Clinical Investigator or Study Physician
A medical researcher in charge of carrying out a clinical study. Researchers are
usually doctors, nurses, pharmacists, or other healthcare professionals.
Clinical Study
A carefully designed study of the effects of medication, medical treatment, or
device on a group of volunteers.
Food and Drug Administration (FDA)
A 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 healthcare professionals as well as members of the local community.
The IRB carefully reviews study activities as it is responsible for protecting the
safety and the rights of the volunteers.
Randomized
The method of assigning a study participant to a specific treatment during a study is done by a random process.
Double Blind
Double blind means both the participants and their study doctors do not know which therapy participants are receiving.
Single Blind
Single blind means participants do not know which therapy they are receiving, but their study doctors do know.
Open Label
This means that both the study doctors and the participants know which treatment is being given during the research study.