Dictionary of Clinical Study Terms

Clinical Study
 A carefully designed study of the effects of a medication, medical treatment or device on a group of volunteers.
Clinical Investigator or Physician
 A medical researcher in charge of carrying out a clinical study. Researchers are usually doctors, nurses, pharmacists or other health care professionals.
Food and Drug Administration (FDA)
 A US government agency that enforces laws on the manufacturing, testing and use of drugs and medical devices. The FDA must approve a drug for marketing before it can become readily available to the medical community and the public.
Informed Consent
 A discussion of procedures, benefits, and risks of a clinical study between clinical investigators and persons interested in participating in the study. The FDA requires that volunteers sign an informed consent form (approved by the IRB) before entering a study.
Institutional Review Board (IRB)
 A group of health care professionals as well as members of the local community. The IRB carefully reviews study activities. It is responsible for protecting the safety and the rights of the volunteers in a clinical study.