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SDTM Theory and Application for Human Clinical Trials (as of SDTM v1.4 & SDTMIGv3.2)

On Demand

Course Schedule: 26-30 Oct (12-3pm US ET each day; total of 15 instruction hours). 

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

This course roughly covers information in standards documentation as of SDTMv1.4 & SDTMIG v3.2. If there is a disparity of information, please ask the instructor during the training.

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