Trial Summary Dataset: An Overview
May01

Trial Summary Dataset: An Overview

The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) Trial Summary dataset has become increasingly useful to reviewers.  The Trial Summary (TS) dataset allows the sponsor to submit a high-level overview of the trial in a structured format. Each record in the Trial Summary dataset contains the value of a parameter, a characteristic of the trial. For example, a Trial Summary dataset is used to record basic information about the study such as trial phase, protocol title, and trial objectives. The Trial Summary dataset contains information about the planned and actual trial characteristics.

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