diff --git a/Unpublished/NEW-RULE/negative/01/data/.env b/Unpublished/NEW-RULE/negative/01/data/.env new file mode 100644 index 000000000..15969bcf2 --- /dev/null +++ b/Unpublished/NEW-RULE/negative/01/data/.env @@ -0,0 +1,6 @@ +PRODUCT=SDTMIG +VERSION=3.4 +SUBSTANDARD= +USE_CASE= +DEFINE_XML= +CT= diff --git a/Unpublished/NEW-RULE/negative/01/data/_datasets.csv b/Unpublished/NEW-RULE/negative/01/data/_datasets.csv new file mode 100644 index 000000000..f916bfb0d --- /dev/null +++ b/Unpublished/NEW-RULE/negative/01/data/_datasets.csv @@ -0,0 +1,3 @@ +Filename,Label +cm,Concomitant/Prior Medications +mh,Medical History diff --git a/Unpublished/NEW-RULE/negative/01/data/_variables.csv b/Unpublished/NEW-RULE/negative/01/data/_variables.csv new file mode 100644 index 000000000..fe2725e51 --- /dev/null +++ b/Unpublished/NEW-RULE/negative/01/data/_variables.csv @@ -0,0 +1,31 @@ +dataset,variable,label,type,length +cm,STUDYID,Study Identifier,Char,12 +cm,DOMAIN,Domain Abbreviation,Char,2 +cm,USUBJID,Unique Subject Identifier,Char,8 +cm,CMSEQ,Sequence Number,Num,8 +cm,CMTRT,"Reported Name of Drug, Med, or Therapy",Char,200 +cm,CMINDC,Indication,Char,200 +cm,CMDOSE,Dose per Administration,Num,8 +cm,CMDOSU,Dose Units,Char,6 +cm,CMDOSFRQ,Dosing Frequency per Interval,Char,3 +cm,CMROUTE,Route of Administration,Char,24 +cm,EPOCH,Epoch,Char,9 +cm,CMSTDTC,Start Date/Time of Medication,Char,10 +cm,CMENDTC,End Date/Time of Medication,Char,10 +cm,CMSTDY,Study Day of Start of Medication,Num,8 +cm,CMENDY,Study Day of End of Medication,Num,8 +cm,CMENRTPT,End Relative to Reference Time Point,Char,7 +cm,CMENTPT,End Reference Time Point,Char,10 +mh,STUDYID,Study Identifier,Char,12 +mh,DOMAIN,Domain Abbreviation,Char,2 +mh,USUBJID,Unique Subject Identifier,Char,8 +mh,MHSEQ,Sequence Number,Num,8 +mh,MHTERM,Reported Term for the Medical History,Char,19 +mh,MHEVDTYP,Medical History Event Date Type,Char,13 +mh,MHSTDTC,Start Date/Time of Medical History Event,Char,10 +mh,MHSTDY,Study Day of Start of Observation,Num,8 +mh,MHENDTC,End Date/Time of Medical History Event,Char,50 +mh,MHENDY,Study Day of End of Observation,Num,8 +mh,MHENRTPT,End Relative to Reference Time Point,Char,50 +mh,MHENTPT,End Reference Time Point,Char,50 + diff --git a/Unpublished/NEW-RULE/negative/01/data/cm.csv b/Unpublished/NEW-RULE/negative/01/data/cm.csv new file mode 100644 index 000000000..712f55cd3 --- /dev/null +++ b/Unpublished/NEW-RULE/negative/01/data/cm.csv @@ -0,0 +1,7 @@ +STUDYID,DOMAIN,USUBJID,CMSEQ,CMTRT,CMINDC,CMDOSE,CMDOSU,CMDOSFRQ,CMROUTE,EPOCH,CMSTDTC,CMENDTC,CMSTDY,CMENDY,CMENRTPT,CMENTPT +CDISCPILOT01,CM,CDISC005,1,CENTRUM SILVER,PROPHYLAXIS OR NON-THERAPEUTIC USE,1,TABLET,,ORAL,SCREENING,2012-03,,,,,2013-08-06 +CDISCPILOT01,CM,CDISC005,4,HYDROCORTISONE,PROPHYLAXIS OR NON-THERAPEUTIC USE,1,TABLET,,TOPICAL,TREATMENT,2013-05-14,,100,,,2013-08-06 +CDISCPILOT01,CM,CDISC017,1,ACETAMINOPHEN,PROPHYLAXIS OR NON-THERAPEUTIC USE,2,TABLET,,ORAL,SCREENING,2008,,,,,2014-03-08 +CDISCPILOT01,CM,CDISC017,2,MULTIVITAMIN,PROPHYLAXIS OR NON-THERAPEUTIC USE,1,TABLET,,ORAL,SCREENING,2011-08,,,,,2014-03-08 +CDISCPILOT01,CM,CDISC017,3,VITAMIN E,PROPHYLAXIS OR NON-THERAPEUTIC USE,400,mg,,ORAL,SCREENING,2011-08,,,,Before,2014-03-08 + diff --git a/Unpublished/NEW-RULE/negative/01/data/mh.csv b/Unpublished/NEW-RULE/negative/01/data/mh.csv new file mode 100644 index 000000000..fa6e5582f --- /dev/null +++ b/Unpublished/NEW-RULE/negative/01/data/mh.csv @@ -0,0 +1,7 @@ +STUDYID,DOMAIN,USUBJID,MHSEQ,MHTERM,MHEVDTYP,MHSTDTC,MHSTDY,MHENDTC,MHENDY,MHENRTPT,MHENTPT +CDISCPILOT01,MH,CDISC001,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2004-05-28,-3108,,,,2021-05-01 +CDISCPILOT01,MH,CDISC002,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2010-03-19,-972,2010-03-21,-970,,2021-02-15 +CDISCPILOT01,MH,CDISC003,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2007-02-09,-2393,2007-02-09,-2393,,2015-05-09 +CDISCPILOT01,MH,CDISC004,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2010-11-05,-1068,,,,2011-06-11 + + diff --git a/Unpublished/NEW-RULE/negative/01/results/results(1).csv b/Unpublished/NEW-RULE/negative/01/results/results(1).csv new file mode 100644 index 000000000..a13018c5f --- /dev/null +++ b/Unpublished/NEW-RULE/negative/01/results/results(1).csv @@ -0,0 +1 @@ +Dataset,Record,Variable,Value diff --git a/Unpublished/NEW-RULE/negative/01/results/results(1).json b/Unpublished/NEW-RULE/negative/01/results/results(1).json new file mode 100644 index 000000000..961fd441b --- /dev/null +++ b/Unpublished/NEW-RULE/negative/01/results/results(1).json @@ -0,0 +1 @@ +{"Conformance_Details": {"Report_Generation": "2026-05-19T12:45:36", "Total_Runtime": "2.75 seconds", "CORE_Engine_Version": "0.16.0", "Issue_Limit_Per_Rule": "None", "Issue_Limit_Per_Dataset": "None", "Issue_Limit_Per_Sheet": null, "Standard": "SDTMIG", "Version": "V3.4", "CT_Version": "", "Define_XML_Version": null}, "Dataset_Details": [{"filename": "CM", "label": "Concomitant/Prior Medications", "path": "C:\\Users\\u818983\\Desktop\\CDISC Training\\Rule_authoring_cdisc_training\\cdisc-open-rules-training\\Unpublished\\NEW-RULE\\negative\\01\\data", "modification_date": "2026-05-19T12:15:40.355492", "size_kb": 0.748, "length": 6}, {"filename": "MH", "label": "Medical History", "path": "C:\\Users\\u818983\\Desktop\\CDISC Training\\Rule_authoring_cdisc_training\\cdisc-open-rules-training\\Unpublished\\NEW-RULE\\negative\\01\\data", "modification_date": "2026-05-19T12:16:59.298619", "size_kb": 0.49, "length": 6}], "Issue_Summary": [], "Issue_Details": [], "Rules_Report": []} \ No newline at end of file diff --git a/Unpublished/NEW-RULE/negative/01/results/results(2).csv b/Unpublished/NEW-RULE/negative/01/results/results(2).csv new