Some studies defined as "clinical research" or a "clinical trial" have special compliance requirements. For compliance purposes, there are three definitions of clinical trials depending on the funding or regulatory oversight. Studies with NIH funding follow the Common Rule definition, which is a similar definition used by other federal funding agencies. FDA-regulated research defines a clinical trial as research meeting the criteria of an "applicable clinical trials" (ACT). Visit the Quality Assurance webpage on clinical trials to learn more.
Research Topic