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ICH E3, Guidance for Industry, Structure and Content of Clinical Study Reports (available at http://www.ich.org/products/guidelines/), Section 9.1, calls for a brief, clear description of the overall plan and design of the study, and supplies examples of charts and diagrams for this purpose in Annex IIIa and Annex IIIb. Each Annex corresponds to an example trial, and each shows a diagram describing the study design and a table showing the schedule of assessments. TOBA-2 DONE The Trial Design Model provides a standardized way to describe those aspects of the planned conduct of a clinical trial TOBA-3 DONE shown in the study design diagrams of these examples. The standard Trial Design Datasets will allow reviewers to:

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