file mode 100644 index 000000000..a13018c5f --- /dev/null +++ b/Unpublished/NEW-RULE/negative/01/results/results(2).csv @@ -0,0 +1 @@ +Dataset,Record,Variable,Value diff --git a/Unpublished/NEW-RULE/negative/01/results/results(2).json b/Unpublished/NEW-RULE/negative/01/results/results(2).json new file mode 100644 index 000000000..ba2327460 --- /dev/null +++ b/Unpublished/NEW-RULE/negative/01/results/results(2).json @@ -0,0 +1 @@ +{"Conformance_Details": {"Report_Generation": "2026-05-19T14:15:15", "Total_Runtime": "2.36 seconds", "CORE_Engine_Version": "0.16.0", "Issue_Limit_Per_Rule": "None", "Issue_Limit_Per_Dataset": "None", "Issue_Limit_Per_Sheet": null, "Standard": "SDTMIG", "Version": "V3.4", "CT_Version": "", "Define_XML_Version": null}, "Dataset_Details": [{"filename": "CM", "label": "Concomitant/Prior Medications", "path": "C:\\Users\\u818983\\Desktop\\CDISC Training\\Rule_authoring_cdisc_training\\cdisc-open-rules-training\\Unpublished\\NEW-RULE\\negative\\01\\data", "modification_date": "2026-05-19T14:13:57.219994", "size_kb": 0.754, "length": 6}, {"filename": "MH", "label": "Medical History", "path": "C:\\Users\\u818983\\Desktop\\CDISC Training\\Rule_authoring_cdisc_training\\cdisc-open-rules-training\\Unpublished\\NEW-RULE\\negative\\01\\data", "modification_date": "2026-05-19T12:16:59.298619", "size_kb": 0.49, "length": 6}], "Issue_Summary": [], "Issue_Details": [], "Rules_Report": []} \ No newline at end of file diff --git a/Unpublished/NEW-RULE/negative/01/results/results(3).csv b/Unpublished/NEW-RULE/negative/01/results/results(3).csv new file mode 100644 index 000000000..a13018c5f --- /dev/null +++ b/Unpublished/NEW-RULE/negative/01/results/results(3).csv @@ -0,0 +1 @@ +Dataset,Record,Variable,Value diff --git a/Unpublished/NEW-RULE/negative/01/results/results(3).json b/Unpublished/NEW-RULE/negative/01/results/results(3).json new file mode 100644 index 000000000..941e4cb46 --- /dev/null +++ b/Unpublished/NEW-RULE/negative/01/results/results(3).json @@ -0,0 +1 @@ +{"Conformance_Details": {"Report_Generation": "2026-06-30T15:53:17", "Total_Runtime": "3.39 seconds", "CORE_Engine_Version": "0.16.0", "Issue_Limit_Per_Rule": "None", "Issue_Limit_Per_Dataset": "None", "Issue_Limit_Per_Sheet": null, "Standard": "SDTMIG", "Version": "V3.4", "CT_Version": "", "Define_XML_Version": null}, "Dataset_Details": [{"filename": "MH", "label": "Medical History", "path": "C:\\Users\\u818983\\Desktop\\CDISC Training\\Rule_authoring_cdisc_training\\cdisc-open-rules-training\\Unpublished\\NEW-RULE\\negative\\01\\data", "modification_date": "2026-05-19T12:16:59.298619", "size_kb": 0.49, "length": 6}, {"filename": "CM", "label": "Concomitant/Prior Medications", "path": "C:\\Users\\u818983\\Desktop\\CDISC Training\\Rule_authoring_cdisc_training\\cdisc-open-rules-training\\Unpublished\\NEW-RULE\\negative\\01\\data", "modification_date": "2026-05-19T14:13:57.219994", "size_kb": 