relationship Type: Value + Model Name: type + Model Representation: Attribute + legalAddress: + Type: + - $ref: '#/Address' + Definition: A USDM relationship between the Organization and Address classes + which provides the legal address for an organization. + Cardinality: 0..1 + Relationship Type: Value + Model Name: legalAddress + Model Representation: Relationship + managedSites: + Type: + - $ref: '#/StudySite' + Definition: A USDM relationship between the Organization and StudySite classes + which identifies the set of study sites managed by the organization. + Cardinality: 0..* + Relationship Type: Value + Model Name: managedSites + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +ParameterMap: + NCI C-Code: C207456 + Preferred Term: Parameter Map + Definition: The paired name and value for a given parameter. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + tag: + Type: + - $ref: '#/string' + NCI C-Code: C207515 + Preferred Term: Programming Tag + Definition: Character strings bounded by angle brackets that act as containers + for programming language elements. + Cardinality: '1' + Relationship Type: Value + Model Name: tag + Model Representation: Attribute + reference: + Type: + - $ref: '#/string' + NCI C-Code: C207516 + Preferred Term: Programming Tag Reference + Definition: The reference for a tag used in programming languages, such as a + markup language (e.g., HTML, XML), to store attributes and elements. + Cardinality: '1' + Relationship Type: Value + Model Name: reference + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +PersonName: + NCI C-Code: C25191 + Preferred Term: Person Name + Definition: A word or group of words indicating the identity of a person usually + consisting of a first (personal) name and a last (family) name with an optional + middle name. In some cultural traditions the family name comes first. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + text: + Type: + - $ref: '#/string' + NCI C-Code: C217001 + Preferred Term: Person Name Text + Definition: An instance of structured text that represents the person's full + name. + Cardinality: 0..1 + Relationship Type: Value + Model Name: text + Model Representation: Attribute + familyName: + Type: + - $ref: '#/string' + NCI C-Code: C40975 + Preferred Term: Person Family Name + Definition: A word or group of words indicating a person's last (family) name. + Cardinality: 0..1 + Relationship Type: Value + Model Name: familyName + Model Representation: Attribute + givenNames: + Type: + - $ref: '#/string' + NCI C-Code: C40974 + Preferred Term: Person Given Name + Definition: A word or group of words indicating a person's first (personal or + given) name; the name that precedes the surname. + Cardinality: 0..* + Relationship Type: Value + Model Name: givenNames + Model Representation: Attribute + prefixes: + Type: + - $ref: '#/string' + NCI C-Code: C217002 + Preferred Term: Person Name Prefix + Definition: An affix occurring at the start of the person name string, usually + denoting a title or honorific. + Cardinality: 0..* + Relationship Type: Value + Model Name: prefixes + Model Representation: Attribute + suffixes: + Type: + - $ref: '#/string' + NCI C-Code: C217003 + Preferred Term: Person Name Suffix + Definition: An affix occurring at the end of the person name, usually denoting + educational or professional degrees and certifications, and/or filial rank. + Cardinality: 0..* + Relationship Type: Value + Model Name: suffixes + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +PopulationDefinition: + NCI C-Code: C207593 + Preferred Term: Population Definition + Definition: A concise explanation of the meaning of a population. + Modifier: Abstract + Sub Classes: + - $ref: '#/StudyCohort' + - $ref: '#/StudyDesignPopulation' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C207544 + Preferred Term: Study Cohort Name + Definition: The literal identifier (i.e., distinctive designation) of the study + cohort. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207543 + Preferred Term: Study Cohort Label + Definition: The short descriptive designation for the study cohort. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C207542 + Preferred Term: Study Cohort Description + Definition: A narrative representation of the study cohort. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + plannedSex: + Type: + - $ref: '#/Code' + NCI C-Code: C207541 + Preferred Term: Study Cohort Planned Sex + Definition: The protocol-defined sex within the study cohort. + Cardinality: 0..2 + Relationship Type: Value + Model Name: plannedSex + Model Representation: Attribute + includesHealthySubjects: + Type: + - $ref: '#/boolean' + NCI C-Code: C207480 + Preferred Term: Study Cohort Includes Healthy Subjects Indicator + Definition: An indication as to whether the study cohort includes healthy subjects, + that is, subjects without the disease or condition under study. + Cardinality: '1' + Relationship Type: Value + Model Name: includesHealthySubjects + Model Representation: Attribute + plannedAge: + Type: + - $ref: '#/Range' + NCI C-Code: C207545 + Preferred Term: Study Cohort Planned Age + Definition: The anticipated age of subjects within the study cohort. + Cardinality: 0..1 + Relationship Type: Value + Model Name: plannedAge + Model Representation: Attribute + plannedCompletionNumber: + Type: + - $ref: '#/QuantityRange' + NCI C-Code: C207546 + Preferred Term: Study Cohort Planned Completion Number + Definition: The value representing the planned number of subjects that must + complete the study in order to meet the objectives and endpoints of the study, + within the study cohort. + Cardinality: 0..1 + Relationship Type: Value + Model Name: plannedCompletionNumber + Model Representation: Attribute + plannedEnrollmentNumber: + Type: + - $ref: '#/QuantityRange' + NCI C-Code: C207702 + Preferred Term: Study Cohort Planned Enrollment Number + Definition: The value representing the planned number of subjects to be entered + in a clinical trial, within the study cohort. + Cardinality: 0..1 + Relationship Type: Value + Model Name: plannedEnrollmentNumber + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215547 + Preferred Term: Study Cohort Notes + Definition: A brief written record relevant to the study cohort. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + criterionIds: + Type: + - $ref: '#/EligibilityCriterion' + Definition: A USDM relationship between the StudyCohort and EligibilityCriterion + classes which identifies the set of eligibility criteria associated with the + study cohort. + Cardinality: 0..* + Relationship Type: Ref + Model Name: criteria + Model Representation: Relationship +Procedure: + NCI C-Code: C98769 + Preferred Term: Procedure + Definition: Any activity performed by manual and/or instrumental means for the purpose + of diagnosis, assessment, therapy, prevention, or palliative care. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C201325 + Preferred Term: Procedure Name + Definition: The literal identifier (i.e., distinctive designation) of the procedure. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207524 + Preferred Term: Procedure Label + Definition: The short descriptive designation for the procedure. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C201324 + Preferred Term: Procedure Description + Definition: A narrative representation of the procedure. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + procedureType: + Type: + - $ref: '#/string' + NCI C-Code: C188848 + Preferred Term: Procedure Type + Definition: A characterization or classification of the study procedure. + Cardinality: '1' + Relationship Type: Value + Model Name: procedureType + Model Representation: Attribute + code: + Type: + - $ref: '#/Code' + NCI C-Code: C154626 + Preferred Term: Procedure Code + Definition: A symbol or combination of symbols which is assigned to medical + procedure. + Cardinality: '1' + Relationship Type: Value + Model Name: code + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215520 + Preferred Term: Procedure Notes + Definition: A brief written record relevant to the procedure. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + studyInterventionId: + Type: + - $ref: '#/StudyIntervention' + Definition: A USDM relationship between the Procedure and StudyInterventionclasses + which provides the details associated with an instance of an intervention + performed during the conduct of a procedure. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: studyIntervention + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +ProductOrganizationRole: + NCI C-Code: C215502 + Preferred Term: Product Organization Role + Definition: A designation that identifies the function of an organization within + the context of the product. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C215622 + Preferred Term: Product Organization Role Name + Definition: The literal identifier (i.e., distinctive designation) of the product + organization role. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C215624 + Preferred Term: Product Organization Role Label + Definition: The short descriptive designation for the product organization role. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C215623 + Preferred Term: Product Organization Role Description + Definition: A narrative representation of the product organization role. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + code: + Type: + - $ref: '#/Code' + NCI C-Code: C215625 + Preferred Term: Product Organization Role Code + Definition: A symbol or combination of symbols which is assigned to the product + organization role. + Cardinality: '1' + Relationship Type: Value + Model Name: code + Model Representation: Attribute + appliesToIds: + Type: + - $ref: '#/AdministrableProduct' + - $ref: '#/MedicalDevice' + Definition: A USDM relationship between the ProductOrganizationRole and either + the AdministrableProduct or MedicalDevice class that identifies the administrable + product or medical device to which the product organization role applies. + Cardinality: 0..* + Relationship Type: Ref + Model Name: appliesTo + Model Representation: Relationship + organizationId: + Type: + - $ref: '#/Organization' + Definition: A USDM relationship between the ProductOrganizationRole and Organization + classes which identifies the organization associated with the product organization + role. + Cardinality: '1' + Relationship Type: Ref + Model Name: organization + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +Quantity: + NCI C-Code: C25256 + Preferred Term: Quantity + Definition: How much there is of something that can be measured; the total amount + or number. + Modifier: Concrete + Super Classes: + - $ref: '#/QuantityRange' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + Inherited From: + - $ref: '#/QuantityRange' + value: + Type: + - $ref: '#/float' + NCI C-Code: C25712 + Preferred Term: Quantity Value + Definition: A numerical quantity measured or assigned or computed. + Cardinality: '1' + Relationship Type: Value + Model Name: value + Model Representation: Attribute + unit: + Type: + - $ref: '#/AliasCode' + NCI C-Code: C44258 + Preferred Term: Quantity Unit + Definition: The type of unit of measure being used to express a quantity. + Cardinality: 0..1 + Relationship Type: Value + Model Name: unit + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +QuantityRange: + NCI C-Code: C217000 + Preferred Term: Quantity or Range + Definition: The total amount (number), or the limits (minimum and maximum) of a + variation. + Modifier: Abstract + Sub Classes: + - $ref: '#/Quantity' + - $ref: '#/Range' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute +Range: + NCI C-Code: C38013 + Preferred Term: Range + Definition: An expression that defines the lower and upper limits of a variation. + Modifier: Concrete + Super Classes: + - $ref: '#/QuantityRange' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + Inherited From: + - $ref: '#/QuantityRange' + minValue: + Type: + - $ref: '#/Quantity' + NCI C-Code: C25570 + Preferred Term: Minimum Value + Definition: The smallest value in quantity or degree in a set of values. + Cardinality: '1' + Relationship Type: Value + Model Name: minValue + Model Representation: Attribute + maxValue: + Type: + - $ref: '#/Quantity' + NCI C-Code: C25564 + Preferred Term: Maximum Value + Definition: The largest value in quantity or degree in a set of values. + Cardinality: '1' + Relationship Type: Value + Model Name: maxValue + Model Representation: Attribute + isApproximate: + Type: + - $ref: '#/boolean' + NCI C-Code: C207525 + Preferred Term: Value Range is Approximate Indicator + Definition: An indication as to whether the value range is almost, but not quite, + exact. + Cardinality: '1' + Relationship Type: Value + Model Name: isApproximate + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +ReferenceIdentifier: + NCI C-Code: C82531 + Preferred Term: Reference Identifier + Definition: A sequence of characters used to identify, name, or characterize the + reference. + Modifier: Concrete + Super Classes: + - $ref: '#/Identifier' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + Inherited From: + - $ref: '#/Identifier' + text: + Type: + - $ref: '#/string' + NCI C-Code: C215572 + Preferred Term: Reference Identifier Text + Definition: An instance of structured text that represents the reference identifier. + Cardinality: '1' + Relationship Type: Value + Model Name: text + Model Representation: Attribute + Inherited From: + - $ref: '#/Identifier' + scopeId: + Type: + - $ref: '#/Organization' + Definition: A USDM relationship between the ReferenceIdentifier and Organization + classes which provides the details associated with each organization that + has assigned the reference identifier. + Cardinality: '1' + Relationship Type: Ref + Model Name: scope + Model Representation: Relationship + Inherited From: + - $ref: '#/Identifier' + type: + Type: + - $ref: '#/Code' + NCI C-Code: C215571 + Preferred Term: Reference Identifier Type + Definition: A characterization or classification of the reference identifier. + Cardinality: '1' + Relationship Type: Value + Model Name: type + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +ResponseCode: + NCI C-Code: C201347 + Preferred Term: Response Code + Definition: A symbol or combination of symbols representing the response to the + question. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C216998 + Preferred Term: Response Code Name + Definition: The literal identifier (i.e., distinctive designation) of the response + code. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C216999 + Preferred Term: Response Code Label + Definition: The short descriptive designation for the response code. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + isEnabled: + Type: + - $ref: '#/boolean' + NCI C-Code: C201330 + Preferred Term: Response Code Enabled Indicator + Definition: An indication as to whether the response code is activated for use + within a given usage context. + Cardinality: '1' + Relationship Type: Value + Model Name: isEnabled + Model Representation: Attribute + code: + Type: + - $ref: '#/Code' + NCI C-Code: C217013 + Preferred Term: Response Code Value + Definition: The literal value of a response code. + Cardinality: '1' + Relationship Type: Value + Model Name: code + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +ScheduleTimeline: + NCI C-Code: C201348 + Preferred Term: Schedule Timeline + Definition: A chronological schedule of planned temporal events. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C201334 + Preferred Term: Schedule Timeline Name + Definition: The literal identifier (i.e., distinctive designation) of the schedule + timeline. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207530 + Preferred Term: Schedule Timeline Label + Definition: The short descriptive designation for the schedule timeline. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C201332 + Preferred Term: Schedule Timeline Description + Definition: A narrative representation of the schedule timeline. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + entryCondition: + Type: + - $ref: '#/string' + NCI C-Code: C201333 + Preferred Term: Schedule Timeline Entry Condition + Definition: A logical evaluation on which rests the validity of entry into a + schedule timeline. + Cardinality: '1' + Relationship Type: Value + Model Name: entryCondition + Model Representation: Attribute + mainTimeline: + Type: + - $ref: '#/boolean' + NCI C-Code: C201331 + Preferred Term: Main Timeline Indicator + Definition: An indication as to whether the timeline or timeline component is + part of the central or principal timeline. + Cardinality: '1' + Relationship Type: Value + Model Name: mainTimeline + Model Representation: Attribute + plannedDuration: + Type: + - $ref: '#/Duration' + NCI C-Code: C217012 + Preferred Term: Schedule Timeline Planned Duration + Definition: The period of time over which the scheduled timeline is intended + to take place. + Cardinality: 0..1 + Relationship Type: Value + Model Name: plannedDuration + Model Representation: Attribute + instances: + Type: + - $ref: '#/ScheduledInstance' + Definition: A USDM relationship between the ScheduleTimeline and ScheduledInstance + classes which identifies the set of scheduled instances (e.g., scheduled activity + instances or scheduled decision instances) associated with the scheduled timeline. + Cardinality: 0..* + Relationship Type: Value + Model Name: instances + Model Representation: Relationship + entryId: + Type: + - $ref: '#/ScheduledInstance' + Definition: A USDM relationship between the ScheduleTimeline and ScheduledInstance + classes which defines the entry into a scheduled instance (e.g., scheduled + activity instances or scheduled decision instances) for a timeline. + Cardinality: '1' + Relationship Type: Ref + Model Name: entry + Model Representation: Relationship + exits: + Type: + - $ref: '#/ScheduleTimelineExit' + Definition: A USDM relationship between the ScheduleTimeline and ScheduleTimelineExit + classes which identifies the set of exits from the scheduled timeline. + Cardinality: 0..* + Relationship Type: Value + Model Name: exits + Model Representation: Relationship + timings: + Type: + - $ref: '#/Timing' + Definition: A USDM relationship between the ScheduleTimeline and Timing classes + which identifies the set of timings associated with the scheduled timeline. + Cardinality: 0..* + Relationship Type: Value + Model Name: timings + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +ScheduleTimelineExit: + NCI C-Code: C201349 + Preferred Term: Schedule Timeline Exit + Definition: To go out of or leave the schedule timeline. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +ScheduledActivityInstance: + NCI C-Code: C201350 + Preferred Term: Scheduled Activity Instance + Definition: A scheduled occurrence of an activity event. + Modifier: Concrete + Super Classes: + - $ref: '#/ScheduledInstance' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + Inherited From: + - $ref: '#/ScheduledInstance' + name: + Type: + - $ref: '#/string' + NCI C-Code: C207533 + Preferred Term: Scheduled Activity Instance Name + Definition: The literal identifier (i.e., distinctive designation) of the scheduled + activity instance. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + Inherited From: + - $ref: '#/ScheduledInstance' + label: + Type: + - $ref: '#/string' + NCI C-Code: C207532 + Preferred Term: Scheduled Activity Instance Label + Definition: The short descriptive designation for the scheduled activity instance. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + Inherited From: + - $ref: '#/ScheduledInstance' + description: + Type: + - $ref: '#/string' + NCI C-Code: C207531 + Preferred Term: Scheduled Activity Instance Description + Definition: A narrative representation of the scheduled activity instance. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + Inherited From: + - $ref: '#/ScheduledInstance' + defaultConditionId: + Type: + - $ref: '#/ScheduledInstance' + Definition: A USDM relationship within the ScheduledActivityInstance class which + identifies the default condition within a scheduled activity instance. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: defaultCondition + Model Representation: Relationship + Inherited From: + - $ref: '#/ScheduledInstance' + epochId: + Type: + - $ref: '#/StudyEpoch' + Definition: A USDM relationship between the ScheduledActivityInstance and StudyEpoch + classes which identifies the study epoch associated with a scheduled activity + instance. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: epoch + Model Representation: Relationship + Inherited From: + - $ref: '#/ScheduledInstance' + activityIds: + Type: + - $ref: '#/Activity' + Definition: A USDM relationship between the ScheduledActivityInstance and Activity + classes which identifies the set of activities associated with a scheduled + activity instance. + Cardinality: 0..* + Relationship Type: Ref + Model Name: activities + Model Representation: Relationship + encounterId: + Type: + - $ref: '#/Encounter' + Definition: A USDM relationship between the ScheduledActivityInstance and Encounter + classes which defines the subject encounter associated with the ScheduleActivityInstance. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: encounter + Model Representation: Relationship + timelineId: + Type: + - $ref: '#/ScheduleTimeline' + Definition: A USDM relationship between the ScheduledActivityInstance and ScheduleTimeline + classes which provides the details associated with an instance of a scheduled + timeline related to a scheduled activity instance. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: timeline + Model Representation: Relationship + timelineExitId: + Type: + - $ref: '#/ScheduleTimelineExit' + Definition: A USDM relationship between the ScheduledActivityInstance and ScheduleTimelineExit + classes which provides the details associated with the exit from a timeline + related to a scheduled activity instance. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: timelineExit + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +ScheduledDecisionInstance: + NCI C-Code: C201351 + Preferred Term: Scheduled Decision Instance + Definition: A scheduled occurrence of a decision event. + Modifier: Concrete + Super Classes: + - $ref: '#/ScheduledInstance' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + Inherited From: + - $ref: '#/ScheduledInstance' + name: + Type: + - $ref: '#/string' + NCI C-Code: C207536 + Preferred Term: Scheduled Decision Instance Name + Definition: The literal identifier (i.e., distinctive designation) of the scheduled + Decision instance. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + Inherited From: + - $ref: '#/ScheduledInstance' + label: + Type: + - $ref: '#/string' + NCI C-Code: C207535 + Preferred Term: Scheduled Decision Instance Label + Definition: The short descriptive designation for the scheduled Decision instance. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + Inherited From: + - $ref: '#/ScheduledInstance' + description: + Type: + - $ref: '#/string' + NCI C-Code: C207534 + Preferred Term: Scheduled Decision Instance Description + Definition: A narrative representation of the scheduled Decision instance. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + Inherited From: + - $ref: '#/ScheduledInstance' + defaultConditionId: + Type: + - $ref: '#/ScheduledInstance' + Definition: A USDM relationship within the ScheduledDecisionInstance class which + identifies the default condition within a scheduled decision instance. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: defaultCondition + Model Representation: Relationship + Inherited From: + - $ref: '#/ScheduledInstance' + epochId: + Type: + - $ref: '#/StudyEpoch' + Definition: A USDM relationship between the ScheduledDecisionInstance and StudyEpoch + classes which identifies the study epoch associated with a scheduled decision + instance. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: epoch + Model Representation: Relationship + Inherited From: + - $ref: '#/ScheduledInstance' + conditionAssignments: + Type: + - $ref: '#/ConditionAssignment' + Definition: A USDM relationship between the ScheduledDecisionInstance and ConditionAssignment + classes which identifies the set of condition assignments associated with + a scheduled decision instance. + Cardinality: 1..* + Relationship Type: Value + Model Name: conditionAssignments + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +ScheduledInstance: + NCI C-Code: C201299 + Preferred Term: Scheduled Instance + Definition: A scheduled occurrence of a temporal event. + Modifier: Abstract + Sub Classes: + - $ref: '#/ScheduledActivityInstance' + - $ref: '#/ScheduledDecisionInstance' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C207533 + Preferred Term: Scheduled Activity Instance Name + Definition: The literal identifier (i.e., distinctive designation) of the scheduled + activity instance. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207532 + Preferred Term: Scheduled Activity Instance Label + Definition: The short descriptive designation for the scheduled activity instance. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C207531 + Preferred Term: Scheduled Activity Instance Description + Definition: A narrative representation of the scheduled activity instance. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + defaultConditionId: + Type: + - $ref: '#/ScheduledInstance' + Definition: A USDM relationship within the ScheduledActivityInstance class which + identifies the default condition within a scheduled activity instance. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: defaultCondition + Model Representation: Relationship + epochId: + Type: + - $ref: '#/StudyEpoch' + Definition: A USDM relationship between the ScheduledActivityInstance and StudyEpoch + classes which identifies the study epoch associated with a scheduled activity + instance. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: epoch + Model Representation: Relationship +Strength: + NCI C-Code: C215495 + Preferred Term: Substance Strength + Definition: The content of an substance expressed quantitatively per dosage unit, + per unit of volume, or per unit of weight, according to the pharmaceutical dose + form of the product. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C215590 + Preferred Term: Substance Strength Name + Definition: The literal identifier (i.e., distinctive designation) of the substance + strength. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C215592 + Preferred Term: Substance Strength Label + Definition: The short descriptive designation for the substance strength. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C215591 + Preferred Term: Substance Strength Description + Definition: A narrative representation of the substance strength. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + numerator: + Type: + - $ref: '#/QuantityRange' + NCI C-Code: C80490 + Preferred Term: Numerator + Definition: The dividend of a fraction. + Cardinality: '1' + Relationship Type: Value + Model Name: numerator + Model Representation: Attribute + denominator: + Type: + - $ref: '#/Quantity' + NCI C-Code: C80489 + Preferred Term: Denominator + Definition: The divisor of a fraction. + Cardinality: 0..1 + Relationship Type: Value + Model Name: denominator + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +Study: + NCI C-Code: C15206 + Preferred Term: Clinical Study + Definition: 'A clinical study involves research using human volunteers (also called + participants) that is intended to add to medical knowledge. There are two main + types of clinical studies: clinical trials (also called interventional studies) + and observational studies. (CDISC Glossary)' + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C68631 + Preferred Term: Clinical Study Name + Definition: The literal identifier (i.e., distinctive designation) of the clinical + study. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207479 + Preferred Term: Clinical Study Label + Definition: The short descriptive designation for the clinical study. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C142704 + Preferred Term: Clinical Study Description + Definition: A narrative representation of the clinical study. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + versions: + Type: + - $ref: '#/StudyVersion' + Definition: A USDM relationship between the Study and StudyVersion classes which + identifies the set of versions associated with the study. + Cardinality: 0..* + Relationship Type: Value + Model Name: versions + Model Representation: Relationship + documentedBy: + Type: + - $ref: '#/StudyDefinitionDocument' + Definition: A USDM relationship between the Study and StudyDefinitionDocument + classes signifying that the study is documented in a study definition document. + Cardinality: 0..* + Relationship Type: Value + Model Name: documentedBy + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +StudyAmendment: + NCI C-Code: C207594 + Preferred Term: Study Amendment + Definition: A written description of a change(s) to, or formal clarification of, + a study. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C216995 + Preferred Term: Study Amendment Name + Definition: The literal identifier (i.e., distinctive designation) of the study + amendment. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C216997 + Preferred Term: Study Amendment Label + Definition: The short descriptive designation for the study amendment. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C216996 + Preferred Term: Study Amendment Description + Definition: A narrative representation of the study amendment. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + number: + Type: + - $ref: '#/string' + NCI C-Code: C207537 + Preferred Term: Study Amendment Number + Definition: A string of numerals that uniquely identifies a protocol amendment. + Cardinality: '1' + Relationship Type: Value + Model Name: number + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215538 + Preferred Term: Study Amendment Notes + Definition: A brief written record relevant to the study amendment. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + summary: + Type: + - $ref: '#/string' + NCI C-Code: C115627 + Preferred Term: Study Amendment Summary + Definition: A short narrative representation describing the changes introduced + in the current version of the protocol. + Cardinality: '1' + Relationship Type: Value + Model Name: summary + Model Representation: Attribute + geographicScopes: + Type: + - $ref: '#/GeographicScope' + Definition: A USDM relationship between the StudyAmendment and GeographicScope + classes which identifies the set of geographic scopes associated with the + study amendment. + Cardinality: 1..* + Relationship Type: Value + Model Name: geographicScopes + Model Representation: Relationship + dateValues: + Type: + - $ref: '#/GovernanceDate' + Definition: A USDM relationship between the StudyAmendment and GovernanceDate + classes which provides the set of governance dates associated with the study + amendment. + Cardinality: 0..* + Relationship Type: Value + Model Name: dateValues + Model Representation: Relationship + impacts: + Type: + - $ref: '#/StudyAmendmentImpact' + Definition: A USDM relationship between the StudyAmendment and StudyAmendmentImpact + classes which identifies the set of impacts that the study amendment has on + the study or study subjects. + Cardinality: 0..* + Relationship Type: Value + Model Name: impacts + Model Representation: Relationship + enrollments: + Type: + - $ref: '#/SubjectEnrollment' + Definition: A USDM relationship between the StudyAmendment and SubjectEnrollment + classes which provides the set of subject enrollments associated with the + study amendment. + Cardinality: 0..* + Relationship Type: Value + Model Name: enrollments + Model Representation: Relationship + secondaryReasons: + Type: + - $ref: '#/StudyAmendmentReason' + Definition: A USDM relationship between the StudyAmendment and StudyAmendmentReason + classes which identifies the set of secondary reasons for issuing the study + amendment. + Cardinality: 0..* + Relationship Type: Value + Model Name: secondaryReasons + Model Representation: Relationship + changes: + Type: + - $ref: '#/StudyChange' + Definition: A USDM relationship between the StudyAmendment and StudyChange + classes which identifies the set of changes associated with the study amendment. + Cardinality: 1..* + Relationship Type: Value + Model Name: changes + Model Representation: Relationship + previousId: + Type: + - $ref: '#/StudyAmendment' + Definition: A USDM relationship within the StudyAmendment class which identifies + the study amendment that chronologically precedes the current study amendment. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: previous + Model Representation: Relationship + primaryReason: + Type: + - $ref: '#/StudyAmendmentReason' + Definition: A USDM relationship between the StudyAmendment and StudyAmendmentReason + classes which identifies the primary reason for issuing the study amendment. + Cardinality: '1' + Relationship Type: Value + Model Name: primaryReason + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +StudyAmendmentImpact: + NCI C-Code: C215500 + Preferred Term: Study Amendment Impact + Definition: The effect or consequence of an amendment on some aspect of the study. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + text: + Type: + - $ref: '#/string' + NCI C-Code: C215611 + Preferred Term: Study Amendment Impact Text + Definition: An instance of unstructured text that represents the study amendment + impact. + Cardinality: '1' + Relationship Type: Value + Model Name: text + Model Representation: Attribute + isSubstantial: + Type: + - $ref: '#/boolean' + NCI C-Code: C207538 + Preferred Term: Study Amendment Impact Substantial Indicator + Definition: An indication as to whether the study amendment's impact on the + study is substantial. + Cardinality: '1' + Relationship Type: Value + Model Name: isSubstantial + Model Representation: Attribute + type: + Type: + - $ref: '#/Code' + NCI C-Code: C215612 + Preferred Term: Study Amendment Impact Type + Definition: A characterization or classification of the study amendment impact. + Cardinality: '1' + Relationship Type: Value + Model Name: type + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215613 + Preferred Term: Study Amendment Impact Notes + Definition: A brief written record relevant to the study amendment impact. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +StudyAmendmentReason: + NCI C-Code: C207457 + Preferred Term: Study Amendment Reason + Definition: The rationale for the change(s) to, or formal clarification of, a protocol. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + otherReason: + Type: + - $ref: '#/string' + NCI C-Code: C207539 + Preferred Term: Other Reason for Study Amendment + Definition: The rationale for the change(s) to, or formal clarification of, + a protocol that is not otherwise specified. + Cardinality: 0..1 + Relationship Type: Value + Model Name: otherReason + Model Representation: Attribute + code: + Type: + - $ref: '#/Code' + NCI C-Code: C207540 + Preferred Term: Study Amendment Reason Code + Definition: A symbol or combination of symbols which is assigned to the study + amendment reason. + Cardinality: '1' + Relationship Type: Value + Model Name: code + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +StudyArm: + NCI C-Code: C174447 + Preferred Term: Study Arm + Definition: A planned pathway assigned to the subject as they progress through the + study, usually referred to by a name that reflects one or more treatments, exposures, + and/or controls included in the path. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C170984 + Preferred Term: Study Arm Name + Definition: The literal identifier (i.e., distinctive designation) of the study + arm. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C172456 + Preferred Term: Study Arm Label + Definition: The short descriptive designation for the study arm. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C93728 + Preferred Term: Study Arm Description + Definition: A narrative representation of the study arm. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + type: + Type: + - $ref: '#/Code' + NCI C-Code: C172457 + Preferred Term: Study Arm Type + Definition: A characterization or classification of the study arm. + Cardinality: '1' + Relationship Type: Value + Model Name: type + Model Representation: Attribute + dataOriginType: + Type: + - $ref: '#/Code' + NCI C-Code: C188829 + Preferred Term: Study Arm Data Origin Type + Definition: A characterization or classification of the study arm with respect + to where the study arm data originates. + Cardinality: '1' + Relationship Type: Value + Model Name: dataOriginType + Model Representation: Attribute + dataOriginDescription: + Type: + - $ref: '#/string' + NCI C-Code: C188828 + Preferred Term: Study Arm Data Origin Description + Definition: The textual representation of the study arm data origin. + Cardinality: '1' + Relationship Type: Value + Model Name: dataOriginDescription + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215515 + Preferred Term: Study Arm Notes + Definition: A brief written record relevant to the study arm. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + populationIds: + Type: + - $ref: '#/PopulationDefinition' + Definition: A USDM relationship between the StudyArm and PopulationDefinition + classes which identifies the set of populations associated with the study + arm. + Cardinality: 0..* + Relationship Type: Ref + Model Name: populations + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +StudyCell: + NCI C-Code: C188810 + Preferred Term: Study Design Cell + Definition: A partitioning of a study arm into individual pieces, which are associated + with an epoch and any number of sequential elements within that epoch. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + armId: + Type: + - $ref: '#/StudyArm' + Definition: A USDM relationship between the StudyCell and StudyArm classes which + identifies the study arm associated with a study cell. + Cardinality: '1' + Relationship Type: Ref + Model Name: arm + Model Representation: Relationship + epochId: + Type: + - $ref: '#/StudyEpoch' + Definition: A USDM relationship between the StudyCell and StudyEpoch classes + which identifies the study epoch associated with a study cell. + Cardinality: '1' + Relationship Type: Ref + Model Name: epoch + Model Representation: Relationship + elementIds: + Type: + - $ref: '#/StudyElement' + Definition: A USDM relationship between the StudyCell and StudyElement classes + which identifies the set of study elements associated with the study cell. + Cardinality: 1..* + Relationship Type: Ref + Model Name: elements + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +StudyChange: + NCI C-Code: C215498 + Preferred Term: Study Change + Definition: The act of alteration or modification to a study. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C215604 + Preferred Term: Study Change Name + Definition: The literal identifier (i.e., distinctive designation) of the study + change. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C215606 + Preferred Term: Study Change Label + Definition: The short descriptive designation for the study change. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C215605 + Preferred Term: Study Change Description + Definition: A narrative representation of the study change. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + rationale: + Type: + - $ref: '#/string' + NCI C-Code: C215608 + Preferred Term: Study Change Rationale + Definition: An explanation as to the logical reasons for why a study change + has occurred. + Cardinality: '1' + Relationship Type: Value + Model Name: rationale + Model Representation: Attribute + summary: + Type: + - $ref: '#/string' + NCI C-Code: C215607 + Preferred Term: Study Change Summary + Definition: A short narrative representation describing the changes introduced + in the current version of the study. + Cardinality: '1' + Relationship Type: Value + Model Name: summary + Model Representation: Attribute + changedSections: + Type: + - $ref: '#/DocumentContentReference' + Definition: A USDM relationship between the StudyChange and DocumentContentReference + class which provides the set of changed document sections related to the study + change. + Cardinality: 1..* + Relationship Type: Value + Model Name: changedSections + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +StudyCohort: + NCI C-Code: C61512 + Preferred Term: Study Cohort + Definition: A group of individuals who share a set of characteristics (e.g., exposures, + experiences, attributes), which logically defines a population under study. + Modifier: Concrete + Super Classes: + - $ref: '#/PopulationDefinition' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + Inherited From: + - $ref: '#/PopulationDefinition' + name: + Type: + - $ref: '#/string' + NCI C-Code: C207544 + Preferred Term: Study Cohort Name + Definition: The literal identifier (i.e., distinctive designation) of the study + cohort. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + Inherited From: + - $ref: '#/PopulationDefinition' + label: + Type: + - $ref: '#/string' + NCI C-Code: C207543 + Preferred Term: Study Cohort Label + Definition: The short descriptive designation for the study cohort. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + Inherited From: + - $ref: '#/PopulationDefinition' + description: + Type: + - $ref: '#/string' + NCI C-Code: C207542 + Preferred Term: Study Cohort Description + Definition: A narrative representation of the study cohort. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + Inherited From: + - $ref: '#/PopulationDefinition' + plannedSex: + Type: + - $ref: '#/Code' + NCI C-Code: C207541 + Preferred Term: Study Cohort Planned Sex + Definition: The protocol-defined sex within the study cohort. + Cardinality: 0..2 + Relationship Type: Value + Model Name: plannedSex + Model Representation: Attribute + Inherited From: + - $ref: '#/PopulationDefinition' + includesHealthySubjects: + Type: + - $ref: '#/boolean' + NCI C-Code: C207480 + Preferred Term: Study Cohort Includes Healthy Subjects Indicator + Definition: An indication as to whether the study cohort includes healthy subjects, + that is, subjects without the disease or condition under study. + Cardinality: '1' + Relationship Type: Value + Model Name: includesHealthySubjects + Model Representation: Attribute + Inherited From: + - $ref: '#/PopulationDefinition' + plannedAge: + Type: + - $ref: '#/Range' + NCI C-Code: C207545 + Preferred Term: Study Cohort Planned Age + Definition: The anticipated age of subjects within the study cohort. + Cardinality: 0..1 + Relationship Type: Value + Model Name: plannedAge + Model Representation: Attribute + Inherited From: + - $ref: '#/PopulationDefinition' + plannedCompletionNumber: + Type: + - $ref: '#/QuantityRange' + NCI C-Code: C207546 + Preferred Term: Study Cohort Planned Completion Number + Definition: The value representing the planned number of subjects that must + complete the study in order to meet the objectives and endpoints of the study, + within the study cohort. + Cardinality: 0..1 + Relationship Type: Value + Model Name: plannedCompletionNumber + Model Representation: Attribute + Inherited From: + - $ref: '#/PopulationDefinition' + plannedEnrollmentNumber: + Type: + - $ref: '#/QuantityRange' + NCI C-Code: C207702 + Preferred Term: Study Cohort Planned Enrollment Number + Definition: The value representing the planned number of subjects to be entered + in a clinical trial, within the study cohort. + Cardinality: 0..1 + Relationship Type: Value + Model Name: plannedEnrollmentNumber + Model Representation: Attribute + Inherited From: + - $ref: '#/PopulationDefinition' + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215547 + Preferred Term: Study Cohort Notes + Definition: A brief written record relevant to the study cohort. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + Inherited From: + - $ref: '#/PopulationDefinition' + criterionIds: + Type: + - $ref: '#/EligibilityCriterion' + Definition: A USDM relationship between the StudyCohort and EligibilityCriterion + classes which identifies the set of eligibility criteria associated with the + study cohort. + Cardinality: 0..