Clinical Trial Protocol

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A Clinical Trial Protocol is a research protocol for a clinical trial.



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    • The clinical trial protocol is a concept that refers to the overall plan or framework for conducting a clinical trial. It outlines the scientific and technical details of the trial, including the study design, methodology, inclusion and exclusion criteria, endpoints, statistical analyses, safety measures, and other essential information. The protocol is typically developed by the sponsor or the principal investigator and is subject to regulatory review and approval.

      The documentation of the clinical trial protocol, on the other hand, refers to the set of documents that support and supplement the protocol itself. These documents are developed to ensure that the protocol and regulatory requirements conduct the trial and provide a standardized data collection, management, and analysis approach. The documentation includes informed consent forms, case report forms, study procedures manuals, standard operating procedures, and other supporting documents.