Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)
Open Posted
- Opportunity number
- PAR-27-013
- 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
-
- Non-501(c)(3) Nonprofits
- Higher Education Inst. (Private)
- County Governments
- Tribal Governments (Federally Recognized)
- Higher Education Inst. (Public)
- Special District Governments
- State Governments
- 501(c)(3) Nonprofits
- Other
- City/Township Governments
- Tribal Organizations (Not Federally Recognized)
- Public or Indian Housing Auth.
- Small Businesses
- Independent School Districts
- For Profit Organizations
- Points of contact
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Heart, Lung, and Blood Institute (NHLBI) is soliciting applications for a Data Coordinating Center (DCC) to support investigator-initiated multi-site clinical trials, with applications due November 2, 2028. This is a milestone-driven cooperative agreement (U24 mechanism) that must be submitted as a collaborative pair with a companion Clinical Coordinating Center (CCC) application (PAR-27-012) on the same due date; both applications are required for NHLBI consideration.
Eligible applicants include higher education institutions (public and private), 501(c)(3) and non-501(c)(3) nonprofits, state and local governments, tribal governments and tribal organizations, special district governments, public or Indian housing authorities, small businesses, independent school districts, and for-profit organizations. Foreign organizations and non-domestic components of U.S. organizations are eligible, but effective May 1, 2025, NIH will not fund applications involving foreign subawards or subcontracts; unfunded international collaborations, foreign components, foreign consultants, and procurement of unique equipment or supplies from foreign vendors remain permissible.
The DCC application must present a comprehensive plan for overall project coordination, administration, data management, and biostatistical support for the clinical trial proposed in the collaborating CCC application. Trials must meet the NIH definition of a clinical trial, be relevant to NHLBI's research mission, and may include efficacy, comparative effectiveness, pragmatic, or implementation research designs. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. The application should describe approaches to collaborate with the CCC on implementation of the clinical trial community engagement plan.
The award period is expected to be 5 years, with up to 7 years if justified. Application budgets are not limited but must reflect actual project needs. Performance is milestone-driven, with milestones required for the first year (UG3 phase) and subsequent years (UH3 phase), addressing recruitment and enrollment targets, accrual goals for women and minorities, protocol approval, site activation, and database lock. Required attachments include a Trial Management Plan (5 pages maximum), Clinical Trial Research Experience table (3 pages maximum), and optional Network Description Plan (6 pages maximum).
Review criteria encompass significance, investigator qualifications, innovation, approach adequacy, study design, data management and statistical analysis, environmental support, study timeline feasibility, human subjects protections, and core milestone appropriateness. Applications are evaluated by an initial review group and receive final secondary review by the National Heart, Lung, and Blood Advisory Council.
This opportunity is associated with 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). Applicants are strongly encouraged to contact the appropriate NHLBI Scientific/Research contact prior to submitting an application.
Synopsis
This Notice of Funding Opportunity (NOFO) supports applications for a collaborating Data Coordinating Center (DCC) for investigator-initiated multi-site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research 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, 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 milestone-driven cooperative agreement mechanism of award and runs in parallel with a companion NOFO (PAR-27-012) for a collaborating Clinical Coordinating Center (CCC). The objective of the DCC application is to present a comprehensive plan to provide overall project coordination, administration, data management, and biostatistical support for the clinical trial proposed in the collaborating CCC application. The application should also describe its approaches to collaborate with the CCC on implementation of the clinical trial community engagement plan. Both a DCC application and a collaborating CCC 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/Foreign 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 |
|---|---|---|
| PKG00292137.pdf | ||
| PAR-27-013-Full-Announcement.html | HTML file |
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