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

• 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