SDTM Theory and Application
The Study Data Tabulation Model (SDTM) is a specification for the submission of pre-clinical and clinical data to the U.S. Food and Drug Administration in support of marketing applications.
This two-day course consists of:
- A detailed review of SDTM concepts, SDTM-based domain models for human clinical data, relationship tables, and trial design
- A discussion of common implementation issues
- Exercises including the annotation of CRFs and the creation of datasets that reinforce attendees' understanding of the SDTM and the SDTM Implementation Guide for clinical data
Recommendation: A basic understanding of relational database design and clinical data flow is helpful but not required.