* + Relationship Type: Ref + Model Name: criteria + Model Representation: Relationship + Inherited From: + - $ref: '#/PopulationDefinition' + characteristics: + Type: + - $ref: '#/Characteristic' + Definition: A USDM relationship between the StudyCohort and Characteristic classes + which identifies the set of subject characteristics associated with the study + cohort. + Cardinality: 0..* + Relationship Type: Value + Model Name: characteristics + Model Representation: Relationship + indicationIds: + Type: + - $ref: '#/Indication' + Definition: A USDM relationship between the StudyCohort and Indication classes + which identifies the set of indications associated with the study cohort. + Cardinality: 0..* + Relationship Type: Ref + Model Name: indications + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +StudyDefinitionDocument: + NCI C-Code: C215490 + Preferred Term: Study Definition Document + Definition: Any physical or electronic document that is related to defining a study + or part of a study. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C215559 + Preferred Term: Study Definition Document Name + Definition: The literal identifier (i.e., distinctive designation) of the study + definition document. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C215561 + Preferred Term: Study Definition Document Label + Definition: The short descriptive designation for the study definition document. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C215560 + Preferred Term: Study Definition Document Description + Definition: A narrative representation of the study definition document. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + type: + Type: + - $ref: '#/Code' + NCI C-Code: C215564 + Preferred Term: Study Definition Document Type + Definition: A characterization or classification of the study definition document. + Cardinality: '1' + Relationship Type: Value + Model Name: type + Model Representation: Attribute + templateName: + Type: + - $ref: '#/string' + NCI C-Code: C215562 + Preferred Term: Study Definition Document Template Name + Definition: The literal identifier (i.e., distinctive designation) of the study + definition document template. + Cardinality: '1' + Relationship Type: Value + Model Name: templateName + Model Representation: Attribute + language: + Type: + - $ref: '#/Code' + NCI C-Code: C215563 + Preferred Term: Study Definition Document Language + Definition: The language in which the study definition document is written. + Cardinality: '1' + Relationship Type: Value + Model Name: language + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215565 + Preferred Term: Study Definition Document Notes + Definition: A brief written record relevant to the study definition document. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + childIds: + Type: + - $ref: '#/StudyDefinitionDocument' + Definition: A USDM relationship within the StudyDefinitionDocument class which + identifies the set of child documents of a study definition document. + Cardinality: 0..* + Relationship Type: Ref + Model Name: children + Model Representation: Relationship + versions: + Type: + - $ref: '#/StudyDefinitionDocumentVersion' + Definition: A USDM relationship between the StudyDefinitionDocument and StudyDefinitionDocumentVersion + classes which identifies the set of versions associated with the study definition + document. + Cardinality: 0..* + Relationship Type: Value + Model Name: versions + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +StudyDefinitionDocumentVersion: + NCI C-Code: C215491 + Preferred Term: Study Definition Document Version + Definition: A representation of a particular edition or snapshot of the study definition + document as it exists at a particular point in time. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + status: + Type: + - $ref: '#/Code' + NCI C-Code: C215567 + Preferred Term: Study Definition Document Status + Definition: A condition of the study definition document at a point in time + with respect to its state of readiness for implementation. + Cardinality: '1' + Relationship Type: Value + Model Name: status + Model Representation: Attribute + version: + Type: + - $ref: '#/string' + NCI C-Code: C215566 + Preferred Term: Study Definition Document Version Identifier + Definition: A sequence of characters used to identify the version of the study + definition document. + Cardinality: '1' + Relationship Type: Value + Model Name: version + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215568 + Preferred Term: Study Definition Document Version Notes + Definition: A brief written record relevant to the study definition document + version. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + dateValues: + Type: + - $ref: '#/GovernanceDate' + Definition: A USDM relationship between the StudyDefinitionDocumentVersion and + GovernanceDate classes which provides the set of governance dates associated + with the study definition document version. + Cardinality: 0..* + Relationship Type: Value + Model Name: dateValues + Model Representation: Relationship + contents: + Type: + - $ref: '#/NarrativeContent' + Definition: A USDM relationship between the StudyDefinitionDocumentVersion and + NarrativeContent classes which identifies the set of narrative content associated + with the version of the study definition document. + Cardinality: 0..* + Relationship Type: Value + Model Name: contents + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +StudyDesign: + NCI C-Code: C15320 + Preferred Term: Study Design + Definition: A plan detailing how a study will be performed in order to represent + the phenomenon under examination, to answer the research questions that have been + asked, and informing the statistical approach. + Modifier: Abstract + Sub Classes: + - $ref: '#/InterventionalStudyDesign' + - $ref: '#/ObservationalStudyDesign' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C215626 + Preferred Term: Interventional Study Design Name + Definition: The literal identifier (i.e., distinctive designation) of the interventional + study design. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C215628 + Preferred Term: Interventional Study Design Label + Definition: The short descriptive designation for the interventional study design. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C215627 + Preferred Term: Interventional Study Design Description + Definition: A narrative representation of the interventional study design. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + rationale: + Type: + - $ref: '#/string' + NCI C-Code: C215629 + Preferred Term: Interventional Study Design Rationale + Definition: Reason(s) for choosing the interventional study design. This may + include reasons for the choice of control or comparator, as well as the scientific + rationale for the study design. + Cardinality: '1' + Relationship Type: Value + Model Name: rationale + Model Representation: Attribute + therapeuticAreas: + Type: + - $ref: '#/Code' + NCI C-Code: C215633 + Preferred Term: Interventional Study Design Therapeutic Areas + Definition: A categorization of a disease, disorder, or other condition based + on common characteristics and often associated with a medical specialty focusing + on research and development of specific therapeutic interventions for the + purpose of treatment and prevention, which is associated with the interventional + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: therapeuticAreas + Model Representation: Attribute + studyType: + Type: + - $ref: '#/Code' + NCI C-Code: C215631 + Preferred Term: Interventional Study Design Study Type + Definition: The study type associated with the interventional study design. + Cardinality: 0..1 + Relationship Type: Value + Model Name: studyType + Model Representation: Attribute + characteristics: + Type: + - $ref: '#/Code' + NCI C-Code: C215632 + Preferred Term: Interventional Study Design Characteristics + Definition: The distinguishing qualities or prominent aspects of an interventional + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: characteristics + Model Representation: Attribute + studyPhase: + Type: + - $ref: '#/AliasCode' + NCI C-Code: C215630 + Preferred Term: Interventional Study Design Study Phase + Definition: The study phase associated with the interventional study design. + Cardinality: 0..1 + Relationship Type: Value + Model Name: studyPhase + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215634 + Preferred Term: Interventional Study Design Notes + Definition: A brief written record relevant to the interventional study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + activities: + Type: + - $ref: '#/Activity' + Definition: A USDM relationship between the InterventionalStudyDesign and Activity + classes which identifies the set of activities associated with the interventional + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: activities + Model Representation: Relationship + biospecimenRetentions: + Type: + - $ref: '#/BiospecimenRetention' + Definition: A USDM relationship between the InterventionalStudyDesign and BiospecimenRetention + classes which identifies the status of biospecimen retentions related to the + interventional study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: biospecimenRetentions + Model Representation: Relationship + eligibilityCriteria: + Type: + - $ref: '#/EligibilityCriterion' + Definition: A USDM relationship between the InterventionalStudyDesign and EligibilityCriterion + classes which identifies the set of eligibility criterion associated with + the interventional study design. + Cardinality: 1..* + Relationship Type: Value + Model Name: eligibilityCriteria + Model Representation: Relationship + encounters: + Type: + - $ref: '#/Encounter' + Definition: A USDM relationship between the InterventionalStudyDesign and Encounter + classes which identifies the set of encounters associated with the interventional + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: encounters + Model Representation: Relationship + estimands: + Type: + - $ref: '#/Estimand' + Definition: A USDM relationship between the InterventionalStudyDesign and Estimand + classes which identifies the set of estimands associated with the interventional + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: estimands + Model Representation: Relationship + indications: + Type: + - $ref: '#/Indication' + Definition: A USDM relationship between the InterventionalStudyDesign and Indication + classes which identifies the set of indications associated with the interventional + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: indications + Model Representation: Relationship + objectives: + Type: + - $ref: '#/Objective' + Definition: A USDM relationship between the InterventionalStudyDesign and Objective + classes which identifies the set of objectives associated with the interventional + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: objectives + Model Representation: Relationship + scheduleTimelines: + Type: + - $ref: '#/ScheduleTimeline' + Definition: A USDM relationship between the InterventionalStudyDesign and ScheduleTimeline + classes which identifies the set of scheduled timelines associated with the + interventional study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: scheduleTimelines + Model Representation: Relationship + arms: + Type: + - $ref: '#/StudyArm' + Definition: A USDM relationship between the InterventionalStudyDesign and StudyArm + classes which identifies the set of study arms associated with the interventional + study design. + Cardinality: 1..* + Relationship Type: Value + Model Name: arms + Model Representation: Relationship + studyCells: + Type: + - $ref: '#/StudyCell' + Definition: 'A USDM relationship between the InterventionalStudyDesign and StudyCell + classes which identifies the set of study cells associated with the interventional + study design. ' + Cardinality: 1..* + Relationship Type: Value + Model Name: studyCells + Model Representation: Relationship + documentVersionIds: + Type: + - $ref: '#/StudyDefinitionDocumentVersion' + Definition: A USDM relationship between the InterventionalStudyDesign and StudyDefinitionDocumentVersion + classes which identifies the version of the study definition documents associated + with the interventional study design. + Cardinality: 0..* + Relationship Type: Ref + Model Name: documentVersions + Model Representation: Relationship + elements: + Type: + - $ref: '#/StudyElement' + Definition: A USDM relationship between the InterventionalStudyDesign and StudyElement + classes which identifies the set of study elements associated with the interventional + study design. + Cardinality: 0..* + Relationship Type: Value + Model Name: elements + Model Representation: Relationship + studyInterventionIds: + Type: + - $ref: '#/StudyIntervention' + Definition: A USDM relationship between the InterventionalStudyDesign and StudyIntervention + classes which identifies the set of study interventions associated with interventional + study design. + Cardinality: 0..* + Relationship Type: Ref + Model Name: studyInterventions + Model Representation: Relationship + epochs: + Type: + - $ref: '#/StudyEpoch' + Definition: A USDM relationship between the InterventionalStudyDesign and StudyEpoch + classes which identifies the set of study epochs associated with the interventional + study design. + Cardinality: 1..* + Relationship Type: Value + Model Name: epochs + Model Representation: Relationship + population: + Type: + - $ref: '#/StudyDesignPopulation' + Definition: A USDM relationship between the InterventionalStudyDesign and StudyDesignPopulation + classes which identifies the population associated with the interventional + study design. + Cardinality: '1' + Relationship Type: Value + Model Name: population + Model Representation: Relationship + analysisPopulations: + Type: + - $ref: '#/AnalysisPopulation' + Cardinality: 0..* + Relationship Type: Value +StudyDesignPopulation: + NCI C-Code: C142728 + Preferred Term: Study Design Population + Definition: The population within the general population to which the study results + can be generalized. + Modifier: Concrete + Super Classes: + - $ref: '#/PopulationDefinition' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + Inherited From: + - $ref: '#/PopulationDefinition' + name: + Type: + - $ref: '#/string' + NCI C-Code: C207553 + Preferred Term: Study Design Population Name + Definition: The literal identifier (i.e., distinctive designation) of the study + design population. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + Inherited From: + - $ref: '#/PopulationDefinition' + label: + Type: + - $ref: '#/string' + NCI C-Code: C207550 + Preferred Term: Study Design Population Label + Definition: The short descriptive designation for the study design population. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + Inherited From: + - $ref: '#/PopulationDefinition' + description: + Type: + - $ref: '#/string' + NCI C-Code: C70834 + Preferred Term: Study Design Population Description + Definition: A narrative representation of the study design population. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + Inherited From: + - $ref: '#/PopulationDefinition' + plannedSex: + Type: + - $ref: '#/Code' + NCI C-Code: C207551 + Preferred Term: Study Design Population Planned Sex + Definition: The protocol-defined sex within the study design population. + Cardinality: 0..2 + Relationship Type: Value + Model Name: plannedSex + Model Representation: Attribute + Inherited From: + - $ref: '#/PopulationDefinition' + includesHealthySubjects: + Type: + - $ref: '#/boolean' + NCI C-Code: C207549 + Preferred Term: Study Design Population Includes Healthy Subjects Indicator + Definition: An indication as to whether the study design population includes + healthy subjects, that is, subjects without the disease or condition under + study. + Cardinality: '1' + Relationship Type: Value + Model Name: includesHealthySubjects + Model Representation: Attribute + Inherited From: + - $ref: '#/PopulationDefinition' + plannedAge: + Type: + - $ref: '#/Range' + NCI C-Code: C207450 + Preferred Term: Study Design Population Planned Age + Definition: The anticipated age of subjects within the study design population. + Cardinality: 0..1 + Relationship Type: Value + Model Name: plannedAge + Model Representation: Attribute + Inherited From: + - $ref: '#/PopulationDefinition' + plannedCompletionNumber: + Type: + - $ref: '#/QuantityRange' + NCI C-Code: C207451 + Preferred Term: Study Design Population Planned Completion Number + Definition: The value representing the planned number of subjects that must + complete the study in order to meet the objectives and endpoints of the study, + within the study design population. + Cardinality: 0..1 + Relationship Type: Value + Model Name: plannedCompletionNumber + Model Representation: Attribute + Inherited From: + - $ref: '#/PopulationDefinition' + plannedEnrollmentNumber: + Type: + - $ref: '#/QuantityRange' + NCI C-Code: C207452 + Preferred Term: Study Design Population Planned Enrollment Number + Definition: The value representing the planned number of subjects to be entered + in a clinical trial, within the study design population. + Cardinality: 0..1 + Relationship Type: Value + Model Name: plannedEnrollmentNumber + Model Representation: Attribute + Inherited From: + - $ref: '#/PopulationDefinition' + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215512 + Preferred Term: Study Design Population Notes + Definition: A brief written record relevant to the study design population. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + Inherited From: + - $ref: '#/PopulationDefinition' + criterionIds: + Type: + - $ref: '#/EligibilityCriterion' + Definition: A USDM relationship between the StudyDesignPopulation and EligibilityCriterion + classes which identifies the set of eligibility criteria associated with the + study design population. + Cardinality: 0..* + Relationship Type: Ref + Model Name: criteria + Model Representation: Relationship + Inherited From: + - $ref: '#/PopulationDefinition' + cohorts: + Type: + - $ref: '#/StudyCohort' + Definition: A USDM relationship between the StudyDesignPopulation and StudyCohort + classes which identifies the set of study cohorts associated with the study + design population. + Cardinality: 0..* + Relationship Type: Value + Model Name: cohorts + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +StudyElement: + NCI C-Code: C142735 + Preferred Term: Study Design Element + Definition: 'A basic building block for time within a clinical study comprising + the following characteristics: a description of what happens to the subject during + the element; a definition of the start of the element; a rule for ending the element.' + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C188833 + Preferred Term: Study Design Element Name + Definition: The literal identifier (i.e., distinctive designation) of the study + design element. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207554 + Preferred Term: Study Design Element Label + Definition: The short descriptive designation for the study design element. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C188834 + Preferred Term: Study Design Element Description + Definition: A narrative representation of the study design element. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215517 + Preferred Term: Study Element Notes + Definition: A brief written record relevant to the study element. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + transitionEndRule: + Type: + - $ref: '#/TransitionRule' + Definition: A USDM relationship between the StudyElement and TransitionRule + classes which provides the details associated with a transition rule used + to trigger the end of a study element. + Cardinality: 0..1 + Relationship Type: Value + Model Name: transitionEndRule + Model Representation: Relationship + studyInterventionIds: + Type: + - $ref: '#/StudyIntervention' + Definition: A USDM relationship between the StudyElement and StudyIntervention + classes which identifies the set of study interventions associated with the + study element. + Cardinality: 0..* + Relationship Type: Ref + Model Name: studyInterventions + Model Representation: Relationship + transitionStartRule: + Type: + - $ref: '#/TransitionRule' + Definition: A USDM relationship between the StudyElement and TransitionRule + classes which provides the details associated with a transition rule used + to trigger the start of a study element. + Cardinality: 0..1 + Relationship Type: Value + Model Name: transitionStartRule + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +StudyEpoch: + NCI C-Code: C71738 + Preferred Term: Study Epoch + Definition: A named time period defined in the protocol, wherein a study activity + is specified and unchanging throughout the interval, to support a study-specific + purpose. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C93825 + Preferred Term: Study Epoch Name + Definition: The literal identifier (i.e., distinctive designation) of the study + epoch, i.e., the named time period defined in the protocol, wherein a study + activity is specified and unchanging throughout the interval, to support a + study-specific purpose. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207555 + Preferred Term: Study Epoch Label + Definition: The short descriptive designation for the study epoch. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C93824 + Preferred Term: Study Epoch Description + Definition: A narrative representation of the study epoch. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + type: + Type: + - $ref: '#/Code' + NCI C-Code: C188830 + Preferred Term: Study Epoch Type + Definition: A characterization or classification of the study epoch, i.e., the + named time period defined in the protocol, wherein a study activity is specified + and unchanging throughout the interval, to support a study-specific purpose. + Cardinality: '1' + Relationship Type: Value + Model Name: type + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215516 + Preferred Term: Study Epoch Notes + Definition: A brief written record relevant to the study epoch. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + previousId: + Type: + - $ref: '#/StudyEpoch' + Definition: A USDM relationship within the StudyEpoch class which identifies + the study epoch that chronologically precedes the current study epoch. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: previous + Model Representation: Relationship + nextId: + Type: + - $ref: '#/StudyEpoch' + Definition: A USDM relationship within the StudyEpoch class which identifies + the study epoch that chronologically follows the current study epoch. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: next + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +StudyIdentifier: + NCI C-Code: C83082 + Preferred Term: Study Identifier + Definition: A sequence of characters used to identify, name, or characterize the + study. + Modifier: Concrete + Super Classes: + - $ref: '#/Identifier' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + Inherited From: + - $ref: '#/Identifier' + text: + Type: + - $ref: '#/string' + NCI C-Code: C215507 + Preferred Term: Study Identifier Text + Definition: An instance of structured text that represents the study identifier. + Cardinality: '1' + Relationship Type: Value + Model Name: text + Model Representation: Attribute + Inherited From: + - $ref: '#/Identifier' + scopeId: + Type: + - $ref: '#/Organization' + Definition: A USDM relationship between the StudyIdentifier and Organization + classes which provides the details associated with each organization that + has assigned the study identifier. + Cardinality: '1' + Relationship Type: Ref + Model Name: scope + Model Representation: Relationship + Inherited From: + - $ref: '#/Identifier' + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +StudyIntervention: + NCI C-Code: C207649 + Preferred Term: Study Intervention + Definition: Any agent, device, or procedure being tested or used as a reference + or comparator in the conduct of a clinical trial. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C207558 + Preferred Term: Study Intervention Name + Definition: The literal identifier (i.e., distinctive designation) of the study + intervention. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207556 + Preferred Term: Study Intervention Label + Definition: The short descriptive designation for the study intervention. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C207647 + Preferred Term: Study Intervention Description + Definition: A narrative representation of the study intervention. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + role: + Type: + - $ref: '#/Code' + NCI C-Code: C207560 + Preferred Term: Study Intervention Role + Definition: The intended use of the trial intervention within the context of + the study design. + Cardinality: '1' + Relationship Type: Value + Model Name: role + Model Representation: Attribute + type: + Type: + - $ref: '#/Code' + NCI C-Code: C98747 + Preferred Term: Study Intervention Type + Definition: The kind of product or procedure studied in a trial. + Cardinality: '1' + Relationship Type: Value + Model Name: type + Model Representation: Attribute + codes: + Type: + - $ref: '#/Code' + NCI C-Code: C207648 + Preferred Term: Study Intervention Code + Definition: A symbol or combination of symbols which is assigned to the study + intervention. + Cardinality: 0..* + Relationship Type: Value + Model Name: codes + Model Representation: Attribute + minimumResponseDuration: + Type: + - $ref: '#/Quantity' + NCI C-Code: C207557 + Preferred Term: Study Intervention Minimum Response Duration + Definition: The value representing the minimum amount of time required to meet + the criteria for response to study intervention. + Cardinality: 0..1 + Relationship Type: Value + Model Name: minimumResponseDuration + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215543 + Preferred Term: Study Intervention Notes + Definition: A brief written record relevant to the study intervention. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + administrations: + Type: + - $ref: '#/Administration' + Definition: A USDM relationship between the StudyIntervention and AgentAdministration + classes which identifies the set of agent administrations associated with + the study intervention. + Cardinality: 0..* + Relationship Type: Value + Model Name: administrations + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +StudyRole: + NCI C-Code: C215497 + Preferred Term: Study Role + Definition: A designation that identifies the function of study personnel or an + organization within the context of the study. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C215600 + Preferred Term: Study Role Name + Definition: The literal identifier (i.e., distinctive designation) of the study + role. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C215602 + Preferred Term: Study Role Label + Definition: The short descriptive designation for the study role. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C215601 + Preferred Term: Study Role Description + Definition: A narrative representation of the study role. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + code: + Type: + - $ref: '#/Code' + NCI C-Code: C215603 + Preferred Term: Study Role Code + Definition: A symbol or combination of symbols which is assigned to the study + role. + Cardinality: '1' + Relationship Type: Value + Model Name: code + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C216994 + Preferred Term: Study Role Notes + Definition: A brief written record relevant to the study role. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + assignedPersons: + Type: + - $ref: '#/AssignedPerson' + Definition: A USDM relationship between the StudyRole and AssignedPerson classes + that identifies the set of individuals that are assigned to fill a particular + role within the study. + Cardinality: 0..* + Relationship Type: Value + Model Name: assignedPersons + Model Representation: Relationship + masking: + Type: + - $ref: '#/Masking' + Definition: A USDM relationship between the StudyRole and Masking classes which + describes the masking associated with the study role. + Cardinality: 0..1 + Relationship Type: Value + Model Name: masking + Model Representation: Relationship + organizationIds: + Type: + - $ref: '#/Organization' + Definition: A USDM relationship between the StudyRole and Organization classes + which identifies the set of organizations associated with the study role. + Cardinality: 0..* + Relationship Type: Ref + Model Name: organizations + Model Representation: Relationship + appliesToIds: + Type: + - $ref: '#/StudyVersion' + - $ref: '#/StudyDesign' + Definition: A USDM relationship between the StudyRole and either StudyVersion + or StudyDesign classes that identifies the study version or study design to + which the study role applies. + Cardinality: 0..* + Relationship Type: Ref + Model Name: appliesTo + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +StudySite: + NCI C-Code: C80403 + Preferred Term: Study Site + Definition: The location at which a study investigator conducts study activities. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C207566 + Preferred Term: Study Site Name + Definition: The literal identifier (i.e., distinctive designation) of the study + site. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207565 + Preferred Term: Study Site Label + Definition: The short descriptive designation for the study site. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C207564 + Preferred Term: Study Site Description + Definition: A narrative representation of the study site. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + country: + Type: + - $ref: '#/Code' + NCI C-Code: C170990 + Preferred Term: Country of Study Site + Definition: The country in which the study site is located. + Cardinality: '1' + Relationship Type: Value + Model Name: country + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +StudyTitle: + NCI C-Code: C49802 + Preferred Term: Study Title + Definition: The sponsor-defined name of the clinical study. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + type: + Type: + - $ref: '#/Code' + NCI C-Code: C207568 + Preferred Term: Study Title Type + Definition: A characterization or classification of the study title. + Cardinality: '1' + Relationship Type: Value + Model Name: type + Model Representation: Attribute + text: + Type: + - $ref: '#/string' + NCI C-Code: C207567 + Preferred Term: Study Title Text + Definition: An instance of unstructured text that represents the study title. + Cardinality: '1' + Relationship Type: Value + Model Name: text + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +StudyVersion: + NCI C-Code: C188816 + Preferred Term: Study Version + Definition: A plan at a particular point in time for a study. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + versionIdentifier: + Type: + - $ref: '#/string' + NCI C-Code: C207570 + Preferred Term: Study Version Identifier + Definition: A sequence of characters used to identify, name, or characterize + the study version. + Cardinality: '1' + Relationship Type: Value + Model Name: versionIdentifier + Model Representation: Attribute + businessTherapeuticAreas: + Type: + - $ref: '#/Code' + NCI C-Code: C201322 + Preferred Term: Business Therapeutic Areas + Definition: A therapeutic area classification based on the structure and operations + of the business unit. + Cardinality: 0..* + Relationship Type: Value + Model Name: businessTherapeuticAreas + Model Representation: Attribute + rationale: + Type: + - $ref: '#/string' + NCI C-Code: C94122 + Preferred Term: Study Rationale + Definition: A statement describing the overall rationale of the study. This + field describes the contribution of this study to product development, i.e., + what knowledge is being contributed from the conduct of this study. + Cardinality: '1' + Relationship Type: Value + Model Name: rationale + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215539 + Preferred Term: Study Version Notes + Definition: A brief written record relevant to the study version. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + abbreviations: + Type: + - $ref: '#/Abbreviation' + Definition: A USDM relationship between the StudyVersion and Abbreviation classes + which provides the set of abbreviations associated with the study version. + Cardinality: 0..* + Relationship Type: Value + Model Name: abbreviations + Model Representation: Relationship + dateValues: + Type: + - $ref: '#/GovernanceDate' + Definition: A USDM relationship between the StudyVersion and GovernanceDate + classes which provides the set of governance dates associated with the study + version. + Cardinality: 0..* + Relationship Type: Value + Model Name: dateValues + Model Representation: Relationship + referenceIdentifiers: + Type: + - $ref: '#/ReferenceIdentifier' + Definition: A USDM relationship between the StudyVersion and ReferenceIdentifier + classes which identifies the set of reference identifiers associated with + the study version. + Cardinality: 0..* + Relationship Type: Value + Model Name: referenceIdentifiers + Model Representation: Relationship + amendments: + Type: + - $ref: '#/StudyAmendment' + Definition: A USDM relationship between the StudyVersion and StudyAmendment + classes which identifies the set of study amendments associated with the study + version. + Cardinality: 0..* + Relationship Type: Value + Model Name: amendments + Model Representation: Relationship + documentVersionIds: + Type: + - $ref: '#/StudyDefinitionDocumentVersion' + Definition: A USDM relationship between the StudyVersion and StudyDefinitionDocumentVersion + classes which identifies the version of the study definition document associated + with the study version. + Cardinality: 0..* + Relationship Type: Ref + Model Name: documentVersions + Model Representation: Relationship + studyDesigns: + Type: + - $ref: '#/StudyDesign' + Definition: A USDM relationship between the StudyVersion and StudyDesign classes + which identifies the set of study designs associated with the study version. + Cardinality: 0..* + Relationship Type: Value + Model Name: studyDesigns + Model Representation: Relationship + studyIdentifiers: + Type: + - $ref: '#/StudyIdentifier' + Definition: A USDM relationship between the StudyVersion and StudyIdentifier + classes which identifies the set of study identifiers associated with the + study version. + Cardinality: 1..* + Relationship Type: Value + Model Name: studyIdentifiers + Model Representation: Relationship + titles: + Type: + - $ref: '#/StudyTitle' + Definition: A USDM relationship between the StudyVersion and StudyTitle classes + which identifies the set of study titles associated with the study version. + Cardinality: 1..* + Relationship Type: Value + Model Name: titles + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + eligibilityCriterionItems: + Type: + - $ref: '#/EligibilityCriterionItem' + Cardinality: 0..* + Relationship Type: Value + narrativeContentItems: + Type: + - $ref: '#/NarrativeContentItem' + Cardinality: 0..* + Relationship Type: Value + roles: + Type: + - $ref: '#/StudyRole' + Cardinality: 0..* + Relationship Type: Value + organizations: + Type: + - $ref: '#/Organization' + Cardinality: 0..* + Relationship Type: Value + studyInterventions: + Type: + - $ref: '#/StudyIntervention' + Cardinality: 0..* + Relationship Type: Value + administrableProducts: + Type: + - $ref: '#/AdministrableProduct' + Cardinality: 0..* + Relationship Type: Value + medicalDevices: + Type: + - $ref: '#/MedicalDevice' + Cardinality: 0..* + Relationship Type: Value + productOrganizationRoles: + Type: + - $ref: '#/ProductOrganizationRole' + Cardinality: 0..* + Relationship Type: Value + biomedicalConcepts: + Type: + - $ref: '#/BiomedicalConcept' + Cardinality: 0..* + Relationship Type: Value + bcCategories: + Type: + - $ref: '#/BiomedicalConceptCategory' + Cardinality: 0..* + Relationship Type: Value + bcSurrogates: + Type: + - $ref: '#/BiomedicalConceptSurrogate' + Cardinality: 0..* + Relationship Type: Value + dictionaries: + Type: + - $ref: '#/SyntaxTemplateDictionary' + Cardinality: 0..* + Relationship Type: Value + conditions: + Type: + - $ref: '#/Condition' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +SubjectEnrollment: + NCI C-Code: C37948 + Preferred Term: Subject Enrollment + Definition: The act of enrolling subjects into a study. The subject will have met + the inclusion/exclusion criteria to participate in the trial and will have signed + an informed consent form. (CDISC Glossary) + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C215540 + Preferred Term: Subject Enrollment Name + Definition: The literal identifier (i.e., distinctive designation) of the subject + enrollment. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C215542 + Preferred Term: Subject Enrollment Label + Definition: The short descriptive designation for the subject enrollment.. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C215541 + Preferred Term: Subject Enrollment Description + Definition: A narrative representation of the subject enrollment. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + quantity: + Type: + - $ref: '#/Quantity' + NCI C-Code: C207573 + Preferred Term: Subject Enrollment Quantity Value + Definition: The value representing the number of individuals enrolled in a study. + Cardinality: '1' + Relationship Type: Value + Model Name: quantity + Model Representation: Attribute + forGeographicScope: + Type: + - $ref: '#/GeographicScope' + Definition: A USDM relationship between the SubjectEnrollment and GeographicScope + classes which identifies the geographic scope to which the subject enrollment + applies. + Cardinality: 0..1 + Relationship Type: Value + Model Name: forGeographicScope + Model Representation: Relationship + forStudyCohortId: + Type: + - $ref: '#/StudyCohort' + Definition: A USDM relationship between the SubjectEnrollment and StudyCohort + classes which identifies the study cohort to which the subject enrollment + applies. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: forStudyCohort + Model Representation: Relationship + forStudySiteId: + Type: + - $ref: '#/StudySite' + Definition: A USDM relationship between the SubjectEnrollment and StudySite + classes which identifies the study site to which the subject enrollment applies. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: forStudySite + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +Substance: + NCI C-Code: C45306 + Preferred Term: Substance + Definition: Any matter of defined composition that has discrete existence, whose + origin may be biological, mineral or chemical. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C215586 + Preferred Term: Substance Name + Definition: The literal identifier (i.e., distinctive designation) of the substance. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C215588 + Preferred Term: Substance Label + Definition: The short descriptive designation for the substance. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C215587 + Preferred Term: Substance Description + Definition: A narrative representation of the substance. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + codes: + Type: + - $ref: '#/Code' + NCI C-Code: C215589 + Preferred Term: Substance Code + Definition: A symbol or combination of symbols which is assigned to the substance. + Cardinality: 0..* + Relationship Type: Value + Model Name: codes + Model Representation: Attribute + strengths: + Type: + - $ref: '#/Strength' + Definition: A USDM relationship between the Substance and Strength class which + provides the values of the strengths of the substance. + Cardinality: 1..* + Relationship Type: Value + Model Name: strengths + Model Representation: Relationship + referenceSubstance: + Type: + - $ref: '#/Substance' + Definition: A USDM relationship within the Substance class that identifies the + association between two substances, one of which is used as a reference for + the other. + Cardinality: 0..1 + Relationship Type: Value + Model Name: referenceSubstance + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +SyntaxTemplate: + NCI C-Code: C207596 + Preferred Term: Syntax Template + Definition: A standardized pattern used for the arrangement of words and phrases + to create well-formed, structured sentences. + Modifier: Abstract + Sub Classes: + - $ref: '#/Characteristic' + - $ref: '#/Condition' + - $ref: '#/EligibilityCriterionItem' + - $ref: '#/Endpoint' + - $ref: '#/IntercurrentEvent' + - $ref: '#/Objective' + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C207477 + Preferred Term: Characteristic Name + Definition: The literal identifier (i.e., distinctive designation) of the characteristic. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207476 + Preferred Term: Characteristic Label + Definition: The short descriptive designation for the characteristic. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C207475 + Preferred Term: Characteristic Description + Definition: A narrative representation of the characteristic. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + text: + Type: + - $ref: '#/string' + NCI C-Code: C207478 + Preferred Term: Characteristic Text + Definition: An instance of structured text that represents the characteristic. + Cardinality: '1' + Relationship Type: Value + Model Name: text + Model Representation: Attribute + notes: + Type: + - $ref: '#/CommentAnnotation' + NCI C-Code: C215548 + Preferred Term: Characteristic Notes + Definition: A brief written record relevant to the characteristic. + Cardinality: 0..* + Relationship Type: Value + Model Name: notes + Model Representation: Attribute + dictionaryId: + Type: + - $ref: '#/SyntaxTemplateDictionary' + Definition: A USDM relationship between the Characteristic and SyntaxTemplateDictionary + classes which provides the set of dictionary entries related to characteristics. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: dictionary + Model Representation: Relationship +SyntaxTemplateDictionary: + NCI C-Code: C207597 + Preferred Term: Syntax Template Dictionary + Definition: A reference source that provides a listing of valid parameter names + and values used in syntax template text strings. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C207581 + Preferred Term: Syntax Template Dictionary Name + Definition: The literal identifier (i.e., distinctive designation) of the syntax + template dictionary. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207580 + Preferred Term: Syntax Template Dictionary Label + Definition: The short descriptive designation for the syntax template dictionary. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C207579 + Preferred Term: Syntax Template Dictionary Description + Definition: A narrative representation of the syntax template dictionary. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + parameterMaps: + Type: + - $ref: '#/ParameterMap' + Definition: A USDM relationship between the SyntaxTemplateDictionary and ParameterMap + classes which identifies the set of parameter maps (parameter map entries) + associated with a syntax template dictionary. + Cardinality: 1..* + Relationship Type: Value + Model Name: parameterMaps + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +Timing: + NCI C-Code: C80484 + Preferred Term: Timing + Definition: The chronological relationship between temporal events. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C207584 + Preferred Term: Timing Name + Definition: The literal identifier (i.e., distinctive designation) of the timing. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207583 + Preferred Term: Timing Label + Definition: The short descriptive designation for the timing. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C164648 + Preferred Term: Timing Description + Definition: A narrative representation of the chronological relationship between + temporal events. