WG1 CAB/VP and OpenCDISC Rules Reconciliation Results

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CAB Row OC Rule ID OC Severity OpenCDISC v1.3 Rule Description Action(s) To
36 SD0031 Warning Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL, when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL Send this rule to the Top 20 Validation Rule Failures project team for further discussion. Amy
76 SD0081 Warning Date/Time of Collection (--DTC) should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC) Send this rule to the Top 20 Validation Rule Failures project team for further discussion. Amy
40 SD0035 Error Dose Units (--DOSU) must be populated, when Dose per Administration (--DOSE) or Dose Description (--DOSTXT) is provided 1. Sergiy to update rule Description on v1.3 OpenCDISC list to add DOSTOT. 2. Send this rule to the SDS Team to confirm what can appear in DOSTXT according to the IG. Should DOSTXT just contain dosage amounts? SDS
43 SD0040 Warning All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD) Send this rule to the SDS Team to clarify what the IG should say regarding the uniqueness of these one-to one relationships SDS
49 SD0046 Warning All values of Qualifier Variable Label (QLABEL) should be the same for a given value of Qualifier Variable Name (QNAM) Send this rule to the SDS Team to clarify what the IG should say regarding the uniqueness of these one-to one relationships SDS
New Rule Error When either Start Reference Time Point (--STTPT) or Start Relative to Reference Time Point (--STRTPT) is present, then both must be present. Send to WG1 arbitration board to add this new rule as an Error. AB
New Rule Error When either End Reference Time Point (--ENTPT) or End Relative to Reference Time Point (--ENRTPT) is present, then both must be present. Send to WG1 arbitration board to add this new rule as an Error. AB
60 SD0057 Warning Variables described in SDTM as Expected should be included in the dataset Send to WG1 arbitration board to be changed to an Error. AB
61 SD0058 Warning Only variables listed in SDTM should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified Send to WG1 arbitration board to be changed to an Error. AB
88 SD0093 Warning Age Units (AGEU) should be provided, when Age (AGE) is populated Send to WG1 arbitration board to be changed to an Error. AB
89 New Rule  ? EPOCH should not be populated when DSCAT = "PROTOCOL MILESTONE" Send to WG1 arbitration board to be added as a new rule. AB
108 New Rule  ? AEOCCUR, AESTAT and AEREASND are not permitted on the AE domain. Send to WG1 arbitration board to be added as a new rule. AB
119 New Rule Notice As long as no data was collected for Permissible variables, a sponsor is free to drop them from the dataset Send to WG1 arbitration board to be added as a new rule as Notice: "All values for a permissable variable are not populated. Delete this variable from the dataset" Note: This rule will fire once per variable per domain. AB
134 New Rule  ? Study Day variable(--DY) is not null but the variables required for the calculation (DM.RFSTDTC and --DTC) are not complete. Send to WG1 arbitration board to be added as a new rule. AB
134 New Rule  ? Study Day variable(--STDY) is not null but the variables required for the calculation (DM.RFSTDTC and --STDTC) are not complete. Send to WG1 arbitration board to be added as a new rule. AB
134 New Rule  ? Study Day variable(--ENDY) is not null but the variables required for the calculation (DM.RFSTDTC and --ENDTC) are not complete. Send to WG1 arbitration board to be added as a new rule. AB
143 SD1053 Warning Records for subjects who failed a screening or were not assigned to study treatment (ARMCD is 'SCRNFAIL' or 'NOTASSGN') should not be included in the Trial Arms (TA) or Trial Visits (TV) datasets Send to WG1 arbitration board. Change wording of this rule to: "ARMCD of "SCRNFAIL" or "NOTASSGN" should not be included in Trial Arms (TA) and Trial Visits (TV) datasets. AB
152 New Rule  ? RelationshipType (RELTYPE) populated as 'ONE' must not have more than one record present in the RDOMAIN with the corresponding IDVAR. Send to WG1 arbitration board to be added as a new rule. AB
156 New Rule  ? A DATE/TIME OF COLLECTION is available, but the STUDY DAY OF VISIT/COLLECTION/EXAM is missing. Send to WG1 arbitration board to be added as a new rule. AB
157 New Rule  ? If both start date of observation and reference date are populated with complete dates, then --STDY should be populated. Send to WG1 arbitration board to be added as a new rule. AB
158 New Rule  ? If both end date of observation and reference date are populated with complete dates, then --ENDY should be populated. Send to WG1 arbitration board to be added as a new rule. AB
160 New Rule  ? Check if there are no other variables added to the CO domain, except when [RDOMAIN is null] for VISIT, VISITNUM, VISITDY, TAETORD, CODY, COTPT, COTPTNUM, COELTM, COTPTREF, CORFTDTC Send to WG1 arbitration board to be added as a new rule. AB
167 New Rule  ? If a value is present for IDVAR or IDVARVAL then a value must be present in RDOMAIN Send to WG1 arbitration board to be added as a new rule. AB