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
German Speaking CDISC UG, 22-Sep-2011
1
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
German Speaking CDISC UG, 22-Sep-2011
2
Document Walk-through
CDER Common Data Standards Issues Document Marked.pdf
German Speaking CDISC UG, 22-Sep-2011
3
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?
German Speaking CDISC UG, 22-Sep-2011
4