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Documents Evolution of SDTM Submission Standards FDA CDER Common Data Standards Issues Tina Apers CRO Manager....

Slide 1Evolution of SDTM Submission Standards FDA CDER Common Data Standards Issues Tina Apers CRO Manager Business & Decision Life Sciences Tel +32 2 774 11 00 Fax +32…

Documents Quick tour of CDISC’s ADaM standard 1. FDA/PHuSE ADaM Kick off Meeting 2.

Slide 1Quick tour of CDISC’s ADaM standard 1 Slide 2 FDA/PHuSE ADaM Kick off Meeting 2 Slide 3 Location in the CDISC Standards 3 Slide 4 Clinical trial data and information…