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. 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.
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. Concepts specific to Trial Design datasets
and recommended steps for working through the design of a trial are also provided in this section.
Overview
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