You Had Clinical Trial K Application Questions, We Have Answers

Are you submitting a K application? Check out some new frequently asked questions (FAQs).

When submitting a K99/R00 application which involves human subjects, do I need to complete a study record in the PHS Human Subjects and Clinical Trials Information form for each phase?

The K99/R00 is a single application for both phases of the award, and the reviewers evaluate both phases. The research plan for the R00 phase of the award should be described in sufficient detail for reviewers to evaluate the merit of this phase of the application. A single study record covering both phases is typically sufficient. You can point out any minor differences between K99 and R00 within the study attachments. At the time of the K99 application submission, inclusion enrollment data should be provided for the K99 phase only.

If you anticipate substantial differences in the study information for each phase, you can complete a separate full study record or a delayed onset study record for the R00 phase. Additional information for delayed onset studies can be provided when submitting the R00 application for administrative review.

I am submitting a K99/R00 application. The K99 will not include a clinical trial but the R00 will. Which Funding Opportunity announcement (FOA) should I use?

You would use the Clinical Trial Required FOA but should designate that it will be a delayed onset clinical trial study. When completing your application, follow the Delayed Onset Study instructions to complete the Delayed Onset Study Justification attachment. Be detailed about the information you need before you can develop definite plans for the involvement of human subjects, factors affecting the availability of the information, why that information is not currently available, and when the information is expected to become available during the course of the project. For more on choosing the right FOA, please see additional information.

I am planning on submitting a Career Development (K) application and want to develop clinical trial research experience by taking part in a clinical trial for which my proposed mentor is not the PI. Is this allowable?

In general, the PI of the clinical trial in which a prospective K applicant wishes to gain clinical trial research experience should be part of the mentorship team for the applicant. If the clinical trial is a large multi-site trial, a proposed mentor or consultant should, at minimum, be a site lead PI for the clinical trial. Please refer to this FAQ for additional information.

For more questions and answers, visit the Human Subject and Clinical Trial Information Form FAQ  and the Clinical Trial-specific FOAs FAQ.