Study Intake & Revision

WHAT IS A CLINICAL TRIAL AND DOES MY STUDY QUALIFY AS ONE?

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.

If you answer yes to the following questions, 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)?

In addition, your study is a clinical trial if:

• You are studying healthy participants
• Your study does not have a comparison group (e.g., placebo or control)
• Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug
• Your study is utilizing a behavioral intervention
• Only one aim or sub-aim of your study meets the clinical trial definition

CLINICAL TRIAL DEFINITION RESOURCES

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

• NIH Decision Tool (link is external)
• Case Studies (link is external)
• Frequently Asked Questions (link is external)