cdisc-org · pendingintent · Aug 13, 2026
diff --git a/Published/CORE-000217/negative/05/data/.env b/Published/CORE-000217/negative/05/data/.env
@@ -1,2 +1,2 @@
-PRODUCT=sendig
-VERSION=3-1
+PRODUCT=SDTMIG
+VERSION=3-4
diff --git a/Published/CORE-000217/negative/05/data/_datasets.csv b/Published/CORE-000217/negative/05/data/_datasets.csv
@@ -1,2 +1,2 @@
 Filename,Label
-te,Trial Elements
+ec,Exposure as Collected
diff --git a/Published/CORE-000217/negative/05/data/_variables.csv b/Published/CORE-000217/negative/05/data/_variables.csv
@@ -1,8 +1,23 @@
 dataset,variable,label,type,length
-te,STUDYID,Study Identifier,Char,12
-te,DOMAIN,Domain Abbreviation,Char,2
-te,ETCD,Element Code,Char,7
-te,ELEMENT,Description of Element,Char,26
-te,TESTRL,Rule for Start of Element,Char,200
-te,TEENRL,Rule for End of Element,Char,200
-te,TEDUR,Planned Duration of Element,Char,50
+ec,STUDYID,Study Identifier,Char,50
+ec,DOMAIN,Domain Abbreviation,Char,50
+ec,USUBJID,Unique Subject Identifier,Char,50
+ec,SPDEVID,Sponsor Device Identifier,Char,200
+ec,ECSEQ,Sequence Number,Num,8
+ec,ECTRT,Name of Treatment,Char,50
+ec,ECPRESP,Pre-Specified,Char,50
+ec,ECOCCUR,Occurrence,Char,50
+ec,ECDOSE,Dose,Num,8
+ec,ECDOSU,Dose Units,Char,50
+ec,ECDOSFRM,Dose Form,Char,50
+ec,ECDOSFRQ,Dosing Frequency per Interval,Char,50
+ec,ECROUTE,Route of Administration,Char,50
+ec,ECLOT,Lot Number,Char,50
+ec,ECPSTRG,Pharmaceutical Strength,Num,8
+ec,ECPSTRGU,Pharmaceutical Strength Units,Char,50
+ec,ECSTAT,Completion Status,Char,50
+ec,EPOCH,Epoch,Char,50
+ec,ECSTDTC,Start Date/Time of Treatment,Char,50
+ec,ECENDTC,End Date/Time of Treatment,Char,50
+ec,ECSTDY,Study Day of Start of Treatment,Num,8
+ec,ECENDY,Study Day of End of Treatment,Num,8
diff --git a/Published/CORE-000217/negative/05/data/ec.csv b/Published/CORE-000217/negative/05/data/ec.csv
@@ -0,0 +1,3 @@
+STUDYID,DOMAIN,USUBJID,SPDEVID,ECSEQ,ECTRT,ECPRESP,ECOCCUR,ECDOSE,ECDOSU,ECDOSFRM,ECDOSFRQ,ECROUTE,ECLOT,ECPSTRG,ECPSTRGU,ECSTAT,EPOCH,ECSTDTC,ECENDTC,ECSTDY,ECENDY
+CDISCPILOT01,EC,CDISC001,DEV0001,1,ZANOMALINE,Y,Y,,,INJECTION,QD,SUBCUTANEOUS,SDS580-359,10.8,g/L,,TREATMENT,2012-11-30,2012-11-30,1,1
+CDISCPILOT01,EC,CDISC002,DEV0002,2,ZANOMALINE,Y,,,,INJECTION,QD,SUBCUTANEOUS,SDS580-360,11.8,g/L,,TREATMENT,2012-11-30,2012-11-30,1,1
diff --git a/Published/CORE-000217/negative/05/data/te.csv b/Published/CORE-000217/negative/05/data/te.csv
diff --git a/Published/CORE-000217/negative/05/results/results.csv b/Published/CORE-000217/negative/05/results/results.csv
@@ -1,3 +1,9 @@
 Dataset,Record,Variable,Value
-TE,1,TEDUR,
-TE,1,TEENRL,
+EC,1,ECDOSE,
+EC,1,ECDOSTXT,Not in dataset
+EC,1,ECOCCUR,Y
+EC,1,ECSTAT,
+EC,2,ECDOSE,
+EC,2,ECDOSTXT,Not in dataset
+EC,2,ECOCCUR,
+EC,2,ECSTAT,
diff --git a/Published/CORE-000217/rule.yml b/Published/CORE-000217/rule.yml
@@ -2,165 +2,193 @@
 # Condition: ECDOSE = null and ECOCCUR ^= 'N' and ECSTAT = null
 # Rule: ECDOSTXT ^= null
 Authorities:
-  - Organization: CDISC
-    Standards:
-      - Name: SDTMIG
-        References:
-          - Citations:
-              - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a
-                  timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is
-                  the standard representation of the collected doses not taken,
-                  not given, or missed. Dose amount variables (e.g., ECDOSE,
-                  ECDOSTXT) must not be set to zero (0) as an alternative method
-                  for indicating doses not taken, not given, or
-                  missed.]|Assumption 4b[Qualifiers that indicate dose amount
-                  (e.g., ECDOSE, ECDOSTXT) may be populated with positive
-                  (non-zero) values in cases where the sponsor feels it is
