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The purpose of Trial Design Model datasets is to represent a brief, clear description of the overall plan and design of a clinical trial or nonclinical study. Trial Design datasets contain study-level, rather than subject-level, information. Implementation of Trial Design datasets requires the explicit statement of certain decision rules that may not be addressed or may not be as explicit in the textual description of a study plan such as an approved study protocol or study plan.

Concepts specific to the Trial Design Model are: