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SEND

Purpose

The The purpose of the SDTM Trial Design Model in the SENDIG provides a standardized way to describe those aspects of the planned conduct of a nonclinical study, as shown in the study design diagram examples within this section. The Trial Design Model in the SENDIG is equivalent to the Trial Design Model within the SDTMIG for clinical trials. is to represent a brief, clear description of the overall plan and design of studies of tobacco products. Trial Design datasets contain study-level, rather than subject-level, information. Note that generally the term "trial" is equivalent to "study" in the nonclinical context. In addition, "subjects" are equivalent to "animals."
The Trial Design Datasets will allow:

• Clear and quick understanding of the design of nonclinical studies (or trials)
• Comparison of the designs of different studies (or trials)
• Comparison of planned and actual treatments and sponsor-defined groups for subjects (or animals) in a study (or trial)

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The Trial Design datasets 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.