Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required) | PAR 19 329

Opportunity Information: Apply for PAR 19 329

The National Institutes of Health (NIH), through the National Heart, Lung, and Blood Institute (NHLBI), issued this funding opportunity to support the creation and operation of a Clinical Coordinating Center (CCC) for investigator-initiated, multi-site clinical trials. The trials covered under this announcement can include efficacy studies, comparative effectiveness trials, pragmatic clinical trials, and implementation research trials, as long as they fit within NHLBI's mission areas (heart, lung, blood, and sleep-related conditions and their public health impact) and meet the NIH definition of a clinical trial referenced in NOT-OD-15-015. In practice, the CCC is expected to serve as the operational hub that turns a scientifically sound trial idea into a well-run, multi-site study that can recruit participants, deliver the intervention reliably, maintain high-quality conduct across locations, and produce results that can be shared and used.

This opportunity uses a cooperative agreement mechanism, meaning NHLBI expects to have substantial involvement in the funded work rather than acting only as a passive funder. The specific mechanism is a two-phase, milestone-driven UG3/UH3 approach. The UG3 phase is generally used for planning, start-up, and demonstrating readiness through concrete benchmarks (for example, finalizing protocols and manuals of operations, setting up site onboarding processes, and confirming recruitment feasibility). If the UG3 milestones are met, the award can transition into the UH3 phase, which typically supports full implementation and execution of the trial. Because progression depends on meeting predefined performance milestones, applicants need to lay out a realistic set of measurable goals and timelines that show NHLBI the project is feasible and that the team can move from planning into active enrollment and follow-up without major delays.

A central feature of the announcement is that it runs in parallel with a companion funding opportunity for a collaborating Data Coordinating Center (DCC). The CCC and DCC are intended to function as a coordinated pair: the CCC focuses on clinical operations and site coordination, while the DCC focuses on data systems, data management, statistical oversight, and related activities. A key requirement is that both a CCC application and a DCC application must be submitted for the same due date in order to be considered by NHLBI. This requirement effectively means applicants must build a coordinated leadership structure and integrated plan across two applications, showing clear division of responsibilities and strong communication pathways between the clinical operations side and the data/statistical side.

The CCC application itself is expected to do more than describe an interesting research question. It must present the scientific rationale for the proposed clinical trial and provide a comprehensive scientific and operational plan for how the study will be carried out across multiple sites. NHLBI is looking for detailed thinking on real-world trial execution: project management structures (governance, leadership roles, decision-making, escalation pathways), site selection and training, participant recruitment and retention strategies, and how the team will ensure consistent implementation of the protocol. The application should also address how the trial will maintain scientific integrity and compliance, including oversight of study conduct, adherence to good clinical practice, and coordination with institutional review boards and other human subjects protections as applicable. Another emphasis is dissemination: applicants should explain how results will be shared with scientific audiences and other stakeholders so that findings can influence practice, policy, or future research.

Eligibility for this announcement is broad and includes many types of organizations. Eligible applicants include various levels of government (state, county, city/township, special districts), independent school districts, public and private institutions of higher education, and a range of nonprofit organizations (including both 501(c)(3) and non-501(c)(3) entities). For-profit organizations (other than small businesses) and small businesses may also apply, and the announcement explicitly notes additional eligible categories such as faith-based or community-based organizations, eligible federal agencies, and a variety of minority-serving institutions and tribal entities. It also allows non-U.S. (foreign) organizations and regional organizations, as well as U.S. territories or possessions. In other words, the opportunity is designed to be accessible to many institutional types, as long as they can credibly lead and manage a complex, multi-site clinical trial coordinating effort.

From a programmatic standpoint, NHLBI strongly encourages prospective applicants to contact the appropriate scientific or research contact before submitting. That guidance signals that NHLBI expects alignment with its current priorities and wants applicants to clarify fit, expectations, and any trial design issues early. Administratively, this is a discretionary grant opportunity under a cooperative agreement funding instrument in the health activity category, and it is associated with CFDA numbers 93.233, 93.340, 93.837, 93.838, and 93.839. The opportunity number is PAR-19-329, it was created on August 5, 2019, and the listed original closing date in the provided record is September 8, 2022.

Overall, this FOA is aimed at teams proposing serious, investigator-initiated, multi-site clinical trials who need support for the clinical coordination backbone required to run those trials well. The strongest applications would be expected to pair a compelling, NHLBI-relevant trial question with an execution-ready operations plan, a milestone framework that proves feasibility in the UG3 phase and drives accountability into the UH3 phase, and a tightly integrated partnership with a DCC application submitted in parallel.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.340, 93.837, 93.838, 93.839.
• This funding opportunity was created on 2019-08-05.
• Applicants must submit their applications by 2022-09-08. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 19 329

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