The clinical trials protocol is a comprehensive plan that explains what will take place in a clinical trial, including the eligibility for participation, how many patients will participate in the study, which medical tests will be conducted, what treatments will be given and how results will be measured.

Every clinical trial has a protocol, which is an action plan that acts like a “recipe” for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary.

The same protocol is used by every doctor or research center taking part in the clinical trial.

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