Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required) | PAR 18 662

Frequently Asked Questions (FAQs): NIH NCCIH Clinical Coordinating Center (CCC) for Multi-Site Mind and Body Trials (PAR-18-662)

1) What is this funding opportunity supporting?

This NIH opportunity (PAR-18-662) from the National Center for Complementary and Integrative Health (NCCIH) supports the creation and operation of a Clinical Coordinating Center (CCC) for an investigator-initiated, multi-site clinical trial testing a mind and body intervention in NCCIH priority research areas.

2) What is a Clinical Coordinating Center (CCC) expected to do?

The CCC is expected to serve as the operational hub for the multi-site clinical trial. It is responsible for turning the scientific concept into a functioning, high-quality trial across multiple locations, with clear operational control and coordination of trial activities.

3) What types of trials are allowed under this FOA?

Trials may be designed as efficacy, effectiveness, or pragmatic studies. Regardless of design, the core expectation is a well-justified, multi-site clinical trial with a credible plan demonstrating the team can actually execute it.

4) Does the CCC application need to include both science and operations?

Yes. A central feature of this FOA is that the CCC application must present both: (1) the scientific rationale for the intervention and condition being studied, and (2) a detailed, end-to-end operational plan for executing the trial across multiple sites.

5) What operational details is NCCIH expecting in the CCC application?

The application is expected to describe how the study will be organized and governed, how sites will be selected and managed, how the intervention will be standardized and delivered across sites, and how the protocol will be implemented consistently.

6) What governance and leadership structures should be addressed?

The CCC should include a comprehensive leadership and oversight approach, such as a steering committee and other oversight bodies, along with clearly defined roles for investigators and participating sites.

7) How important are project management, timelines, and communications in the application?

They are a core expectation. The CCC is expected to lay out comprehensive project management and trial operations, typically including timelines, communication plans, training procedures, and coordination approaches to keep multiple sites aligned.

8) What does NCCIH expect for training, quality assurance, and monitoring?

The CCC application is expected to include training procedures, quality assurance approaches, and monitoring plans designed to maintain protocol fidelity and consistent implementation across sites.

9) What does "protocol fidelity" mean in the context of this FOA?

In the context of a multi-site mind and body trial, protocol fidelity refers to implementing the protocol consistently across all locations, including consistent intervention delivery and adherence to the planned procedures.

10) What is expected for participant recruitment and retention?

NCCIH expects detailed participant recruitment and retention strategies. The FOA emphasizes that enrolling and keeping participants engaged is often the make-or-break factor in multi-site mind and body trials, so the plan should be practical and specific.

11) Are performance milestones required?

Yes. The FOA emphasizes milestone-driven progress, including performance milestones and tracking progress against them, as part of demonstrating readiness and maintaining accountability over the course of the project.

12) What does the UG3/UH3 mechanism mean for applicants?

Funding uses a two-phase, milestone-driven cooperative agreement mechanism (UG3/UH3). The UG3 phase is usually a planning and start-up period to complete key preparatory tasks and demonstrate readiness to launch, and the UH3 phase supports full implementation of the clinical trial once predefined milestones are met.

13) How is a cooperative agreement different from a standard research grant?

Because this is a cooperative agreement, NCCIH staff typically have substantial scientific and programmatic involvement, and progress is tied to milestone achievement. Applicants should be prepared for a more collaborative, accountability-driven environment than a traditional R01-style award.

14) Can a CCC application be submitted by itself?

No. The CCC application cannot stand alone. It must be paired with a separate, companion Data Coordinating Center (DCC) application submitted under PAR-18-116 for the same clinical project.

15) What is the role of the companion Data Coordinating Center (DCC)?

The DCC is responsible for the data management and data analysis plan for the same clinical project. NCCIH will only consider applications that are submitted together as a coordinated package.

16) Why does NCCIH require both a CCC and a DCC?

The paired structure indicates NCCIH wants a strong separation of responsibilities: the CCC drives clinical execution and site operations, while the DCC provides robust data infrastructure, quality control, and analytic rigor for the shared trial.

17) What organizations are eligible to apply?

Eligibility is broad and includes many U.S.-based organizations and government entities, including state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments; tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); and small businesses.

18) Are community-connected and minority-serving institutions specifically encouraged or included?

Yes. The FOA highlights participation from a wide range of institution types and community-connected organizations, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.

19) Are non-U.S. institutions eligible to apply?

No. Non-U.S. institutions are not eligible to apply as applicant organizations, and non-U.S. components of U.S. organizations are not eligible. However, foreign components (as defined by NIH policy) may be allowed as discrete elements under a U.S. applicant when justified and compliant with NIH rules.

20) How should applicants ensure the project fits NCCIH priorities?

Applicants are encouraged to align proposals with NCCIH's mission, strategic vision, and high-priority research areas, and the FOA explicitly recommends reviewing NCCIH planning materials on the NCCIH website.

21) Is contacting NCCIH before submitting recommended?

Yes. The FOA strongly encourages potential applicants to contact the relevant NCCIH scientific/research program contact before submitting to confirm fit with NCCIH priorities, understand expectations for the UG3/UH3 structure, and avoid misalignment between the proposed trial and what NCCIH is prepared to support.

22) What category and CFDA number are associated with this opportunity?

The activity category is Health, and the CFDA number is 93.213.

23) What is the funding instrument used for this opportunity?

The funding instrument is a cooperative agreement.

24) When was this opportunity created, and what closing date is listed in the summary?

The opportunity was created on 2018-02-14, and the original listed closing date in the provided summary was 2020-06-29.

25) Are award ceiling, budget limits, or expected number of awards provided here?

No. The provided summary states that the award ceiling and expected number of awards are not specified. Applicants would typically need to consult the full FOA and NIH Guide notices for budget expectations, limits, and current application cycles.

26) What does NCCIH expect regarding scientific conduct and protections?

The FOA expects plans for scientific conduct, including adherence to good clinical practice, human subjects protections, and consistent intervention delivery across sites.

27) Does the FOA mention dissemination of results?

Yes. The CCC is expected to include a thoughtful approach to dissemination so findings can reach clinicians, communities, and researchers.