Collaborative Innovation Award Frequently Asked Questions

PAR-15-172/173 FAQs

NOT-TR-16-012 FAQs

PAR-15-172/173 FAQs

Does the application have to be submitted by the CTSA U54 principal investigator (PI) or from the home institution of the CTSA U54 PI?

An application must be submitted through the office of sponsored programs of an institution with an active CTSA Program award (U54) or by a partner institution as identified in the application for the active CTSA Program award.

We encourage applicants considering an X02 application submission to first contact the CTSA Program PI. While letters of support are not required for the X02, supporting letters from the CTSA Program PI will be required for the U01 application submission (see NOT-TR-15-012).

How many biosketches should be included?

Include biosketches for all members of the team whom you designate as key personnel.

Should these collaborations be set up with a PI and subcontracts to the other sites or as a multi-PI consortium?

Within the parameters set forth in the funding opportunity announcement, each applicant needs to determine the management structure that is best for that project.

Will the reviewers of a U01 application be the same individuals who reviewed the corresponding X02 application?

The scientific review officer will make every effort to maintain continuity between the two reviews.

Will the U01 reviewers have access to the summary statement from the X02 review?

No. The U01 applications will not be linked to the summary statements from the X02 review.

What is clinical research?

As defined in the PHS 398 Definitions and the Grants Policy Statement, clinical research is:

  1. Patient-oriented research. Research conducted with human subjects (or on material of human origin, such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes:
    • Mechanisms of human disease,
    • Therapeutic interventions,
    • Clinical trials, or
    • Development of new technologies.
  2. Epidemiologic and behavioral studies.
  3. Outcomes research and health services research.

NOT-TR-16-012 FAQs

Why did NCATS make this change?

In an effort to streamline processes and accelerate timelines, NCATS is discontinuing the X02 step for future CTSA Collaborative Innovation Awards.

Can applicants who previously did not receive a notification to submit a U01 apply now?

Yes. Applicants may apply without a specific notification. However, because the X02 pre-application underwent an assessment of programmatic priority, potential U01 applicants are strongly encouraged to contact program staff and explore the programmatic priority of their applications.

If an applicant submitted an X02 pre-application previously and received an email from NCATS discouraging submission of a U01 application to PAR-15-172 for funding of the project proposed in the X02 pre-application, may the applicant now submit a U01 based on his or her X02 pre-application?

The decision to discontinue the X02 does not change the evaluation of previous X02 pre-applications.

Are investigators permitted to apply for either the July 7, 2016, or November 10, 2016, U01 application dates without having submitted an X02 pre-application?

Yes. Investigators can submit a U01 application on either July 7 or November 10, 2016, without having submitted an X02 pre-application. However, as indicated in the Notice, the U01 applications coming in on July 7 and November 10, 2016, will have gone through the X02 pre-application process. As such, investigators will have gotten feedback from the X02 pre-application review, and that feedback will likely have been used in preparing the U01 submission. Those who did not submit an X02 pre-application will not have had the benefit of such feedback. The first U01 submission date that does not have a corresponding X02 pre-application would be March 9, 2017, which is why NCATS is recommending that date.