The Trial Summary (TS) dataset allows the applicant to submit a summary of the study in a structured format. The TS dataset contains information about the planned study characteristics, identical for all study subjects, which is usually found in the protocol. Each record in the TS dataset contains the value of a parameter, a characteristic of the study, or study level information. For example, TS is used to record basic information about the study such as study title, study type, and GLP status.
Example: Simple Parallel Design With Recovery
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Example: Crossover Design (Latin Square)
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Overview
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