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Chapter 1 - clinical refers to the section of a clinical trial protocol that outlines the objectives, design, methodology, and organization of the trial.
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Chapter 1 - clinical is typically filled out by the principal investigator in collaboration with the sponsor following the guidelines set forth in the protocol document.
The purpose of chapter 1 - clinical is to provide a comprehensive overview of the clinical trial including its objectives, design, methodology, and organization.
Chapter 1 - clinical must report details such as the trial objectives, design, methodology, study population, inclusion/exclusion criteria, and study procedures.
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