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + type: + Type: + - $ref: '#/Code' + NCI C-Code: C201298 + Preferred Term: Timing Type + Definition: A characterization or classification of the chronological relationship + between temporal events. + Cardinality: '1' + Relationship Type: Value + Model Name: type + Model Representation: Attribute + relativeToFrom: + Type: + - $ref: '#/Code' + NCI C-Code: C201297 + Preferred Term: Timing Relative To From + Definition: The name of the reference event used to define the temporal relationship + with another event. + Cardinality: '1' + Relationship Type: Value + Model Name: relativeToFrom + Model Representation: Attribute + value: + Type: + - $ref: '#/string' + NCI C-Code: C201341 + Preferred Term: Timing Value + Definition: The temporal value of the chronological relationship between temporal + events. + Cardinality: '1' + Relationship Type: Value + Model Name: value + Model Representation: Attribute + valueLabel: + Type: + - $ref: '#/string' + NCI C-Code: C207585 + Preferred Term: Timing Value Label + Definition: The short descriptive designation for the timing value. + Cardinality: '1' + Relationship Type: Value + Model Name: valueLabel + Model Representation: Attribute + windowLabel: + Type: + - $ref: '#/string' + NCI C-Code: C207586 + Preferred Term: Timing Window Label + Definition: The short descriptive designation for a time period, or other type + of interval, during which a temporal event may be achieved, obtained, or observed. + Cardinality: 0..1 + Relationship Type: Value + Model Name: windowLabel + Model Representation: Attribute + windowLower: + Type: + - $ref: '#/string' + NCI C-Code: C201342 + Preferred Term: Timing Window, Lower + Definition: The earliest chronological value of an allowable period of time + during which a temporal event takes place. + Cardinality: 0..1 + Relationship Type: Value + Model Name: windowLower + Model Representation: Attribute + windowUpper: + Type: + - $ref: '#/string' + NCI C-Code: C201343 + Preferred Term: Timing Window, Upper + Definition: The latest chronological value of an allowable period of time during + which a temporal event takes place. + Cardinality: 0..1 + Relationship Type: Value + Model Name: windowUpper + Model Representation: Attribute + relativeToScheduledInstanceId: + Type: + - $ref: '#/ScheduledInstance' + Definition: A USDM relationship between the Timing and ScheduledInstance classes + which identifies the scheduled instance (e.g., scheduled activity instances + or scheduled decision instances) to which the timing is relative to. + Cardinality: 0..1 + Relationship Type: Ref + Model Name: relativeToScheduledInstance + Model Representation: Relationship + relativeFromScheduledInstanceId: + Type: + - $ref: '#/ScheduledInstance' + Definition: A USDM relationship between the Timing and ScheduledInstance classes + which identifies the scheduled instance (e.g., scheduled activity instances + or scheduled decision instances) to which the timing applies. + Cardinality: '1' + Relationship Type: Ref + Model Name: relativeFromScheduledInstance + Model Representation: Relationship + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value +TransitionRule: + NCI C-Code: C82567 + Preferred Term: Transition Rule + Definition: A guide that governs the allocation of subjects to operational options + at a discrete decision point or branch (e.g., assignment to a particular arm, + discontinuation) within a clinical trial plan. + Modifier: Concrete + Attributes: + id: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value + Model Name: id + Model Representation: Attribute + name: + Type: + - $ref: '#/string' + NCI C-Code: C207588 + Preferred Term: Transition Rule Name + Definition: The literal identifier (i.e., distinctive designation) of the transition + rule. + Cardinality: '1' + Relationship Type: Value + Model Name: name + Model Representation: Attribute + label: + Type: + - $ref: '#/string' + NCI C-Code: C207587 + Preferred Term: Transition Rule Label + Definition: The short descriptive designation for the transition rule. + Cardinality: 0..1 + Relationship Type: Value + Model Name: label + Model Representation: Attribute + description: + Type: + - $ref: '#/string' + NCI C-Code: C188835 + Preferred Term: Transition Rule Description + Definition: A narrative representation of the transition rule. + Cardinality: 0..1 + Relationship Type: Value + Model Name: description + Model Representation: Attribute + text: + Type: + - $ref: '#/string' + NCI C-Code: C207589 + Preferred Term: Transition Rule Text + Definition: An instance of unstructured text that represents the transition + rule. + Cardinality: '1' + Relationship Type: Value + Model Name: text + Model Representation: Attribute + extensionAttributes: + Type: + - $ref: '#/ExtensionAttribute' + Cardinality: 0..* + Relationship Type: Value + instanceType: + Type: + - $ref: '#/string' + Cardinality: '1' + Relationship Type: Value diff --git a/src/soa_builder.egg-info/PKG-INFO b/src/soa_builder.egg-info/PKG-INFO index acbc707..356e83c 100644 --- a/src/soa_builder.egg-info/PKG-INFO +++ b/src/soa_builder.egg-info/PKG-INFO @@ -133,6 +133,64 @@ SOA_EAGER_BCP_POPULATION=1 | `CDISC_API_KEY` | _(shell env)_ | CDISC Library API key — set in shell, not `config.env` | | `CDISC_SUBSCRIPTION_KEY` | _(shell env)_ | CDISC Library subscription key — set in shell, not `config.env` | +### Configurable CT codelist codes (dropdowns) + +Many dropdowns in the UI (Epoch Type, Arm Type, Role Type, Timing Type, +etc.) present CDISC controlled terminology preferred terms while storing +the underlying codelist C-code in the database. The C-code that backs +each dropdown is itself configurable via `config.env` — edit the value +and restart the server to point that dropdown at an alternate/custom +codelist. Defaults are read by +[`src/soa_builder/web/codelist_config.py`](src/soa_builder/web/codelist_config.py). + +```ini +CODELIST_EPOCH_TYPE=C99079 +CODELIST_ARM_TYPE=C174222 +CODELIST_ARM_DATA_ORIGIN_TYPE=C188727 +CODELIST_ROLE_TYPE=C215480 +CODELIST_ORGANIZATION_TYPE=C215480 +CODELIST_AMENDMENT_REASON=C207415 +CODELIST_AMENDMENT_IMPACT_TYPE=C215481 +CODELIST_GEOGRAPHIC_SCOPE_TYPE=C207412 +CODELIST_GOVERNANCE_DATE_TYPE=C207413 +CODELIST_STUDY_TITLE_TYPE=C207419 +CODELIST_INTERVENTION_ROLE=C207417 +CODELIST_INTERVENTION_TYPE=C99078 +CODELIST_INTERVENTION_UNIT=C66781 +CODELIST_OBJECTIVE_LEVEL=C188725 +CODELIST_ENDPOINT_LEVEL=C188726 +CODELIST_ENCOUNTER_ENVIRONMENTAL_SETTING=C127262 +CODELIST_ENCOUNTER_CONTACT_MODE=C171445 +CODELIST_TIMING_TYPE=C201264 +CODELIST_TIMING_RELATIVE_TO_FROM=C201265 +``` + +| Variable | Default | Dropdown / feature | +|---|---|---| +| `CODELIST_EPOCH_TYPE` | `C99079` | Epoch Type | +| `CODELIST_ARM_TYPE` | `C174222` | Arm Type | +| `CODELIST_ARM_DATA_ORIGIN_TYPE` | `C188727` | Arm Data Origin Type | +| `CODELIST_ROLE_TYPE` | `C215480` | Study Role Type | +| `CODELIST_ORGANIZATION_TYPE` | `C215480` | Organization Type | +| `CODELIST_AMENDMENT_REASON` | `C207415` | Amendment Reason | +| `CODELIST_AMENDMENT_IMPACT_TYPE` | `C215481` | Amendment Impact Type | +| `CODELIST_GEOGRAPHIC_SCOPE_TYPE` | `C207412` | Geographic Scope Type | +| `CODELIST_GOVERNANCE_DATE_TYPE` | `C207413` | Governance Date Type | +| `CODELIST_STUDY_TITLE_TYPE` | `C207419` | Study Title Type | +| `CODELIST_INTERVENTION_ROLE` | `C207417` | Study Intervention Role | +| `CODELIST_INTERVENTION_TYPE` | `C99078` | Study Intervention Type | +| `CODELIST_INTERVENTION_UNIT` | `C66781` | Study Intervention Dose Unit | +| `CODELIST_OBJECTIVE_LEVEL` | `C188725` | Objective Level | +| `CODELIST_ENDPOINT_LEVEL` | `C188726` | Endpoint Level | +| `CODELIST_ENCOUNTER_ENVIRONMENTAL_SETTING` | `C127262` | Encounter Environmental Setting | +| `CODELIST_ENCOUNTER_CONTACT_MODE` | `C171445` | Encounter Contact Mode | +| `CODELIST_TIMING_TYPE` | `C201264` | Timing Type | +| `CODELIST_TIMING_RELATIVE_TO_FROM` | `C201265` | Timing Relative To/From | + +> These codes identify which CDISC CT *codelist* populates a dropdown's +> options — they are unrelated to `CDISC_API_KEY`/`CDISC_SUBSCRIPTION_KEY` +> (API credentials) or `CDISC_CONCEPTS_JSON` (Biomedical Concept overrides). + --- ## Start web server diff --git a/src/soa_builder.egg-info/SOURCES.txt b/src/soa_builder.egg-info/SOURCES.txt index 9202cfb..727b53c 100644 --- a/src/soa_builder.egg-info/SOURCES.txt +++ b/src/soa_builder.egg-info/SOURCES.txt @@ -19,6 +19,7 @@ src/soa_builder/mcp/__init__.py src/soa_builder/mcp/server.py src/soa_builder/web/app.py src/soa_builder/web/audit.py +src/soa_builder/web/codelist_config.py src/soa_builder/web/db.py src/soa_builder/web/initialize_database.py src/soa_builder/web/migrate_database.py @@ -80,6 +81,7 @@ src/usdm/generate_endpoints.py src/usdm/generate_estimands.py src/usdm/generate_extension_attributes.py src/usdm/generate_indications.py +src/usdm/generate_narrative_content.py src/usdm/generate_objectives.py src/usdm/generate_organizations.py src/usdm/generate_roles.py @@ -101,6 +103,7 @@ tests/test_categories_cache.py tests/test_categories_ui_force.py tests/test_cdisc_api_status.py tests/test_code_uid_generation.py +tests/test_codelist_config.py tests/test_concept_categories.py tests/test_concept_category_force_refresh.py tests/test_concepts_by_category_ui_force.py @@ -111,13 +114,16 @@ tests/test_element_id_generation.py tests/test_element_id_monotonic.py tests/test_epoch_reorder_audit_api.py tests/test_epoch_type_options.py +tests/test_fetch_crf_specializations.py tests/test_fetch_sdtm_specializations.py tests/test_generate_biomedical_concept_properties.py tests/test_generate_endpoints.py tests/test_generate_extension_attributes.py +tests/test_generate_narrative_content.py tests/test_generate_objectives.py tests/test_instances_audit.py tests/test_mcp_server.py +tests/test_migrate_backfill_crf_href.py tests/test_routers_activities.py tests/test_routers_activities_crf.py tests/test_routers_amendments.py diff --git a/src/soa_builder/web/app.py b/src/soa_builder/web/app.py index 26d8b46..4a5c22f 100644 --- a/src/soa_builder/web/app.py +++ b/src/soa_builder/web/app.py @@ -79,6 +79,7 @@ _migrate_add_activity_surrogate_table, _migrate_add_bc_surrogate_audit_table, _migrate_add_concept_group_table, + _migrate_concept_group_add_cdisc_source_columns, _migrate_activity_concept_add_concept_group_uid, _migrate_surrogate_add_concept_group_uid, _migrate_activity_surrogate_add_concept_group_uid, @@ -145,6 +146,7 @@ _migrate_soa_add_tool_extension_uids, _migrate_add_element_intervention_table, _migrate_backfill_crf_href_latest_version, + _migrate_add_activity_grouping_extension_table, ) from .routers import activities as activities_router from .routers import arms as arms_router @@ -218,6 +220,8 @@ ) from .utils import ( get_cdisc_api_key as _get_cdisc_api_key, + get_cdisc_crf_api_key as _get_cdisc_crf_api_key, + get_cdisc_crf_subscription_key as _get_cdisc_crf_subscription_key, get_concepts_override as _get_concepts_override, get_next_code_uid as _get_next_code_uid, get_next_concept_uid as _get_next_concept_uid, @@ -339,7 +343,10 @@ def _configure_logging(): _migrate_biomedical_concept_audit() _migrate_backfill_biomedical_concept_codes() _migrate_repoint_stale_bc_code_chains() -if os.environ.get("SOA_EAGER_BCP_POPULATION", "1").strip().lower() not in ("0", "false"): +if os.environ.get("SOA_EAGER_BCP_POPULATION", "1").strip().lower() not in ( + "0", + "false", +): _bcp_backfill() _migrate_add_soa_id_indexes() _migrate_add_footnote_table() @@ -352,6 +359,7 @@ def _configure_logging(): _migrate_add_activity_surrogate_table() _migrate_add_bc_surrogate_audit_table() _migrate_add_concept_group_table() +_migrate_concept_group_add_cdisc_source_columns() _migrate_activity_concept_add_concept_group_uid() _migrate_surrogate_add_concept_group_uid() _migrate_activity_surrogate_add_concept_group_uid() @@ -418,6 +426,7 @@ def _configure_logging(): _migrate_soa_add_tool_extension_uids() _migrate_add_element_intervention_table() _migrate_backfill_crf_href_latest_version() +_migrate_add_activity_grouping_extension_table() # Include routers @@ -1451,8 +1460,8 @@ def _normalize_href(h): f"?biomedicalconcept={code}" ) headers = {"Accept": "application/json"} - api_key = _get_cdisc_api_key() - subscription_key = os.environ.get("CDISC_SUBSCRIPTION_KEY") or api_key + api_key = _get_cdisc_crf_api_key() + subscription_key = _get_cdisc_crf_subscription_key() or api_key if subscription_key: headers["Ocp-Apim-Subscription-Key"] = subscription_key if api_key: @@ -1550,8 +1559,8 @@ def _normalize_href(h): return [] headers = {"Accept": "application/json"} - api_key = _get_cdisc_api_key() - subscription_key = os.environ.get("CDISC_SUBSCRIPTION_KEY") or api_key + api_key = _get_cdisc_crf_api_key() + subscription_key = _get_cdisc_crf_subscription_key() or api_key if subscription_key: headers["Ocp-Apim-Subscription-Key"] = subscription_key if api_key: @@ -1638,6 +1647,13 @@ async def lifespan(app: FastAPI): logger.info("Lifespan preload CRF specializations count=%d", len(crf_specs)) except Exception as e: logger.error("Lifespan CRF specializations preload failed: %s", e) + try: + from .routers.concept_groups import sync_cdisc_concept_groups + + summary = sync_cdisc_concept_groups(force=True) + logger.info("Lifespan CDISC concept-group sync: %s", summary) + except Exception as e: + logger.error("Lifespan CDISC concept-group sync failed: %s", e) try: import threading from concurrent.futures import ThreadPoolExecutor @@ -2335,17 +2351,65 @@ def _get_activity_concepts(activity_id: int): return rows -def _get_concept_groups_for_cell(soa_id: int, activity_id: int): - """Return (concept_groups, activity_group_uids) for concepts_cell rendering.""" +_CDISC_SCHEME_HEADING_ORDER = [ + "COA Type", + "Collection Method", + "Concept Group", + "Implementation Domain Code", + "Age Category", + "Therapeutic Area", +] + + +def _get_concept_group_sections(): + """Return concept_group rows organized into "Add group" dropdown + sections: one per CDISC classification scheme (in a fixed display + order), then "Custom Concept Groups" last. Only non-empty sections + are included. Each group dict has {id, concept_group_uid, name, + label} — unchanged shape from before CDISC groups existed. + """ conn = _connect() cur = conn.cursor() cur.execute( - "SELECT id, concept_group_uid, name, label FROM concept_group ORDER BY id" + "SELECT id, concept_group_uid, name, label, source, cdisc_scheme_name " + "FROM concept_group ORDER BY id" ) - concept_groups = [ - {"id": r[0], "concept_group_uid": r[1], "name": r[2], "label": r[3]} - for r in cur.fetchall() + rows = cur.fetchall() + conn.close() + + by_heading = {} + for r in rows: + source, cdisc_scheme_name = r[4], r[5] + heading = ( + cdisc_scheme_name + if source == "cdisc" and cdisc_scheme_name + else "Custom Concept Groups" + ) + by_heading.setdefault(heading, []).append( + {"id": r[0], "concept_group_uid": r[1], "name": r[2], "label": r[3]} + ) + + sections = [ + {"heading": heading, "groups": by_heading[heading]} + for heading in _CDISC_SCHEME_HEADING_ORDER + if heading in by_heading ] + if "Custom Concept Groups" in by_heading: + sections.append( + { + "heading": "Custom Concept Groups", + "groups": by_heading["Custom Concept Groups"], + } + ) + return sections + + +def _get_concept_groups_for_cell(soa_id: int, activity_id: int): + """Return (concept_group_sections, activity_group_uids) for + concepts_cell rendering.""" + concept_groups = _get_concept_group_sections() + conn = _connect() + cur = conn.cursor() has_group = _table_has_columns(cur, "activity_concept", ("concept_group_uid",)) if has_group: cur.execute( diff --git a/src/soa_builder/web/migrate_database.py b/src/soa_builder/web/migrate_database.py index ebaa923..5f729fc 100644 --- a/src/soa_builder/web/migrate_database.py +++ b/src/soa_builder/web/migrate_database.py @@ -1581,6 +1581,36 @@ def _migrate_add_concept_group_table(): logger.warning("_migrate_add_concept_group_table failed: %s", e) +def _migrate_concept_group_add_cdisc_source_columns(): + """Add columns to concept_group distinguishing CDISC-sourced rows + (materialized from the cdisc-biomedical-concept-groupings service) + from user-created Custom Concept Groups. + """ + try: + conn = _connect() + cur = conn.cursor() + cur.execute("PRAGMA table_info(concept_group)") + cols = {r[1] for r in cur.fetchall()} + if "source" not in cols: + cur.execute( + "ALTER TABLE concept_group ADD COLUMN source TEXT DEFAULT 'custom'" + ) + logger.info("Added source column to concept_group") + if "cdisc_scheme_id" not in cols: + cur.execute("ALTER TABLE concept_group ADD COLUMN cdisc_scheme_id TEXT") + logger.info("Added cdisc_scheme_id column to concept_group") + if "cdisc_scheme_name" not in cols: + cur.execute("ALTER TABLE concept_group ADD COLUMN cdisc_scheme_name TEXT") + logger.info("Added cdisc_scheme_name column to concept_group") + if "cdisc_value_id" not in cols: + cur.execute("ALTER TABLE concept_group ADD COLUMN cdisc_value_id TEXT") + logger.info("Added cdisc_value_id column to concept_group") + conn.commit() + conn.close() + except Exception as e: + logger.warning("_migrate_concept_group_add_cdisc_source_columns failed: %s", e) + + def _migrate_activity_concept_add_concept_group_uid(): """Add concept_group_uid column to activity_concept if missing.""" try: @@ -3320,6 +3350,38 @@ def _migrate_soa_add_tool_extension_uids(): logger.warning("_migrate_soa_add_tool_extension_uids failed: %s", e) +def _migrate_add_activity_grouping_extension_table(): + """Create activity_grouping_extension table. + + Persists stable ExtensionAttribute_N / ExtensionClass_N UIDs for + each (soa, activity, concept_group) assignment so USDM export can + reuse identical UIDs across regenerations. + """ + try: + conn = _connect() + cur = conn.cursor() + cur.execute( + """ + CREATE TABLE IF NOT EXISTS activity_grouping_extension ( + id INTEGER PRIMARY KEY AUTOINCREMENT, + soa_id INTEGER NOT NULL, + activity_uid TEXT NOT NULL, + concept_group_uid TEXT NOT NULL, + ea_outer_uid TEXT, + ec_uid TEXT, + ea_scheme_uid TEXT, + ea_value_uid TEXT, + UNIQUE(soa_id, activity_uid, concept_group_uid) + ) + """ + ) + conn.commit() + conn.close() + logger.info("_migrate_add_activity_grouping_extension_table complete") + except Exception as e: + logger.warning("_migrate_add_activity_grouping_extension_table failed: %s", e) + + def _migrate_backfill_crf_href_latest_version(): """Rewrite activity_concept_crf.crf_href from the dated-package format to the latest-version format, e.g.: diff --git a/src/soa_builder/web/routers/activities.py b/src/soa_builder/web/routers/activities.py index 8f0a67e..9dde93d 100644 --- a/src/soa_builder/web/routers/activities.py +++ b/src/soa_builder/web/routers/activities.py @@ -18,6 +18,8 @@ table_has_columns as _table_has_columns, get_next_concept_uid as _get_next_concept_uid, get_cdisc_api_key as _get_cdisc_api_key, + get_cdisc_crf_api_key as _get_cdisc_crf_api_key, + get_cdisc_crf_subscription_key as _get_cdisc_crf_subscription_key, ) import html as _html @@ -721,14 +723,11 @@ def ui_list_activities(request: Request, soa_id: int): ) break - # Fetch concept groups globally (for the dropdown in concepts_cell) - cur.execute( - "SELECT id, concept_group_uid, name, label FROM concept_group ORDER BY id" - ) - concept_groups = [ - {"id": r[0], "concept_group_uid": r[1], "name": r[2], "label": r[3]} - for r in cur.fetchall() - ] + # Fetch concept groups globally (for the dropdown in concepts_cell), + # organized into CDISC-scheme + Custom Concept Groups sections. + from ..app import _get_concept_group_sections + + concept_groups = _get_concept_group_sections() conn.close() # Fetch CDISC BC categories list (for the category dropdown in concepts_cell) @@ -1524,8 +1523,8 @@ def ui_crf_detail_from_activity( import requests as _requests import json as _json - api_key = _get_cdisc_api_key() - subscription_key = os.environ.get("CDISC_SUBSCRIPTION_KEY") + api_key = _get_cdisc_crf_api_key() + subscription_key = _get_cdisc_crf_subscription_key() unified_key = subscription_key or api_key headers: dict = {} if unified_key: diff --git a/src/soa_builder/web/routers/bc_surrogates.py b/src/soa_builder/web/routers/bc_surrogates.py index 7f8e8ba..b1ecb3c 100644 --- a/src/soa_builder/web/routers/bc_surrogates.py +++ b/src/soa_builder/web/routers/bc_surrogates.py @@ -507,7 +507,7 @@ def _render_concepts_cell(request: Request, soa_id: int, activity_id: int): if has_group_uid and has_category: cur.execute( "SELECT ac.concept_code, ac.concept_title, ac.concept_group_uid, " - "cg.name AS group_name, ac.bc_category_name " + "cg.name AS group_name, cg.cdisc_scheme_name, ac.bc_category_name " "FROM activity_concept ac " "LEFT JOIN concept_group cg ON cg.concept_group_uid=ac.concept_group_uid " "WHERE ac.activity_id=? AND ac.soa_id=? " @@ -523,14 +523,15 @@ def _render_concepts_cell(request: Request, soa_id: int, activity_id: int): "dss_href": "", "concept_group_uid": r[2], "group_name": r[3], - "bc_category_name": r[4], + "cdisc_scheme_name": r[4], + "bc_category_name": r[5], } for r in cur.fetchall() ] elif has_group_uid: cur.execute( "SELECT ac.concept_code, ac.concept_title, ac.concept_group_uid, " - "cg.name AS group_name " + "cg.name AS group_name, cg.cdisc_scheme_name " "FROM activity_concept ac " "LEFT JOIN concept_group cg ON cg.concept_group_uid=ac.concept_group_uid " "WHERE ac.activity_id=? AND ac.soa_id=? " @@ -545,6 +546,7 @@ def _render_concepts_cell(request: Request, soa_id: int, activity_id: int): "dss_href": "", "concept_group_uid": r[2], "group_name": r[3], + "cdisc_scheme_name": r[4], "bc_category_name": None, } for r in cur.fetchall() @@ -563,6 +565,7 @@ def _render_concepts_cell(request: Request, soa_id: int, activity_id: int): "dss_href": "", "concept_group_uid": None, "group_name": None, + "cdisc_scheme_name": None, "bc_category_name": None, } for r in cur.fetchall() @@ -572,7 +575,7 @@ def _render_concepts_cell(request: Request, soa_id: int, activity_id: int): # Fetch linked surrogates (include concept_group_uid and group name) cur.execute( "SELECT bcs.id, bcs.surrogate_uid, bcs.name, bcs.label," - " asr.concept_group_uid, cg.name AS group_name " + " asr.concept_group_uid, cg.name AS group_name, cg.cdisc_scheme_name " "FROM activity_surrogate asr " "JOIN biomedical_concept_surrogate bcs " "ON bcs.surrogate_uid=asr.surrogate_uid AND bcs.soa_id=asr.soa_id " @@ -590,6 +593,7 @@ def _render_concepts_cell(request: Request, soa_id: int, activity_id: int): "label": r[3], "concept_group_uid": r[4], "group_name": r[5], + "cdisc_scheme_name": r[6], } for r in cur.fetchall() ] @@ -616,14 +620,11 @@ def _render_concepts_cell(request: Request, soa_id: int, activity_id: int): {c["bc_category_name"] for c in selected_list if c.get("bc_category_name")} ) - # Fetch all concept groups (for the dropdown) - cur.execute( - "SELECT id, concept_group_uid, name, label FROM concept_group ORDER BY id" - ) - concept_groups = [ - {"id": r[0], "concept_group_uid": r[1], "name": r[2], "label": r[3]} - for r in cur.fetchall() - ] + # Fetch all concept groups (for the dropdown), organized into + # CDISC-scheme + Custom Concept Groups sections. + from ..app import _get_concept_group_sections + + concept_groups = _get_concept_group_sections() activity_group_uids = list( {c["concept_group_uid"] for c in selected_list if c["concept_group_uid"]} | { diff --git a/src/soa_builder/web/routers/concept_groups.py b/src/soa_builder/web/routers/concept_groups.py index 79519d9..5fbe0f7 100644 --- a/src/soa_builder/web/routers/concept_groups.py +++ b/src/soa_builder/web/routers/concept_groups.py @@ -1,7 +1,10 @@ import logging import os +import re +import time from typing import List, Optional +import requests from fastapi import APIRouter, BackgroundTasks, Form, HTTPException, Request from fastapi.responses import HTMLResponse, JSONResponse, RedirectResponse from fastapi.templating import Jinja2Templates @@ -45,18 +48,39 @@ def _next_group_uid(cur) -> str: return f"{prefix}{max_n + 1}" -def _fetch_group_row(cur, group_id: int): - """Return (id, concept_group_uid, name) or raise 404.""" +def _fetch_group_row(cur, group_id: int, require_custom: bool = False): + """Return (id, concept_group_uid, name, source) or raise 404/400. + + When require_custom is True, reject (400) a CDISC-sourced group — + those are materialized from the bc-grouping service and must not + be edited/deleted through the Custom Concept Groups admin routes + (they'd just be overwritten by the next sync anyway). + """ cur.execute( - "SELECT id, concept_group_uid, name FROM concept_group WHERE id=?", + "SELECT id, concept_group_uid, name, source FROM concept_group WHERE id=?", (group_id,), ) row = cur.fetchone() if not row: raise HTTPException(404, "Group not found") + if require_custom and row[3] == "cdisc": + raise HTTPException( + 400, + "This group is sourced from CDISC classification data " + "and cannot be edited or deleted here.", + ) return row +def _fetch_custom_group_uid(cur, group_id: int) -> str: + """Return concept_group_uid for a group_id, rejecting CDISC-sourced + rows (400) and unknown ids (404). For routes that mutate a group's + definition (member concepts/surrogates) rather than assign it. + """ + row = _fetch_group_row(cur, group_id, require_custom=True) + return row[1] + + def _expand_group_to_activity( cur, soa_id: int, activity_id: int, activity_uid: str, group_uid: str ) -> int: @@ -162,7 +186,7 @@ def list_concept_groups(): cur = conn.cursor() cur.execute( "SELECT id, concept_group_uid, name, label, description " - "FROM concept_group ORDER BY id" + "FROM concept_group WHERE source='custom' OR source IS NULL ORDER BY id" ) groups = [ { @@ -229,7 +253,7 @@ def update_concept_group(group_id: int, payload: ConceptGroupUpdate): conn = _connect() cur = conn.cursor() cur.execute( - "SELECT id, concept_group_uid, name, label, description " + "SELECT id, concept_group_uid, name, label, description, source " "FROM concept_group WHERE id=?", (group_id,), ) @@ -237,6 +261,13 @@ def update_concept_group(group_id: int, payload: ConceptGroupUpdate): if not row: conn.close() raise HTTPException(404, "Group not found") + if row[5] == "cdisc": + conn.close() + raise HTTPException( + 400, + "This group is sourced from CDISC classification data " + "and cannot be edited or deleted here.", + ) new_name = _nz(payload.name) if payload.name is not None else row[2] new_label = _nz(payload.label) if payload.label is not None else row[3] new_desc = _nz(payload.description) if payload.description is not None else row[4] @@ -268,7 +299,7 @@ def update_concept_group(group_id: int, payload: ConceptGroupUpdate): def delete_concept_group(group_id: int): conn = _connect() cur = conn.cursor() - row = _fetch_group_row(cur, group_id) + row = _fetch_group_row(cur, group_id, require_custom=True) uid = row[1] cur.execute("DELETE FROM concept_group_concept WHERE concept_group_uid=?", (uid,)) cur.execute("PRAGMA table_info(activity_concept)") @@ -293,7 +324,7 @@ def delete_concept_group(group_id: int): def add_concepts_to_group(group_id: int, payload: ConceptsAdd): conn = _connect() cur = conn.cursor() - row = _fetch_group_row(cur, group_id) + row = _fetch_group_row(cur, group_id, require_custom=True) uid = row[1] from ..app import fetch_biomedical_concepts as _fetch_concepts @@ -324,7 +355,7 @@ def add_concepts_to_group(group_id: int, payload: ConceptsAdd): def remove_concept_from_group(group_id: int, concept_code: str): conn = _connect() cur = conn.cursor() - row = _fetch_group_row(cur, group_id) + row = _fetch_group_row(cur, group_id, require_custom=True) uid = row[1] cur.execute( "DELETE FROM concept_group_concept " @@ -349,7 +380,7 @@ def remove_concept_from_group(group_id: int, concept_code: str): def add_category_to_group(group_id: int, payload: CategoryAdd): conn = _connect() cur = conn.cursor() - row = _fetch_group_row(cur, group_id) + row = _fetch_group_row(cur, group_id, require_custom=True) uid = row[1] from ..app import ( fetch_biomedical_concepts_by_category as _fetch_by_cat, @@ -437,7 +468,7 @@ def ui_list_concept_groups(request: Request): cur = conn.cursor() cur.execute( "SELECT id, concept_group_uid, name, label, description " - "FROM concept_group ORDER BY id" + "FROM concept_group WHERE source='custom' OR source IS NULL ORDER BY id" ) groups = [ { @@ -573,12 +604,8 @@ def ui_update_concept_group( ): conn = _connect() cur = conn.cursor() - cur.execute("SELECT id, name FROM concept_group WHERE id=?", (group_id,)) - row = cur.fetchone() - if not row: - conn.close() - raise HTTPException(404, "Group not found") - new_name = name.strip() or row[1] + row = _fetch_group_row(cur, group_id, require_custom=True) + new_name = name.strip() or row[2] cur.execute( "UPDATE concept_group SET name=?, label=?, description=? WHERE id=?", (new_name, _nz(label), _nz(description), group_id), @@ -592,14 +619,7 @@ def ui_update_concept_group( def ui_delete_concept_group(request: Request, group_id: int): conn = _connect() cur = conn.cursor() - cur.execute( - "SELECT id, concept_group_uid FROM concept_group WHERE id=?", - (group_id,), - ) - row = cur.fetchone() - if not row: - conn.close() - raise HTTPException(404, "Group not found") + row = _fetch_group_row(cur, group_id, require_custom=True) uid = row[1] cur.execute("DELETE FROM concept_group_concept WHERE concept_group_uid=?", (uid,)) cur.execute("PRAGMA table_info(activity_concept)") @@ -629,12 +649,7 @@ def ui_add_concept_to_group( raise HTTPException(400, "concept_code required") conn = _connect() cur = conn.cursor() - cur.execute("SELECT concept_group_uid FROM concept_group WHERE id=?", (group_id,)) - row = cur.fetchone() - if not row: - conn.close() - raise HTTPException(404, "Group not found") - uid = row[0] + uid = _fetch_custom_group_uid(cur, group_id) from ..app import fetch_biomedical_concepts as _fetch_concepts lookup = {c["code"]: c["title"] for c in _fetch_concepts()} @@ -660,12 +675,7 @@ def ui_remove_concept_from_group( ): conn = _connect() cur = conn.cursor() - cur.execute("SELECT concept_group_uid FROM concept_group WHERE id=?", (group_id,)) - row = cur.fetchone() - if not row: - conn.close() - raise HTTPException(404, "Group not found") - uid = row[0] + uid = _fetch_custom_group_uid(cur, group_id) cur.execute( "DELETE FROM concept_group_concept " "WHERE concept_group_uid=? AND concept_code=?", @@ -687,12 +697,7 @@ def ui_add_category_to_group( ): conn = _connect() cur = conn.cursor() - cur.execute("SELECT concept_group_uid FROM concept_group WHERE id=?", (group_id,)) - row = cur.fetchone() - if not row: - conn.close() - raise HTTPException(404, "Group not found") - uid = row[0] + uid = _fetch_custom_group_uid(cur, group_id) from ..app import ( fetch_biomedical_concepts_by_category as _fetch_by_cat, ) @@ -724,12 +729,7 @@ def ui_add_surrogate_to_group( ): conn = _connect() cur = conn.cursor() - cur.execute("SELECT concept_group_uid FROM concept_group WHERE id=?", (group_id,)) - row = cur.fetchone() - if not row: - conn.close() - raise HTTPException(404, "Group not found") - group_uid = row[0] + group_uid = _fetch_custom_group_uid(cur, group_id) cur.execute( "UPDATE biomedical_concept_surrogate SET concept_group_uid=? WHERE id=?", (group_uid, surrogate_id), @@ -868,3 +868,283 @@ def ui_remove_group_from_activity( from .bc_surrogates import _render_concepts_cell return _render_concepts_cell(request, soa_id, activity_id) + + +# --------------------------------------------------------------------------- +# BC Grouping Explorer — proxy to the cdisc-biomedical-concept-groupings +# service. This section is independent of the Custom Concept Groups +# code above: it makes no changes to ui_list_concept_groups and adds +# no data to its response. +# --------------------------------------------------------------------------- + +_BC_GROUPING_SERVICE_URL = os.environ.get( + "BC_GROUPING_SERVICE_URL", "http://127.0.0.1:8901" +) +_BC_GROUPING_REQUEST_TIMEOUT = float(os.environ.get("BC_GROUPING_REQUEST_TIMEOUT", "3")) +_BC_GROUPING_CACHE_TTL = int(os.environ.get("BC_GROUPING_CACHE_TTL", "300")) +_BC_GROUPING_PAGE_LIMIT = 500 + +_bc_grouping_cache = {"data": None, "fetched_at": 0} + + +def _bc_grouping_fetch_all(path: str, limit: int = _BC_GROUPING_PAGE_LIMIT) -> list: + """GET every page of a paginated bc-grouping-service list endpoint.""" + items = [] + offset = 0 + while True: + resp = requests.get( + f"{_BC_GROUPING_SERVICE_URL}{path}", + params={"limit": limit, "offset": offset}, + timeout=_BC_GROUPING_REQUEST_TIMEOUT, + ) + resp.raise_for_status() + page = resp.json() + items.extend(page.get("items", [])) + offset += limit + if offset >= page.get("total", 0): + break + return items + + +def fetch_bc_grouping_data(force: bool = False) -> dict: + """Fetch (and cache) BC/scheme/value/assignment data from the + bc-grouping service. Never raises — on any failure, returns + available=False with a human-readable detail message. + """ + now = time.time() + if ( + not force + and _bc_grouping_cache.get("data") + and now - _bc_grouping_cache.get("fetched_at", 0) < _BC_GROUPING_CACHE_TTL + ): + return _bc_grouping_cache["data"] + + try: + data = { + "bcs": _bc_grouping_fetch_all("/biomedical-concepts"), + "schemes": _bc_grouping_fetch_all("/classification-schemes"), + "values": _bc_grouping_fetch_all("/classification-values"), + "assignments": _bc_grouping_fetch_all("/classification-assignments"), + } + result = {"available": True, "detail": "", "data": data} + except requests.exceptions.Timeout: + result = { + "available": False, + "detail": ( + "BC Grouping service timed out. It may be slow to start " + "or temporarily unavailable." + ), + "data": None, + } + except requests.exceptions.ConnectionError: + result = { + "available": False, + "detail": ( + "BC Grouping service is not reachable at " + f"{_BC_GROUPING_SERVICE_URL}. Make sure it is running " + "(python run.py in cdisc-biomedical-concept-groupings)." + ), + "data": None, + } + except Exception as exc: + logger.warning("BC Grouping service fetch failed: %s", exc) + result = { + "available": False, + "detail": "BC Grouping service request failed. See server logs.", + "data": None, + } + + if result["available"]: + _bc_grouping_cache["data"] = result + _bc_grouping_cache["fetched_at"] = now + return result + + +_NCIT_CODE_RE = re.compile(r"^C\d+$") + + +def sync_cdisc_concept_groups(force: bool = False) -> dict: + """Materialize CDISC classification values as `concept_group` / + `concept_group_concept` rows tagged source='cdisc', so the whole + existing group add/remove/display pipeline works for them + unchanged. Full idempotent replace-sync scoped strictly to + source='cdisc' rows — never touches source='custom' rows. + + Never raises. If the bc-grouping service is unavailable, logs a + warning and returns without touching the database — previously + synced groups must keep working through a transient outage. + """ + result = fetch_bc_grouping_data(force=force) + if not result["available"]: + logger.warning( + "sync_cdisc_concept_groups: service unavailable (%s), skipping sync", + result["detail"], + ) + return {"synced": False, "detail": result["detail"]} + + data = result["data"] + bcs_by_id = {bc["bc_id"]: bc for bc in data["bcs"]} + schemes_by_id = {s["scheme_id"]: s for s in data["schemes"]} + assignments_by_value = {} + for a in data["assignments"]: + assignments_by_value.setdefault(a["value_id"], []).append(a) + + conn = _connect() + cur = conn.cursor() + try: + current_uids = set() + groups_synced = 0 + members_synced = 0 + + for value in data["values"]: + scheme = schemes_by_id.get(value["scheme_id"]) + if not scheme: + continue + uid = f"cdisc:{value['scheme_id']}:{value['value_id']}" + current_uids.add(uid) + cur.execute( + """INSERT INTO concept_group + (concept_group_uid, name, label, description, source, + cdisc_scheme_id, cdisc_scheme_name, cdisc_value_id) + VALUES (?,?,?,?,'cdisc',?,?,?) + ON CONFLICT(concept_group_uid) DO UPDATE SET + name=excluded.name, + description=excluded.description, + source='cdisc', + cdisc_scheme_id=excluded.cdisc_scheme_id, + cdisc_scheme_name=excluded.cdisc_scheme_name, + cdisc_value_id=excluded.cdisc_value_id""", + ( + uid, + value["label"], + None, + value.get("description"), + value["scheme_id"], + scheme["name"], + value["value_id"], + ), + ) + groups_synced += 1 + + desired_codes = set() + for a in assignments_by_value.get(value["value_id"], []): + bc = bcs_by_id.get(a["bc_id"]) + if not bc: + continue + ncit_code = bc.get("ncit_code") or "" + code = ncit_code if _NCIT_CODE_RE.match(ncit_code) else bc["bc_id"] + desired_codes.add(code) + cur.execute( + """INSERT INTO concept_group_concept + (concept_group_uid, concept_code, concept_title) + VALUES (?,?,?) + ON CONFLICT(concept_group_uid, concept_code) DO UPDATE SET + concept_title=excluded.concept_title""", + (uid, code, bc["short_name"]), + ) + members_synced += 1 + + # Remove members no longer assigned to this value. + if desired_codes: + placeholders = ",".join("?" for _ in desired_codes) + cur.execute( + "DELETE FROM concept_group_concept " + f"WHERE concept_group_uid=? AND concept_code NOT IN ({placeholders})", + (uid, *desired_codes), + ) + else: + cur.execute( + "DELETE FROM concept_group_concept WHERE concept_group_uid=?", + (uid,), + ) + + # Remove CDISC-sourced groups no longer present upstream. + cur.execute("SELECT concept_group_uid FROM concept_group WHERE source='cdisc'") + existing_cdisc_uids = {r[0] for r in cur.fetchall()} + stale_uids = existing_cdisc_uids - current_uids + for uid in stale_uids: + cur.execute( + "DELETE FROM concept_group_concept WHERE concept_group_uid=?", (uid,) + ) + cur.execute( + "DELETE FROM concept_group WHERE concept_group_uid=? AND source='cdisc'", + (uid,), + ) + + conn.commit() + summary = { + "synced": True, + "groups": groups_synced, + "members": members_synced, + "removed": len(stale_uids), + } + logger.info("sync_cdisc_concept_groups: %s", summary) + return summary + except Exception as exc: + conn.rollback() + logger.warning("sync_cdisc_concept_groups failed: %s", exc) + return {"synced": False, "detail": str(exc)} + finally: + conn.close() + + +@ui_router.get("/ui/concept-groups/bc-status", response_class=HTMLResponse) +def ui_bc_grouping_status(request: Request): + """Return HTML partial indicating BC Grouping service availability.""" + try: + resp = requests.get( + f"{_BC_GROUPING_SERVICE_URL}/health", + timeout=_BC_GROUPING_REQUEST_TIMEOUT, + ) + if resp.status_code < 500: + status, detail = "ok", "BC Grouping service is connected." + else: + status = "error" + detail = f"BC Grouping service returned HTTP {resp.status_code}." + except requests.exceptions.Timeout: + status, detail = ( + "error", + "BC Grouping service timed out. It may be temporarily unavailable.", + ) + except requests.exceptions.ConnectionError: + status, detail = ( + "error", + (f"BC Grouping service is not reachable at {_BC_GROUPING_SERVICE_URL}."), + ) + except Exception as exc: + logger.warning("BC Grouping service health check failed: %s", exc) + status, detail = ( + "error", + "BC Grouping service check failed. See server logs.", + ) + + return templates.TemplateResponse( + request, + "bc_status.html", + {"status": status, "detail": detail}, + ) + + +@ui_router.get("/ui/concept-groups/bc-explorer", response_class=HTMLResponse) +def ui_bc_explorer(request: Request): + """Return the BC Grouping Explorer partial (or an unavailable card).""" + result = fetch_bc_grouping_data() + return templates.TemplateResponse( + request, + "bc_explorer.html", + { + "available": result["available"], + "detail": result["detail"], + "data": result["data"], + }, + ) + + +@ui_router.post("/ui/concept-groups/bc-explorer/refresh", response_class=HTMLResponse) +def ui_bc_explorer_refresh(request: Request): + """Force refresh of the BC Grouping cache and redirect back to the list.""" + fetch_bc_grouping_data(force=True) + sync_cdisc_concept_groups(force=True) + if request.headers.get("HX-Request") == "true": + return HTMLResponse("", headers={"HX-Redirect": "/ui/concept-groups"}) + return HTMLResponse("") diff --git a/src/soa_builder/web/static/bc_explorer.js b/src/soa_builder/web/static/bc_explorer.js new file mode 100644 index 0000000..810a450 --- /dev/null +++ b/src/soa_builder/web/static/bc_explorer.js @@ -0,0 +1,417 @@ +// BC Grouping Explorer — adapted from cdisc-biomedical-concept-groupings/ +// bc-explorer-prototype.html. Data is seeded server-side into BC_DATA +// (see templates/bc_explorer.html) instead of being loaded from an +// embedded mock or a client-side XLSX import. + +let store = BC_DATA; +let activeFilters = {}; // scheme_id -> Set of value_ids +let collapsedSchemes = new Set(); +let showZeros = false; +let searchQuery = ''; +let searchAllProperties = false; +let currentView = 'explorer'; +let selectedBcId = null; + +// ─── Lookup helpers ─── +function valueById(id) { return store.values.find(v => v.value_id === id); } +function schemeById(id) { return store.schemes.find(s => s.scheme_id === id); } +function bcById(id) { return store.bcs.find(b => b.bc_id === id); } +function assignmentsForBc(bcId) { return store.assignments.filter(a => a.bc_id === bcId); } +function bcsForValue(valueId) { + const bcIds = new Set(store.assignments.filter(a => a.value_id === valueId).map(a => a.bc_id)); + return store.bcs.filter(b => bcIds.has(b.bc_id)); +} +function valuesForScheme(schemeId) { return store.values.filter(v => v.scheme_id === schemeId); } + +// ─── Search match helper ─── +function bcMatchesSearch(bc, q) { + if (bc.short_name.toLowerCase().includes(q)) return true; + if (bc.bc_id.toLowerCase().includes(q)) return true; + if (bc.ncit_code.toLowerCase().includes(q)) return true; + if (!searchAllProperties) return false; + const asgns = assignmentsForBc(bc.bc_id); + return asgns.some(a => { + const v = valueById(a.value_id); + if (!v) return false; + if (v.label.toLowerCase().includes(q)) return true; + if (v.description && v.description.toLowerCase().includes(q)) return true; + return false; + }); +} + +// ─── Filtering logic ─── +function getFilteredBcs() { + let bcs = store.bcs; + + if (searchQuery) { + const q = searchQuery.toLowerCase(); + bcs = bcs.filter(bc => bcMatchesSearch(bc, q)); + } + + // Facet filters: AND across schemes, OR within a scheme + const activeSchemes = Object.keys(activeFilters).filter(k => activeFilters[k].size > 0); + if (activeSchemes.length > 0) { + bcs = bcs.filter(bc => { + const asgns = assignmentsForBc(bc.bc_id); + return activeSchemes.every(schemeId => { + const selectedValues = activeFilters[schemeId]; + return asgns.some(a => a.scheme_id === schemeId && selectedValues.has(a.value_id)); + }); + }); + } + + return bcs; +} + +function getValueCountForFiltered(valueId, schemeId) { + // count how many currently-filtered BCs have this value + // but ignore filters from the same scheme (so counts stay useful) + const activeSchemes = Object.keys(activeFilters).filter(k => activeFilters[k].size > 0 && k !== schemeId); + let bcs = store.bcs; + + if (searchQuery) { + const q = searchQuery.toLowerCase(); + bcs = bcs.filter(bc => bcMatchesSearch(bc, q)); + } + + if (activeSchemes.length > 0) { + bcs = bcs.filter(bc => { + const asgns = assignmentsForBc(bc.bc_id); + return activeSchemes.every(sid => { + const sv = activeFilters[sid]; + return asgns.some(a => a.scheme_id === sid && sv.has(a.value_id)); + }); + }); + } + + const bcIds = new Set(bcs.map(b => b.bc_id)); + return store.assignments.filter(a => a.value_id === valueId && bcIds.has(a.bc_id)).length; +} + +// ─── Highlight helper ─── +function highlight(text, query) { + if (!query) return text; + const esc = query.replace(/[.*+?^${}()|[\]\\]/g, '\\$&'); + return text.replace(new RegExp(`(${esc})`, 'gi'), '$1'); +} + +// ─── Expand/collapse all helper ─── +function updateExpandAllBtn() { + const btn = document.getElementById('expandAllBtn'); + if (!btn || !store.schemes.length) return; + const allCollapsed = store.schemes.every(s => collapsedSchemes.has(s.scheme_id)); + btn.textContent = allCollapsed ? 'Expand all' : 'Collapse all'; +} + +// ─── Render: Facet sidebar ─── +function renderFacets() { + const container = document.getElementById('facets'); + const hasFilters = Object.values(activeFilters).some(s => s.size > 0); + const hasActive = hasFilters || searchQuery.length > 0; + document.getElementById('clearFilters').classList.toggle('visible', hasActive); + + container.innerHTML = store.schemes.map(scheme => { + const values = valuesForScheme(scheme.scheme_id); + const isActive = activeFilters[scheme.scheme_id] && activeFilters[scheme.scheme_id].size > 0; + const isCollapsed = collapsedSchemes.has(scheme.scheme_id); + + return ` +
+
+

