Most of them have the doubts about what the clinical trial protocol is. It is nothing but the document filled with the contents about the trial design to obtain the conformation from the panel of experts in spite of being conducted in different countries. What does it contain?
Clinical trial protocol describes the scientific rationale, objective(s), design, methodology, statistical considerations, and organization of the planned trial. The investigator brochure of the clinical protocol adds all the supporting documents for the details mentioned in the clinical trial protocol. The detailed study plan in the protocol assures the safety of the participants besides providing investigators a template for the trial. It also details the list of administrators, researchers and other team responsible for handling the clinical trial. The format of the clinical trial protocol sponsored by pharmaceutical, biotechnology or medical device companies.
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