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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.

Concepts specific to the Trial Design Model and subsequent datasets are described below. When concepts or aspects of concepts are related to either Nonclinical or Product Impact on Individual Health use cases but not both, this is denoted in the Description column.  

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