0.754, "length": 6}], "Issue_Summary": [], "Issue_Details": [], "Rules_Report": []} \ No newline at end of file diff --git a/Unpublished/NEW-RULE/negative/01/results/results(4).csv b/Unpublished/NEW-RULE/negative/01/results/results(4).csv new file mode 100644 index 000000000..a13018c5f --- /dev/null +++ b/Unpublished/NEW-RULE/negative/01/results/results(4).csv @@ -0,0 +1 @@ +Dataset,Record,Variable,Value diff --git a/Unpublished/NEW-RULE/negative/01/results/results(4).json b/Unpublished/NEW-RULE/negative/01/results/results(4).json new file mode 100644 index 000000000..0302e0e41 --- /dev/null +++ b/Unpublished/NEW-RULE/negative/01/results/results(4).json @@ -0,0 +1 @@ +{"Conformance_Details": {"Report_Generation": "2026-06-30T16:21:52", "Total_Runtime": "3.03 seconds", "CORE_Engine_Version": "0.16.0", "Issue_Limit_Per_Rule": "None", "Issue_Limit_Per_Dataset": "None", "Issue_Limit_Per_Sheet": null, "Standard": "SDTMIG", "Version": "V3.4", "CT_Version": "", "Define_XML_Version": null}, "Dataset_Details": [{"filename": "MH", "label": "Medical History", "path": "C:\\Users\\u818983\\Desktop\\CDISC Training\\Rule_authoring_cdisc_training\\cdisc-open-rules-training\\Unpublished\\NEW-RULE\\negative\\01\\data", "modification_date": "2026-05-19T12:16:59.298619", "size_kb": 0.49, "length": 6}, {"filename": "CM", "label": "Concomitant/Prior Medications", "path": "C:\\Users\\u818983\\Desktop\\CDISC Training\\Rule_authoring_cdisc_training\\cdisc-open-rules-training\\Unpublished\\NEW-RULE\\negative\\01\\data", "modification_date": "2026-05-19T14:13:57.219994", "size_kb": 0.754, "length": 6}], "Issue_Summary": [], "Issue_Details": [], "Rules_Report": []} \ No newline at end of file diff --git a/Unpublished/NEW-RULE/negative/01/results/results.csv b/Unpublished/NEW-RULE/negative/01/results/results.csv new file mode 100644 index 000000000..a13018c5f --- /dev/null +++ b/Unpublished/NEW-RULE/negative/01/results/results.csv @@ -0,0 +1 @@ +Dataset,Record,Variable,Value diff --git a/Unpublished/NEW-RULE/positive/01/data/.env b/Unpublished/NEW-RULE/positive/01/data/.env new file mode 100644 index 000000000..15969bcf2 --- /dev/null +++ b/Unpublished/NEW-RULE/positive/01/data/.env @@ -0,0 +1,6 @@ +PRODUCT=SDTMIG +VERSION=3.4 +SUBSTANDARD= +USE_CASE= +DEFINE_XML= +CT= diff --git a/Unpublished/NEW-RULE/positive/01/data/_datasets.csv b/Unpublished/NEW-RULE/positive/01/data/_datasets.csv new file mode 100644 index 000000000..f916bfb0d --- /dev/null +++ b/Unpublished/NEW-RULE/positive/01/data/_datasets.csv @@ -0,0 +1,3 @@ +Filename,Label +cm,Concomitant/Prior Medications +mh,Medical History diff --git a/Unpublished/NEW-RULE/positive/01/data/_variables.csv b/Unpublished/NEW-RULE/positive/01/data/_variables.csv new file mode 100644 index 000000000..fe2725e51 --- /dev/null +++ b/Unpublished/NEW-RULE/positive/01/data/_variables.csv @@ -0,0 +1,31 @@ +dataset,variable,label,type,length +cm,STUDYID,Study Identifier,Char,12 +cm,DOMAIN,Domain Abbreviation,Char,2 +cm,USUBJID,Unique Subject Identifier,Char,8 +cm,CMSEQ,Sequence Number,Num,8 +cm,CMTRT,"Reported Name of Drug, Med, or Therapy",Char,200 +cm,CMINDC,Indication,Char,200 +cm,CMDOSE,Dose per Administration,Num,8 +cm,CMDOSU,Dose Units,Char,6 +cm,CMDOSFRQ,Dosing Frequency per Interval,Char,3 +cm,CMROUTE,Route of Administration,Char,24 +cm,EPOCH,Epoch,Char,9 +cm,CMSTDTC,Start Date/Time of Medication,Char,10 +cm,CMENDTC,End Date/Time of Medication,Char,10 +cm,CMSTDY,Study Day of Start of Medication,Num,8 +cm,CMENDY,Study Day of End of Medication,Num,8 +cm,CMENRTPT,End Relative to Reference Time Point,Char,7 +cm,CMENTPT,End Reference Time Point,Char,10 +mh,STUDYID,Study Identifier,Char,12 +mh,DOMAIN,Domain Abbreviation,Char,2 +mh,USUBJID,Unique Subject Identifier,Char,8 +mh,MHSEQ,Sequence Number,Num,8 +mh,MHTERM,Reported Term for the Medical History,Char,19 +mh,MHEVDTYP,Medical History Event Date Type,Char,13 +mh,MHSTDTC,Start Date/Time of Medical History Event,Char,10 +mh,MHSTDY,Study Day of Start of Observation,Num,8 +mh,MHENDTC,End Date/Time of Medical History Event,Char,50 +mh,MHENDY,Study Day of End of Observation,Num,8 +mh,MHENRTPT,End Relative to Reference Time Point,Char,50 +mh,MHENTPT,End Reference Time Point,Char,50 + diff --git a/Unpublished/NEW-RULE/positive/01/data/cm.csv b/Unpublished/NEW-RULE/positive/01/data/cm.csv new file mode 100644 index 000000000..15d7ae2f2 --- /dev/null +++ b/Unpublished/NEW-RULE/positive/01/data/cm.csv @@ -0,0 +1,6 @@ +STUDYID,DOMAIN,USUBJID,CMSEQ,CMTRT,CMINDC,CMDOSE,CMDOSU,CMDOSFRQ,CMROUTE,EPOCH,CMSTDTC,CMENDTC,CMSTDY,CMENDY,CMENRTPT,CMENTPT +CDISCPILOT01,CM,CDISC005,1,CENTRUM SILVER,PROPHYLAXIS OR NON-THERAPEUTIC USE,1,TABLET,,ORAL,SCREENING,2012-03,,,,ONGOING,2013-08-06 +CDISCPILOT01,CM,CDISC005,4,HYDROCORTISONE,PROPHYLAXIS OR NON-THERAPEUTIC USE,1,TABLET,,TOPICAL,TREATMENT,2013-05-14,,100,,BEFORE,2013-08-06 +CDISCPILOT01,CM,CDISC017,1,ACETAMINOPHEN,PROPHYLAXIS OR NON-THERAPEUTIC USE,2,TABLET,,ORAL,SCREENING,2008,,,,AFTER,2014-03-08 +CDISCPILOT01,CM,CDISC017,2,MULTIVITAMIN,PROPHYLAXIS OR NON-THERAPEUTIC USE,1,TABLET,,ORAL,SCREENING,2011-08,,,,,2014-03-08 +CDISCPILOT01,CM,CDISC017,3,VITAMIN E,PROPHYLAXIS OR NON-THERAPEUTIC USE,400,mg,,ORAL,SCREENING,2011-08,,,,,2014-03-08 \ No newline at end of file diff --git a/Unpublished/NEW-RULE/positive/01/data/mh.csv b/Unpublished/NEW-RULE/positive/01/data/mh.csv new file mode 100644 index 000000000..fa6e5582f --- /dev/null +++ b/Unpublished/NEW-RULE/positive/01/data/mh.csv @@ -0,0 +1,7 @@ +STUDYID,DOMAIN,USUBJID,MHSEQ,MHTERM,MHEVDTYP,MHSTDTC,MHSTDY,MHENDTC,MHENDY,MHENRTPT,MHENTPT +CDISCPILOT01,MH,CDISC001,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2004-05-28,-3108,,,,2021-05-01 +CDISCPILOT01,MH,CDISC002,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2010-03-19,-972,2010-03-21,-970,,2021-02-15 +CDISCPILOT01,MH,CDISC003,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2007-02-09,-2393,2007-02-09,-2393,,2015-05-09 +CDISCPILOT01,MH,CDISC004,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2010-11-05,-1068,,,,2011-06-11 + + diff --git a/Unpublished/NEW-RULE/positive/01/results/results(1).csv b/Unpublished/NEW-RULE/positive/01/results/results(1).csv new file mode 100644 index 000000000..a13018c5f --- /dev/null +++ b/Unpublished/NEW-RULE/positive/01/results/results(1).csv @@ -0,0 +1 @@ +Dataset,Record,Variable,Value diff --git a/Unpublished/NEW-RULE/positive/01/results/results(1).json b/Unpublished/NEW-RULE/positive/01/results/results(1).json new file mode 100644 index 000000000..9fa57ef93 --- /dev/null +++ b/Unpublished/NEW-RULE/positive/01/results/results(1).json @@ -0,0 +1 @@ +{"Conformance_Details": {"Report_Generation": "2026-05-19T14:14:49", "Total_Runtime": "2.94 seconds", "CORE_Engine_Version": "0.16.0", "Issue_Limit_Per_Rule": "None", "Issue_Limit_Per_Dataset": "None", "Issue_Limit_Per_Sheet": null, "Standard": "SDTMIG", "Version": "V3.4", "CT_Version": "", "Define_XML_Version": null}, "Dataset_Details": [{"filename": "CM", "label": "Concomitant/Prior Medications", "path": "C:\\Users\\u818983\\Desktop\\CDISC Training\\Rule_authoring_cdisc_training\\cdisc-open-rules-training\\Unpublished\\NEW-RULE\\positive\\01\\data", "modification_date": "2026-05-19T12:15:40.355492", "size_kb": 0.748, "length": 6}, {"filename": "MH", "label": "Medical History", "path": "C:\\Users\\u818983\\Desktop\\CDISC Training\\Rule_authoring_cdisc_training\\cdisc-open-rules-training\\Unpublished\\NEW-RULE\\positive\\01\\data", "modification_date": "2026-05-19T12:16:59.298619", "size_kb": 0.49, "length": 6}], "Issue_Summary": [], "Issue_Details": [], "Rules_Report": []} \ No newline at end of file diff --git a/Unpublished/NEW-RULE/positive/01/results/results(2).csv b/Unpublished/NEW-RULE/positive/01/results/results(2).csv new file mode 100644 index 000000000..a13018c5f --- /dev/null +++ b/Unpublished/NEW-RULE/positive/01/results/results(2).csv @@ -0,0 +1 @@ +Dataset,Record,Variable,Value diff --git a/Unpublished/NEW-RULE/positive/01/results/results(2).json b/Unpublished/NEW-RULE/positive/01/results/results(2).json new file mode 100644 index 000000000..f405ad536 --- /dev/null +++ b/Unpublished/NEW-RULE/positive/01/results/results(2).json @@ -0,0 +1 @@ +{"Conformance_Details": {"Report_Generation": "2026-06-30T14:12:48", "Total_Runtime": "3.28 seconds", "CORE_Engine_Version": "0.16.0", "Issue_Limit_Per_Rule": "None", "Issue_Limit_Per_Dataset": "None", "Issue_Limit_Per_Sheet": null, "Standard": "SDTMIG", "Version": "V3.4", "CT_Version": "", "Define_XML_Version": null}, "Dataset_Details": [{"filename": "CM", "label": "Concomitant/Prior