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. The Trial Design datasets (TE, TA, TX, TS) based on the Trial Design Model describe the planned design of the study, and provide the representation of the study product in its most granular components, as well as the representation of all sequences of these components as descripted in the protocol. The TA and TE datasets are interrelated, and they provide the building blocks for the development of actual 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.
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