What is the purpose of a protocol in clinical trials?

The purpose of a protocol in clinical trials is vital for ensuring the study is conducted systematically and ethically. One of the main functions of a protocol is to outline the specific objectives of the study and the design that will be utilized to achieve these objectives. This includes detailed information on the methodology, participant selection criteria, treatment plans, and data analysis strategies. By clearly defining these elements, the protocol serves as a roadmap for researchers and provides a basis for evaluating the trial's integrity and compliance with regulatory standards.

Additionally, a well-structured protocol helps to ensure that all team members and participating sites understand the study's goals and operations, which is essential for maintaining consistency and quality throughout the study. Ultimately, the protocol serves as a foundational document that guides the entire research process, facilitating communication among researchers and ensuring adherence to Good Clinical Practice (GCP) standards.