The NIH recently announced new requirements for proposal applications with due dates of January 25, 2018, and beyond. All proposals must use an updated application forms package (FORMS-E), which includes a new definition for clinical trials and a new form.

The new NIH clinical trial definition includes the following criteria:

·      Involvement of human participants

·      Participants prospectively assigned to an intervention

·      Study is designed to evaluate the effect of the intervention on the participants

·      The effect that will be evaluated is a health-related or behavioral outcome

For additional assistance to ensure your proposal meets this definition, use the Decision Tree for NIH CT Definition.

Once you have confirmed that your proposal meets this definition, work with your Research Process Manager in RMG to submit your applications electronically via the Application Submission System & Interface for Submission Tracking (ASSIST).  

For information on the new form please also review this nine minute video.

If anticipating an NIH award, make sure your human subjects and Good Clinical Practice training have been completed in the last three years. Information on how to log in and what training modules to complete can be found on the Research Compliance Office website.

If you have specific questions about the proposal application, please contact your RPM.