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The purpose of the SDTM Trial Design Model datasets is to represent a brief, clear description of the overall plan and design of a clinical trial or nonclinical study. studies of tobacco products. Trial Design datasets contain study-level, rather than subject-level, information. Implementation of The 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:

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 described in the protocol. 

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". The TIG guides implementation of the Trial Design datasets described in the following table for use cases as indicated.