-                  necessary and/or appropriate to represent specific dose
-                  amounts not taken, not given, or missed.]
-                Document: IG v3.4
-                Item: Assumption 4a|Assumption 4b
-                Section: 6.1.3.2
-            Origin: SDTM and SDTMIG Conformance Rules
-            Rule Identifier:
-              Id: CG0462
-              Version: '2'
-            Version: '2.0'
-        Version: '3.4'
-      - Name: SDTMIG
-        References:
-          - Citations:
-              - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a
-                  timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is
-                  the standard representation of the collected doses not taken,
-                  not given, or missed. Dose amount variables (e.g., ECDOSE,
-                  ECDOSTXT) must not be set to zero (0) as an alternative method
-                  for indicating doses not taken, not given, or
-                  missed.]|Assumption 4b[Qualifiers that indicate dose amount
-                  (e.g., ECDOSE, ECDOSTXT) may be populated with positive
-                  (non-zero) values in cases where the sponsor feels it is
-                  necessary and/or appropriate to represent specific dose
-                  amounts not taken, not given, or missed.]
-                Document: IG v3.3
-                Item: Assumption 4a|Assumption 4b
-                Section: 6.1.3
-            Origin: SDTM and SDTMIG Conformance Rules
-            Rule Identifier:
-              Id: CG0462
-              Version: '2'
-            Version: '2.0'
-        Version: '3.3'
-      - Name: SDTMIG
-        References:
-          - Citations:
-              - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a
-                  timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is
-                  the standard representation of the collected doses not taken,
-                  not given, or missed. Dose amount variables (e.g., ECDOSE,
-                  ECDOSTXT) must not be set to zero (0) as an alternative method
-                  for indicating doses not taken, not given, or
-                  missed.]|Assumption 4b[Qualifiers that indicate dose amount
-                  (e.g., ECDOSE, ECDOSTXT) may be populated with positive
-                  (non-zero) values in cases where the sponsor feels it is
-                  necessary and/or appropriate to represent specific dose
-                  amounts not taken, not given, or missed.]
-                Document: IG v3.2
-                Item: Assumption 4a|Assumption 4b
-                Section: '6.1'
-            Origin: SDTM and SDTMIG Conformance Rules
-            Rule Identifier:
-              Id: CG0462
-              Version: '2'
-            Version: '2.0'
-        Version: '3.2'
-      - Name: TIG
-        References:
-          - Citations:
-              - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a
-                  timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is
-                  the standard representation of the collected doses not taken,
-                  not given, or missed. Dose amount variables (e.g., ECDOSE,
-                  ECDOSTXT) must not be set to zero (0) as an alternative method
-                  for indicating doses not taken, not given, or
-                  missed.]|Assumption 4b[Qualifiers that indicate dose amount
-                  (e.g., ECDOSE, ECDOSTXT) may be populated with positive
-                  (non-zero) values in cases where the sponsor feels it is
-                  necessary and/or appropriate to represent specific dose
-                  amounts not taken, not given, or missed.]
