Clinical Investigation Law and Legal Definition

Clinical investigation refers to the systematic study conducted for evaluating a product such as a drug, device, or biological substance in the treatment, prevention, or diagnosis of a disease or condition using human subjects and to determine the product's benefits relative to its risks. Clinical investigations are conducted with the approval of the Food and Drug Administration (FDA).

The term "clinical investigation” is defined under 42 USCS § 1320a-7h (e) (3) as any experiment involving 1 or more human subjects, or materials derived from human subjects, in which a drug or device is administered, dispensed, or used.