The US Department of Health and Human Services defines a clinical trial as a research study conducted to evaluate a medical procedure or medical product, such as a drug or device. Not all studies at the University of Arizona involve drugs or interventions; some studies use surveys or evaluate medical records to find new and better ways to help people. Other studies recruit healthy volunteers, or control subjects, to better evaluate and compare their results with those of non-healthy subjects.
The US Food and Drug Administration (FDA) defines a clinical investigation as any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under section 505(i) or 520(g) of the act, or need not meet the requirements for prior submission to the FDAn under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58, regarding nonclinical laboratory studies. The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for purposes of this part.