Definition of Clinical Protocol

According to the U.S. National Institute of Health, the term clinical protocol is the developed study plan for conducting a clinical trial. In general, a clinical trial is a research study in humans with established protocols that is health or biomedically related.

Protocol Plan

• Before conducting a clinical trial, a plan is created to protect the well-being of the participants. The plan also establishes the intent of the clinical trial to answer specific questions. The protocol defines the type of people required to participate in the trial, what tests to conduct, the procedures used, the time frame of the study and what medications and dosages will be given.

Professional Participants

• Establishing the protocol for a clinical trial involves the researchers conducting the trial and the clinical team. The team may consist of doctors, nurses, health care professionals and social workers depending on the specific research being conducted.

Research Participants

• Protocols are necessary to determine who can be a participant in the clinical trial. Criteria are established called "inclusion/exclusion" to ensure that the results of the trial are reliable. For example, the protocol for a clinical trial on diabetes may require people with the disease. Other protocol factors may be a person's age, previous treatment or gender. These and many other factors may include or exclude a person from participating.