${scheme.name}

+ +
+
+ ${values.map(v => { + const count = getValueCountForFiltered(v.value_id, scheme.scheme_id); + const active = activeFilters[scheme.scheme_id] && activeFilters[scheme.scheme_id].has(v.value_id); + if (!showZeros && count === 0 && !active) return ''; + return ` +
+
+ ${v.label} + ${count} +
`; + }).join('')} +
+
`; + }).join(''); + + // Event delegation + container.querySelectorAll('.facet-header').forEach(h => { + h.addEventListener('click', () => { + const schemeId = h.dataset.scheme; + if (collapsedSchemes.has(schemeId)) { + collapsedSchemes.delete(schemeId); + } else { + collapsedSchemes.add(schemeId); + } + h.classList.toggle('collapsed'); + h.nextElementSibling.classList.toggle('collapsed'); + updateExpandAllBtn(); + }); + }); + updateExpandAllBtn(); + + container.querySelectorAll('.facet-item').forEach(item => { + item.addEventListener('click', () => { + const schemeId = item.dataset.scheme; + const valueId = item.dataset.value; + if (!activeFilters[schemeId]) activeFilters[schemeId] = new Set(); + if (activeFilters[schemeId].has(valueId)) { + activeFilters[schemeId].delete(valueId); + } else { + activeFilters[schemeId].add(valueId); + } + renderAll(); + }); + }); + + const showZerosBtn = document.getElementById('showZerosBtn'); + if (showZerosBtn) { + showZerosBtn.disabled = store.bcs.length === 0; + showZerosBtn.textContent = showZeros ? 'Hide zeros' : 'Show zeros'; + showZerosBtn.classList.toggle('on', showZeros); + showZerosBtn.title = showZeros + ? 'Currently showing all classification values, including those with 0 BCs. Click to hide them.' + : 'Some classification values are hidden because they have 0 matching BCs. Click to reveal them.'; + } +} + +// ─── Render: Explorer view ─── +function renderExplorer() { + const container = document.getElementById('explorerView'); + const bcs = getFilteredBcs(); + + container.innerHTML = `
${bcs.map((bc, i) => { + const asgns = assignmentsForBc(bc.bc_id); + const tags = asgns.map(a => { + const v = valueById(a.value_id); + return v ? `${highlight(v.label, searchQuery)}` : ''; + }).join(''); + + return ` +
+
${highlight(bc.bc_id, searchQuery)}
+
${highlight(bc.short_name, searchQuery)}
+
${tags}
+
`; + }).join('')}
`; + + container.querySelectorAll('.bc-card').forEach(card => { + card.addEventListener('click', () => openDetail(card.dataset.bc)); + }); +} + +// ─── Render: Browse view (grouped by scheme, then value) ─── +function renderMatrix() { + const container = document.getElementById('matrixView'); + const filteredBcIds = new Set(getFilteredBcs().map(b => b.bc_id)); + + const schemeBlocks = store.schemes.map(scheme => { + const values = valuesForScheme(scheme.scheme_id); + + const valueRows = values.map(v => { + const bcs = bcsForValue(v.value_id).filter(b => filteredBcIds.has(b.bc_id)); + if (bcs.length === 0) return ''; + return ` +
+
+ ${v.label} + ${bcs.length} + → +
+
+ ${bcs.map(bc => `${highlight(bc.short_name, searchQuery)}`).join('')} +
+
`; + }).join(''); + + if (!valueRows.trim()) return ''; + return ` +
+
+

