CG0045 create

Unpublished/NEW-RULE/negative/01/data/.env

@@ -0,0 +1,2 @@
+PRODUCT=SDTMIG
+VERSION=3-4

Unpublished/NEW-RULE/negative/01/data/_datasets.csv

@@ -0,0 +1,2 @@
+Filename,Label
+cm,Concomitant/Prior Medications

Unpublished/NEW-RULE/negative/01/data/_variables.csv

@@ -0,0 +1,18 @@
+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

Unpublished/NEW-RULE/negative/01/data/cm.csv

@@ -0,0 +1,12 @@
+STUDYID,DOMAIN,USUBJID,CMSEQ,CMTRT,CMINDC,CMDOSE,CMDOSU,CMDOSFRQ,CMROUTE,EPOCH,CMSTDTC,CMENDTC,CMSTDY,CMENDY,CMENRTPT,CMENTPT
+CDISCPILOT01,CM,CDISC003,1,ADVIL,PROPHYLAXIS OR NON-THERAPEUTIC USE,2,TABLET,,ORAL,SCREENING,2010,,,,ONGOING,2014-02-13
+CDISCPILOT01,CM,CDISC003,2,MULTIVITAMINS,PROPHYLAXIS OR NON-THERAPEUTIC USE,1,TABLET,,ORAL,SCREENING,2010,,,,ONGOING,2014-02-13
+CDISCPILOT01,CM,CDISC003,3,EXCEDRIN,PROPHYLAXIS OR NON-THERAPEUTIC USE,2,TABLET,,ORAL,SCREENING,2011,,,,ONGOING,2014-02-13
+CDISCPILOT01,CM,CDISC003,4,METAMUCIL,PROPHYLAXIS OR NON-THERAPEUTIC USE,2,TABLET,,ORAL,SCREENING,2012-03-01,,-546,,ONGOING,2014-02-13
+CDISCPILOT01,CM,CDISC003,5,NEO-SYNEPHRINE,PROPHYLAXIS OR NON-THERAPEUTIC USE,1,TABLET,,NASAL,TREATMENT,2013-09-01,2013-09-30,4,33,,
+CDISCPILOT01,CM,CDISC003,6,PSEUDOEPHEDRINE HYDROCHLORIDE,PROPHYLAXIS OR NON-THERAPEUTIC USE,2,TABLET,,ORAL,TREATMENT,2013-09-02,2013-09-30,5,33,,
+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

Unpublished/NEW-RULE/negative/01/results/results.csv

@@ -0,0 +1,11 @@
+Dataset,Record,Variable,Value
+CM,7,CMENRTPT,null
+CM,7,CMENTPT,2013-08-06
+CM,8,CMENRTPT,null
+CM,8,CMENTPT,2013-08-06
+CM,9,CMENRTPT,null
+CM,9,CMENTPT,2014-03-08
+CM,10,CMENRTPT,null
+CM,10,CMENTPT,2014-03-08
+CM,11,CMENRTPT,null
+CM,11,CMENTPT,2014-03-08

Unpublished/NEW-RULE/negative/02/data/.env

@@ -0,0 +1,2 @@
+PRODUCT=SDTMIG
+VERSION=3-4

Unpublished/NEW-RULE/negative/02/data/_datasets.csv

@@ -0,0 +1,2 @@
+Filename,Label
+mh,Medical History

Unpublished/NEW-RULE/negative/02/data/_variables.csv

@@ -0,0 +1,13 @@
+dataset,variable,label,type,length
+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

Unpublished/NEW-RULE/negative/02/data/mh.csv

@@ -0,0 +1,9 @@
+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
+CDISCPILOT01,MH,CDISC005,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2006-08-20,-2360,,,,2000-06-11
+CDISCPILOT01,MH,CDISC006,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2008-06-17,-1736,,,,2021-05-01
+CDISCPILOT01,MH,CDISC007,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2008-05-21,-1690,2008-05-26,-1685,,2021-05-02
+CDISCPILOT01,MH,CDISC008,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2012-11-11,-546,2012-11-11,-546,,2021-11-23

Unpublished/NEW-RULE/negative/02/results/results.csv

@@ -0,0 +1,17 @@
+Dataset,Record,Variable,Value
+MH,1,MHENRTPT,null
+MH,1,MHENTPT,2021-05-01
+MH,2,MHENRTPT,null
+MH,2,MHENTPT,2021-02-15
+MH,3,MHENRTPT,null
+MH,3,MHENTPT,2015-05-09
+MH,4,MHENRTPT,null
+MH,4,MHENTPT,2011-06-11
+MH,5,MHENRTPT,null
+MH,5,MHENTPT,2000-06-11
+MH,6,MHENRTPT,null
+MH,6,MHENTPT,2021-05-01
+MH,7,MHENRTPT,null
+MH,7,MHENTPT,2021-05-02
+MH,8,MHENRTPT,null
+MH,8,MHENTPT,2021-11-23

