Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for organizations planning to establish a Clinical Coordinating Center for multi-site investigator-initiated clinical trials relevant to NHLBI research priorities. Eligible applicants include domestic and foreign research institutions, universities, hospitals, and nonprofit organizations with research capacity. Both a CCC application and a Data Coordinating Center application must be submitted together on the same deadline. Trials must meet NIH definition of clinical trials and align with NHLBI mission; foreign subawards/subcontracts are not permitted under this NOFO.
Applicants should have substantial experience managing multi-site clinical trials and coordinating complex research networks. The project must address recruitment, retention, performance monitoring, and community engagement throughout the trial lifecycle. Prior coordination of large clinical trials is strongly preferred.
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Program description
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 engagement from conceptual design of the intervention through implementation and sustainability and close gaps in health outcomes within the US population and increase health for all.Both a CCC application and a collaborating Data Coordinating Center (DCC) application must be submitted on the same application due date for consideration by NHLBI. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 Federal Application for Grants and Cooperative Agreements
- Project Narrative describing trial rationale, design, and comprehensive operational plan
- Budget and Budget Narrative
- Biographical Sketches of key personnel
- Letters of Support from participating trial sites
- Data Coordinating Center Application (companion submission)
Program contact
- 👤 National Institutes of Health
- 📧 NHLBIDCVSClinical@mail.nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.838 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$64,183,283
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$53,344,199
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$43,989,024
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$38,428,037
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$34,243,478
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$27,859,190
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$26,861,834
-
$26,624,924
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$26,063,829
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$25,153,102
Top States by Funding
- MA 14 awards $246.9M
- CA 15 awards $199.1M
- CO 8 awards $139.0M
- IL 7 awards $107.8M
- NC 4 awards $95.8M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.838). How funding has trended year over year.
| 2024 | $760,925,134 | |
| 2025 | $789,408,855 |
FAQ
Who can apply for this grant?
Domestic and foreign research institutions, universities, and nonprofit organizations are eligible. Both a Clinical Coordinating Center and Data Coordinating Center application must be submitted together by the same deadline.
Can my organization include international partners?
Unfunded collaborations and foreign consultants are allowed. However, foreign subawards and subcontracts are prohibited under this NOFO as of May 2025.
What types of trials does this support?
The CCC supports efficacy, comparative effectiveness, pragmatic, and implementation science trials. Innovative designs like platform, adaptive, and Bayesian approaches are encouraged.
How should I approach the application?
Contact the NHLBI scientific officer before submitting. Your proposal should detail project management, recruitment/retention strategies, performance milestones, scientific conduct, and dissemination plans.
Is cost sharing required?
No, cost sharing is not required. This is a cooperative agreement mechanism with milestone-driven funding phases.
💡 Tips for applicants
- Contact your assigned NHLBI scientific officer early to discuss trial design and alignment with strategic priorities before writing your proposal.
- Submit your CCC and DCC applications simultaneously on the same deadline; they should be clearly coordinated and complementary in scope.
- Emphasize your institutional capacity for managing multi-site networks, including proven subject recruitment and retention strategies for your target population.
- Build community engagement and health equity approaches into your trial design from conception, not as an afterthought.
- Detail specific performance milestones, success metrics, and contingency plans for addressing recruitment or retention challenges in your operational plan.
⚠️ Common mistakes
Submitting only a CCC application without the required companion DCC application on the same deadline. Not demonstrating alignment with NHLBI research mission or including trial designs that fall outside clinical trial definition. Proposing international subawards or subcontracts, which violates current NIH policy effective May 2025.
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