Top 20 Validation Rule Failures (CBER)

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SDTM Compliance

Rule Problem Proposed Solution Status Assigned To Discussion
SD0006: No baseline result in [Domain] for subject SDTM requires baseline for EG, LB, QS, VS, not all TEST have a baseline Validation rule and standard needs to align with use cases Under Review TBD Comment
SD0029: Missing value for --STRESU, when --STRESC is provided Under Review TBD Comment
SD0031: Missing values for --STDTC and --STRF, when --ENDTC or --ENRF is provided Data collection issue. In some cases caused by imputation of dates for ISO8601. Obtain understanding of how this check fires Under Review TBD Comment
SD0081: Observation date is after the latest Disposition date Under Review TBD Comment

Terminology Compliance

Rule Problem Proposed Solution/Action Items Discussion
CT0037: Value for --BODSYS not found in (SOC) CT codelist Case sensitivity mis-match between CDISC Terminology and MedDRA
  • Ask CDISC team to change Terminology Codelist according to MedDRA SOC Terms, or
  • Use MedDRA SOC codelist for validation rather than C66783 codelist of CDISC Terminology

Define.xml Compliance

DD0010: ODM attribute should not be included in Define.xml

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Last revision by Mkanevsky on 05/18/2012