Definition: A study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
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Source:
ClinicalTrials.gov
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Source:
ClinicalTrials.gov
Examples: The protocol must be firmly established so that a plan exists to meet any contingencies.
