Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)
Open Posted
- Opportunity number
- PAR-27-012
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Category
-
- Health
- Eligible applicants
-
- Higher Education Inst. (Public)
- Independent School Districts
- State Governments
- City/Township Governments
- 501(c)(3) Nonprofits
- Special District Governments
- Public or Indian Housing Auth.
- Higher Education Inst. (Private)
- Small Businesses
- Tribal Organizations (Not Federally Recognized)
- Non-501(c)(3) Nonprofits
- County Governments
- Tribal Governments (Federally Recognized)
- For Profit Organizations
- Other
- Points of contact
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Heart, Lung, and Blood Institute (NHLBI) is soliciting applications to develop and implement a Clinical Coordinating Center (CCC) for investigator-initiated multi-site clinical trials, with quarterly application due dates from May 2, 2026 through October 2, 2028; both a CCC application and a companion Data Coordinating Center (DCC) application must be submitted simultaneously for consideration. The award uses a bi-phasic, milestone-driven cooperative agreement mechanism with UG3/UH3 activity codes: the UG3 phase supports up to one year of protocol development, site activation, and initial recruitment, while the UH3 phase covers up to four years (extendable to six years with justification) for full trial execution.
Eligible applicants include higher education institutions (public and private), nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations, state and local governments, tribal organizations (federally recognized and not federally recognized), and foreign entities. Foreign subawards and subcontracts are prohibited; foreign components, unfunded international collaborations, and foreign consultants are permitted. The NOFO supports Phase II and above efficacy, effectiveness, pragmatic, dissemination, and implementation science clinical trials, including innovative designs such as platform, adaptive, and Bayesian trials, testing therapeutic, behavioral, dissemination, implementation, and prevention strategies. Trials must be relevant to the NHLBI research mission (cardiovascular sciences, lung diseases, blood diseases and resources, translation and implementation science, and sleep disorders) and meet the NIH definition of a clinical trial.
Applications must address project management, subject recruitment and retention, performance milestones, scientific conduct, and dissemination of results. Community engagement approaches to close health outcome gaps and increase health equity across the U.S. population are required. Budget amounts are not capped but must reflect project needs; year one costs are typically lower than subsequent years. Applicants must demonstrate feasibility of meeting core recruitment and enrollment milestones, including representation of women, minorities, and individuals across age groups. An independent Data and Safety Monitoring Board must be established, and the NHLBI Project Scientist will participate substantially as a non-voting Steering Committee member. Standard NIH registrations (SAM, UEI, eRA Commons, Grants.gov) and required attachments including a Trial Management Plan (5 pages maximum), Clinical Trial Research Experience table (3 pages maximum), Community-Engagement Plan (1 page maximum), and optional Network Description (6 pages maximum) apply. The opportunity is cross-listed under CFDA 93.837 (Cardiovascular Diseases Research), 93.838 (Lung Diseases Research), 93.839 (Blood Diseases and Resources Research), 93.840 (Translation and Implementation Science Research), and 93.233 (National Center on Sleep Disorders Research).
Synopsis
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.
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 longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.
Files
| File | Type | Posted |
|---|---|---|
| PKG00292136.pdf | ||
| PAR-27-012-Full-Announcement.html | HTML file |
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