High Quality Content by WIKIPEDIA articles! A Clinical Trial Protocol is a document that describes the objective, design, methodology, statistical considerations, and organization of a clinical trial. The protocol usually also gives the background and reason the trial is being conducted, but these could be provided in other documents referenced in the protocol. The protocol contains a study plan on which the clinical trial is based. The plan is designed to safeguard the health of the participants as well as answer specific research questions. The protocol describes, among other things, 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, study participants are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of the treatment they are receiving.

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