Unpublished/NEW-RULE/positive/01/data/.env

@@ -0,0 +1,2 @@
+PRODUCT=SDTMIG
+VERSION=3-4

Unpublished/NEW-RULE/positive/01/data/_datasets.csv

@@ -0,0 +1,2 @@
+Filename,Label
+cm,Concomitant/Prior Medications

Unpublished/NEW-RULE/positive/01/data/_variables.csv

@@ -0,0 +1,18 @@
+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

Unpublished/NEW-RULE/positive/01/data/cm.csv

@@ -0,0 +1,11 @@
+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,
+CDISCPILOT01,CM,CDISC007,5,PREDNISONE,PROPHYLAXIS OR NON-THERAPEUTIC USE,20,mg,,ORAL,SCREENING,2013-02-18,2013-05-10,45,126,,
+CDISCPILOT01,CM,CDISC007,6,TEMOVATE,PROPHYLAXIS OR NON-THERAPEUTIC USE,1,TABLET,,TOPICAL,SCREENING,2013-02-18,2013-02-20,45,47,,
+CDISCPILOT01,CM,CDISC011,1,MOTRIN,PROPHYLAXIS OR NON-THERAPEUTIC USE,400,mg,,ORAL,SCREENING,1998-10,2013-06-05,,181,,
+CDISCPILOT01,CM,CDISC011,2,PRINIVIL,PROPHYLAXIS OR NON-THERAPEUTIC USE,10,mg,,ORAL,SCREENING,2011-07-15,2013-06-05,-511,181,,

Unpublished/NEW-RULE/positive/01/results/results.csv

@@ -0,0 +1 @@
+Dataset,Record,Variable,Value

Unpublished/NEW-RULE/positive/02/data/.env

@@ -0,0 +1,2 @@
+PRODUCT=SDTMIG
+VERSION=3-4

Unpublished/NEW-RULE/positive/02/data/_datasets.csv

@@ -0,0 +1,2 @@
+Filename,Label
+mh,Medical History

Unpublished/NEW-RULE/positive/02/data/_variables.csv

@@ -0,0 +1,13 @@
+dataset,variable,label,type,length
+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

Unpublished/NEW-RULE/positive/02/data/mh.csv

@@ -0,0 +1,10 @@
+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,,,,
+CDISCPILOT01,MH,CDISC013,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2011-07-19,-734,,,ONGOING,2013-10-24
+CDISCPILOT01,MH,CDISC014,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2011-07-25,-618,2011-07-26,-617,,
+CDISCPILOT01,MH,CDISC016,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2011-04-29,-705,2011-04-29,-705,,
+CDISCPILOT01,MH,CDISC017,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2008-08-20,-1858,2008-08-20,-1858,,
+CDISCPILOT01,MH,CDISC018,1,ALZHEIMER'S DISEASE,SYMPTOM ONSET,2010-05-03,-959,2010-05-03,-959,,

Unpublished/NEW-RULE/positive/02/results/results.csv

@@ -0,0 +1 @@
+Dataset,Record,Variable,Value

Unpublished/NEW-RULE/rule.yml

@@ -0,0 +1,96 @@
+# Variable: --ENRTPT
+# Condition: --ENTPT ^= null
+# Rule: --ENRTPT ^= null
+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'
+      - Name: TIG
+        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: SDTM v2.1
+                Item: --ENTPT
+                Section: Section 3.1.5 Timing Variables for All Classes
+            Origin: TIG Conformance Rules
+            Rule Identifier:
+              Id: TIG0324
+              Version: '1'
+            Version: '1.0'
+        Substandard: SDTM
+        Version: '1.0'
+Check:
+  all:
+    - name: --ENTPT
+      operator: non_empty
+    - name: --ENRTPT
+      operator: empty
+Core:
+  Id: CORE-000106
+  Status: Published
+  Version: '1'
+Description: Raise an error when --ENTPT is completed and --ENRTPT is not completed.
+Executability: Fully Executable
+Outcome:
+  Message: --ENTPT is completed, but --ENRTPT is not completed.
+  Output Variables:
+    - --ENRTPT
+    - --ENTPT
+Rule Type: Record Data
+Scope:
+  Classes:
+    Include:
+      - ALL
+  Domains:
+    Include:
+      - ALL
+  Use Case: INDH, PROD
+Sensitivity: Record