Versions Compared

Old Version 55

changes.mady.by.user Christine Connolly

Saved on

compared with

New Version 56

changes.mady.by.user Christine Connolly

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

The purpose of the SDTM Trial Design Model is to represent a brief, clear description of the overall plan and design of a nonclinical study or clinical trial. Trial Design datasets contain study-level, rather than subject-level, information. Guidance in this section is applicable to TIG Nonclinical and Product Impact on Individual Health use cases only. In this section, the term "trial" is equivalent to "study" in the nonclinical context. The TIG guides implementation of the Trial Design datasets described in the table below for use cases as indicated. 

...