1. German Speaking CDISC UG, 22-Sep-20111 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. German Speaking CDISC UG, 22-Sep-20112 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. German Speaking CDISC UG, 22-Sep-20113 Document Walk-through CDER Common Data Standards Issues Document Marked.pdf

4. German Speaking CDISC UG, 22-Sep-20114 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?