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. 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.


    1. When you answer “yes” to all 4 questions in 1.4 of the Human Subjects Section of the grant.

      1.4 Clinical Trial Questionnaire
      The Clinical Trial Questionnaire is required.

      Note for basic and mechanistic studies involving human participants: The NIH definition of a clinical trial encompasses a broad range of studies, including studies using human participants that aim to understand fundamental aspects of phenomena, the pathophysiology of a disease, or the mechanism of action of an intervention. This includes many mechanistic studies and studies submitted to Basic Experimental Studies with Humans FOAs.

      Answer “Yes” or “No” to the following questions to determine whether this study involves a clinical trial. Answer the following questions based only on the study you are describing in this Study Record.

      1.4.a. Does the study involve human participants? Yes/No
      1.4.b. Are the participants prospectively assigned to an intervention? Yes/No
      1.4.c. Is the study designed to evaluate the effect of the intervention on the participants? Yes/No
      1.4.d. Is the effect that will be evaluated a health-related biomedical or behavioral outcome? Yes/No
      If you answered “Yes” to all the questions in the Clinical Trial Questionnaire, this study meets the definition of a clinical trial.

      Refer to the table below for information about what sections of this form are required, based on your answers to Question 1.4 “Clinical Trial Questionnaire.”

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