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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

 

Current Course Material Used: 
SDTM v1.4, SDTMIG v3.2, SDTM Exercises
Prerequisites: 

Recommendation: A basic understanding of relational database design and clinical data flow is helpful but not required.

Course Length: 
2 Days
Course Type: 
Public, Private, Licensed