CenterWatch's glossary of clinical trials terms provide patients and industry professionals with a quick reference to many of the most commonly used terms and phrases used in clinical trials.

An unintended reaction to a drug taken at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. In clinical trials, an ADR would include any injuries by overdosing, abuse/dependence, and unintended interactions with other medicinal products.

A negative experience encountered by an individual during the course of a clinical trial, that is associated with the drug. An AE can include previously undetected symptoms, or the exacerbation of a pre-existing condition. When an AE has been determined to be related to the investigational product, it is considered an Adverse Drug Reaction.

Investigator reports of all serious and adverse events, injury and deaths given to the sponsor, the IRB and the FDA.

An unwanted effect caused by the administration of drugs. Onset may be sudden or develop over time.

Organizations and groups that actively support participants and their families with valuable resources, including self-empowerment and survival tools.

In the U.S., the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed. The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, [..]

Any of the treatment groups in a randomized trial. Most randomized trials have two "arms," but some have three "arms," or even more.

A child’s affirmative agreement to participate in a clinical investigation. Mere failure to object may not, absent affirmative agreement, be construed as assent.

A renewable permit granted by the federal government to an institution or research center to conduct clinical trials.