Report from SDS: SDTMIG 4.0

About this session

Part of Session 4, Track A: Foundational Standards - SDS (Chair: Erin Muhlbradt, NIH/NCI).

2: SDTM Implementation Guide 4.0
Version 4.0 of the SDTMIG is now in the publication process. We review the changes since version 3.4, including domains added after the initial review process and the split of clinical classifications from disease response assessments.
Following these releases, the primary focus of the SDS team activites will be shifting from revising existing standard documents to supporting the development of more complete digital standards, including biomedical concepts, as part of the larger CDISC 360i project. This presentation will discuss the new activities that the SDS team will be undertaking in the months and years to come.

Speaker

• MS

  Maria Sekac

  Merck

  Speaker