Source: NIH Extramural NEXUS

If One Aim or a Small Part of My Proposed Project in an NIH Grant Application Meets the NIH Definition of a Clinical Trial, Is My Entire Application Considered a Clinical Trial?

Yes. If only one aim or a small part of your project meets the NIH definition of a clinical trial, your entire NIH grant application is considered a clinical trial even if the other aims or parts of the research project are not clinical trials. An FOA that allows clinical trials should be chosen, and at least one study record in the application will need to be designated as a clinical trial.

For more on the NIH definition of a clinical trial, visit the Clinical Trials FAQs page.