Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3) - Clinical Trial Required | PAR 18 407

Opportunity Information: Apply for PAR 18 407

The NIH, through the National Heart, Lung, and Blood Institute (NHLBI), is offering a cooperative agreement opportunity (PAR-18-407) to support the creation and operation of a Clinical Coordinating Center (CCC) for an investigator-initiated, multi-site clinical trial. The trial must fall within the NHLBI mission areas (heart, lung, blood, and sleep-related conditions) and must meet the NIH definition of a clinical trial. This announcement is specifically aimed at Phase II and later-stage studies, meaning projects should be sufficiently mature to justify multi-site testing with clear clinical endpoints and operational readiness.

A key feature of this opportunity is its two-stage (bi-phasic), milestone-driven structure using the UG3/UH3 cooperative agreement mechanism. In practical terms, the UG3 phase is intended to support early implementation activities and to demonstrate that the project can meet clearly defined milestones (for example, finalizing protocols and manuals of operations, setting up site management processes, meeting regulatory requirements, confirming feasibility of recruitment pipelines, and preparing for trial launch). Transition to the UH3 phase depends on successful completion of those milestones, and UH3 supports full execution of the clinical trial. Because it is a cooperative agreement rather than a traditional grant, NHLBI is expected to have substantial programmatic involvement during the project, with active oversight and collaboration around progress, milestones, and trial conduct.

The application is centered on explaining both why the trial should be done and exactly how it will be run across multiple sites. Applicants are expected to present a strong scientific rationale for the clinical trial and a detailed operational plan. The CCC is responsible for the on-the-ground clinical trial leadership and coordination functions, so the proposal should spell out a comprehensive approach to project management, site coordination, participant recruitment and retention, training and communication across sites, adherence to the protocol, and maintaining high-quality clinical trial conduct. The FOA also expects applicants to define performance milestones up front and to describe how progress will be tracked, managed, and corrected if targets are not met. In addition, the plan should address dissemination, meaning how results will be communicated to the scientific community and other stakeholders, typically through publications, presentations, and other appropriate reporting avenues.

This FOA is explicitly paired with a companion announcement for a collaborating Data Coordinating Center (DCC) (PAR-16-301). NHLBI requires that both the CCC application and a DCC application be submitted for the same due date in order to be considered. The two centers are meant to function as a coordinated team: the CCC focuses on clinical implementation and site operations, while the DCC focuses on data systems, data management, statistical support, and related analytics. The requirement to submit both applications concurrently signals that NHLBI is looking for well-integrated trial leadership from the start, with clear delineation of responsibilities and strong collaboration between clinical operations and data/statistical operations.

Eligibility is broad and includes many types of organizations that can lead or host a coordinating center. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized Native American tribal governments and other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, faith-based or community-based organizations, U.S. territories or possessions, regional organizations, and foreign (non-U.S.) entities, among others. The awarding agency is NIH, and the opportunity is categorized as discretionary funding in the health area, with CFDA program numbers listed as 93.233, 93.340, 93.837, 93.838, and 93.839.

From a practical applicant standpoint, NHLBI strongly encourages prospective applicants to contact the appropriate Scientific/Research contact before submission. This is typically important for confirming that the proposed trial aligns with NHLBI priorities, that the UG3/UH3 milestone structure fits the project’s stage of readiness, and that the CCC/DCC partnership approach is responsive to the institute’s expectations. The original closing date listed for this specific posting was August 5, 2019, and the record shows a creation date of October 25, 2017, which is useful context if someone is looking at it historically or searching for updated reissues or related active announcements.

• 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 2017-10-25.
• Applicants must submit their applications by 2019-08-05. (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 18 407

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