Revised NIH Definition of Clinical Trial

Notice of Revised NIH Definition of Clinical Trial(NOT-OD-15-015) National Institutes of Health

(see notice for complete information such as definition of prospectively assigned, intervention and health-related biomedical or behavioral outcome)

The revised definition will replace the current clinical trial definition in relevant extramural and intramural NIH policies, guidance, and instructional materials. It will apply to competing grant applications that are submitted to NIH for the January 25, 2015 due date and subsequent due dates and contracts proposals that are submitted to NIH on or after January 25, 2015.

NIH Clinical Trial Definition

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.