${scheme.name}

+

${scheme.purpose}

+
+
${valueRows}
+
`; + }).join(''); + + container.innerHTML = `
${schemeBlocks}
`; + + container.querySelectorAll('.bc-chip').forEach(chip => { + chip.addEventListener('click', () => openDetail(chip.dataset.bc)); + }); + + container.querySelectorAll('.grouped-value-meta').forEach(meta => { + meta.addEventListener('click', () => { + const schemeId = meta.dataset.scheme; + const valueId = meta.dataset.value; + if (!activeFilters[schemeId]) activeFilters[schemeId] = new Set(); + activeFilters[schemeId].clear(); + activeFilters[schemeId].add(valueId); + switchView('explorer'); + renderAll(); + }); + }); +} + +// ─── Detail panel ─── +function openDetail(bcId) { + selectedBcId = bcId; + const bc = bcById(bcId); + if (!bc) return; + + const asgns = assignmentsForBc(bcId); + const panel = document.getElementById('detailPanel'); + const content = document.getElementById('detailContent'); + + // Group assignments by scheme + const grouped = {}; + asgns.forEach(a => { + if (!grouped[a.scheme_id]) grouped[a.scheme_id] = []; + grouped[a.scheme_id].push(a); + }); + + // Find related BCs (share at least one value) + const myValues = new Set(asgns.map(a => a.value_id)); + const relatedIds = new Set(); + store.assignments.forEach(a => { + if (a.bc_id !== bcId && myValues.has(a.value_id)) relatedIds.add(a.bc_id); + }); + + content.innerHTML = ` +
${bc.ncit_code}
+
${bc.short_name}
+
+ ${store.schemes.map(scheme => { + const vals = grouped[scheme.scheme_id] || []; + if (vals.length === 0) return ''; + return ` +
+
${scheme.name}
+ ${vals.map(a => { + const v = valueById(a.value_id); + return v ? `
+
${v.label}
+
${v.description}
+
` : ''; + }).join('')} +
`; + }).join('')} +
+
Related BCs (${relatedIds.size})
+
${[...relatedIds].map(rid => { + const r = bcById(rid); + return r ? `${r.short_name}` : ''; + }).join('')}
+
`; + + panel.classList.add('open'); + + content.querySelectorAll('.related-bc').forEach(el => { + el.addEventListener('click', () => openDetail(el.dataset.bc)); + }); + + // Update card / chip selection + document.querySelectorAll('.bc-card, .bc-chip').forEach(c => c.classList.toggle('selected', c.dataset.bc === bcId)); +} + +function closeDetail() { + selectedBcId = null; + document.getElementById('detailPanel').classList.remove('open'); + document.querySelectorAll('.bc-card.selected, .bc-chip.selected').forEach(c => c.classList.remove('selected')); +} + +// ─── View switching ─── +function switchView(view) { + currentView = view; + document.querySelectorAll('.view-tab').forEach(t => t.classList.toggle('active', t.dataset.view === view)); + document.getElementById('explorerView').classList.toggle('hidden', view !== 'explorer'); + document.getElementById('matrixView').classList.toggle('hidden', view !== 'matrix'); + document.getElementById('sidebar').style.display = ''; +} + +// ─── Master render ─── +function renderAll() { + const count = getFilteredBcs().length; + document.getElementById('searchCount').textContent = `${count} of ${store.bcs.length} BCs`; + renderFacets(); + if (currentView === 'explorer') renderExplorer(); + else if (currentView === 'matrix') renderMatrix(); +} + +// ─── Event wiring ─── +// NOTE: this script is injected dynamically by an HTMX swap, well after +// the page's own DOMContentLoaded has already fired — so it must not +// wait for that event (it would never fire again). By the time this +// script runs, the explorer's markup (from bc_explorer.html) is already +// in the DOM, since HTMX swaps the HTML in before executing scripts +// found within it. +(() => { + // View tabs + document.querySelectorAll('.view-tab').forEach(tab => { + tab.addEventListener('click', () => { + switchView(tab.dataset.view); + renderAll(); + }); + }); + + // Search + document.getElementById('globalSearch').addEventListener('input', e => { + searchQuery = e.target.value.trim(); + document.getElementById('searchClearBtn').classList.toggle('hidden', !searchQuery); + renderAll(); + }); + + // Clear search ✕ + document.getElementById('searchClearBtn').addEventListener('click', () => { + searchQuery = ''; + document.getElementById('globalSearch').value = ''; + document.getElementById('searchClearBtn').classList.add('hidden'); + renderAll(); + }); + + // Search scope toggle + document.getElementById('searchScopeBtn').addEventListener('click', () => { + searchAllProperties = !searchAllProperties; + const btn = document.getElementById('searchScopeBtn'); + btn.textContent = searchAllProperties ? 'All fields' : 'Names only'; + btn.classList.toggle('on', searchAllProperties); + if (searchQuery) renderAll(); + }); + + // Clear all (filters + search) + document.getElementById('clearFilters').addEventListener('click', () => { + activeFilters = {}; + searchQuery = ''; + document.getElementById('globalSearch').value = ''; + document.getElementById('searchClearBtn').classList.add('hidden'); + renderAll(); + }); + + // Show / hide zero-count facet values + document.getElementById('showZerosBtn').addEventListener('click', () => { + showZeros = !showZeros; + renderFacets(); + }); + + // Expand / collapse all facets + document.getElementById('expandAllBtn').addEventListener('click', () => { + const allCollapsed = store.schemes.every(s => collapsedSchemes.has(s.scheme_id)); + if (allCollapsed) { + collapsedSchemes.clear(); + } else { + store.schemes.forEach(s => collapsedSchemes.add(s.scheme_id)); + } + renderFacets(); + }); + + // Close detail + document.getElementById('detailClose').addEventListener('click', closeDetail); + document.addEventListener('keydown', e => { if (e.key === 'Escape') closeDetail(); }); + + switchView('explorer'); + renderAll(); +})(); diff --git a/src/soa_builder/web/static/style.css b/src/soa_builder/web/static/style.css index 33f5111..6857a71 100644 --- a/src/soa_builder/web/static/style.css +++ b/src/soa_builder/web/static/style.css @@ -5,22 +5,34 @@ z-index: 1; top: 0; left: 0; - background-color: #111; + background-color: var(--cdisc-navy); overflow-x: hidden; padding-top: 20px; } +.am-sidenav-brand { + padding: 0 16px 16px; + text-align: center; +} + +.am-sidenav-logo { + max-width: 120px; + height: auto; + display: block; + margin: 0 auto; +} + .sidenav a { padding: 6px 8px 6px 16px; text-decoration: none; font-size: 20px; - color: #818181; + color: var(--am-sidenav-link); display: block; } .sidenav a:hover { - color: #f1f1f1; - background-color: #575757; + color: var(--cdisc-white); + background-color: var(--cdisc-blue-700); } /* Reset list styles */ @@ -40,12 +52,12 @@ padding: 6px 8px 6px 16px; text-decoration: none; font-size: 20px; - color: #818181; + color: var(--am-sidenav-link); } .sidenav ul > li > a:hover { - color: #f1f1f1; - background-color: #575757; + color: var(--cdisc-white); + background-color: var(--cdisc-blue-700); } /* Submenu hidden by default */ @@ -64,28 +76,29 @@ } .sidenav ul > li.open > a { - color: #f1f1f1; + color: var(--cdisc-white); } /* Submenu item styling */ .sidenav ul li ul li a { display: block; padding-left: 30px; - background-color: #444; + background-color: var(--am-sidenav-submenu-bg); font-size: 18px; text-decoration: none; - color: #818181; + color: var(--am-sidenav-link); } .sidenav ul li ul li a:hover { - background-color: #575757; - color: #f1f1f1; + background-color: var(--cdisc-blue-700); + color: var(--cdisc-white); } body { margin: 0; - font-family: Arial, Helvetica, sans-serif + font-family: Arial, Helvetica, "Segoe UI", system-ui, sans-serif; } +button, input, select, textarea { font-family: inherit; } .main { margin-left: 220px; @@ -98,20 +111,20 @@ body { } .table, table { border-collapse: collapse; } -th, td { border: 1px solid #ccc; padding: 4px 8px; font-size: 0.9rem; } -th { background: #f2f2f2; } +th, td { border: 1px solid var(--am-border-med); padding: 4px 8px; font-size: 0.9rem; } +th { background: var(--am-surface); } .flex { display: flex; gap: 2rem; } .matrix td.cell { cursor: pointer; min-width: 40px; text-align: center; } .matrix td.cell:hover { background: #ffe; } form input { margin-right: 0.5rem; } button { cursor: pointer; } -.delete-btn { background:#c62828; color:#fff; border:none; padding:0 6px; cursor:pointer; } -.delete-btn:hover { background:#b71c1c; } +.delete-btn { background: var(--am-danger); color:#fff; border:none; padding:0 6px; cursor:pointer; } +.delete-btn:hover { background: var(--am-danger-hover); } .export-buttons { margin-top:8px; } -.export-buttons .btn { display:inline-block; margin-right:10px; background:#1976d2; color:#fff; padding:4px 10px; text-decoration:none; border-radius:3px; font-size:0.9em; } -.export-buttons .btn:hover { background:#125aa0; } -.small-btn { background:#2e7d32; color:#fff; border:none; padding:2px 8px; margin-top:4px; cursor:pointer; font-size:0.75em; } -.small-btn:hover { background:#1b5e20; } +.export-buttons .btn { display:inline-block; margin-right:10px; background: var(--am-slate); color:#fff; padding:4px 10px; text-decoration:none; border-radius:3px; font-size:0.9em; } +.export-buttons .btn:hover { background: var(--am-slate-dark); } +.small-btn { background: var(--am-success); color:#fff; border:none; padding:2px 8px; margin-top:4px; cursor:pointer; font-size:0.75em; } +.small-btn:hover { background: var(--am-success-hover); } details.collapsible { border: 1px solid var(--am-border); border-radius: var(--am-radius); @@ -144,6 +157,7 @@ details.collapsible > *:not(summary) { padding: 0 14px 12px; } .drag-item form { margin-left:0; } .visit-actions { display:inline-flex; align-items:center; gap:8px; margin-left:auto; } .activity-actions { display:inline-flex; align-items:center; gap:8px; margin-left:auto; } +.transition-rule-actions { display:inline-flex; align-items:center; gap:8px; margin-left:auto; } .hint { font-weight:400; font-size:0.7em; color:#666; } @media screen and (max-height: 450px) { @@ -157,29 +171,55 @@ details.collapsible > *:not(summary) { padding: 0 14px 12px; } ================================================================ */ :root { - --am-purple: #6a1b9a; - --am-purple-hover: #5a1580; - --am-purple-light: #f5eeff; - --am-purple-border: #d8b4fe; - --am-slate: #455a64; - --am-slate-dark: #37474f; - --am-danger: #c62828; - --am-danger-hover: #a91e1e; - --am-success: #2e7d32; - --am-warn: #e65100; - --am-info: #1565c0; - --am-border: #e2e8f0; - --am-border-med: #cbd5e1; - --am-surface: #f8fafc; - --am-surface-purple:#faf5ff; - --am-text: #1e293b; - --am-text-mid: #475569; - --am-text-muted: #94a3b8; - --am-radius: 6px; - --am-radius-sm: 3px; - --am-shadow-sm: 0 1px 3px rgba(0,0,0,0.06); - --am-shadow: 0 2px 8px rgba(0,0,0,0.08); - --am-mono: 'SF Mono','Consolas','Liberation Mono',monospace; + /* CDISC official brand palette — source of truth, do not use directly + in selectors; reference via the semantic --am-* names below. */ + --cdisc-blue: #134678; + --cdisc-purple: #553278; + --cdisc-orange: #D57E00; + --cdisc-green: #286040; + --cdisc-light-blue: #40B4E5; + --cdisc-teal: #A1D0CA; + --cdisc-red: #C94543; + --cdisc-dark-gray: #525349; + --cdisc-yellow-green: #AAAD00; + --cdisc-yellow: #FFCE00; + --cdisc-gold: #EDAA00; + --cdisc-light-gray: #929288; + --cdisc-bg: #F5F5F5; + --cdisc-white: #FFFFFF; + --cdisc-navy: #0E2841; + --cdisc-blue-700: #0f3a63; + + --am-primary: var(--cdisc-blue); + --am-primary-hover: var(--cdisc-blue-700); + --am-purple: var(--cdisc-purple); + --am-purple-hover: #452868; + --am-purple-light: #f3eef8; + --am-purple-border: #c9b8dc; + --am-slate: #455a64; + --am-slate-dark: #37474f; + --am-danger: var(--cdisc-red); + --am-danger-hover: #a73938; + --am-success: var(--cdisc-green); + --am-success-hover: #1e4830; + --am-warn: #e65100; + --am-info: var(--cdisc-purple); + --am-info-hover: #452868; + --am-sidenav-link: #B9C6D4; + --am-sidenav-submenu-bg: #163a5c; + --am-border: #e2e8f0; + --am-border-med: #cbd5e1; + --am-surface: #f8fafc; + --am-surface-purple: #faf5ff; + --am-text: #1e293b; + --am-text-mid: #475569; + --am-text-muted: #94a3b8; + --am-white: var(--cdisc-white); + --am-radius: 6px; + --am-radius-sm: 3px; + --am-shadow-sm: 0 1px 3px rgba(0,0,0,0.06); + --am-shadow: 0 2px 8px rgba(0,0,0,0.08); + --am-mono: 'SF Mono','Consolas','Liberation Mono',monospace; } /* ---- Back / nav links ---------------------------------------- */ @@ -332,8 +372,8 @@ details.collapsible > *:not(summary) { padding: 0 14px 12px; } .am-textarea:focus, .am-select:focus { outline: none; - border-color: var(--am-purple); - box-shadow: 0 0 0 3px rgba(106,27,154,0.1); + border-color: var(--am-primary); + box-shadow: 0 0 0 3px rgba(19,70,120,0.1); } .am-textarea { resize: vertical; min-height: 54px; } @@ -349,8 +389,8 @@ details.collapsible > *:not(summary) { padding: 0 14px 12px; } } .am-input-sm:focus { outline: none; - border-color: var(--am-purple); - box-shadow: 0 0 0 2px rgba(106,27,154,0.1); + border-color: var(--am-primary); + box-shadow: 0 0 0 2px rgba(19,70,120,0.1); } .am-input-xs-w { width: 70px; } .am-input-flex { flex: 1; min-width: 120px; } @@ -375,8 +415,8 @@ details.collapsible > *:not(summary) { padding: 0 14px 12px; } } .am-btn:active { transform: translateY(1px); } -.am-btn-primary { background: var(--am-purple); color: #fff; } -.am-btn-primary:hover { background: var(--am-purple-hover); color: #fff; } +.am-btn-primary { background: var(--am-primary); color: #fff; } +.am-btn-primary:hover { background: var(--am-primary-hover); color: #fff; } .am-btn-slate { background: var(--am-slate); color: #fff; } .am-btn-slate:hover { background: var(--am-slate-dark); color: #fff; } @@ -385,10 +425,10 @@ details.collapsible > *:not(summary) { padding: 0 14px 12px; } .am-btn-danger:hover { background: var(--am-danger-hover); color: #fff; } .am-btn-success { background: var(--am-success); color: #fff; } -.am-btn-success:hover { background: #1b5e20; color: #fff; } +.am-btn-success:hover { background: var(--am-success-hover); color: #fff; } .am-btn-info { background: var(--am-info); color: #fff; } -.am-btn-info:hover { background: #0d47a1; color: #fff; } +.am-btn-info:hover { background: var(--am-info-hover); color: #fff; } .am-btn-sm { padding: 3px 10px; font-size: 0.80em; } .am-btn-xs { padding: 1px 7px; font-size: 0.76em; } @@ -606,8 +646,8 @@ details.collapsible > *:not(summary) { padding: 0 14px 12px; } } .fz-version-input:focus { outline: none; - border-color: var(--am-purple); - box-shadow: 0 0 0 3px rgba(106,27,154,0.1); + border-color: var(--am-primary); + box-shadow: 0 0 0 3px rgba(19,70,120,0.1); } .fz-feedback { font-size: 0.78em; @@ -712,8 +752,8 @@ details.collapsible > *:not(summary) { padding: 0 14px 12px; } } .fz-table .am-input-compact:focus { outline: none; - border-color: var(--am-purple); - box-shadow: 0 0 0 2px rgba(106,27,154,0.1); + border-color: var(--am-primary); + box-shadow: 0 0 0 2px rgba(19,70,120,0.1); } .fz-table .am-select-compact { width: 100%; @@ -766,7 +806,7 @@ details.collapsible > *:not(summary) { padding: 0 14px 12px; } margin: 0 0 10px; font-size: 0.78em; font-weight: 700; - color: #1565c0; + color: var(--am-info); text-transform: uppercase; letter-spacing: 0.07em; } @@ -1011,4 +1051,844 @@ details.collapsible > *:not(summary) { padding: 0 14px 12px; } .am-change-form-grid .am-form-actions { grid-column: 2; padding-top: 2px; +} + +/* ===== Utilities: spacing, truncation, display toggles, widths ===== */ +/* Prefer an existing am-/fz- component class over these when one + fits; these exist only to eliminate one-off inline styles. */ +.am-mt-4 { margin-top: 4px; } +.am-mt-6 { margin-top: 6px; } +.am-mt-8 { margin-top: 8px; } +.am-mt-10 { margin-top: 10px; } +.am-mb-8 { margin-bottom: 8px; } +.am-mb-12 { margin-bottom: 12px; } +.am-m-0 { margin: 0; } +.am-truncate { + flex: 1; + overflow: hidden; + text-overflow: ellipsis; + white-space: nowrap; +} +.am-tl-visible { display: block; } +.am-tl-hidden { display: none; } +.am-meta-line { font-size: 0.82em; color: var(--am-text-mid); } +.am-w-55 { width: 55px; } +.am-w-80 { width: 80px; } +.am-w-90 { width: 90px; } +.am-w-100 { width: 100px; } +.am-w-110 { width: 110px; } +.am-w-160 { width: 160px; } +.am-w-200 { width: 200px; } + +/* ===== Legacy audit-log table pattern ===== */ +.am-audit-table { + width: 100%; + font-size: 0.75em; + border-collapse: collapse; +} +.am-audit-thead-row { background: #eee; } +.am-audit-th { text-align: left; padding: 4px; } +.am-audit-td { padding: 4px; } +.am-audit-td-json { + padding: 4px; + white-space: pre-wrap; + max-width: 320px; +} +.am-empty-note { font-size: 0.75em; color: #777; } + +/* ===== Matrix header row labels (edit / edit-column-collapse) ===== */ +.am-matrix-label-th { text-align: right; font-size: 0.50em; } +.am-matrix-value-th { text-align: center; font-size: 0.50em; } +.am-td-shrink { width: 1%; white-space: nowrap; } + +/* ===== Notice banner variants (legacy, kept pixel-for-pixel to + avoid a visual change vs. am-api-notice's card treatment) ===== */ +.am-legacy-error-notice { + padding: 8px 12px; + margin-bottom: 12px; + border: 1px solid #c33; + background: #fee; + color: #900; + font-size: 0.85em; + border-radius: 4px; +} +.am-legacy-warn-notice { + padding: 8px 12px; + margin-bottom: 12px; + border: 1px solid #cc9; + background: #ffd; + color: #660; + font-size: 0.85em; + border-radius: 4px; +} + +/* ---- Edit page: rules moved from edit-column-collapse.html's + embedded - {% endblock %} \ No newline at end of file diff --git a/src/soa_builder/web/templates/base.html b/src/soa_builder/web/templates/base.html index dc756db..be95ec6 100644 --- a/src/soa_builder/web/templates/base.html +++ b/src/soa_builder/web/templates/base.html @@ -3,11 +3,15 @@ SoA Workbench - + +
+
+ +
🏠 Home diff --git a/src/soa_builder/web/templates/bc_explorer.html b/src/soa_builder/web/templates/bc_explorer.html new file mode 100644 index 0000000..9874262 --- /dev/null +++ b/src/soa_builder/web/templates/bc_explorer.html @@ -0,0 +1,866 @@ +{% if not available %} +
+ ✗ +
+ BC Grouping Explorer unavailable. + {{ detail }} +
+
+ +
+
+{% else %} + + +
+ +
+
+
+ +
+
+
+ CDISC + BC Grouping Explorer +
+
+ +
+ + + + + + + +
+ + +
+ + +
+ +
+ +
+
+ +
+ + +
+
+ +
+
+ +
+ +
+
+ +
+ + + +{% endif %} diff --git a/src/soa_builder/web/templates/bc_status.html b/src/soa_builder/web/templates/bc_status.html new file mode 100644 index 0000000..2041e66 --- /dev/null +++ b/src/soa_builder/web/templates/bc_status.html @@ -0,0 +1,14 @@ +{% if status == "ok" %} +
+ ✓ + BC Grouping Service is connected. +
+{% elif status == "error" %} +
+ ✗ +
+ BC Grouping Service unavailable. + {{ detail }} +
+
+{% endif %} diff --git a/src/soa_builder/web/templates/bc_unassigned_concepts.html b/src/soa_builder/web/templates/bc_unassigned_concepts.html index bfa690c..d406621 100644 --- a/src/soa_builder/web/templates/bc_unassigned_concepts.html +++ b/src/soa_builder/web/templates/bc_unassigned_concepts.html @@ -2,7 +2,7 @@ {% block content %}

Unassigned Biomedical Concepts

-
+
← Concepts Explorer
@@ -19,7 +19,7 @@

About This Report

-
+
diff --git a/src/soa_builder/web/templates/cdash_terminology.html b/src/soa_builder/web/templates/cdash_terminology.html index 1937258..5a9cad0 100644 --- a/src/soa_builder/web/templates/cdash_terminology.html +++ b/src/soa_builder/web/templates/cdash_terminology.html @@ -2,12 +2,12 @@ {% block content %}

CDASH Controlled Terminology{% if slug %} — {{ slug }}{% else %} — (unavailable){% endif %}

-
+
← Home
{% if error %} -
+
Error: {{ error }}
{% endif %} @@ -35,12 +35,12 @@

Filter

- +
-
+
@@ -48,7 +48,7 @@

Filter

-

+

Total: {{ total_count }} | Matched: {{ matched_count }} | Showing limit {{ limit }} offset {{ offset }}

@@ -68,7 +68,7 @@

Filter

{% if matched_count > limit %} {% set next_offset = offset + limit %} {% if next_offset < matched_count %} -
+
diff --git a/src/soa_builder/web/templates/concept_categories.html b/src/soa_builder/web/templates/concept_categories.html index c06f75d..e89ad25 100644 --- a/src/soa_builder/web/templates/concept_categories.html +++ b/src/soa_builder/web/templates/concept_categories.html @@ -1,25 +1,25 @@ {% extends 'base.html' %} {% block content %}

Biomedical Concept Categories ({{ count }})

-

+

Derived from the CDISC Library API. Each link lists biomedical concepts in that category.

-
+
← Home ↻ Refresh - {% if force %}Cache refreshed{% endif %} + {% if force %}Cache refreshed{% endif %}
-
+
+ class="fz-version-input am-w-280" oninput="filterCategories()" />
- +
{% if rows %} diff --git a/src/soa_builder/web/templates/concept_category_detail.html b/src/soa_builder/web/templates/concept_category_detail.html index df02857..74edfd7 100644 --- a/src/soa_builder/web/templates/concept_category_detail.html +++ b/src/soa_builder/web/templates/concept_category_detail.html @@ -3,7 +3,7 @@

Biomedical Concepts in Category: {{ category }}

Refresh (bypass cache) - {% if force %}Cache bypassed{% endif %} + {% if force %}Cache bypassed{% endif %} | Back to Categories

Total concepts: {{ count }}

@@ -12,15 +12,15 @@

Biomedical Concepts in Category: {{ category }}

- - + + {% for r in rows %} - @@ -52,19 +52,17 @@ {# ── Variables of Interest (Endpoints) subsection ── #} - - -
TitleBiomedical Concept CodeTitleBiomedical Concept Code
{{ r.title }} + {% if r.code %} {{ r.code }} {% else %}n/a{% endif %} @@ -34,4 +34,4 @@

Biomedical Concepts in Category: {{ category }}

{% endif %}

← Back to Categories

-{% endblock %} \ No newline at end of file +{% endblock %} diff --git a/src/soa_builder/web/templates/concept_detail.html b/src/soa_builder/web/templates/concept_detail.html index 4f4d71e..fc094a4 100644 --- a/src/soa_builder/web/templates/concept_detail.html +++ b/src/soa_builder/web/templates/concept_detail.html @@ -6,7 +6,7 @@

Concept: {{ code }}

Directly opening this URL in your browser omits required headers and may return 401. Use this internal page or an API client with headers: Ocp-Apim-Subscription-Key: <key>{% if not missing_key %}, Authorization: Bearer <key>{% endif %}. {% if missing_key %} -
+
Notice: No API key detected; set CDISC_SUBSCRIPTION_KEY or CDISC_API_KEY to retrieve live JSON.
{% endif %} @@ -14,18 +14,18 @@

Concept: {{ code }}

{% if status %}

Upstream Status: {{ status }}

{% endif %} {% if summary or parent_bc_href or parent_pkg_href %} -

Summary

- +

Summary

+
{% for key, val in summary.items() %} - - + + {% endfor %} {% if parent_bc_href %} - - + @@ -33,8 +33,8 @@

Summary

{% endif %} {% if parent_pkg_href %} - - + @@ -45,26 +45,26 @@

Summary

{% if data_element_concepts %}

Data Element Concepts

-
{{ key }}{{ val }}{{ key }}{{ val }}
parentBiomedicalConcept + parentBiomedicalConcept {% if parent_bc_title %}{{ parent_bc_title }} — {% endif %} {{ parent_bc_href }}
parentPackage + parentPackage {% if parent_pkg_name %}{{ parent_pkg_name }} — {% endif %} {{ parent_pkg_href }}
+
- - - - - - - + + + + + + + {% for d in data_element_concepts %} - - - - - - + + + + + diff --git a/src/soa_builder/web/templates/crf_specialization_detail.html b/src/soa_builder/web/templates/crf_specialization_detail.html index 7e5d735..c90e980 100644 --- a/src/soa_builder/web/templates/crf_specialization_detail.html +++ b/src/soa_builder/web/templates/crf_specialization_detail.html @@ -2,29 +2,29 @@ {% block content %}

CRF Specialization Detail

-
+
← Back to CRF Specializations
-

+

Title: {{ title }}
{% if href %} API HREF: {{ href }} + class="am-lib-href-wrap">{{ href }} {% else %} No href available {% endif %}

{% if missing_key %} -
+
Notice: No API key detected; set CDISC_SUBSCRIPTION_KEY or CDISC_API_KEY to retrieve live JSON.
{% endif %} {% if error %} -
+
Error: {{ error }}
{% endif %} @@ -43,14 +43,14 @@

CRF Specialization Detail

{% if scalar_items %}

Summary

-
Concept IDShort NameData TypeExample SetSynonymsHref
Concept IDShort NameData TypeExample SetSynonymsHref
{{ d.conceptId or '' }}{{ d.shortName or '' }}{{ d.dataType or '' }}{{ (d.exampleSet or []) | join(', ') }}{{ (d.synonyms or []) | join(', ') }} + {{ d.conceptId or '' }}{{ d.shortName or '' }}{{ d.dataType or '' }}{{ (d.exampleSet or []) | join(', ') }}{{ (d.synonyms or []) | join(', ') }} {%- if d.href -%} link {%- endif -%} @@ -76,13 +76,13 @@

Data Element Concepts

{% endif %} {% if pretty_json %} -
+
- Raw JSON - 
{{ pretty_json }}
+ Raw JSON + 
{{ pretty_json }}
{% endif %} -

← Back to concepts list

+

← Back to concepts list

{% endblock %} diff --git a/src/soa_builder/web/templates/concept_groups.html b/src/soa_builder/web/templates/concept_groups.html index b24ba9c..c2c1466 100644 --- a/src/soa_builder/web/templates/concept_groups.html +++ b/src/soa_builder/web/templates/concept_groups.html @@ -1,7 +1,7 @@ {% extends "base.html" %} {% block content %} -
+
← Home
@@ -9,14 +9,23 @@

CDISC Concept Groups

-
-

__PLACEHOLDER__

+
+
+ +
+
Loading BC Grouping Explorer…

Custom Concept Groups

-

+

Custom Groups are global (not SOA-specific) and can be assigned to activities in any SoA. Biomedical Concepts added to a Custom Group via an activity assignment can be individually removed from that activity without affecting the group definition. @@ -61,19 +70,18 @@

Groups ({{ groups|length }})

{% endif %} {% for g in groups %} -
+
-
+
{{ g.concept_group_uid }} - - ▸{{ g.name }} - {% if g.label %} — {{ g.label }}{% endif %} + ▸{{ g.name }} + {% if g.label %} — {{ g.label }}{% endif %} - {{ g.concepts|length }} concept(s) - + {{ g.concepts|length }} concept(s) + @@ -82,14 +90,14 @@

Groups ({{ groups|length }})
-
+ {% if edit %} - -
+ +
-
+ +
@@ -39,8 +39,8 @@ })(); {% else %} -
- +
+
@@ -52,7 +52,7 @@
-
+ {% set crf_concepts = activity_concepts.get(activity_id, []) %} {% if crf_concepts %} {% set ns = namespace(total=0) %} @@ -17,51 +17,47 @@ -
+
- + {% for item in scalar_items %} - + {% endfor %} @@ -83,8 +83,8 @@

Summary

{% endif %}

{{ items_key | title }}

-
-
FieldField Value
{{ item.key }}{{ item.key }} {{ item.val }}
+
+
{% for col in col_keys %} @@ -115,16 +115,13 @@

{{ items_key | title }}

{% endif %} {# ── Raw JSON dropdown ───────────────────────────────────────────────────── #} -
- Raw JSON - 
{{ spec_json }}
+
+ Raw JSON + 
{{ spec_json }}
{% elif not error %} -

No data available for this CRF specialization.

+

No data available for this CRF specialization.

{% endif %} {% endblock %} diff --git a/src/soa_builder/web/templates/crf_specializations.html b/src/soa_builder/web/templates/crf_specializations.html index 55f62c1..14b931e 100644 --- a/src/soa_builder/web/templates/crf_specializations.html +++ b/src/soa_builder/web/templates/crf_specializations.html @@ -1,36 +1,36 @@ {% extends 'base.html' %} {% block content %}

CRF Specializations ({{ count }})

-

+

Data sourced from CDISC Library {{ spec_path }}.

-
+
← Home
{% if last_error %} -
+
Fetch diagnostics: Status {{ last_status }}{% if last_url %} from {{ last_url }}{% endif %}.
Error: {{ last_error }}
{% if missing_key %}No API key detected — set CDISC_SUBSCRIPTION_KEY or CDISC_API_KEY.{% endif %}
{% elif missing_key %} -
+
Notice: No API key provided; response may be empty or unauthorized. Set CDISC_SUBSCRIPTION_KEY or CDISC_API_KEY.
{% endif %}
-
+
+ class="fz-version-input am-w-300" oninput="filterSpecs()" />
- -
+ +
@@ -55,7 +55,7 @@

CRF Specializations ({{ count }}<

{{ col }}
{% else %}

No CRF specializations available.

-
    +
    • Verify API key env (CDISC_SUBSCRIPTION_KEY or CDISC_API_KEY).
    • If testing offline, export CDISC_CRF_SPECIALIZATIONS_JSON with sample JSON.
    • Confirm network access to the CDISC Library domain.
      • diff --git a/src/soa_builder/web/templates/dair.html b/src/soa_builder/web/templates/dair.html index 3dbe0cf..eeb763f 100644 --- a/src/soa_builder/web/templates/dair.html +++ b/src/soa_builder/web/templates/dair.html @@ -4,36 +4,36 @@

      Generate Digital Amendment Impact Report (DAIR) {% if study_label %}— {{ study_label }}{% elif study_name %}— {{ study_name }}{% endif %}

      -
      +
      ← Return to Edit Page
      {% if study_id_value %} -

      Study ID: {{ study_id_value }}

      +

      Study ID: {{ study_id_value }}

      {% endif %}
      -

      +

      A DAIR compares two snapshots of your study and surfaces every structural change to the protocol model — study design, endpoints, Schedule of Activities, and Biomedical Concept linkages — along with inferred downstream impact signals for eCRF, SDTM, ADaM, and TLFs. Select a base version and a revised version below.

      -
      +
      Note: This is a machine-generated change intelligence artifact. It is not a regulatory submission document. Study team review is required before acting on inferred impacts.
      {% if freezes | length < 2 %} -
      +
      No comparison available.
      You need at least two snapshots to generate a DAIR. Create snapshots via Snapshots and Amendments.
      {% else %} -
      +

      Select Versions to Compare

      @@ -66,7 +66,7 @@

      Select Versions to Compare

      -
      +
      @@ -74,9 +74,9 @@

      Select Versions to Compare

      -
      -

      Available Snapshots

      - +
      +

      Available Snapshots

      +
      diff --git a/src/soa_builder/web/templates/ddf_controlled_terminology.html b/src/soa_builder/web/templates/ddf_controlled_terminology.html index 8db2d8b..20da344 100644 --- a/src/soa_builder/web/templates/ddf_controlled_terminology.html +++ b/src/soa_builder/web/templates/ddf_controlled_terminology.html @@ -2,12 +2,12 @@ {% block content %}

      DDF Controlled Terminology{% if slug %} — {{ slug }}{% else %} — (unavailable){% endif %}

      -
      +
      ← Home
      {% if error %} -
      +
      Error: {{ error }}
      {% endif %} @@ -35,12 +35,12 @@

      Filter

      - +
      -
      +
      @@ -48,7 +48,7 @@

      Filter

      -

      +

      Total: {{ total_count }} | Matched: {{ matched_count }} | Showing limit {{ limit }} offset {{ offset }}

      @@ -68,7 +68,7 @@

      Filter

      {% if matched_count > limit %} {% set next_offset = offset + limit %} {% if next_offset < matched_count %} -
      +
      diff --git a/src/soa_builder/web/templates/define_json.html b/src/soa_builder/web/templates/define_json.html index 6629b43..18fb0f2 100644 --- a/src/soa_builder/web/templates/define_json.html +++ b/src/soa_builder/web/templates/define_json.html @@ -1,6 +1,6 @@ {% extends 'base.html' %} {% block content %} -
      +
      ← Return to Edit Page
      @@ -9,20 +9,20 @@

      Generate Data Definition Specification for Study: {% if study_id_value %} -

      Study ID: {{ study_id_value }}

      +

      Study ID: {{ study_id_value }}

      {% endif %}
      EXPERIMENTAL -

      +

      The Data Definition Specification (DDS) JSON is a metadata contract that describes which datasets and variables this study produces. It complements USDM and is suitable for inclusion in a regulatory submission package alongside Dataset-JSON.

