Proposed SDTM Submission Exceptions

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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.

Tasks

  • 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

Proposed SDTM Submission Exceptions


Deliverables