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

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
Comment

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