Funder: National Institutes of Health (NIH)
Due Dates: February 11, 2025 | June 11, 2025 | October 10, 2025 | January 12, 2026 (final deadline)
Funding Amounts: No budget cap; project period up to 1 year (UG3) + up to 4 years (UH3), with possible extension to 6 years for UH3 if justified.
Summary: Supports the development and implementation of a Clinical Coordinating Center for multi-site, investigator-initiated clinical trials relevant to the NHLBI mission.
Key Information: Requires paired submission with a Data Coordinating Center (DCC) application for consideration.
Description
This NIH opportunity funds the creation and operation of a Clinical Coordinating Center (CCC) for investigator-initiated, multi-site clinical trials in areas relevant to the National Heart, Lung, and Blood Institute (NHLBI). Supported trials may include efficacy, comparative effectiveness, pragmatic, and/or implementation studies using innovative designs (e.g., adaptive, platform, Bayesian). The CCC is responsible for overall trial management, recruitment, protocol development, milestone attainment, and dissemination of results. This program uses a bi-phasic UG3/UH3 cooperative agreement mechanism: an initial 1-year start-up (UG3), followed by a full trial implementation phase (UH3) of up to 4 years (with up to 6 years possible for UH3 with strong justification).
Applicants must submit both a CCC (UG3/UH3) and a collaborating Data Coordinating Center (DCC, U24) application on the same due date. Applications without a paired DCC will not be reviewed.
Due Dates
- Standard application cycles:
- February 11, 2025
- June 11, 2025
- October 10, 2025
- January 12, 2026 (final deadline)
- Letters of intent are requested 30 days prior to the application due date.
- All applications are due by 5:00 PM local time of the applicant organization.
Funding Amount
- Budget: No budget cap; budgets must reflect actual project needs.
- Project Period:
- UG3 phase: up to 1 year
- UH3 phase: up to 4 years (up to 6 years with strong justification)
- Combined Direct Costs: If combined CCC+DCC direct costs are $500,000 or more in any year, prior approval is required.
- Number of Awards: Dependent on NIH appropriations and the number of meritorious applications.
Eligibility
- Eligible Applicants:
- Higher education institutions (public and private)
- Nonprofits (with or without 501(c)(3) status)
- For-profit organizations (including small businesses)
- State, county, city, township, and special district governments
- Independent school districts
- Public housing authorities/Indian housing authorities
- Native American tribal governments and organizations (federally recognized and other)
- U.S. territories and possessions
- Faith-based and community-based organizations
- Regional organizations
- Non-domestic (non-U.S.) entities (foreign organizations)
- Eligible agencies of the Federal Government
- Individuals: Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as PD(s)/PI(s) may apply.
- Special Requirements: Both a CCC and a DCC application must be submitted as a collaborative pair for consideration.
Application Process
- Application Submission: Use NIH ASSIST, Grants.gov Workspace, or institutional system-to-system solutions.
- Required Attachments:
- Trial Management Plan (max 5 pages)
- Clinical Trial Research Experience (max 3 pages)
- Community-Engagement Plan (max 1 page)
- Optional: Network Description (if leveraging an existing network, max 6 pages)
- Collaborative Submission: Applications must be submitted as a set (CCC and DCC), with matching project titles (using a “1/N” indicator).
- Budget Justification: Provide detailed annual budgets and justification, including community engagement and dissemination costs.
- Other Key Application Elements:
- Letters of support from key clinical leaders
- Detailed research strategy and milestones
- Data Management and Sharing Plan
- Human Subjects and Clinical Trials Information
Additional Information
- Scope: Only multi-site (≥2 recruitment sites) clinical trials are eligible. Phase I, single-site, drug/device safety, and observational studies that do not meet the NIH clinical trial definition are not supported.
- Milestone-driven: Transition from UG3 to UH3 is contingent on successful completion of predefined milestones.
- Community Engagement: Strong emphasis on plans to engage communities and reduce health disparities.
- Consultation: Early contact with NHLBI staff is strongly encouraged (at least 12 weeks before submission). Required for direct costs ≥$500,000 in any year.
External Links
Contact Information