Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)
About
This Notice of Funding Opportunity (NOFO) supports applications to develop and conduct a Clinical Coordinating Center (CCC) for investigator-initiated multi-site clinical trials including efficacy, comparative effectiveness, pragmatic and/or dissemination and implementation science clinical trials. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. These trials may include ones that test different therapeutic, behavioral, dissemination and implementation science clinical trials and/or prevention strategies. Trials for which this NOFO applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website. This NOFO will utilize a bi-phasic, milestone-driven cooperative agreement mechanism of award and runs in parallel with a companion NOFO for a collaborating Data Coordinating Center (PAR-27-013). The objective of the CCC application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The application should also describe its approaches to increasing community engag.
The Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required) is a federal funding opportunity designed for researchers and institutions seeking to establish coordinating centers for large-scale, multi-site clinical trials. This grant supports the development and operational management of clinical trials that advance the National Heart, Lung, and Blood Institute's (NHLBI) research mission, including efficacy studies, comparative effectiveness research, pragmatic trials, and dissemination and implementation science initiatives. The program encourages innovative trial designs such as platform trials, adaptive designs, and Bayesian methodologies. Eligible trials may test therapeutic, behavioral, and prevention strategies. Researchers should apply if they are leading a multi-site clinical trial that requires comprehensive project management, subject recruitment and retention strategies, and structured dissemination plans. The bi-phasic, milestone-driven cooperative agreement mechanism ensures accountability and progress tracking. International collaborations are permitted, making this opportunity accessible to both domestic and non-domestic organizations. Applicants must demonstrate strong scientific rationale, operational expertise, and commitment to community engagement to be competitive.
Funding Facts
● Applications openDeadline
November 2, 2028
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Varies by cycle
Deadline
2028-11-02
Grant Type
federal
Application Cycle
Specific deadline: November 2, 2028
Best For
Research institutions and investigators establishing coordinating centers for multi-site clinical trials
Eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.NIH will no l
Frequently Asked Questions
Who is eligible for Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)?
Eligibility includes both domestic and non-domestic (foreign) organizations, as well as non-domestic components of U.S. organizations. Foreign components are allowed under NIH Grants Policy Statement guidelines. Applicants must be prepared to establish and operate a Clinical Coordinating Center for a multi-site, investigator-initiated clinical trial relevant to NHLBI's research mission. For complete eligibility requirements, refer to Section III of the official Notice of Funding Opportunity (NOFO) on the NIH website.
How much funding does Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required) provide?
Specific funding amounts are not specified in the available information. Award amounts vary and depend on the scope and complexity of the proposed clinical trial and coordinating center. Applicants should consult the official NOFO and contact the NHLBI directly for current funding levels and budget guidance.
How do I apply for Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)?
Applications should present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan addressing project management, subject recruitment and retention, performance milestones, scientific conduct, and dissemination of results. Community engagement approaches should also be described. Applications utilize a bi-phasic, milestone-driven cooperative agreement mechanism. The program runs in parallel with a companion Data Coordinating Center NOFO (PAR-27-013). Submit applications through the official NIH grants portal. Consult the complete NOFO and NHLBI website for detailed instructions and requirements.
What can Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required) funding be used for?
Funding supports the development and operation of a Clinical Coordinating Center for multi-site investigator-initiated clinical trials. This includes support for project management, subject recruitment and retention infrastructure, trial conduct activities, performance milestone tracking, and dissemination of research results. The program supports various trial types including efficacy, comparative effectiveness, pragmatic, and dissemination and implementation science trials with innovative designs such as platform, adaptive, and Bayesian approaches.
Last updated: July 5, 2026