-                Document: TIG 1.0
-                Item: Assumption 4a|4b
-                Section: 2.8.10.11
-            Origin: TIG Conformance Rules
-            Rule Identifier:
-              Id: TIG0592
-              Version: '1'
-            Version: '1.0'
-        Substandard: SDTM
-        Version: '1.0'
+- Organization: CDISC
+  Standards:
+  - Name: SDTMIG
+    References:
+    - Citations:
+      - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL
+          infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected 
+          doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must
+          not be set to zero (0) as an alternative method for indicating doses not taken, not given,
+          or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) 
+          may be populated with positive (non-zero) values in cases where the sponsor feels it is 
+          necessary and/or appropriate to represent specific dose amounts not taken, not given, or 
+          missed.]
+        Document: IG v3.4
+        Item: Assumption 4a|Assumption 4b
+        Section: 6.1.3.2
+      Origin: SDTM and SDTMIG Conformance Rules
+      Rule Identifier:
+        Id: CG0462
+        Version: "2"
+      Version: "2.0"
+    Version: "3.4"
+  - Name: SDTMIG
+    References:
+    - Citations:
+      - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL
+          infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected 
+          doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must
+          not be set to zero (0) as an alternative method for indicating doses not taken, not given,
+          or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) 
+          may be populated with positive (non-zero) values in cases where the sponsor feels it is 
+          necessary and/or appropriate to represent specific dose amounts not taken, not given, or 
+          missed.]
+        Document: IG v3.3
+        Item: Assumption 4a|Assumption 4b
+        Section: 6.1.3
+      Origin: SDTM and SDTMIG Conformance Rules
+      Rule Identifier:
+        Id: CG0462
+        Version: "2"
+      Version: "2.0"
+    Version: "3.3"
+  - Name: SDTMIG
+    References:
+    - Citations:
+      - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL
+          infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected 
+          doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must
+          not be set to zero (0) as an alternative method for indicating doses not taken, not given,
+          or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) 
+          may be populated with positive (non-zero) values in cases where the sponsor feels it is 
+          necessary and/or appropriate to represent specific dose amounts not taken, not given, or 
+          missed.]
+        Document: IG v3.2
+        Item: Assumption 4a|Assumption 4b
+        Section: "6.1"
+      Origin: SDTM and SDTMIG Conformance Rules
+      Rule Identifier:
+        Id: CG0462
+        Version: "2"
+      Version: "2.0"
+    Version: "3.2"
+  - Name: TIG
+    References:
+    - Citations:
+      - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL
+          infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected 
+          doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must
+          not be set to zero (0) as an alternative method for indicating doses not taken, not given,
+          or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) 
+          may be populated with positive (non-zero) values in cases where the sponsor feels it is 
+          necessary and/or appropriate to represent specific dose amounts not taken, not given, or 
+          missed.]
