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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 only to TIG Nonclinical and Product Impact on Individual Health use cases. In this section, the term "trial" is equivalent to "study" in the nonclinical context. 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.

The TIG guides implementation for the following Trial Design datasets: 

• Trial Arms: Describes the sequences of elements in each epoch for each arm, and thus describes the complete sequence of elements in each arm
• Trial Elements: Describes the elements used in the trial
• Trial Visits: Describes the planned schedule of visits
• Trial Inclusion/Exclusion Criteria: Describes the criteria used to screen subjects
• Trial Summary: Lists key facts (parameters) about the trial that are likely to appear in a registry of clinical trials

Concepts specific to the Trial Design Model and subsequent datasets are described below. When concepts or aspects of concepts are related to either nonclinical studies or clinical trials but not both, this is denoted in the Description column.  

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