Dear P21 Team,
no urgent request, but I am curious if there are any plans to react to the following situation (in terms of validation rules), and if so, how:
(1) FDA: Latest applicable and approved SDTM-IG is v3.4, requiring usage of non-extensible codelists ETHNIC (C66790) for DM.ETHNIC and RACE (C74457) for DM.RACE.
(2) In the latest release of SDTM-CT (2026-03-27), both CT codelists mentioned are deprecated and have completely been removed.
Thanks in advance and Kind regards,
Harald
Hi Harald,
This issue is still under internal discussion.
My understanding is that CDISC decided to remove RACE and ETHNIC codelists as USA-centric.
We try to clarify if FDA still want to use and enforce RACE and ETHINC Controlled Terminology or decide to ignore it. The challenge is to confirm that all FDA stakeholders are involved in this decision.
Pinnacle 21 provides support for regulatory submissions of study data. We will do implementation of our validation tool per FDA requirements.
Kind Regards,
Sergiy