Clinical trials follow a plan known as a protocol. The protocol is carefully designed to balance the potential benefits and risks to participants, and answer specific research questions. A protocol describes the following:
- the goal of the study
- who is eligible to take part in the trial
- protections against risks to participants
- details about tests, procedures, and treatments
- how long the trial is expected to last
- what information will be gathered
A clinical trial is led by a principal investigator. Members of the research team regularly monitor the participants’ health to determine the study’s safety and effectiveness.
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