sdtm global working group
DESCRIPTION
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. - PowerPoint PPT PresentationTRANSCRIPT
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