      -
      +

      Download Parameters

      @@ -42,7 +42,7 @@

      Download Parameters

      -
      +
      diff --git a/src/soa_builder/web/templates/define_xml_terminology.html b/src/soa_builder/web/templates/define_xml_terminology.html index f6d70a1..665f098 100644 --- a/src/soa_builder/web/templates/define_xml_terminology.html +++ b/src/soa_builder/web/templates/define_xml_terminology.html @@ -2,12 +2,12 @@ {% block content %}

      Define-XML Controlled Terminology{% if slug %} — {{ slug }}{% else %} — (unavailable){% endif %}

      -
      +
      ← Home
      {% if error %} -
      +
      Error: {{ error }}
      {% endif %} @@ -35,12 +35,12 @@

      Filter

      - +
      -
      +
      @@ -48,7 +48,7 @@

      Filter

      -

      +

      Total: {{ total_count }} | Matched: {{ matched_count }} | Showing limit {{ limit }} offset {{ offset }}

      @@ -68,7 +68,7 @@

      Filter

      {% if matched_count > limit %} {% set next_offset = offset + limit %} {% if next_offset < matched_count %} -
      +
      diff --git a/src/soa_builder/web/templates/dss_cell.html b/src/soa_builder/web/templates/dss_cell.html index 074f1b1..c159b1b 100644 --- a/src/soa_builder/web/templates/dss_cell.html +++ b/src/soa_builder/web/templates/dss_cell.html @@ -1,5 +1,5 @@ {# Partial for DSS assignment cell — lazy-loaded options per concept #} -

      diff --git a/src/soa_builder/web/templates/edit.html b/src/soa_builder/web/templates/edit.html index 02ba7a4..b8362c6 100644 --- a/src/soa_builder/web/templates/edit.html +++ b/src/soa_builder/web/templates/edit.html @@ -20,17 +20,17 @@

      Study Metadata

      -
      +
      - Study ID must be unique and cannot be cleared once set. + Study ID must be unique and cannot be cleared once set.
      -
      +
      {% include "study_identifiers_partial.html" %} -
      +
      @@ -38,11 +38,11 @@

      Study Metadata

      -
      +
      -
      +
      Last fetch: {% if concepts_last_fetch_relative %} {{ concepts_last_fetch_relative }} @@ -50,7 +50,7 @@

      Study Metadata

      n/a {% endif %}
      - (forces remote re-fetch & cache reset) + (forces remote re-fetch & cache reset)
      @@ -69,11 +69,11 @@

      Study Metadata

    • {{ a.order_index }}. {{ a.name }} -
      + - - - + + +
      @@ -84,7 +84,7 @@

      Study Metadata

      • {% endfor %} - +
      @@ -98,24 +98,6 @@

      Study Metadata

      - {% if timelines and timelines|length > 0 %}
      Select Timeline: @@ -132,25 +114,24 @@

      Study Metadata

      {% endif %} {% macro epoch_th(soa_id, epoch_id, value, colspan, superscript) %} -
      + {% endmacro %} {% for timeline_uid, timeline_instances in instances_by_timeline.items() %} -
      +

      Matrix: {% if timeline_instances and timeline_instances[0].timeline_name %}{{ timeline_instances[0].timeline_name }}{% else %}{{ timeline_uid }}{% endif %}

      {% if timeline_instances|length == 0 %} -

      No scheduled activity instances for this timeline.

      +

      No scheduled activity instances for this timeline.

      {% else %}
      ID + {% set dss_concepts = activity_concepts.get(activity_id, []) %} {% if dss_concepts %} {% set ns = namespace(total=0) %} @@ -17,51 +17,47 @@ - {{ value }}{% if superscript %}{{ superscript }}{% endif %}{% if epoch_id %}✎{% endif %}{{ value }}{% if superscript %}{{ superscript }}{% endif %}{% if epoch_id %}✎{% endif %}
      - + {% set prev_epoch = namespace(value=None, count=0, id=None, superscript=None) %} {% for inst in timeline_instances %} {% set current_epoch = inst.epoch_label if inst.epoch_label else inst.epoch_name %} @@ -177,9 +158,9 @@

      Matrix: {% if timeline_instances and timeline_instances[0].timeline_name %}{

      - + {% for inst in timeline_instances %} - {% endfor %} @@ -187,19 +168,19 @@

      Matrix: {% if timeline_instances and timeline_instances[0].timeline_name %}{

      - + {% for inst in timeline_instances %} - {% endfor %} - + {% for inst in timeline_instances %} - {% endfor %} @@ -207,9 +188,9 @@

      Matrix: {% if timeline_instances and timeline_instances[0].timeline_name %}{

      - + {% for inst in timeline_instances %} - {% endfor %} @@ -217,19 +198,19 @@

      Matrix: {% if timeline_instances and timeline_instances[0].timeline_name %}{

      - + {% for inst in timeline_instances %} - {% endfor %} - + {% for inst in timeline_instances %} - + {% endfor %} {% for a in activities_by_timeline.get(timeline_uid, []) %} @@ -265,9 +246,9 @@

      Matrix: {% if timeline_instances and timeline_instances[0].timeline_name %}{ {% endfor %} {% if footnotes %} -
      +
      {% for fn in footnotes %} -
      +
      {{ fn.name }}: {{ fn.text | safe }}
      @@ -275,12 +256,12 @@

      Matrix: {% if timeline_instances and timeline_instances[0].timeline_name %}{

      {% endif %} -
      +
      Manage Footnotes ({{ footnotes|length }}) {% for fn in footnotes %} -
      +
      + class="fz-form-2row am-flex-1">
      {{ fn.footnote_uid }} @@ -299,17 +280,17 @@

      Matrix: {% if timeline_instances and timeline_instances[0].timeline_name %}{

      - +
      - +
      + onsubmit="return confirm('Delete this footnote?');" class="fz-inline-form am-pt-22">
      {% endfor %} -
      +
      @@ -325,14 +306,14 @@

      Matrix: {% if timeline_instances and timeline_instances[0].timeline_name %}{

      - +
      - +
      -
      +
      Element Audit (latest {{ element_audits|length }}) {% if element_audits %} -

      Epoch:->Epoch:->
      Encounter:->Encounter:-> + {% if inst.encounter_label %}{{ inst.encounter_label }}{% else %}{{ inst.encounter_name }}{% endif %}{% if inst.encounter_superscript %}{{ inst.encounter_superscript }}{% endif %}{% if inst.encounter_id %}✎{% endif %}
      Instance:->Instance:-> -
      {% if inst.label %}{{ inst.label }}{% else %}{{ inst.name }}{% endif %}
      +       		+
      {% if inst.label %}{{ inst.label }}{% else %}{{ inst.name }}{% endif %}
      Study Day:->Study Day:-> + {% if inst.study_day %}{{ inst.study_day }}{% endif %}
      Timing:->Timing:-> + {% if inst.timing_label %}{{ inst.timing_label }}{% else %}{{ inst.timing_name }}{% endif %}
      Visit Window:->Visit Window:-> + {% if inst.window_label %}{{ inst.window_label }}{% endif %}
      ActivityConceptsConcepts
      - - - - - - - +
      IDElementActionPerformedBeforeAfter
      + + + + + + + {% for au in element_audits %} - - - - - - + + + + + + {% endfor %}
      IDElementActionPerformedBeforeAfter
      {{ au.id }}{{ au.element_id }}{{ au.action }}{{ au.performed_at }}{{ au.before_json or '' }}{{ au.after_json or '' }}{{ au.id }}{{ au.element_id }}{{ au.action }}{{ au.performed_at }}{{ au.before_json or '' }}{{ au.after_json or '' }}
      {% else %} -
      No element audit entries yet.
      +
      No element audit entries yet.
      {% endif %} diff --git a/src/soa_builder/web/templates/elements.html b/src/soa_builder/web/templates/elements.html index b21419f..8a6bfc0 100644 --- a/src/soa_builder/web/templates/elements.html +++ b/src/soa_builder/web/templates/elements.html @@ -2,7 +2,7 @@ {% block content %}

      Elements for Study: {% if study_label %}{{ study_label }}{% else %}{{ study_name }}{% endif %}

      -
      +
      ← Return to Edit Page
      @@ -44,7 +44,7 @@

      Create Element

      {% if interventions %}
      - {% for iv in interventions %} {% endfor %} @@ -93,7 +93,7 @@

      Elements ({{ elements|length }})

 - {% for iv in (interventions or []) %} {{ est.estimand_uid }} {{ est.name }} - {% if est.label %}
{{ est.label }}
{% endif %} + {% if est.label %}
{{ est.label }}
{% endif %} 		{{ est.population_summary or '—' }} {% if est.variable_names %} {{ est.variable_names | join(', ') }} {% else %} - — + — {% endif %} {% if est.intervention_names %} {{ est.intervention_names | join(', ') }} {% else %} - — + — {% endif %}
+ class="am-inline-form">
-
- Variables of Interest +
+
+ Variables of Interest {% for uid in est.variable_uids %} - + {{ est.variable_names[loop.index0] }}
+ class="am-inline-form"> + class="am-chip-remove-btn">×
{% endfor %} @@ -79,8 +77,8 @@ {% if unlinked_eps %}
- {% for ep in unlinked_eps %} @@ -95,19 +93,17 @@ {# ── Linked Interventions subsection ── #}
-
- Linked Interventions +
+
+ Linked Interventions {% for uid in est.intervention_uids %} - + {{ est.intervention_names[loop.index0] }} + class="am-inline-form"> + class="am-chip-remove-btn">× {% endfor %} @@ -121,8 +117,8 @@ {% if unlinked_ints %}
- {% for av in unlinked_ints %} @@ -137,14 +133,14 @@ {# ── Intercurrent Events subsection ── #}
- + + Intercurrent Events ({{ est.intercurrent_events | length }}) + class="am-grid-2 am-mt-6">
-
+
{% if est.intercurrent_events %} - +
{% for ice in est.intercurrent_events %} - + - - + + diff --git a/src/soa_builder/web/templates/freeze_modal.html b/src/soa_builder/web/templates/freeze_modal.html index 3a01f6e..0718ce3 100644 --- a/src/soa_builder/web/templates/freeze_modal.html +++ b/src/soa_builder/web/templates/freeze_modal.html @@ -27,45 +27,45 @@ {% endif %} {% if axis_type == 'instance' %}Inst {{ axis_value or '?' }}{% else %}Visit {{ axis_value or '?' }}{% endif %} {%- endmacro %} -
-
-
+
+
+
{% if mode == 'view' %} -

Freeze {{ freeze.version_label }} ({{ freeze.created_at }})

+

Freeze {{ freeze.version_label }} ({{ freeze.created_at }})

{% elif mode == 'diff' %} -

Diff {{ diff.left.label }} → {{ diff.right.label }}

+

Diff {{ diff.left.label }} → {{ diff.right.label }}

{% endif %} - +
{% if mode == 'view' %} {% set snap = freeze.snapshot %} -
+
Scheduled Activity Instance: {{ snap.visits|length }}
Activities: {{ snap.activities|length }}
Cells: {{ snap.cells|length }}
Concept Mappings: {{ snap.activity_concepts|length }}
Frozen At: {{ snap.frozen_at }}
-
- -
- +
+ + +
- Visits -
    + Visits +
      {% for v in snap.visits %}
    • {{ v.order_index }}. {{ v.name }}
      • {% endfor %}
- Activities & Concepts -
    + Activities & Concepts +
      {% for a in snap.activities %}
    • {{ a.order_index }}. {{ a.name }} {% set cmap = snap.activity_concepts.get(a.id, []) %} {% if cmap %} -
        +
          {% for c in cmap %}
        • {{ c.title }} ({{ c.code }})
          • {% endfor %}
        {% endif %} @@ -74,100 +74,100 @@

        Diff {{ diff.left.label }} → {{ diff.right.label }}

- Cells (non-empty) -
    + Cells (non-empty) +
      {% for c in snap.cells if c.status %}
    • {{ cell_axis_label(c) }} / Activity {{ c.activity_id }} = {{ c.status }}
      • {% endfor %}
{% elif mode == 'diff' %} -
+
Visits + {{ diff.visits.added|length }}/{{ diff.meta.visits.added_total }} • - {{ diff.visits.removed|length }}/{{ diff.meta.visits.removed_total }}
Activities + {{ diff.activities.added|length }}/{{ diff.meta.activities.added_total }} • - {{ diff.activities.removed|length }}/{{ diff.meta.activities.removed_total }}
Cells + {{ diff.cells.added|length }}/{{ diff.meta.cells.added_total }} • - {{ diff.cells.removed|length }}/{{ diff.meta.cells.removed_total }} • Δ {{ diff.cells.changed|length }}/{{ diff.meta.cells.changed_total }}
Concept Changes {{ diff.concepts|length }}/{{ diff.meta.concepts.changes_total }}
-
- Download XLSX (with ConceptDiff) +
+ Download XLSX (with ConceptDiff)
{% if diff.meta.limit and (diff.meta.visits.added_truncated or diff.meta.visits.removed_truncated or diff.meta.activities.added_truncated or diff.meta.activities.removed_truncated or diff.meta.cells.added_truncated or diff.meta.cells.removed_truncated or diff.meta.cells.changed_truncated or diff.meta.concepts.changes_truncated) %} -
Showing first {{ diff.meta.limit }} items per list.
+
Showing first {{ diff.meta.limit }} items per list.
{% endif %}
- Visits Added/Removed -
+ Visits Added/Removed +
Added -
    +
      {% for v in diff.visits.added %}
    • {{ v.order_index }}. {{ v.name }}
      • {% endfor %} - {% if diff.visits.added|length == 0 %}
    • None
      • {% endif %} + {% if diff.visits.added|length == 0 %}
    • None
      • {% endif %}
Removed -
    +
      {% for v in diff.visits.removed %}
    • {{ v.order_index }}. {{ v.name }}
      • {% endfor %} - {% if diff.visits.removed|length == 0 %}
    • None
      • {% endif %} + {% if diff.visits.removed|length == 0 %}
    • None
      • {% endif %}
- Activities Added/Removed -
+ Activities Added/Removed +
Added -
    +
      {% for a in diff.activities.added %}
    • {{ a.order_index }}. {{ a.name }}
      • {% endfor %} - {% if diff.activities.added|length == 0 %}
    • None
      • {% endif %} + {% if diff.activities.added|length == 0 %}
    • None
      • {% endif %}
Removed -
    +
      {% for a in diff.activities.removed %}
    • {{ a.order_index }}. {{ a.name }}
      • {% endfor %} - {% if diff.activities.removed|length == 0 %}
    • None
      • {% endif %} + {% if diff.activities.removed|length == 0 %}
    • None
      • {% endif %}
- Cells Added/Removed/Changed -
+ Cells Added/Removed/Changed +
Added -
    +
      {% for c in diff.cells.added %}
    • {{ cell_axis_label(c) }} / A{{ c.activity_id }} = {{ c.status }}
      • {% endfor %} - {% if diff.cells.added|length == 0 %}
    • None
      • {% endif %} + {% if diff.cells.added|length == 0 %}
    • None
      • {% endif %}
Removed -
    +
      {% for c in diff.cells.removed %}
    • {{ cell_axis_label(c) }} / A{{ c.activity_id }} = {{ c.status }}
      • {% endfor %} - {% if diff.cells.removed|length == 0 %}
    • None
      • {% endif %} + {% if diff.cells.removed|length == 0 %}
    • None
      • {% endif %}
Changed -
    +
      {% for c in diff.cells.changed %}
    • {{ cell_axis_label(c) }} / A{{ c.activity_id }}: {{ c.old_status }} → {{ c.new_status }}
      • {% endfor %} - {% if diff.cells.changed|length == 0 %}
    • None
      • {% endif %} + {% if diff.cells.changed|length == 0 %}
    • None
      • {% endif %}
- Concept Changes -
    + Concept Changes +
      {% for ch in diff.concepts %}
    • Activity {{ ch.activity_id }} -
        -
      • Added: {% if ch.added %}{{ ch.added|join(', ') }}{% else %}None{% endif %}
        • -
      • Removed: {% if ch.removed %}{{ ch.removed|join(', ') }}{% else %}None{% endif %}
        • +
          +
        • Added: {% if ch.added %}{{ ch.added|join(', ') }}{% else %}None{% endif %}
          • +
        • Removed: {% if ch.removed %}{{ ch.removed|join(', ') }}{% else %}None{% endif %}
        • Title Changes: {% if ch.title_changes %} -
            +
              {% for tc in ch.title_changes %}
            • {{ tc.code }}: "{{ tc.old_title }}" → "{{ tc.new_title }}"
              • {% endfor %}
            - {% else %}None{% endif %} + {% else %}None{% endif %}
          • {% endfor %} - {% if diff.concepts|length == 0 %}
        • None
          • {% endif %} + {% if diff.concepts|length == 0 %}
        • None
          • {% endif %}
{% if diff.entities %} @@ -190,23 +190,23 @@

Diff {{ diff.left.label }} → {{ diff.right.label }}

'extension_attributes': 'Extension Attributes (ExtensionAttribute)' } %}
- USDM Entities + USDM Entities {% for ent_key, ent_data in diff.entities.items() %} {% set has_changes = ent_data.added|length > 0 or ent_data.removed|length > 0 or ent_data.changed|length > 0 %} {% if has_changes %} -
- +
+ {{ _entity_labels.get(ent_key, ent_key) }} - + {% if ent_data.added|length > 0 %}+{{ ent_data.added|length }}{% endif %} {% if ent_data.removed|length > 0 %}-{{ ent_data.removed|length }}{% endif %} {% if ent_data.changed|length > 0 %}Δ{{ ent_data.changed|length }}{% endif %} -
+
{% if ent_data.added %} -
Added -
    +
    Added +
      {% for e in ent_data.added %}
    • {{ e.get('name') or e.get('amendment_uid') or e.get('study_cell_uid') or e.get('schedule_timeline_uid') or e.get('instance_uid') or e.get('surrogate_uid') or e.get('biomedical_concept_uid') or e.get('biomedical_concept_property_uid') or e.get('extension_attribute_uid') or e.get('epoch_uid') or e.get('arm_uid') or e.get('timing_uid') or e.get('objective_uid') or e.get('endpoint_uid') or e.get('encounter_uid') or '?' }}
      • {% endfor %} @@ -214,8 +214,8 @@

      Diff {{ diff.left.label }} → {{ diff.right.label }}

    {% endif %} {% if ent_data.removed %} -
    Removed -
      +
      Removed +
        {% for e in ent_data.removed %}
      • {{ e.get('name') or e.get('amendment_uid') or e.get('study_cell_uid') or e.get('schedule_timeline_uid') or e.get('instance_uid') or e.get('surrogate_uid') or e.get('biomedical_concept_uid') or e.get('biomedical_concept_property_uid') or e.get('extension_attribute_uid') or e.get('epoch_uid') or e.get('arm_uid') or e.get('timing_uid') or e.get('objective_uid') or e.get('endpoint_uid') or e.get('encounter_uid') or '?' }}
        • {% endfor %} @@ -223,11 +223,11 @@

        Diff {{ diff.left.label }} → {{ diff.right.label }}

      {% endif %} {% if ent_data.changed %} -
      Changed -
        +
        Changed +
          {% for e in ent_data.changed %}
        • {{ e.uid }} -
            +
              {% for field, vals in e.changes.items() %}
            • {{ field }}: "{{ vals.old }}" → "{{ vals.new }}"
              • {% endfor %} @@ -248,31 +248,31 @@

              Diff {{ diff.left.label }} → {{ diff.right.label }}

              {% endif %} {% endfor %} {% if not _any_entity_changes.found %} -

              No USDM entity changes detected.

              +

              No USDM entity changes detected.

              {% endif %}
{% endif %} -
-
- +
+ + -
- + +
{% elif mode == 'rollback_preview' %} -
Rollback Preview for {{ freeze.version_label }}
-
    +
    Rollback Preview for {{ freeze.version_label }}
    +
    • Visits to restore: {{ preview.visits_to_restore }}
    • Activities to restore: {{ preview.activities_to_restore }}
    • Cells to restore: {{ preview.cells_to_restore }}
    • Concept mappings to restore: {{ preview.concept_mappings_to_restore }}
    -
    -
    - +
    + + - +
    {% endif %}
    diff --git a/src/soa_builder/web/templates/freezes.html b/src/soa_builder/web/templates/freezes.html index 6e994a4..03d2374 100644 --- a/src/soa_builder/web/templates/freezes.html +++ b/src/soa_builder/web/templates/freezes.html @@ -2,7 +2,7 @@ {% block content %}

    Snapshots & Amendments

    -
    +
    ← Return to Edit Page
    diff --git a/src/soa_builder/web/templates/index.html b/src/soa_builder/web/templates/index.html index 6089893..f2697ac 100644 --- a/src/soa_builder/web/templates/index.html +++ b/src/soa_builder/web/templates/index.html @@ -36,7 +36,7 @@

    Create New Study

    -
    +

    Import Study from Bundle

    @@ -74,7 +74,7 @@

    Existing Studies ({{ soas|length }})

- @@ -95,30 +95,27 @@

Existing Studies ({{ soas|length }})

 - - @@ -85,7 +85,7 @@ {% endfor %}
UIDNameTextStrategy
{{ ice.event_uid }}{{ ice.event_uid }} {{ ice.name }} {% if ice.label %} -
{{ ice.label }}
+
{{ ice.label }}
{% endif %} 		{{ ice.text or '—' }}{{ ice.strategy or '—' }}{{ ice.text or '—' }}{{ ice.strategy or '—' }}
+ class="am-inline-form">
{{ s.name }} {{ s.study_id or '' }} {{ s.study_label or '' }}{{ s.study_description or '' }} {{ s.created_at }} Edit + {% if ind.is_rare_disease %} - ✓ + ✓ {% else %} - — + — {% endif %} {% if ind.codes %} {{ ind.codes | length }} code{{ 's' if ind.codes|length != 1 else '' }} {% else %} - — + — {% endif %} + class="am-inline-form"> @@ -60,15 +60,14 @@ {# ── Codes subsection ── #}
- + + Codes ({{ ind.codes | length }}) + class="am-grid-2 am-mt-6">
-
+
@@ -97,7 +96,7 @@ {% if ind.codes %} - +
@@ -109,17 +108,17 @@ {% for c in ind.codes %} - - - - + + + + - @@ -76,7 +76,7 @@ {% endfor %}
UID Code
- {{ c.code_uid }} + {{ c.code_uid }} {{ c.code or '—' }}{{ c.code_system or '—' }}{{ c.code_system_version or '—' }}{{ c.decode or '—' }}{{ c.code or '—' }}{{ c.code_system or '—' }}{{ c.code_system_version or '—' }}{{ c.decode or '—' }}
+ class="am-inline-form">
diff --git a/src/soa_builder/web/templates/objectives.html b/src/soa_builder/web/templates/objectives.html index 45749f3..4d315a6 100644 --- a/src/soa_builder/web/templates/objectives.html +++ b/src/soa_builder/web/templates/objectives.html @@ -2,7 +2,7 @@ {% block content %}

Objectives & Endpoints for Study: {% if study_label %}{{ study_label }}{% else %}{{ study_name }}{% endif %}

-
+
← Return to Edit Page
@@ -135,7 +135,7 @@

Create Endpoint

{% endif %}
-

Endpoints ({{ endpoints_by_objective.values()|map('length')|sum }})

+

Endpoints ({{ endpoints_by_objective.values()|map('length')|sum }})

diff --git a/src/soa_builder/web/templates/organizations_partial.html b/src/soa_builder/web/templates/organizations_partial.html index 0ec2a76..5eb902f 100644 --- a/src/soa_builder/web/templates/organizations_partial.html +++ b/src/soa_builder/web/templates/organizations_partial.html @@ -18,11 +18,11 @@ - @@ -91,7 +91,7 @@ {% endfor %}
{{ o.organization_uid }} + class="am-input-compact am-w-120" /> + class="am-input-compact am-w-80" /> + placeholder="Scheme" class="am-input-compact am-w-55" /> + placeholder="ID" class="am-input-compact am-w-80" /> + placeholder="City" class="am-input-compact am-w-80" /> + placeholder="State" class="am-input-compact am-w-55" /> + placeholder="ZIP" class="am-input-compact am-w-55" /> +
-
+
-
- +
+ Legal Address
@@ -182,7 +181,7 @@ id="org-country-name-{{ soa_id }}" value="" />
-
+
diff --git a/src/soa_builder/web/templates/orgs_roles_persons.html b/src/soa_builder/web/templates/orgs_roles_persons.html index 73948c8..b3281bb 100644 --- a/src/soa_builder/web/templates/orgs_roles_persons.html +++ b/src/soa_builder/web/templates/orgs_roles_persons.html @@ -3,10 +3,10 @@

Organizations, Roles & Persons

{% if study_label %} -

{{ study_label }}

+

{{ study_label }}

{% endif %} -
+
← Return to Edit Page
@@ -17,12 +17,12 @@

Organizations

{% include "organizations_partial.html" %}
-
+

Roles

{% include "roles_partial.html" %}
-
+

Persons

{% include "persons_partial.html" %}
diff --git a/src/soa_builder/web/templates/persons_partial.html b/src/soa_builder/web/templates/persons_partial.html index e97bbf2..296fae0 100644 --- a/src/soa_builder/web/templates/persons_partial.html +++ b/src/soa_builder/web/templates/persons_partial.html @@ -17,34 +17,34 @@
{{ p.person_name_uid }} + class="am-input-compact am-w-110" /> + placeholder="Job title" class="am-input-compact am-w-120" /> + class="am-input-compact am-w-120" /> + placeholder="Family name" class="am-input-compact am-w-90" /> + placeholder="Given names" class="am-input-compact am-w-90" /> + placeholder="e.g. Dr" class="am-input-compact am-w-55" /> + placeholder="e.g. MD" class="am-input-compact am-w-55" /> +
-
+
-
+
diff --git a/src/soa_builder/web/templates/protocol_controlled_terminology.html b/src/soa_builder/web/templates/protocol_controlled_terminology.html index c82013c..e3f1b5e 100644 --- a/src/soa_builder/web/templates/protocol_controlled_terminology.html +++ b/src/soa_builder/web/templates/protocol_controlled_terminology.html @@ -2,12 +2,12 @@ {% block content %}

Protocol Controlled Terminology{% if slug %} — {{ slug }}{% else %} — (unavailable){% endif %}

-
+
← Home
{% if error %} -
+
Error: {{ error }}
{% endif %} @@ -35,12 +35,12 @@

Filter

- +
-
+
@@ -48,7 +48,7 @@

Filter

-

+

Total: {{ total_count }} | Matched: {{ matched_count }} | Showing limit {{ limit }} offset {{ offset }}

@@ -68,7 +68,7 @@

Filter

{% if matched_count > limit %} {% set next_offset = offset + limit %} {% if next_offset < matched_count %} -
+
diff --git a/src/soa_builder/web/templates/reorder_audit_modal.html b/src/soa_builder/web/templates/reorder_audit_modal.html index 7207852..d98e788 100644 --- a/src/soa_builder/web/templates/reorder_audit_modal.html +++ b/src/soa_builder/web/templates/reorder_audit_modal.html @@ -1,20 +1,20 @@ -
-
-
-

Reorder Audit Log

- +
+
+
+

Reorder Audit Log

+
-
Tracks manual drag & drop ordering changes for visits and activities. Old/New columns show ID sequences (left to right order_index ascending).
+
Tracks manual drag & drop ordering changes for visits and activities. Old/New columns show ID sequences (left to right order_index ascending).
{% if audit %} - +
- - - - - - - + + + + + + + @@ -22,12 +22,12 @@

Reorder Audit Log

{% set old_map = {} %} {% for oid in r.old_order %}{% set _ = old_map.update({oid: loop.index}) %}{% endfor %} - - - - - - + + + + + @@ -46,7 +46,7 @@

Reorder Audit Log

IDEntityPerformed At (UTC)Old OrderNew OrderChanges
IDEntityPerformed At (UTC)Old OrderNew OrderChanges
{{ r.id }}{{ r.entity_type }}{{ r.performed_at }}{{ r.old_order|join(',') }}{{ r.new_order|join(',') }} + {{ r.id }}{{ r.entity_type }}{{ r.performed_at }}{{ r.old_order|join(',') }}{{ r.new_order|join(',') }} {% set moved = [] %} {% for nid in r.new_order %} {% set old_pos = old_map.get(nid) %} @@ -38,7 +38,7 @@

Reorder Audit Log

{% if moved %} {{ moved|join('; ') }} {% else %} - reindexed only + reindexed only {% endif %}
{% else %} -
No reorder operations recorded yet.
+
No reorder operations recorded yet.
{% endif %}
diff --git a/src/soa_builder/web/templates/roles_partial.html b/src/soa_builder/web/templates/roles_partial.html index e416034..41da1a9 100644 --- a/src/soa_builder/web/templates/roles_partial.html +++ b/src/soa_builder/web/templates/roles_partial.html @@ -16,15 +16,15 @@
{{ r.role_uid }} + class="am-input-compact am-w-110" /> + class="am-input-compact am-w-80" /> + placeholder="Description" class="am-input-compact am-w-140" /> +
-
+
{% endfor %} - Hold Ctrl / Cmd to select multiple + Hold Ctrl / Cmd to select multiple
@@ -140,19 +140,19 @@ {% endfor %} - Hold Ctrl / Cmd to select multiple + Hold Ctrl / Cmd to select multiple
-
-
+
diff --git a/src/soa_builder/web/templates/rollback_audit_modal.html b/src/soa_builder/web/templates/rollback_audit_modal.html index e638ef8..b225f82 100644 --- a/src/soa_builder/web/templates/rollback_audit_modal.html +++ b/src/soa_builder/web/templates/rollback_audit_modal.html @@ -1,38 +1,38 @@ -
-
-
-

Rollback Audit Log

- +
+
+
+

Rollback Audit Log

+
{% if audit %} - +
- - - - - - - - + + + + + + + + {% for r in audit %} - - - - - - - + + + + + + + {% endfor %}
IDFreeze IDPerformed AtVisitsActivitiesCellsConcepts
IDFreeze IDPerformed AtVisitsActivitiesCellsConcepts
{{ r.id }}{{ r.freeze_id }}{{ r.performed_at }}{{ r.visits_restored }}{{ r.activities_restored }}{{ r.cells_restored }}{{ r.concepts_restored }}{{ r.id }}{{ r.freeze_id }}{{ r.performed_at }}{{ r.visits_restored }}{{ r.activities_restored }}{{ r.cells_restored }}{{ r.concepts_restored }}
{% else %} -
No rollback operations recorded yet.
+
No rollback operations recorded yet.
{% endif %}
diff --git a/src/soa_builder/web/templates/rules.html b/src/soa_builder/web/templates/rules.html index da90e77..781e67c 100644 --- a/src/soa_builder/web/templates/rules.html +++ b/src/soa_builder/web/templates/rules.html @@ -2,7 +2,7 @@ {% block content %}

Transition Rules for Study: {% if study_label %}{{ study_label }}{% else %}{{ study_name }}{% endif %}

-
+
← Return to Edit Page
diff --git a/src/soa_builder/web/templates/sdtm_specialization_detail.html b/src/soa_builder/web/templates/sdtm_specialization_detail.html index 7cd6644..806b722 100644 --- a/src/soa_builder/web/templates/sdtm_specialization_detail.html +++ b/src/soa_builder/web/templates/sdtm_specialization_detail.html @@ -5,27 +5,27 @@

SDTM Dataset Specialization Detail

Index: {{ index }} of {{ total }}
{% if href %}API HREF: {{ href }}{% else %}No href available{% endif %}

{% if missing_key %} -
+
Notice: No API key detected; set CDISC_SUBSCRIPTION_KEY or CDISC_API_KEY to retrieve live JSON.
{% endif %} {% if error %} -
+
Error: {{ error }}
- {% if raw_text_snippet %}
+ {% if raw_text_snippet %}
Raw response snippet - 
{{ raw_text_snippet }}
+ 
{{ raw_text_snippet }}
{% endif %}
{% elif pretty_json %} {% if summary is defined and summary %} -

Summary

- +

Summary

+
{% for key, val in summary.items() %} - - + + {% endfor %}
{{ key }}{{ val }}{{ key }}{{ val }}
@@ -33,42 +33,42 @@

Summary

{% if variables is defined and variables %}

Variables

- +
- - - - - - - - - - - - - + + + + + + + + + + + + + {% for v in variables %} - - - - - - - + + + + + + - - - - - + + + +
NameData Element ConceptOrdinalRoleData TypeLengthRelationshipMandatory VariableMandatory ValueOrigin TypeOrigin SourceAssigned Value / Codelist
NameData Element ConceptOrdinalRoleData TypeLengthRelationshipMandatory VariableMandatory ValueOrigin TypeOrigin SourceAssigned Value / Codelist
{{ v.name or '' }}{{ v.dataElementConceptId or '' }}{{ v.ordinal or '' }}{{ v.role or '' }}{{ v.dataType or '' }}{{ v.length or '' }} + {{ v.name or '' }}{{ v.dataElementConceptId or '' }}{{ v.ordinal or '' }}{{ v.role or '' }}{{ v.dataType or '' }}{{ v.length or '' }} {%- if v.relationship is defined and v.relationship -%} {{ v.relationship.subject or '' }} {{ v.relationship.linkingPhrase or '' }} {{ v.relationship.predicateTerm or '' }} {{ v.relationship.object or '' }} {%- endif -%} {{ v.mandatoryVariable if v.mandatoryVariable is defined else '' }}{{ v.mandatoryValue if v.mandatoryValue is defined else '' }}{{ v.originType or '' }}{{ v.originSource or '' }} + {{ v.mandatoryVariable if v.mandatoryVariable is defined else '' }}{{ v.mandatoryValue if v.mandatoryValue is defined else '' }}{{ v.originType or '' }}{{ v.originSource or '' }} {%- if v.assignedTerm is defined and v.assignedTerm -%} {{ v.assignedTerm.value or v.assignedTerm.conceptId or '' }} {%- elif v.valueList is defined and v.valueList -%} @@ -83,16 +83,16 @@

Variables

{% endif %} -
+
- Raw JSON - 
{{ pretty_json }}
+ Raw JSON + 
{{ pretty_json }}
{% else %}

No JSON payload available.