+        Document: TIG 1.0
+        Item: Assumption 4a|4b
+        Section: 2.8.10.11
+      Origin: TIG Conformance Rules
+      Rule Identifier:
+        Id: TIG0592
+        Version: "1"
+      Version: "1.0"
+    Substandard: SDTM
+    Version: "1.0"
 Check:
   any:
-    - all:
-        - name: ECDOSE
-          operator: empty
-        - name: ECOCCUR
-          operator: not_equal_to
-          value: N
-          value_is_literal: true
-        - name: ECSTAT
-          operator: empty
-        - name: ECDOSTXT
-          operator: empty
-    - all:
-        - name: ECDOSE
-          operator: empty
-        - name: ECOCCUR
-          operator: not_equal_to
-          value: N
-          value_is_literal: true
-        - name: ECSTAT
-          operator: not_exists
-        - name: ECDOSTXT
-          operator: empty
-    - all:
-        - name: ECDOSE
-          operator: empty
-        - name: ECOCCUR
-          operator: not_exists
-        - name: ECSTAT
-          operator: empty
-        - name: ECDOSTXT
-          operator: empty
-    - all:
-        - name: ECDOSE
-          operator: empty
-        - name: ECOCCUR
-          operator: not_exists
-        - name: ECSTAT
-          operator: not_exists
-        - name: ECDOSTXT
-          operator: empty
+  - all:
+    - name: ECDOSE
+      operator: empty
+    - name: ECOCCUR
+      operator: not_equal_to
+      value: N
+      value_is_literal: true
+    - name: ECSTAT
+      operator: empty
+    - name: ECDOSTXT
+      operator: empty
+  - all:
+    - name: ECDOSE
+      operator: empty
+    - name: ECOCCUR
+      operator: not_equal_to
+      value: N
+      value_is_literal: true
+    - name: ECSTAT
+      operator: empty
+    - name: ECDOSTXT
+      operator: not_exists
+  - all:
+    - name: ECDOSE
+      operator: empty
+    - name: ECOCCUR
+      operator: not_equal_to
+      value: N
+      value_is_literal: true
+    - name: ECSTAT
+      operator: not_exists
+    - name: ECDOSTXT
+      operator: empty
+  - all:
+    - name: ECDOSE
+      operator: empty
+    - name: ECOCCUR
+      operator: not_equal_to
+      value: N
+      value_is_literal: true
+    - name: ECSTAT
+      operator: not_exists
+    - name: ECDOSTXT
+      operator: not_exists
+  - all:
+    - name: ECDOSE
+      operator: empty
+    - name: ECOCCUR
+      operator: not_exists
+    - name: ECSTAT
+      operator: empty
+    - name: ECDOSTXT
+      operator: empty
+  - all:
+    - name: ECDOSE
+      operator: empty
+    - name: ECOCCUR
+      operator: not_exists
+    - name: ECSTAT
+      operator: empty
+    - name: ECDOSTXT
+      operator: not_exists
+  - all:
+    - name: ECDOSE
+      operator: empty
+    - name: ECOCCUR
+      operator: not_exists
+    - name: ECSTAT
+      operator: not_exists
+    - name: ECDOSTXT
+      operator: empty
+  - all:
+    - name: ECDOSE
+      operator: empty
+    - name: ECOCCUR
+      operator: not_exists
+    - name: ECSTAT
+      operator: not_exists
+    - name: ECDOSTXT
+      operator: not_exists
 Core:
   Id: CORE-000217
   Status: Published
-  Version: '1'
-Description: Raise an error when ECDOSE is empty, ECOCCUR is not equal to 'N',
-  ECSTAT is empty and ECDOSTXT is empty
+  Version: "1"
+Description: Raise an error when ECDOSE is empty, ECOCCUR is not equal to 'N', ECSTAT is empty and 
+  ECDOSTXT is empty
 Executability: Fully Executable
 Outcome:
-  Message: ECDOSE is empty, ECOCCUR is not equal to 'N' and ECSTAT is empty, but
-    ECDOSTXT is also empty.
+  Message: ECDOSE is empty, ECOCCUR is not equal to 'N' and ECSTAT is empty, but ECDOSTXT is also 
+    empty.
   Output Variables:
-    - ECDOSE
-    - ECOCCUR
-    - ECSTAT
-    - ECDOSTXT
+  - ECDOSE
+  - ECOCCUR
+  - ECSTAT
+  - ECDOSTXT
 Rule Type: Record Data
 Scope:
   Classes:
     Include:
-      - INTERVENTIONS
+    - INTERVENTIONS
   Domains:
     Include:
-      - EC
+    - EC
   Use Case: INDH
 Sensitivity: Record