Pharmacovigilance & Drug Safety

Clinical Trial Protocols

A clinical protocol is required for any experiments in which a drug is administered to, dispensed to, or used in one or more human subjects. The protocol is a written plan for how the drug or biologic is to be studied and the procedure to be followed by each investigator. A protocol is a written document that serves many purposes: It instructs the physician (primary investigator) and staff (study coordinators) how to execute the trial. It describes how a trial is conducted, ensures the safety of study participants and ensures the integrity of the data collected throughout the trial.