Top 20 Validation Rule Failures (CBER)

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The purpose of this project is to evaluate the top 20 validation rule failures experienced at CBER. The goals is to determine the cause and coordinate with CDISC, OpenCDISC, and FDA to find and propose a solution. Typically a rule failure is due to any number of the following factors:

  • Bad or incorrectly implemented rule
  • Unclear or conflicting underlying standards
  • Lack of understanding


Discussion Topics

  • Action Item Updates
  1. Add date of external communication to Wiki – completed
  2. Update on progress of change control board for changes to OpenCDISC
  • Charter completed
  • Request for members due by end of August
  • Stand up operational by Sept.

SDTM Compliance

Rule Problem Proposed Solution Status Assignee Date 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 Jul 30, 2012 Comment
SD0007: Inconsistent value for Standard Units Under Review TBD Comment
SD0026: Missing value for --ORRESU, when --ORRES is provided Not all tets have units Identify tests with no units and update rule implementation Under Review TBD Comment
SD0029: Missing value for --STRESU, when --STRESC is provided Not all tets have units Identify tests with no units and update rule implementation 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
  • Follow on studies, exposure occurred in first study
  • Randomized not treated (high risk trials – subjects die before treatment)
  • Not identified as screen failure
  • Phase 0 study looking at population, no exposure (gene/biomarker), used to select population for exposure
Need to clarify rule Under Review TBD Comment
SD0080: AE start date is after the latest Disposition date
  • May be a partial date issue
  • No disposition date or date is missing
  • May need business rule for example: Followed 30 days post exposure
Need to clarify rule 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 Date 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 Date Discussion
DD0010: ODM attribute should not be included in Define.xml Likely a lack of understanding by the users Need to clarify CDISC documentation and rule Under Review TBD Jul 30, 2012 Comment
DD0024: Invalid Codelist for variable Effects non-extensible codelists in legacy studies Clarify CDISC documentation Under Review TBD Comment

Other

Rule Problem Proposed Solution Status Assignee Date 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 Jul 30, 2012 N/A



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Last revision by Hany.aboutaleb on 09/24/2012