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CDER Common Data Standards Issues Document

CDER Common Data Standards Issues Document. Motivation CDISC submissions received varied more than expected Contents Current FDA‘s preferences/recommendation for SDTM/ADaM More guidance on SDTM implementation than ADaM DIA Webinar with CDER And CBER representatives Mainly Q&A

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CDER Common Data Standards Issues Document

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  1. CDER Common Data Standards Issues Document • Motivation • CDISC submissions received varied more than expected • Contents • Current FDA‘s preferences/recommendation for SDTM/ADaM • More guidance on SDTM implementation than ADaM • DIA Webinar with CDER And CBER representatives • Mainly Q&A • More answers on SDTM than on ADaM • Document is under Revision • to be updated periodically

  2. Key Messages • SDTM is best considered early • Just legacy conversion of raw data to SDTM is not good enough • Ensure traceability between data and results • ADaM ADSL is considered mandatory • Provide a define.pdf along with the define.xml • some reviewers insist that the data definition document should be printable • Discuss with FDA specific submission requirements

  3. Document Walk-through • CDER Common Data Standards Issues Document Marked.pdf

  4. Points for Discussion • What do you do in your current projects? • Implement Draft Amendment to SDTM V1.2? • No/Yes/Parts of it and Why? • Implement other Recommendations? Any changes needed? • define.xml + define.pdf? • EPOCH, ELEMENT, ETCD? • Dictionary Versions (e.g., MedDRA)? • Splitting of (SDTM) Datasets? What to submit and document in define? • --BLFL, --DY, --STDY, --ENDY? • Process to ensure traceability in legacy conversion projects? • ADaM implementation? If yes, source for ADaM? • Define schema validation? • Did you submit comments to the FDA? • Any recent experiences with FDA?

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