{% endif %} -

+

{% if back_url %}Back to Activities | {% endif %} Back to list

diff --git a/src/soa_builder/web/templates/sdtm_specializations.html b/src/soa_builder/web/templates/sdtm_specializations.html index d560fd7..7da86b4 100644 --- a/src/soa_builder/web/templates/sdtm_specializations.html +++ b/src/soa_builder/web/templates/sdtm_specializations.html @@ -1,36 +1,36 @@ {% extends 'base.html' %} {% block content %}

SDTM Dataset Specializations ({{ count }})

-

+

Data sourced from CDISC Library /mdr/specializations/sdtm/datasetspecializations.

-
+
← Home
{% if last_error %} -
+
Fetch diagnostics: Status {{ last_status }}{% if last_url %} from {{ last_url }}{% endif %}.
Error: {{ last_error }}
{% if missing_key %}No API key detected — set CDISC_SUBSCRIPTION_KEY or CDISC_API_KEY.{% endif %}
{% elif missing_key %} -
+
Notice: No API key provided; response may be empty or unauthorized. Set CDISC_SUBSCRIPTION_KEY or CDISC_API_KEY.
{% endif %}
-
+
+ class="fz-version-input am-w-300" oninput="filterSpecs()" />
- -
+ +
@@ -56,7 +56,7 @@

SDTM Dataset Specializations ({{ count }})

{% else %}

No SDTM dataset specializations available.

-
    +
    • Verify API key env (CDISC_SUBSCRIPTION_KEY or CDISC_API_KEY).
    • If testing offline, export CDISC_SDTM_SPECIALIZATIONS_JSON with sample JSON.
    • Confirm network access to the CDISC Library domain.
      • diff --git a/src/soa_builder/web/templates/sdtm_terminology.html b/src/soa_builder/web/templates/sdtm_terminology.html index 2d36675..6ecbe2d 100644 --- a/src/soa_builder/web/templates/sdtm_terminology.html +++ b/src/soa_builder/web/templates/sdtm_terminology.html @@ -2,12 +2,12 @@ {% block content %}

      SDTM Controlled Terminology{% if slug %} — {{ slug }}{% else %} — (unavailable){% endif %}

      -
      +
      ← Home
      {% if error %} -
      +
      Error: {{ error }}
      {% endif %} @@ -35,12 +35,12 @@

      Filter

      - +
      -
      +
      @@ -48,7 +48,7 @@

      Filter

      -

      +

      Total: {{ total_count }} | Matched: {{ matched_count }} | Showing limit {{ limit }} offset {{ offset }}

      @@ -68,7 +68,7 @@

      Filter

      {% if matched_count > limit %} {% set next_offset = offset + limit %} {% if next_offset < matched_count %} -
      +
      diff --git a/src/soa_builder/web/templates/soa_matrix_export.html b/src/soa_builder/web/templates/soa_matrix_export.html index 0d4b12f..16b8c0d 100644 --- a/src/soa_builder/web/templates/soa_matrix_export.html +++ b/src/soa_builder/web/templates/soa_matrix_export.html @@ -9,6 +9,7 @@ /* Export-only overrides */ body { font-size: 0.82em; padding: 18px; } .matrix td.cell { cursor: default; } + .matrix { font-size: 0.78em; } details > summary { cursor: pointer; } .matrix-container { margin-bottom: 32px; } @media print { @@ -18,16 +19,16 @@ -

      +

      SoA Matrix: {{ study.study_label or study.name or ("SoA " ~ soa_id) }}

      {% if study.study_id %} -

      +

      Study ID: {{ study.study_id }}

      {% endif %} -

      +

      Generated {{ generated_at }}

      @@ -36,18 +37,18 @@

      {% set tl_instances = instances_by_tl.get(tl_uid, []) %} {% if tl_instances %}
      -

      +

      {{ tl.name }}{% if tl.main_timeline %} - + (main timeline) {% endif %}

      -
      - +
      +
      - + {% set prev_epoch = namespace(value=None, count=0, superscript=None) %} {% for inst in tl_instances %} {% set cur_epoch = inst.epoch_label if inst.epoch_label else inst.epoch_name %} @@ -55,7 +56,7 @@

      {% set prev_epoch.count = prev_epoch.count + 1 %} {% else %} {% if prev_epoch.value is not none %} -

      {% endif %} {% set prev_epoch.value = cur_epoch %} @@ -63,7 +64,7 @@

      {% set prev_epoch.superscript = inst.epoch_superscript %} {% endif %} {% if loop.last %} -

      {% endif %} {% endfor %} @@ -71,9 +72,9 @@

      - + {% for inst in tl_instances %} - {% endfor %} @@ -81,19 +82,19 @@

      - + {% for inst in tl_instances %} - {% endfor %} - + {% for inst in tl_instances %} - {% endfor %} @@ -101,9 +102,9 @@

      - + {% for inst in tl_instances %} - {% endfor %} @@ -111,9 +112,9 @@

      - + {% for inst in tl_instances %} - {% endfor %} @@ -121,9 +122,9 @@

      - + {% for inst in tl_instances %} - + {% endfor %} @@ -135,26 +136,22 @@

      {% set act_surrogates = surrogates_map.get(act.id, []) %} {% if act_concepts or act_surrogates %}
      - + {{ act_concepts | length + act_surrogates | length }} concept(s) ▸ -
        +
          {% for c in act_concepts %} -
        • {{ c.title }} - ({{ c.code }}) + ({{ c.code }})
          • {% endfor %} {% for s in act_surrogates %} -
        • +
        • [S] {{ s.label or s.name }} - + ({{ s.surrogate_uid }})
          • @@ -162,13 +159,13 @@

      {% else %} - — + — {% endif %} {% for inst in tl_instances %} {% set status = cell_map.get((inst.id, act.id), '') %} {% set sup = superscript_map.get((inst.id, act.id)) %} -

      {% endfor %} @@ -181,12 +178,10 @@

      {% endfor %} {% if footnotes %} -
      +
      Footnotes {% for fn in footnotes %} -
      +
      {{ fn.name }}: {{ fn.text | safe }}
      {% endfor %} diff --git a/src/soa_builder/web/templates/study_cells.html b/src/soa_builder/web/templates/study_cells.html index 0a9884f..93d2a70 100644 --- a/src/soa_builder/web/templates/study_cells.html +++ b/src/soa_builder/web/templates/study_cells.html @@ -2,7 +2,7 @@ {% block content %}

      Study Cells for Study: {% if study_label %}{{ study_label }}{% else %}{{ study_name }}{% endif %}

      -
      +
      ← Return to Edit Page
      diff --git a/src/soa_builder/web/templates/study_identifiers_partial.html b/src/soa_builder/web/templates/study_identifiers_partial.html index a14aef5..a3521a5 100644 --- a/src/soa_builder/web/templates/study_identifiers_partial.html +++ b/src/soa_builder/web/templates/study_identifiers_partial.html @@ -1,15 +1,13 @@
      {% if study_identifiers %} -
        +
          {% for si in study_identifiers %} -
        • -
          - {{ si.study_identifier_uid }} - {{ si.text }} +
        • +
          + {{ si.study_identifier_uid }} + {{ si.text }} {% if si.org_name %} - + ({{ si.org_name }}) {% endif %} @@ -17,7 +15,7 @@ + class="am-flex-shrink-0">
          diff --git a/src/soa_builder/web/templates/study_interventions_partial.html b/src/soa_builder/web/templates/study_interventions_partial.html index 68ba7d5..71ae773 100644 --- a/src/soa_builder/web/templates/study_interventions_partial.html +++ b/src/soa_builder/web/templates/study_interventions_partial.html @@ -15,10 +15,10 @@

      @@ -34,7 +34,7 @@ + class="am-inline-form"> @@ -44,14 +44,14 @@ {# Codes subsection — renders below each intervention row #} -
      Epoch:->Epoch:->{{ prev_epoch.value }}{% if prev_epoch.superscript %}{{ prev_epoch.superscript }}{% endif %}{{ prev_epoch.value }}{% if prev_epoch.superscript %}{{ prev_epoch.superscript }}{% endif %}
      Encounter:->Encounter:-> + {{ inst.encounter_label or inst.encounter_name or '' }}{% if inst.encounter_superscript %}{{ inst.encounter_superscript }}{% endif %}
      Instance:->Instance:-> -
      {{ inst.label or inst.name }}
      +       		+
      {{ inst.label or inst.name }}
      Study Day:->Study Day:-> + {{ inst.study_day or '' }}
      Timing:->Timing:-> + {{ inst.timing_label or inst.timing_name or '' }}
      Visit Window:->Visit Window:-> + {{ inst.window_label or '' }}
      ActivityConceptsConcepts
      + {{ status or '' }}{% if sup %}{{ sup }}{% endif %} {{ si.name }} {% if si.label %} - ({{ si.label }}) + ({{ si.label }}) {% endif %} {% if si.description %} -
      {{ si.description }} +
      {{ si.description }} {% endif %}       		{{ si.role_decode or '—' }}
      -
      -

      +

      		+
      +

      Codes ({{ si.codes|length }})

      {% if si.codes %} - +
      @@ -71,7 +71,7 @@ + class="am-inline-form"> @@ -83,25 +83,25 @@ -
      - + class="fz-form-row" style="gap:6px;"> +
      +
      -
      - +
      +
      -
      - +
      +
      -
      - +
      +
      -
      +
      diff --git a/src/soa_builder/web/templates/study_timing.html b/src/soa_builder/web/templates/study_timing.html index 0389ed8..6d96165 100644 --- a/src/soa_builder/web/templates/study_timing.html +++ b/src/soa_builder/web/templates/study_timing.html @@ -2,7 +2,7 @@ {% block content %}

      Study Timing for Study: {% if study_label %}{{ study_label }}{% else %}{{ study_name }}{% endif %}

      -
      +
      ← Return to Edit Page
      diff --git a/src/soa_builder/web/templates/study_titles_partial.html b/src/soa_builder/web/templates/study_titles_partial.html index 1aaebde..f64ef98 100644 --- a/src/soa_builder/web/templates/study_titles_partial.html +++ b/src/soa_builder/web/templates/study_titles_partial.html @@ -1,14 +1,12 @@
      {% if study_titles %} -
        +
          {% for t in study_titles %} -
        • -
          - {{ t.text }} +
        • +
          + {{ t.text }} {% if t.type_decode %} - + ({{ t.type_decode }}) {% endif %} @@ -16,7 +14,7 @@
          + class="am-flex-shrink-0">
      UID Code
      +
      - - - + + + {% for key, label, json_file, csv_file in domains %} diff --git a/src/soa_builder/web/templates/tdd_view_partial.html b/src/soa_builder/web/templates/tdd_view_partial.html index 00f1300..9067c5e 100644 --- a/src/soa_builder/web/templates/tdd_view_partial.html +++ b/src/soa_builder/web/templates/tdd_view_partial.html @@ -1,21 +1,20 @@ -
      -
      -

      +
      +
      +

      {{ domain }} — {{ rows|length }} record(s)

      {% if rows %} -
      -

      DomainJSONCSVViewJSONCSVView
      +
      +
      {% for col in fieldnames %} - + {% endfor %} @@ -31,7 +30,7 @@

      {{ col }}{{ col }}
      {% else %} -

      +

      No records generated for this domain.

      {% endif %} diff --git a/src/soa_builder/web/templates/transition_rules_list.html b/src/soa_builder/web/templates/transition_rules_list.html index ebe217d..afb25e1 100644 --- a/src/soa_builder/web/templates/transition_rules_list.html +++ b/src/soa_builder/web/templates/transition_rules_list.html @@ -3,17 +3,17 @@
    • {{ rule.order_index }}. {% if rule.label %}{{ rule.label }}{% else %}{{ rule.name }}{% endif %} - + - - - - - + + + + + -
      + -
      diff --git a/src/soa_builder/web/templates/usdm_json.html b/src/soa_builder/web/templates/usdm_json.html index 9a6a32c..7d97fe6 100644 --- a/src/soa_builder/web/templates/usdm_json.html +++ b/src/soa_builder/web/templates/usdm_json.html @@ -2,20 +2,20 @@ {% block content %}

      Generate USDM JSON for Study: {% if study_label %}{{ study_label }}{% else %}{{ study_name }}{% endif %}

