Glossary of Clinical Research Terms
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Glossary of Clinical Research Terms  

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Glossary of Clinical Research Terms
Information for Industry Sponsors
A Patients’ Guide to Clinical Research

Confused about some of the terminology involved with clinical research? Try our Glossary of Terms.

Clinical Trial – A carefully designed investigation of the effects of drug, medical treatment or device on a group of patients.

Coordinator – This individual manages the conduct of the clinical trial.

Food and Drug Administration (FDA) – A government agency that enforces laws on the manufacture, testing and use of drugs and medical devices. All drugs and medical devices must be approved by the FDA before they can be used by the general public.

Informed Consent – A discussion of all procedures, benefits, risks and expectations of a clinical trial between the clinical investigators and the potential patients. The FDA requires that all patients sign an informed consent before participating in a trial.

Institutional Review Board (IRB) – A board consisting of health care professionals from the institution where the clinical trial takes place, as well as members of the local community. The board scrutinizes all trial activities including recruitment, advertising and potential risks. The IRB also makes sure that FDA regulations are being followed in a particular trial.

Principle Investigator – A medical professional who is overseeing the treatment of patients in the clinical trial.

Protocol – A plan that sets guidelines for a trial.

Standard Treatment – An FDA-approved treatment currently in wide use. Generally, the goal of the clinical trial is to introduce an investigation treatment that is safer and more effective than the standard treatment


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