Proposed SDTM Submission Exceptions
Overview & Scope
REV-30: Sponsors often include unnecssary operational content that should not be submitted (e.g. subject initials) in sponsor-defined domains, core domain variables, supplemental qualifiers or FA.
The scope of this project is to determine elements of data which are acceptable not to include in SDTM submissions. Either a guidance document or list will be create and reviewed with CDER/CBER for approval.
- Review and modify proposed list from FDA/PhUSE Anunual Computational Science/Symposium
- Create document for proposal and finalize
- Send document to FDA for review/approval
- Update/finalize document
- Decide best way to share with Industry
Proposed SDTM Submission Exceptions Examples