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?

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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. A 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.

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