Difference between revisions of "Top 20 Validation Rule Failures (CBER)"

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Revision as of 00:45, 21 May 2012

SDTM Compliance

Rule Problem Proposed Solution Status Assignee Discussion
SD0002: Null value in variable marked as Required Under Review TBD Comment
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
SD0007: Inconsistent value for Standard Units Under Review TBD Comment
SD0026: Missing value for --ORRESU, when --ORRES is provided 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
SD0035: Missing value for --DOSU, when --DOSE, --DOSTXT or --DOSTOT is provided Under Review TBD Comment
SD0063: SDTM/dataset variable label mismatch Under Review TBD Comment
SD0070: No Exposure record found for subject Under Review TBD Comment
SD0080: AE start date is after the latest Disposition date Under Review TBD Comment
SD0081: Observation date is after the latest Disposition date Under Review TBD Comment
SD0087: RFSTDTC is not provided for a randomized subject Under Review TBD Comment
SD0088: RFENDTC is not provided for a randomized subject Under Review TBD Comment

Terminology Compliance

Rule Problem Proposed Solution Status Assignee Discussion
CT0027: Value for --OUT not found in (OUT) CT codelist Under Review TBD Comment
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
Under Review TBD Comment

Define.xml Compliance

Rule Problem Proposed Solution Status Assignee Discussion
DD0010: ODM attribute should not be included in Define.xml Under Review TBD Comment
DD0024: Invalid Codelist for variable Under Review TBD Comment

Other

Rule Problem Proposed Solution Status Assignee Discussion
SKIP_xxnnnn: SKIP messages Indicate that a domain (ex: DM) is missing and cannot be used for cross-dataset validation This is extraneous information and should be hidden from the user Under Review OpenCDISC N/A



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Last revision by Mkanevsky on 05/21/2012