cdisc-org · PolinaVyniavska · May 19, 2026 · May 19, 2026
@@ -0,0 +1,3 @@
+PRODUCT=SDTMIG
+VERSION=3-4
+
@@ -0,0 +1,3 @@
+Filename,Label
+cm,Concomitant/Prior Medications
+mh,Medical History
@@ -0,0 +1,30 @@
+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
@@ -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
@@ -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
@@ -0,0 +1 @@
+Dataset,Record,Variable,Value
@@ -0,0 +1,2 @@
+PRODUCT=SDTMIG
+VERSION=3-4
@@ -0,0 +1,3 @@
+Filename,Label
+cm,Concomitant/Prior Medications
+mh,Medical History
@@ -0,0 +1,30 @@
+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
@@ -0,0 +1,7 @@
+STUDYID,DOMAIN,USUBJID,CMSEQ,CMTRT,CMINDC,CMDOSE,CMDOSU,CMDOSFRQ,CMROUTE,EPOCH,CMSTDTC,CMENDTC,CMSTDY,CMENDY,CMENRTPT,CMENTPT
+CDISCPILOT01,CM,CDISC004,1,VITAMIN C,PROPHYLAXIS OR NON-THERAPEUTIC USE,500,mg,,ORAL,SCREENING,1983,,,,ONGOING,2014-03-18
+CDISCPILOT01,CM,CDISC004,2,VITAMIN E,PROPHYLAXIS OR NON-THERAPEUTIC USE,400,mg,,ORAL,SCREENING,1983,,,,ONGOING,2014-03-18
+CDISCPILOT01,CM,CDISC007,1,METAMUCIL,PROPHYLAXIS OR NON-THERAPEUTIC USE,3,mg,,ORAL,SCREENING,2009,,,,ONGOING,2013-06-20
+CDISCPILOT01,CM,CDISC007,2,ADVIL,PROPHYLAXIS OR NON-THERAPEUTIC USE,200,mg,,ORAL,SCREENING,2011,,,,ONGOING,2013-06-20
+CDISCPILOT01,CM,CDISC007,3,DOCUSATE SODIUM,PROPHYLAXIS OR NON-THERAPEUTIC USE,100,mg,,ORAL,SCREENING,2012-11,2013-01-05,,1,,
+CDISCPILOT01,CM,CDISC007,4,BENADRYL,PROPHYLAXIS OR NON-THERAPEUTIC USE,75,mg,,ORAL,SCREENING,2013-02-18,2013-05-10,45,126,ONGOING,
@@ -0,0 +1,5 @@
+STUDYID,DOMAIN,USUBJID,MHSEQ,MHTERM,MHEVDTYP,MHSTDTC,MHSTDY,MHENDTC,MHENDY,MHENRTPT,MHENTPT
+CDISCPILOT01,MH,CDISC009,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2008-09-02,-1511,,,ONGOING,2021-05-04
+CDISCPILOT01,MH,CDISC010,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2012-09-08,-378,,,ONGOING,2021-05-05
+CDISCPILOT01,MH,CDISC011,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2002-12-01,-3659,,,ONGOING,2021-05-06
+CDISCPILOT01,MH,CDISC012,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2009-03-16,-1632,,,,
@@ -0,0 +1 @@
+Dataset,Record,Variable,Value
@@ -0,0 +1,75 @@
+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 and --ENRTPT is not populated.'
+Executability: Fully Executable
+Outcome:
+  Message: '--ENTPT is populated, but --ENRTPT is not populated.'
+  Output Variables:
+    - '--ENTPT'
+    - '--ENRTPT'
+Rule Type: 'Record Data'
+Scope:
+  Classes:
+    Include:
+      - ALL
+  Domains:
+    Include:
+      - ALL
+Sensitivity: 'Record'