Medications", "path": "C:\\Users\\u818983\\Desktop\\CDISC Training\\Rule_authoring_cdisc_training\\cdisc-open-rules-training\\Unpublished\\NEW-RULE\\positive\\01\\data", "modification_date": "2026-05-19T12:15:40.355492", "size_kb": 0.748, "length": 6}, {"filename": "MH", "label": "Medical History", "path": "C:\\Users\\u818983\\Desktop\\CDISC Training\\Rule_authoring_cdisc_training\\cdisc-open-rules-training\\Unpublished\\NEW-RULE\\positive\\01\\data", "modification_date": "2026-05-19T12:16:59.298619", "size_kb": 0.49, "length": 6}], "Issue_Summary": [], "Issue_Details": [], "Rules_Report": []} \ No newline at end of file diff --git a/Unpublished/NEW-RULE/positive/01/results/results(3).csv b/Unpublished/NEW-RULE/positive/01/results/results(3).csv new file mode 100644 index 000000000..a13018c5f --- /dev/null +++ b/Unpublished/NEW-RULE/positive/01/results/results(3).csv @@ -0,0 +1 @@ +Dataset,Record,Variable,Value diff --git a/Unpublished/NEW-RULE/positive/01/results/results(3).json b/Unpublished/NEW-RULE/positive/01/results/results(3).json new file mode 100644 index 000000000..8f238b706 --- /dev/null +++ b/Unpublished/NEW-RULE/positive/01/results/results(3).json @@ -0,0 +1 @@ +{"Conformance_Details": {"Report_Generation": "2026-06-30T16:21:28", "Total_Runtime": "2.12 seconds", "CORE_Engine_Version": "0.16.0", "Issue_Limit_Per_Rule": "None", "Issue_Limit_Per_Dataset": "None", "Issue_Limit_Per_Sheet": null, "Standard": "SDTMIG", "Version": "V3.4", "CT_Version": "", "Define_XML_Version": null}, "Dataset_Details": [{"filename": "CM", "label": "Concomitant/Prior Medications", "path": "C:\\Users\\u818983\\Desktop\\CDISC Training\\Rule_authoring_cdisc_training\\cdisc-open-rules-training\\Unpublished\\NEW-RULE\\positive\\01\\data", "modification_date": "2026-06-30T15:52:19.265747", "size_kb": 0.764, "length": 5}, {"filename": "MH", "label": "Medical History", "path": "C:\\Users\\u818983\\Desktop\\CDISC Training\\Rule_authoring_cdisc_training\\cdisc-open-rules-training\\Unpublished\\NEW-RULE\\positive\\01\\data", "modification_date": "2026-05-19T12:16:59.298619", "size_kb": 0.49, "length": 6}], "Issue_Summary": [], "Issue_Details": [], "Rules_Report": []} \ No newline at end of file diff --git a/Unpublished/NEW-RULE/positive/01/results/results.csv b/Unpublished/NEW-RULE/positive/01/results/results.csv new file mode 100644 index 000000000..a13018c5f --- /dev/null +++ b/Unpublished/NEW-RULE/positive/01/results/results.csv @@ -0,0 +1 @@ +Dataset,Record,Variable,Value diff --git a/Unpublished/NEW-RULE/rule.yml b/Unpublished/NEW-RULE/rule.yml new file mode 100644 index 000000000..cf158f360 --- /dev/null +++ b/Unpublished/NEW-RULE/rule.yml @@ -0,0 +1,76 @@ +Authorities: + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The description or date and/or time of a time point that acts as + a fixed reference for characterizing