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SDTM Global Working Group

SDTM Global Working Group. Version 1.2 / IG 3.1.2 ready for release No major changes vs version 1.0 / IG 3.1.1 New domains, variables, etc. in line with previous version HL7: discussions ongoing – no impact on our current daily work SDS team waiting on FDA – 6 months…?. SDTM Workstream.

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SDTM Global Working Group

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  1. SDTM Global Working Group • Version 1.2 / IG 3.1.2 ready for release • No major changes vs version 1.0 / IG 3.1.1 • New domains, variables, etc. in line with previous version • HL7: discussions ongoing – no impact on our current daily work • SDS team waiting on FDA – 6 months…?

  2. SDTM Workstream • 1 TC so far • Knowledge management • Program today: • Managing SDTM across studies • How to use trial design domains • How to manage CRO’s using our company standards

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