Blind Study:  One in which the subject or the investigator (or both=Double Blinded) are unaware of what trial product a subject is taking.

Clinical Study:  A clinical research study is also called a clinical trial.  Each study tests the safety, effectiveness, and side effects of an investigational medicine(s) or an investigational device on a group of volunteers. Clinical research studies are an important step in making new investigational medications available for future use.

Control or Control Group:  A control is the standard by which experimental observations are evaluated.  In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

Exclusion Criteria:  A list of criteria, any one of which excludes a potential subject from participation in a study. 

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 an investigational drug for marketing before it can become readily available to the medical community and the public.

Good Clinical Practice (GCP):  A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

Inclusion Criteria:  The criteria that prospective subjects must meet to be eligible for participation in a study.

Informed Consent:  A discussion of procedures, benefits, and risks of clinical research 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):  An independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

Investigator:  A person responsible for the conduct of the clinical trial at a trial site.

Open Study:  A trial in which subjects and investigators know which product each subject is receiving.

Pharmacology:  The science that deals with the characteristics, effects, and uses of drugs and their interactions with living organisms.

Placebo:  A placebo is an inactive pill, liquid, or powder that has no treatment value.  In clinical trials, experimental treatments are often compared with placebos to assess the treatment’s effectiveness.  In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.

Principal Investigator or Study Physician:  A medical researcher in charge of carrying out a clinical research study.  Researchers are usually doctors, nurses, pharmacists, or other healthcare professionals.

Protocol:  A protocol is a study plan on which all clinical trials are based.  The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.  While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.