Define protocol in clinical research. Explain in detail process of protocol design and development.
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Protocol development and complexity depends greatly upon the type of clinical study being conducted. ... A research protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project.
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Trial Objectives and Purpose: A detailed description of the objectives and the purpose of the trial. Trial Design: The scientific integrity of the trial and the credibility
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