ClinicalTrials.gov - What is a Protocol?
Question: What is a protocol?
All clinical trials must be conducted according to strict scientific and ethical principles. Every clinical trial must have a protocol, or action plan that describes what will be done in the study, how it will be conducted, and why each part of the study is necessary - including details such as the criteria for patient participation, the schedule of tests, procedures, and medications, and the length of the study.
Additional Resource Information on clinical trials can be found at http://clinicaltrials.gov/info/resources
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