the end of an + observation. This is the sponsor-defined reference point + referred to by --ENRTPT. + Document: Model v2.0 + Item: --ENTPT + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0045 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifies the end of the observation as being before or after + the sponsor-defined reference time point defined by variable + --ENTPT. + Document: Model v1.7 + Item: Table 2.2.5.1 --ENTPT + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0045 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: (--ENRTPT) Identifies the end of the observation as being before + or after the sponsor-defined reference time point defined by + variable --ENTPT. + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0045 + Version: '1' + Version: '2.0' + Version: '3.2' + +Check: + all: + - operator: 'non_empty' + name: '--ENTPT' + - operator: 'empty' + name: '--ENRTPT' +Core: + Id: '' + Status: Draft + Version: '1' +Description: 'Raise an error when --Entpt is populated but --Enrtpt is not populated.' +Executability: Fully Executable +Outcome: + Message: '--ENRTPT must be populated when --ENTPT is populated.' + Output Variables: + - '--ENTPT' + - '--ENRTPT' +Rule Type: 'Record Data' +Scope: + Classes: + Include: + - ALL + Domains: + Include: + - ALL +Sensitivity: 'Record' diff --git a/cm.csv b/cm.csv new file mode 100644 index 000000000..ee0b43961 --- /dev/null +++ b/cm.csv @@ -0,0 +1,6 @@ +STUDYID,DOMAIN,USUBJID,CMSEQ,CMTRT,CMINDC,CMDOSE,CMDOSU,CMDOSFRQ,CMROUTE,EPOCH,CMSTDTC,CMENDTC,CMSTDY,CMENDY,CMENRTPT,CMENTPT +CDISCPILOT01,CM,CDISC005,1,CENTRUM SILVER,PROPHYLAXIS OR NON-THERAPEUTIC USE,1,TABLET,,ORAL,SCREENING,2012-03,,,,,2013-08-06 +CDISCPILOT01,CM,CDISC005,4,HYDROCORTISONE,PROPHYLAXIS OR NON-THERAPEUTIC USE,1,TABLET,,TOPICAL,TREATMENT,2013-05-14,,100,,,2013-08-06 +CDISCPILOT01,CM,CDISC017,1,ACETAMINOPHEN,PROPHYLAXIS OR NON-THERAPEUTIC USE,2,TABLET,,ORAL,SCREENING,2008,,,,,2014-03-08 +CDISCPILOT01,CM,CDISC017,2,MULTIVITAMIN,PROPHYLAXIS OR NON-THERAPEUTIC USE,1,TABLET,,ORAL,SCREENING,2011-08,,,,,2014-03-08 +CDISCPILOT01,CM,CDISC017,3,VITAMIN E,PROPHYLAXIS OR NON-THERAPEUTIC USE,400,mg,,ORAL,SCREENING,2011-08,,,,,2014-03-08 diff --git a/mh.csv b/mh.csv new file mode 100644 index 000000000..2f823c0bf --- /dev/null +++ b/mh.csv @@ -0,0 +1,5 @@ +STUDYID,DOMAIN,USUBJID,MHSEQ,MHTERM,MHEVDTYP,MHSTDTC,MHSTDY,MHENDTC,MHENDY,MHENRTPT,MHENTPT +CDISCPILOT01,MH,CDISC001,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2004-05-28,-3108,,,,2021-05-01 +CDISCPILOT01,MH,CDISC002,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2010-03-19,-972,2010-03-21,-970,,2021-02-15 +CDISCPILOT01,MH,CDISC003,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2007-02-09,-2393,2007-02-09,-2393,,2015-05-09 +CDISCPILOT01,MH,CDISC004,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2010-11-05,-1068,,,,2011-06-11