NIH Definition of Clinical Trial

The NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (NOT-OD-16-149) became effective on January 18, 2017. This initiative involves additional requirements for any NIH-supported research that engages human participants. These requirements include:

• dedicated funding opportunity announcements (FOA's)
• Good Clinical Practice training
• registration and results reporting on ClinicalTrials.gov
• single IRBs for multi-site studies

Four Questions for Researchers and Institutions

If the answer to all four of these questions is yes, then the NIH considers your research to be a clinical trial.

1. Does the study involve human participants?
2. Are the participants prospectively assigned to an intervention?
3. Is the study designed to evaluate the effect of the intervention on the participants?
4. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

NIH has provided guidance on answering these questions.

Additional guidance and help

Completing Forms E - Human Subjects & Clinical Trials Information page

NIH Clinical Trial Requirements for Grants and Contracts

Does Your Human Subjects Research Study Meet the NIH Definition of a Clinical Trial?

NIH Definition of Clinical Trial Case Studies

Guidance for Basic Experimental Studies with Humans (BESH) Clinical Trials

Comparison of Clinical Trials FOAs by Type

Frequently Asked Questions (NIH)

Background Information - NIH Extramural Nexus - Open Mike