Definitions

In this Act: (1) Clinical trial The term clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. (2) Sponsor The term sponsor has the meaning given such term in section 50.3 of title 21, Code of Federal Regulations (or successor regulations).