Is Your Study a Clinical Trial?

A clinical trial is 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. Correctly identifying whether your study is a clinical trial is crucial in complying with NIH policies and Michigan Medicine.

If you answer yes to the following questions, then your study qualifies as a clinical trial:

• Does the study involve one or more human subjects?
• Does the study involve the use of one or more interventions?
• Does the study prospectively assign human subject(s) to an intervention(s)?
• Does the study have a health-related biomedical or behavioral outcome(s)?

Learn more about the NIH Clinical Trial Definition at grants.nih.gov, and see below for more helpful resources.

• NIH Decision Tool
• Case Studies
• Frequently Asked Questions