What is a protocol?
A protocol is 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. |