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SDTM Global Working Group Update 1.2

Get the latest updates on SDTM. No major changes. New domains, variables, etc. in line with previous version. Discussing HL7 with ongoing talks. SDS team awaiting FDA approval. Join the SDTM Workstream for knowledge management and insights on program management.

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SDTM Global Working Group Update 1.2

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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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