A clinical protocol is a detailed plan that outlines the objectives, design, methodology, and statistical considerations for a clinical trial. It serves as a guide for researchers and healthcare professionals to ensure that the study is conducted consistently and ethically. The protocol includes information about the target population, treatment procedures, and how data will be collected and analyzed.
In addition to guiding the research, a clinical protocol also helps protect the rights and welfare of participants. It is reviewed and approved by regulatory bodies and ethics committees to ensure compliance with standards. This process is crucial for maintaining the integrity of the study and the safety of individuals involved.