Trial Protocol

A trial protocol is a comprehensive document that serves as an agreed-upon plan for a clinical trial. It is issued by the sponsor, typically a pharmaceutical company, research institution, or organization, and provides detailed information about the objectives, design, methodology, statistical considerations, and organizational aspects of the study.

The trial protocol serves as a blueprint or roadmap for conducting the clinical trial, outlining the specific procedures, guidelines, and requirements to ensure the trial’s integrity, quality, and scientific validity. It is developed before the trial begins and acts as a reference document for all parties involved in the study, including investigators, study coordinators, ethics committees, and regulatory authorities.