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The TIG guides implementation for the following Trial Design datasets:
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- 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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