Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)
Description
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.
Agency: National Institutes of Health
CFDA: 93.838, 93.233, 93.839, 93.840, 93.837
Eligible Applicants: 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.
Applicant Types: State governments; Independent school districts; Others (see text field entitled "Additional Information on Eligibility" for clarification); Public housing authorities/Indian housing authorities; For profit organizations other than small businesses; Public and State controlled institutions of higher education; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; County governments; Small businesses; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Private institutions of higher education; Special district governments; Native American tribal governments (Federally recognized); Native American tribal organizations (other than Federally recognized tribal governments); City or township governments
Cost Sharing: No
Contact: National Institutes of Health
Email: NHLBIDCVSClinical@mail.nih.gov
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About This Opportunity
This is a grants contract in the health and medical services sector. Located in United States, North America, this opportunity is open to firms and consortiums. Proposals must be submitted before November 2, 2028.
Published through Grants.gov, a national government procurement portal. Public procurement tenders follow the country's national bidding regulations and may have specific eligibility and documentation requirements for grants in the health and medical services sector. Grant applications generally require a detailed project proposal, a clear results framework, and evidence of the applicant's capacity to deliver the proposed activities. Interested parties should review the full documentation on the original source before submitting their proposal.