      -
      +
      ← Return to Edit Page
      {% if study_id_value %} -

      Study ID: {{ study_id_value }}

      +

      Study ID: {{ study_id_value }}

      {% endif %}
      - +
      - + {% for key, label, filename in components %} diff --git a/src/soa_builder/web/utils.py b/src/soa_builder/web/utils.py index c3c0d78..966842d 100644 --- a/src/soa_builder/web/utils.py +++ b/src/soa_builder/web/utils.py @@ -176,6 +176,27 @@ def get_cdisc_api_key(): return os.environ.get("CDISC_API_KEY") +def get_cdisc_crf_api_key(): + """Return the API key for the CDISC Library CRF Specializations API. + + Falls back to `CDISC_API_KEY` when `CDISC_CRF_API_KEY` is unset, + since the CRF Specializations API may share credentials with the + main CDISC Library API in some environments. + """ + return os.environ.get("CDISC_CRF_API_KEY") or os.environ.get("CDISC_API_KEY") + + +def get_cdisc_crf_subscription_key(): + """Return the subscription key for the CDISC Library CRF API. + + Falls back to `CDISC_SUBSCRIPTION_KEY` when + `CDISC_CRF_SUBSCRIPTION_KEY` is unset. + """ + return os.environ.get("CDISC_CRF_SUBSCRIPTION_KEY") or os.environ.get( + "CDISC_SUBSCRIPTION_KEY" + ) + + def get_concepts_override(): return os.environ.get("CDISC_CONCEPTS_JSON") @@ -681,8 +702,9 @@ def get_next_response_code_uid(cur: Any, soa_id: int) -> str: def get_next_extension_attribute_uid(cur: Any, soa_id: int) -> str: """Compute next unique ExtensionAttribute_N for the given SOA. - Scans both activity_concept_dss and activity_concept_crf to ensure - the returned UID does not collide with any existing EA UID. + Scans activity_concept_dss, activity_concept_crf, + soa_tool_extension, and activity_grouping_extension to ensure the + returned UID does not collide with any existing EA UID. Assumes `cur` is a sqlite cursor within an open transaction. """ cur.execute( @@ -692,8 +714,25 @@ def get_next_extension_attribute_uid(cur: Any, soa_id: int) -> str: " UNION ALL" " SELECT extension_attribute_uid FROM activity_concept_crf" " WHERE soa_id=?" - " AND extension_attribute_uid LIKE 'ExtensionAttribute_%'", - (soa_id, soa_id), + " AND extension_attribute_uid LIKE 'ExtensionAttribute_%'" + " UNION ALL" + " SELECT ea_outer_uid FROM soa_tool_extension WHERE soa_id=?" + " UNION ALL" + " SELECT ea_name_uid FROM soa_tool_extension WHERE soa_id=?" + " UNION ALL" + " SELECT ea_version_uid FROM soa_tool_extension WHERE soa_id=?" + " UNION ALL" + " SELECT ea_date_uid FROM soa_tool_extension WHERE soa_id=?" + " UNION ALL" + " SELECT ea_outer_uid FROM activity_grouping_extension" + " WHERE soa_id=?" + " UNION ALL" + " SELECT ea_scheme_uid FROM activity_grouping_extension" + " WHERE soa_id=?" + " UNION ALL" + " SELECT ea_value_uid FROM activity_grouping_extension" + " WHERE soa_id=?", + (soa_id,) * 9, ) existing = [x[0] for x in cur.fetchall() if x[0]] n = 1 @@ -708,14 +747,19 @@ def get_next_extension_attribute_uid(cur: Any, soa_id: int) -> str: def get_next_extension_class_uid(cur: Any, soa_id: int) -> str: """Compute next unique ExtensionClass_N for the given SOA. - Scans soa_tool_extension.ec_uid for existing ExtensionClass UIDs. - Assumes `cur` is a sqlite cursor within an open transaction. + Scans soa_tool_extension.ec_uid and + activity_grouping_extension.ec_uid for existing ExtensionClass + UIDs. Assumes `cur` is a sqlite cursor within an open transaction. """ cur.execute( "SELECT ec_uid FROM soa_tool_extension" " WHERE soa_id=?" + " AND ec_uid LIKE 'ExtensionClass_%'" + " UNION ALL" + " SELECT ec_uid FROM activity_grouping_extension" + " WHERE soa_id=?" " AND ec_uid LIKE 'ExtensionClass_%'", - (soa_id,), + (soa_id, soa_id), ) existing = [x[0] for x in cur.fetchall() if x[0]] n = 1 diff --git a/src/usdm/generate_activities.py b/src/usdm/generate_activities.py index 95b98eb..4bd2070 100755 --- a/src/usdm/generate_activities.py +++ b/src/usdm/generate_activities.py @@ -2,6 +2,10 @@ from typing import List, Dict, Any from soa_builder.web.db import _connect from soa_builder.web.utils import _nz +from usdm.generate_activity_grouping_extensions import ( + populate_activity_grouping_extensions, + build_usdm_activity_grouping_extensions_bulk, +) def build_usdm_activities(soa_id: int) -> List[Dict[str, Any]]: @@ -22,9 +26,13 @@ def build_usdm_activities(soa_id: int) -> List[Dict[str, Any]]: - bcSurrogateIds: string[] (left empty here) - timelineId?: string | null (left null here) - notes: CommentAnnotation-Output[] (left empty here) - - extensionAttributes: ExtensionAttribute-Output[] (empty) + - extensionAttributes: ExtensionAttribute-Output[] + (one nested entry per assigned CDISC BC grouping) - instanceType: "Activity" """ + populate_activity_grouping_extensions(soa_id) + grouping_ext_map = build_usdm_activity_grouping_extensions_bulk(soa_id) + conn = _connect() cur = conn.cursor() # Order by order_index if present, else by id for deterministic output @@ -99,7 +107,7 @@ def build_usdm_activities(soa_id: int) -> List[Dict[str, Any]]: activity = { "id": aid, - "extensionAttributes": [], + "extensionAttributes": grouping_ext_map.get(aid, []), "name": name, "label": _nz(label), "description": _nz(description), diff --git a/src/usdm/generate_activity_grouping_extensions.py b/src/usdm/generate_activity_grouping_extensions.py new file mode 100644 index 0000000..f7b24bc --- /dev/null +++ b/src/usdm/generate_activity_grouping_extensions.py @@ -0,0 +1,171 @@ +#!/usr/bin/env python3 +"""USDM generator for Activity.extensionAttributes: BC groupings. + +Sources data from Activities that have been assigned a CDISC +Biomedical Concept Grouping (a classification scheme + value, from +the ``cdisc-biomedical-concept-groupings`` service) via +``activity_concept.concept_group_uid`` / ``activity_surrogate +.concept_group_uid`` joined back to ``concept_group`` where +``source='cdisc'``. + +Each (activity, concept_group) assignment carries a stable set of +UIDs persisted in ``activity_grouping_extension``, backfilled +idempotently by :func:`populate_activity_grouping_extensions`. + +One assigned group produces one outer ``ExtensionAttribute`` whose +``valueExtensionClass`` wraps two flat sibling ``ExtensionAttribute`` +children (classification scheme id, classification value id). +""" + +import logging +from typing import Any, Dict, List + +from soa_builder.web.db import _connect +from soa_builder.web.utils import ( + get_next_extension_attribute_uid, + get_next_extension_class_uid, +) + +logger = logging.getLogger("usdm.generate_activity_grouping_extensions") + +EXTENSION_URL = "http://www.cdisc.org/usdm/extensions/biomedicalConceptGrouping" +EXTENSION_CLASS_URL = "http://www.cdisc.org/usdm/extensions/BiomedicalConceptGrouping" + + +def _assigned_cdisc_groups(cur: Any, soa_id: int) -> List[tuple]: + """Return distinct (activity_uid, concept_group_uid) pairs for + CDISC-sourced groups assigned to activities in this SOA. + """ + cur.execute( + "SELECT DISTINCT ac.activity_uid, ac.concept_group_uid" + " FROM activity_concept ac" + " INNER JOIN concept_group cg" + " ON cg.concept_group_uid = ac.concept_group_uid" + " WHERE ac.soa_id=? AND cg.source='cdisc'" + " AND ac.concept_group_uid IS NOT NULL" + " UNION" + " SELECT DISTINCT asr.activity_uid, asr.concept_group_uid" + " FROM activity_surrogate asr" + " INNER JOIN concept_group cg" + " ON cg.concept_group_uid = asr.concept_group_uid" + " WHERE asr.soa_id=? AND cg.source='cdisc'" + " AND asr.concept_group_uid IS NOT NULL", + (soa_id, soa_id), + ) + return cur.fetchall() + + +def populate_activity_grouping_extensions(soa_id: int) -> None: + """Backfill activity_grouping_extension rows for newly-discovered + (activity_uid, concept_group_uid) assignments. + + Idempotent: existing rows for a given (soa_id, activity_uid, + concept_group_uid) are left untouched. + """ + conn = _connect() + cur = conn.cursor() + try: + pairs = _assigned_cdisc_groups(cur, soa_id) + if not pairs: + return + cur.execute( + "SELECT activity_uid, concept_group_uid" + " FROM activity_grouping_extension WHERE soa_id=?", + (soa_id,), + ) + existing_pairs = set(cur.fetchall()) + new_pairs = [p for p in pairs if p not in existing_pairs] + if not new_pairs: + return + ea_n = int(get_next_extension_attribute_uid(cur, soa_id).split("_")[1]) + ec_n = int(get_next_extension_class_uid(cur, soa_id).split("_")[1]) + for activity_uid, concept_group_uid in new_pairs: + cur.execute( + "INSERT INTO activity_grouping_extension" + " (soa_id, activity_uid, concept_group_uid," + " ea_outer_uid, ec_uid, ea_scheme_uid, ea_value_uid)" + " VALUES (?, ?, ?, ?, ?, ?, ?)", + ( + soa_id, + activity_uid, + concept_group_uid, + f"ExtensionAttribute_{ea_n}", + f"ExtensionClass_{ec_n}", + f"ExtensionAttribute_{ea_n + 1}", + f"ExtensionAttribute_{ea_n + 2}", + ), + ) + ea_n += 3 + ec_n += 1 + conn.commit() + except Exception: + conn.rollback() + logger.exception( + "populate_activity_grouping_extensions failed soa_id=%s", soa_id + ) + raise + finally: + conn.close() + + +def build_usdm_activity_grouping_extensions_bulk( + soa_id: int, +) -> Dict[str, List[Dict[str, Any]]]: + """Return one nested ExtensionAttribute dict per assigned CDISC + group, grouped by activity_uid. + """ + conn = _connect() + cur = conn.cursor() + try: + cur.execute( + "SELECT age.activity_uid, age.ea_outer_uid, age.ec_uid," + " age.ea_scheme_uid, age.ea_value_uid," + " cg.cdisc_scheme_id, cg.cdisc_value_id" + " FROM activity_grouping_extension age" + " INNER JOIN concept_group cg" + " ON cg.concept_group_uid = age.concept_group_uid" + " WHERE age.soa_id=?" + " ORDER BY age.id", + (soa_id,), + ) + rows = cur.fetchall() + finally: + conn.close() + + out: Dict[str, List[Dict[str, Any]]] = {} + for ( + activity_uid, + ea_outer_uid, + ec_uid, + ea_scheme_uid, + ea_value_uid, + scheme_id, + value_id, + ) in rows: + out.setdefault(activity_uid, []).append( + { + "id": ea_outer_uid, + "url": EXTENSION_URL, + "valueExtensionClass": { + "id": ec_uid, + "url": EXTENSION_CLASS_URL, + "extensionAttributes": [ + { + "id": ea_scheme_uid, + "url": "classification-scheme-id", + "valueString": scheme_id or "", + "instanceType": "ExtensionAttribute", + }, + { + "id": ea_value_uid, + "url": "classification-value-id", + "valueString": value_id or "", + "instanceType": "ExtensionAttribute", + }, + ], + "instanceType": "ExtensionClass", + }, + "instanceType": "ExtensionAttribute", + } + ) + return out diff --git a/src/usdm/generate_bc_surrogates.py b/src/usdm/generate_bc_surrogates.py index fb3319c..84524fd 100644 --- a/src/usdm/generate_bc_surrogates.py +++ b/src/usdm/generate_bc_surrogates.py @@ -27,8 +27,13 @@ def build_usdm_bc_surrogates(soa_id: int) -> List[Dict[str, Any]]: conn = _connect() cur = conn.cursor() cur.execute( - "SELECT surrogate_uid, name, label, description, reference " - "FROM biomedical_concept_surrogate WHERE soa_id=? ORDER BY id", + "SELECT DISTINCT bcs.surrogate_uid, bcs.name, bcs.label, " + "bcs.description, bcs.reference " + "FROM biomedical_concept_surrogate bcs " + "INNER JOIN activity_surrogate asr " + "ON bcs.surrogate_uid = asr.surrogate_uid " + "AND bcs.soa_id = asr.soa_id " + "WHERE bcs.soa_id=? ORDER BY bcs.id", (soa_id,), ) rows = cur.fetchall() diff --git a/src/usdm/generate_encounters.py b/src/usdm/generate_encounters.py index 2c8852d..0c86b89 100644 --- a/src/usdm/generate_encounters.py +++ b/src/usdm/generate_encounters.py @@ -227,7 +227,7 @@ def build_usdm_encounters(soa_id: int) -> List[Dict[str, Any]]: "id": environmentalSettings, "extensionAttributes": [], "code": e_code[0], - "codeSystem": e_codesystem[0], + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": code_system_version, "decode": decode, "instanceType": "Code", @@ -251,7 +251,7 @@ def build_usdm_encounters(soa_id: int) -> List[Dict[str, Any]]: "id": contactModes, "extensionAttributes": [], "code": c_code[0], - "codeSystem": c_codesystem[0], + "codeSystem": "http://www.cdisc.org", "codeSystemVersion": c_code_system_version, "decode": c_decode, "instanceType": "Code", diff --git a/src/usdm/generate_narrative_content.py b/src/usdm/generate_narrative_content.py index b674b15..70758ba 100644 --- a/src/usdm/generate_narrative_content.py +++ b/src/usdm/generate_narrative_content.py @@ -25,7 +25,7 @@ from pathlib import Path from typing import Any, Dict, List, Optional, Tuple -from usdm.usdm_utils import _get_soa_metadata +from usdm.usdm_utils import _get_latest_sdtmct_version, _get_soa_metadata logger = logging.getLogger("usdm.generate_narrative_content") @@ -193,6 +193,7 @@ def build_usdm_study_definition_document( if not _soa_has_narrative_content(soa_id): return None contents = build_usdm_narrative_contents(soa_id) + sdtmct_version = _get_latest_sdtmct_version() version: Dict[str, Any] = { "id": document_version_id, @@ -203,7 +204,7 @@ def build_usdm_study_definition_document( "extensionAttributes": [], "code": "C25508", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", + "codeSystemVersion": sdtmct_version, "decode": "Final", "instanceType": "Code", }, @@ -219,7 +220,7 @@ def build_usdm_study_definition_document( "extensionAttributes": [], "code": "C215663", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", + "codeSystemVersion": sdtmct_version, "decode": "Effective Date", "instanceType": "Code", }, @@ -259,7 +260,7 @@ def build_usdm_study_definition_document( "extensionAttributes": [], "code": "C70817", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", + "codeSystemVersion": sdtmct_version, "decode": "Protocol", "instanceType": "Code", }, diff --git a/src/usdm/usdm_utils.py b/src/usdm/usdm_utils.py index 1e0a41f..966ec06 100644 --- a/src/usdm/usdm_utils.py +++ b/src/usdm/usdm_utils.py @@ -3,9 +3,9 @@ import functools import requests import logging -from urllib.parse import urlparse from typing import List, Dict, Optional, Any, Tuple +from soa_builder.web.codelist_config import EPOCH_TYPE_CODELIST from soa_builder.web.db import _connect from soa_builder.web.utils import get_latest_sdtm_ct_href as _get_latest_sdtm_ct_href @@ -188,6 +188,19 @@ def _get_dss_response_codes( return _fetch_dss_variable_map(row[0]).get(variable_name, []) +@functools.lru_cache(maxsize=1) +def _get_latest_sdtmct_version() -> str: + """Return the latest SDTM CT package date string (e.g. '2025-09-26'). + + Wraps ``_get_latest_sdtm_ct_href`` (which reads ``_links.packages`` + from the CDISC Library packages endpoint) and strips the + ``sdtmct-`` prefix, so every SDTM-CT-derived ``codeSystemVersion`` + in the USDM export is pinned to the same, current package. + Falls back to '' on any error. + """ + return (_get_latest_sdtm_ct_href() or "").removeprefix("sdtmct-") + + @functools.lru_cache(maxsize=1) def _get_latest_bc_package_version() -> str: """Return the latest CDISC BC package date string (e.g. '2024-09-27'). @@ -242,18 +255,36 @@ def _get_latest_bc_package_version() -> str: return latest_version -@functools.lru_cache(maxsize=256) +_biomedical_concept_cache: Dict[str, Dict[str, Any]] = {} + + def _get_biomedical_concept_data(concept_code: str) -> Dict[str, Any]: - """Fetch the full CDISC Biomedical Concept API response. Cached per code.""" + """Fetch the full CDISC Biomedical Concept API response. + + Cached per code, but only successful (200) responses are cached — + a transient failure (rate limit, timeout, auth hiccup) must not + permanently poison the cache for the life of the process. + """ + if concept_code in _biomedical_concept_cache: + return _biomedical_concept_cache[concept_code] url = URL_PREFIX + "mdr/bc/biomedicalconcepts/" + concept_code try: resp = requests.get(url, headers=_build_api_headers(), timeout=15) if resp.status_code != 200: + logger.warning( + "_get_biomedical_concept_data: %s returned %s", + url, + resp.status_code, + ) return {} - return resp.json() + data = resp.json() except (requests.RequestException, ValueError) as e: - print(f"Error fetching biomedical concept: {e}") + logger.warning( + "_get_biomedical_concept_data failed for %s: %s", concept_code, e + ) return {} + _biomedical_concept_cache[concept_code] = data + return data def _absolute_url(href: str) -> str: @@ -810,7 +841,18 @@ def _get_epoch_code_values( code_system_version = "" decode = "" - url = "https://library.cdisc.org/api/mdr/ct/packages/sdtmct-2025-09-26/codelists/C99079" + package_slug = _get_latest_sdtm_ct_href() + if not package_slug: + logger.warning( + "Could not discover latest SDTM CT package for epoch code %s", + code, + ) + return code_system, code_system_version, decode + + url = ( + "https://library.cdisc.org/api/mdr/ct/packages/" + f"{package_slug}/codelists/{EPOCH_TYPE_CODELIST}" + ) try: resp = requests.get(url, headers=_build_api_headers(), timeout=10) @@ -824,9 +866,8 @@ def _get_epoch_code_values( return code_system, code_system_version, decode content = resp.json() - parsed_url = urlparse(url) - code_system = parsed_url.scheme + "://" + parsed_url.netloc - code_system_version = parsed_url.path.split("/", 7)[5] + code_system = "http://www.cdisc.org" + code_system_version = package_slug.removeprefix("sdtmct-") # Guard against missing 'terms' key top_terms = content.get("terms") or [] diff --git a/tests/test_cdisc_concept_group_sync.py b/tests/test_cdisc_concept_group_sync.py new file mode 100644 index 0000000..9250699 --- /dev/null +++ b/tests/test_cdisc_concept_group_sync.py @@ -0,0 +1,396 @@ +"""Tests for materializing CDISC classification groups (from the +cdisc-biomedical-concept-groupings service) into the concept_group / +concept_group_concept tables, so they appear alongside Custom Concept +Groups in the "Add group" dropdown — while Custom Concept Groups +behavior stays completely unaffected. +""" + +import pytest +import requests +from fastapi.testclient import TestClient + +from soa_builder.web.app import _get_concept_group_sections +from soa_builder.web.db import _connect +from soa_builder.web.app import app +from soa_builder.web.routers.concept_groups import ( + _bc_grouping_cache, + sync_cdisc_concept_groups, +) + +client = TestClient(app) + + +@pytest.fixture(autouse=True) +def clean_concept_group_tables(): + _bc_grouping_cache["data"] = None + _bc_grouping_cache["fetched_at"] = 0 + conn = _connect() + cur = conn.cursor() + cur.execute("DELETE FROM concept_group_concept") + cur.execute("DELETE FROM concept_group") + conn.commit() + conn.close() + yield + conn = _connect() + cur = conn.cursor() + cur.execute("DELETE FROM concept_group_concept") + cur.execute("DELETE FROM concept_group") + conn.commit() + conn.close() + + +SCHEMES = [ + { + "scheme_id": "coa_type", + "name": "COA Type", + "description": "", + "purpose": "", + "intended_use": "", + }, + { + "scheme_id": "concept_group", + "name": "Concept Group", + "description": "", + "purpose": "", + "intended_use": "", + }, +] +BCS = [ + {"bc_id": "C1", "short_name": "Weight", "ncit_code": "C1"}, + {"bc_id": "NEW_1", "short_name": "Retired Thing [RETIRED]", "ncit_code": "nan"}, +] + + +def _values_and_assignments(include_cg_value=True, include_new1_assignment=True): + values = [ + { + "value_id": "coa_v1", + "scheme_id": "coa_type", + "label": "Clinician Reported", + "description": "", + }, + ] + assignments = [ + { + "assignment_id": "a1", + "bc_id": "C1", + "scheme_id": "coa_type", + "value_id": "coa_v1", + }, + ] + if include_cg_value: + values.append( + { + "value_id": "cg_v1", + "scheme_id": "concept_group", + "label": "Vital Signs", + "description": "", + } + ) + assignments.append( + { + "assignment_id": "a2", + "bc_id": "C1", + "scheme_id": "concept_group", + "value_id": "cg_v1", + } + ) + if include_new1_assignment: + assignments.append( + { + "assignment_id": "a3", + "bc_id": "NEW_1", + "scheme_id": "concept_group", + "value_id": "cg_v1", + } + ) + return values, assignments + + +class DummyResponse: + def __init__(self, payload, status_code=200): + self._payload = payload + self.status_code = status_code + + def json(self): + return self._payload + + def raise_for_status(self): + if self.status_code >= 400: + raise requests.exceptions.HTTPError(f"HTTP {self.status_code}") + + +def _fake_get(schemes, values, assignments, bcs): + def fake_get(url, params=None, timeout=None): + if url.endswith("/biomedical-concepts"): + return DummyResponse({"items": bcs, "total": len(bcs)}) + if url.endswith("/classification-schemes"): + return DummyResponse({"items": schemes, "total": len(schemes)}) + if url.endswith("/classification-values"): + return DummyResponse({"items": values, "total": len(values)}) + if url.endswith("/classification-assignments"): + return DummyResponse({"items": assignments, "total": len(assignments)}) + raise AssertionError(f"Unexpected URL: {url}") + + return fake_get + + +def _row_for_uid(uid): + conn = _connect() + cur = conn.cursor() + cur.execute( + "SELECT id, name, source, cdisc_scheme_id, cdisc_scheme_name, cdisc_value_id " + "FROM concept_group WHERE concept_group_uid=?", + (uid,), + ) + row = cur.fetchone() + conn.close() + return row + + +def _members_for_uid(uid): + conn = _connect() + cur = conn.cursor() + cur.execute( + "SELECT concept_code FROM concept_group_concept WHERE concept_group_uid=?", + (uid,), + ) + codes = {r[0] for r in cur.fetchall()} + conn.close() + return codes + + +def test_sync_materializes_groups_and_prefers_ncit_code(monkeypatch): + values, assignments = _values_and_assignments() + monkeypatch.setattr("requests.get", _fake_get(SCHEMES, values, assignments, BCS)) + + summary = sync_cdisc_concept_groups(force=True) + assert summary["synced"] is True + assert summary["groups"] == 2 + + coa_row = _row_for_uid("cdisc:coa_type:coa_v1") + assert coa_row is not None + assert coa_row[1] == "Clinician Reported" + assert coa_row[2] == "cdisc" + assert coa_row[4] == "COA Type" + + cg_row = _row_for_uid("cdisc:concept_group:cg_v1") + assert cg_row is not None + assert cg_row[1] == "Vital Signs" + + # C1's ncit_code ("C1") is used directly; NEW_1's ncit_code ("nan") + # doesn't match ^C\d+$ so it falls back to bc_id ("NEW_1"). + assert _members_for_uid("cdisc:concept_group:cg_v1") == {"C1", "NEW_1"} + assert _members_for_uid("cdisc:coa_type:coa_v1") == {"C1"} + + +def test_sync_idempotent_and_preserves_custom_groups(monkeypatch): + # Seed a custom group first — must survive untouched across syncs. + resp = client.post("/concept-groups", json={"name": "My Custom Group"}) + assert resp.status_code == 200 + custom_id = resp.json()["id"] + + values, assignments = _values_and_assignments() + monkeypatch.setattr("requests.get", _fake_get(SCHEMES, values, assignments, BCS)) + + sync_cdisc_concept_groups(force=True) + row1 = _row_for_uid("cdisc:concept_group:cg_v1") + id_after_first_sync = row1[0] + + sync_cdisc_concept_groups(force=True) + row2 = _row_for_uid("cdisc:concept_group:cg_v1") + assert row2[0] == id_after_first_sync # stable id: real upsert, not delete+reinsert + + # Custom group untouched. + resp = client.get("/concept-groups") + assert resp.status_code == 200 + custom_groups = [g for g in resp.json() if g["id"] == custom_id] + assert len(custom_groups) == 1 + assert custom_groups[0]["name"] == "My Custom Group" + + +def test_sync_bidirectional_stale_cleanup(monkeypatch): + values, assignments = _values_and_assignments() + monkeypatch.setattr("requests.get", _fake_get(SCHEMES, values, assignments, BCS)) + sync_cdisc_concept_groups(force=True) + assert _row_for_uid("cdisc:concept_group:cg_v1") is not None + + # Re-sync with the concept_group value removed entirely upstream. + values2, assignments2 = _values_and_assignments(include_cg_value=False) + monkeypatch.setattr("requests.get", _fake_get(SCHEMES, values2, assignments2, BCS)) + sync_cdisc_concept_groups(force=True) + assert _row_for_uid("cdisc:concept_group:cg_v1") is None + assert _members_for_uid("cdisc:concept_group:cg_v1") == set() + # The still-current coa_type group is untouched. + assert _row_for_uid("cdisc:coa_type:coa_v1") is not None + + +def test_sync_stale_member_cleanup(monkeypatch): + values, assignments = _values_and_assignments() + monkeypatch.setattr("requests.get", _fake_get(SCHEMES, values, assignments, BCS)) + sync_cdisc_concept_groups(force=True) + assert _members_for_uid("cdisc:concept_group:cg_v1") == {"C1", "NEW_1"} + + # Re-sync with NEW_1's assignment to cg_v1 removed. + values2, assignments2 = _values_and_assignments(include_new1_assignment=False) + monkeypatch.setattr("requests.get", _fake_get(SCHEMES, values2, assignments2, BCS)) + sync_cdisc_concept_groups(force=True) + assert _members_for_uid("cdisc:concept_group:cg_v1") == {"C1"} + + +def test_sync_resilience_on_service_unavailable(monkeypatch): + values, assignments = _values_and_assignments() + monkeypatch.setattr("requests.get", _fake_get(SCHEMES, values, assignments, BCS)) + sync_cdisc_concept_groups(force=True) + assert _row_for_uid("cdisc:concept_group:cg_v1") is not None + + def raising_get(url, params=None, timeout=None): + raise requests.exceptions.ConnectionError("boom") + + monkeypatch.setattr("requests.get", raising_get) + summary = sync_cdisc_concept_groups(force=True) + assert summary["synced"] is False + + # Previously-synced rows survive the outage untouched. + assert _row_for_uid("cdisc:concept_group:cg_v1") is not None + assert _members_for_uid("cdisc:concept_group:cg_v1") == {"C1", "NEW_1"} + + +def test_migration_idempotent(): + from soa_builder.web.migrate_database import ( + _migrate_concept_group_add_cdisc_source_columns, + ) + + _migrate_concept_group_add_cdisc_source_columns() + _migrate_concept_group_add_cdisc_source_columns() + + conn = _connect() + cur = conn.cursor() + cur.execute("PRAGMA table_info(concept_group)") + cols = [r[1] for r in cur.fetchall()] + conn.close() + for expected in ( + "source", + "cdisc_scheme_id", + "cdisc_scheme_name", + "cdisc_value_id", + ): + assert cols.count(expected) == 1 + + +def test_get_concept_group_sections_ordering_and_filtering(monkeypatch): + resp = client.post("/concept-groups", json={"name": "My Custom Group"}) + assert resp.status_code == 200 + + values, assignments = _values_and_assignments() + monkeypatch.setattr("requests.get", _fake_get(SCHEMES, values, assignments, BCS)) + sync_cdisc_concept_groups(force=True) + + sections = _get_concept_group_sections() + headings = [s["heading"] for s in sections] + + # COA Type appears before Concept Group (fixed order), schemes with + # no values (Collection Method, etc.) are omitted, and Custom + # Concept Groups comes last. + assert headings == ["COA Type", "Concept Group", "Custom Concept Groups"] + + coa_section = sections[0] + assert [g["name"] for g in coa_section["groups"]] == ["Clinician Reported"] + + custom_section = sections[-1] + assert any(g["name"] == "My Custom Group" for g in custom_section["groups"]) + + +def test_admin_page_excludes_cdisc_groups(monkeypatch): + resp = client.post("/concept-groups", json={"name": "My Custom Group"}) + assert resp.status_code == 200 + + values, assignments = _values_and_assignments() + monkeypatch.setattr("requests.get", _fake_get(SCHEMES, values, assignments, BCS)) + sync_cdisc_concept_groups(force=True) + + resp = client.get("/ui/concept-groups") + assert resp.status_code == 200 + assert "Vital Signs" not in resp.text + assert "Clinician Reported" not in resp.text + assert "My Custom Group" in resp.text + + # The plain JSON listing API is likewise scoped to custom groups. + resp = client.get("/concept-groups") + assert resp.status_code == 200 + names = [g["name"] for g in resp.json()] + assert "Vital Signs" not in names + assert "My Custom Group" in names + + +def test_admin_crud_guard_rejects_cdisc_group(monkeypatch): + values, assignments = _values_and_assignments() + monkeypatch.setattr("requests.get", _fake_get(SCHEMES, values, assignments, BCS)) + sync_cdisc_concept_groups(force=True) + cdisc_id = _row_for_uid("cdisc:concept_group:cg_v1")[0] + + resp = client.patch(f"/concept-groups/{cdisc_id}", json={"name": "Hacked"}) + assert resp.status_code == 400 + + resp = client.delete(f"/concept-groups/{cdisc_id}") + assert resp.status_code == 400 + + resp = client.post( + f"/ui/concept-groups/{cdisc_id}/update", + data={"name": "Hacked"}, + ) + assert resp.status_code == 400 + + resp = client.post(f"/ui/concept-groups/{cdisc_id}/delete") + assert resp.status_code == 400 + + # The group survives all of the above untouched. + assert _row_for_uid("cdisc:concept_group:cg_v1")[1] == "Vital Signs" + + +def test_end_to_end_assign_cdisc_group_to_activity(monkeypatch): + values, assignments = _values_and_assignments() + monkeypatch.setattr("requests.get", _fake_get(SCHEMES, values, assignments, BCS)) + sync_cdisc_concept_groups(force=True) + + soa_resp = client.post("/soa", json={"name": "CDISC Group E2E Test"}) + soa_id = soa_resp.json()["id"] + act_resp = client.post(f"/soa/{soa_id}/activities", json={"name": "Vitals"}) + activity_id = act_resp.json()["activity_id"] + + resp = client.post( + f"/ui/soa/{soa_id}/activity/{activity_id}/concept-groups/add", + data={"concept_group_uid": "cdisc:concept_group:cg_v1"}, + ) + assert resp.status_code == 200 + assert "Concept Group: Vital Signs" in resp.text + + conn = _connect() + cur = conn.cursor() + cur.execute( + "SELECT concept_code, concept_group_uid FROM activity_concept " + "WHERE activity_id=? AND soa_id=?", + (activity_id, soa_id), + ) + rows = {r[0]: r[1] for r in cur.fetchall()} + conn.close() + assert rows == { + "C1": "cdisc:concept_group:cg_v1", + "NEW_1": "cdisc:concept_group:cg_v1", + } + + # Removal (×all) works unchanged too. + resp = client.post( + f"/ui/soa/{soa_id}/activity/{activity_id}/concept-groups/remove", + data={"concept_group_uid": "cdisc:concept_group:cg_v1"}, + ) + assert resp.status_code == 200 + conn = _connect() + cur = conn.cursor() + cur.execute( + "SELECT COUNT(*) FROM activity_concept WHERE activity_id=? AND soa_id=?", + (activity_id, soa_id), + ) + count = cur.fetchone()[0] + conn.close() + assert count == 0 diff --git a/tests/test_generate_activity_grouping_extensions.py b/tests/test_generate_activity_grouping_extensions.py new file mode 100644 index 0000000..1c5617f --- /dev/null +++ b/tests/test_generate_activity_grouping_extensions.py @@ -0,0 +1,212 @@ +"""Tests for the Activity BC-grouping ExtensionAttribute generator.""" + +from soa_builder.web.app import app # noqa: F401 (triggers DB init) +from soa_builder.web.db import _connect +from usdm.generate_activity_grouping_extensions import ( + populate_activity_grouping_extensions, + build_usdm_activity_grouping_extensions_bulk, +) + +SOA_ID = 9201 +ACTIVITY_UID = "Activity_1" +ACTIVITY_UID_2 = "Activity_2" +CG_CONCEPT_GROUP = "cdisc:concept_group:cg_6mwt" +CG_THERAPEUTIC_AREA = "cdisc:therapeutic_area:ta_onc" +CG_CUSTOM = "custom:1" + + +def _clean(): + conn = _connect() + cur = conn.cursor() + cur.execute("DELETE FROM activity_grouping_extension WHERE soa_id=?", (SOA_ID,)) + cur.execute("DELETE FROM activity_concept WHERE soa_id=?", (SOA_ID,)) + cur.execute( + "DELETE FROM concept_group WHERE concept_group_uid IN (?, ?, ?)", + (CG_CONCEPT_GROUP, CG_THERAPEUTIC_AREA, CG_CUSTOM), + ) + conn.commit() + conn.close() + + +def _seed_concept_group( + concept_group_uid, + scheme_id="concept_group", + scheme_name="Concept Group", + value_id="cg_6mwt", + source="cdisc", +): + conn = _connect() + cur = conn.cursor() + cur.execute( + "INSERT INTO concept_group" + " (concept_group_uid, name, source," + " cdisc_scheme_id, cdisc_scheme_name, cdisc_value_id)" + " VALUES (?, ?, ?, ?, ?, ?)", + (concept_group_uid, value_id, source, scheme_id, scheme_name, value_id), + ) + conn.commit() + conn.close() + + +def _seed_ac(activity_uid, concept_group_uid, activity_id=1): + conn = _connect() + cur = conn.cursor() + cur.execute( + "INSERT INTO activity_concept" + " (soa_id, activity_id, activity_uid, concept_uid," + " concept_code, concept_title, concept_group_uid)" + " VALUES (?, ?, ?, ?, ?, ?, ?)", + ( + SOA_ID, + activity_id, + activity_uid, + "BiomedicalConcept_1", + "C25564", + "Vital Signs", + concept_group_uid, + ), + ) + conn.commit() + conn.close() + + +def test_populate_creates_row_for_assigned_cdisc_group(): + _clean() + _seed_concept_group(CG_CONCEPT_GROUP) + _seed_ac(ACTIVITY_UID, CG_CONCEPT_GROUP) + + populate_activity_grouping_extensions(SOA_ID) + + conn = _connect() + cur = conn.cursor() + cur.execute( + "SELECT activity_uid, concept_group_uid, ea_outer_uid, ec_uid," + " ea_scheme_uid, ea_value_uid" + " FROM activity_grouping_extension WHERE soa_id=?", + (SOA_ID,), + ) + rows = cur.fetchall() + conn.close() + assert len(rows) == 1 + activity_uid, cg_uid, ea_outer, ec, ea_scheme, ea_value = rows[0] + assert activity_uid == ACTIVITY_UID + assert cg_uid == CG_CONCEPT_GROUP + assert ea_outer.startswith("ExtensionAttribute_") + assert ec.startswith("ExtensionClass_") + assert ea_scheme.startswith("ExtensionAttribute_") + assert ea_value.startswith("ExtensionAttribute_") + assert len({ea_outer, ea_scheme, ea_value}) == 3 + + +def test_populate_is_idempotent(): + _clean() + _seed_concept_group(CG_CONCEPT_GROUP) + _seed_ac(ACTIVITY_UID, CG_CONCEPT_GROUP) + + populate_activity_grouping_extensions(SOA_ID) + conn = _connect() + cur = conn.cursor() + cur.execute( + "SELECT ea_outer_uid FROM activity_grouping_extension WHERE soa_id=?", + (SOA_ID,), + ) + first_uid = cur.fetchall() + conn.close() + + populate_activity_grouping_extensions(SOA_ID) + conn = _connect() + cur = conn.cursor() + cur.execute( + "SELECT ea_outer_uid FROM activity_grouping_extension WHERE soa_id=?", + (SOA_ID,), + ) + second_uid = cur.fetchall() + conn.close() + + assert first_uid == second_uid + assert len(second_uid) == 1 + + +def test_populate_skips_custom_source_group(): + _clean() + _seed_concept_group(CG_CUSTOM, source="custom", value_id="my_custom_group") + _seed_ac(ACTIVITY_UID, CG_CUSTOM) + + populate_activity_grouping_extensions(SOA_ID) + + conn = _connect() + cur = conn.cursor() + cur.execute( + "SELECT COUNT(*) FROM activity_grouping_extension WHERE soa_id=?", + (SOA_ID,), + ) + count = cur.fetchone()[0] + conn.close() + assert count == 0 + + +def test_build_returns_nested_shape_with_correct_values(): + _clean() + _seed_concept_group(CG_CONCEPT_GROUP) + _seed_ac(ACTIVITY_UID, CG_CONCEPT_GROUP) + populate_activity_grouping_extensions(SOA_ID) + + out = build_usdm_activity_grouping_extensions_bulk(SOA_ID) + assert list(out.keys()) == [ACTIVITY_UID] + units = out[ACTIVITY_UID] + assert len(units) == 1 + ea = units[0] + assert ea["instanceType"] == "ExtensionAttribute" + assert ea["url"] == ( + "http://www.cdisc.org/usdm/extensions/biomedicalConceptGrouping" + ) + ec = ea["valueExtensionClass"] + assert ec["instanceType"] == "ExtensionClass" + assert ec["url"] == ( + "http://www.cdisc.org/usdm/extensions/BiomedicalConceptGrouping" + ) + children = ec["extensionAttributes"] + assert len(children) == 2 + scheme_child, value_child = children + assert scheme_child["url"] == "classification-scheme-id" + assert scheme_child["valueString"] == "concept_group" + assert scheme_child["instanceType"] == "ExtensionAttribute" + assert value_child["url"] == "classification-value-id" + assert value_child["valueString"] == "cg_6mwt" + assert value_child["instanceType"] == "ExtensionAttribute" + + +def test_build_two_groups_on_one_activity_emit_distinct_units(): + _clean() + _seed_concept_group(CG_CONCEPT_GROUP, scheme_id="concept_group", value_id="cg_6mwt") + _seed_concept_group( + CG_THERAPEUTIC_AREA, scheme_id="therapeutic_area", value_id="ta_onc" + ) + _seed_ac(ACTIVITY_UID, CG_CONCEPT_GROUP, activity_id=1) + _seed_ac(ACTIVITY_UID, CG_THERAPEUTIC_AREA, activity_id=1) + populate_activity_grouping_extensions(SOA_ID) + + out = build_usdm_activity_grouping_extensions_bulk(SOA_ID) + units = out[ACTIVITY_UID] + assert len(units) == 2 + + all_ids = set() + for unit in units: + all_ids.add(unit["id"]) + all_ids.add(unit["valueExtensionClass"]["id"]) + for child in unit["valueExtensionClass"]["extensionAttributes"]: + all_ids.add(child["id"]) + assert len(all_ids) == 8 + + value_ids = { + unit["valueExtensionClass"]["extensionAttributes"][1]["valueString"] + for unit in units + } + assert value_ids == {"cg_6mwt", "ta_onc"} + + +def test_build_returns_empty_for_activity_without_groups(): + _clean() + + out = build_usdm_activity_grouping_extensions_bulk(SOA_ID) + assert out.get(ACTIVITY_UID_2, []) == [] diff --git a/tests/test_routers_bc_grouping.py b/tests/test_routers_bc_grouping.py new file mode 100644 index 0000000..a310a9b --- /dev/null +++ b/tests/test_routers_bc_grouping.py @@ -0,0 +1,226 @@ +"""Tests for the BC Grouping Explorer proxy routes on the Concept +Groups page (routers/concept_groups.py). These cover only the new +BC-grouping-service integration; the Custom Concept Groups feature +on the same page is covered by the regression smoke test below. +""" + +from types import SimpleNamespace + +import pytest +import requests +from fastapi.testclient import TestClient + +from soa_builder.web.app import app +from soa_builder.web.routers.concept_groups import _bc_grouping_cache + +client = TestClient(app) + + +class DummyResponse: + def __init__(self, payload, status_code=200): + self._payload = payload + self.status_code = status_code + + def json(self): + return self._payload + + def raise_for_status(self): + if self.status_code >= 400: + raise requests.exceptions.HTTPError(f"HTTP {self.status_code}") + + +@pytest.fixture(autouse=True) +def clear_bc_grouping_cache(): + _bc_grouping_cache["data"] = None + _bc_grouping_cache["fetched_at"] = 0 + + +def _paged_get(pages_by_path): + """Build a fake requests.get that pages through pages_by_path. + + pages_by_path: {path: [ (items, total), ... ]} — one page per call, + keyed by request-count for that path. + """ + call_index = {} + + def fake_get(url, params=None, timeout=None): + for path, pages in pages_by_path.items(): + if url.endswith(path): + idx = call_index.get(path, 0) + items, total = pages[idx] + call_index[path] = idx + 1 + return DummyResponse({"items": items, "total": total}) + raise AssertionError(f"Unexpected URL: {url}") + + return fake_get + + +def _happy_path_get(monkeypatch, call_counter=None): + bcs = [{"bc_id": "C1", "short_name": "Sex", "ncit_code": "C1"}] + schemes = [ + { + "scheme_id": "concept_group", + "name": "Concept Group", + "description": "", + "purpose": "", + "intended_use": "", + } + ] + values = [ + { + "value_id": "cg_demo", + "scheme_id": "concept_group", + "label": "Demographics", + "description": "", + } + ] + # Two pages of assignments to exercise the pagination loop. + assignments_page1 = [ + { + "assignment_id": "a1", + "bc_id": "C1", + "scheme_id": "concept_group", + "value_id": "cg_demo", + } + ] + assignments_page2 = [ + { + "assignment_id": "a2", + "bc_id": "C1", + "scheme_id": "concept_group", + "value_id": "cg_demo", + } + ] + + fake_get = _paged_get( + { + "/biomedical-concepts": [(bcs, 1)], + "/classification-schemes": [(schemes, 1)], + "/classification-values": [(values, 1)], + "/classification-assignments": [ + (assignments_page1, 2), + (assignments_page2, 2), + ], + } + ) + + def counting_get(url, params=None, timeout=None): + if call_counter is not None: + call_counter.n += 1 + return fake_get(url, params=params, timeout=timeout) + + monkeypatch.setattr("requests.get", counting_get) + + +def test_bc_explorer_happy_path(monkeypatch): + _happy_path_get(monkeypatch) + + resp = client.get("/ui/concept-groups/bc-explorer") + assert resp.status_code == 200 + assert "BC Grouping Explorer unavailable" not in resp.text + assert "Demographics" in resp.text + assert "Sex" in resp.text + + +def test_bc_explorer_connection_error(monkeypatch): + def fake_get(url, params=None, timeout=None): + raise requests.exceptions.ConnectionError("boom") + + monkeypatch.setattr("requests.get", fake_get) + + resp = client.get("/ui/concept-groups/bc-explorer") + assert resp.status_code == 200 + assert "BC Grouping Explorer unavailable" in resp.text + assert "not reachable" in resp.text + + +def test_bc_explorer_timeout(monkeypatch): + def fake_get(url, params=None, timeout=None): + raise requests.exceptions.Timeout("boom") + + monkeypatch.setattr("requests.get", fake_get) + + resp = client.get("/ui/concept-groups/bc-explorer") + assert resp.status_code == 200 + assert "BC Grouping Explorer unavailable" in resp.text + assert "timed out" in resp.text + + +def test_bc_explorer_cache_hit_and_refresh(monkeypatch): + call_counter = SimpleNamespace(n=0) + _happy_path_get(monkeypatch, call_counter=call_counter) + + resp1 = client.get("/ui/concept-groups/bc-explorer") + assert resp1.status_code == 200 + calls_after_first = call_counter.n + assert calls_after_first > 0 + + # Second call within TTL should hit the cache — no new HTTP calls. + resp2 = client.get("/ui/concept-groups/bc-explorer") + assert resp2.status_code == 200 + assert call_counter.n == calls_after_first + + # Refresh forces a bypass. + refresh_resp = client.post("/ui/concept-groups/bc-explorer/refresh") + assert refresh_resp.status_code == 200 + assert call_counter.n > calls_after_first + + +def test_bc_grouping_pagination_helper_concatenates_all_pages(monkeypatch): + """Focused unit test of the pagination loop: total exceeds one page.""" + from soa_builder.web.routers.concept_groups import _bc_grouping_fetch_all + + pages = [ + ({"items": [{"id": 1}, {"id": 2}], "total": 5}), + ({"items": [{"id": 3}, {"id": 4}], "total": 5}), + ({"items": [{"id": 5}], "total": 5}), + ] + call_count = SimpleNamespace(n=0) + + def fake_get(url, params=None, timeout=None): + page = pages[call_count.n] + call_count.n += 1 + return DummyResponse(page) + + monkeypatch.setattr("requests.get", fake_get) + + items = _bc_grouping_fetch_all("/classification-assignments", limit=2) + assert call_count.n == 3 + assert [i["id"] for i in items] == [1, 2, 3, 4, 5] + + +def test_bc_status_ok(monkeypatch): + def fake_get(url, timeout=None): + return DummyResponse({"status": "ok"}) + + monkeypatch.setattr("requests.get", fake_get) + + resp = client.get("/ui/concept-groups/bc-status") + assert resp.status_code == 200 + assert "BC Grouping Service is connected" in resp.text + + +def test_bc_status_connection_error(monkeypatch): + def fake_get(url, timeout=None): + raise requests.exceptions.ConnectionError("boom") + + monkeypatch.setattr("requests.get", fake_get) + + resp = client.get("/ui/concept-groups/bc-status") + assert resp.status_code == 200 + assert "BC Grouping Service unavailable" in resp.text + + +def test_concept_groups_page_smoke_and_custom_groups_unchanged(): + """GET /ui/concept-groups makes no bc-grouping-service call itself, + so no monkeypatching is needed here. Regression guard: Custom + Concept Groups markup must still be present and the placeholder + must be gone. + """ + resp = client.get("/ui/concept-groups") + assert resp.status_code == 200 + assert "Custom Concept Groups" in resp.text + assert 'action="/ui/concept-groups/create"' in resp.text + assert "bc-explorer-root" in resp.text + assert "bc-status-notice" in resp.text + assert "__PLACEHOLDER__" not in resp.text diff --git a/tests/test_routers_bc_surrogates.py b/tests/test_routers_bc_surrogates.py index 9292907..899d0b5 100644 --- a/tests/test_routers_bc_surrogates.py +++ b/tests/test_routers_bc_surrogates.py @@ -220,3 +220,26 @@ def test_surrogate_appears_in_usdm_output(): matching = next(s for s in surrogates if s["id"] == sur_uid) assert matching["name"] == "PupilDilation" assert matching["instanceType"] == "BiomedicalConceptSurrogate" + + +def test_unlinked_surrogate_excluded_from_usdm_output(): + soa_id = _make_soa() + act_id = _make_activity(soa_id, "SoA Activity") + + create_r = client.post( + f"/soa/{soa_id}/bc-surrogates", json={"name": "OrphanSurrogate"} + ) + sur_id = create_r.json()["id"] + sur_uid = create_r.json()["surrogate_uid"] + + from usdm.generate_bc_surrogates import build_usdm_bc_surrogates + + # Never linked to an activity — must not appear in the USDM export. + surrogates = build_usdm_bc_surrogates(soa_id) + assert not any(s["id"] == sur_uid for s in surrogates) + + # Link then unlink — still must not appear. + client.post(f"/soa/{soa_id}/activities/{act_id}/bc-surrogates/{sur_id}") + client.delete(f"/soa/{soa_id}/activities/{act_id}/bc-surrogates/{sur_id}") + surrogates = build_usdm_bc_surrogates(soa_id) + assert not any(s["id"] == sur_uid for s in surrogates)
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