Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)
This NOFO funds a collaborating Data Coordinating Center to provide project coordination, data management, and biostatistical support for NHLBI-relevant multi-site investigator-initiated clinical trials submitted with a companion Clinical Coordinating Center application.
⚑ Must be submitted with a collaborating CCC application on the same due date. · Clinical trial required; NIH definition applies. · NHLBI mission-relevant only. · Foreign organizations/components are allowed, but foreign subawards/subcontracts are not allowed under current NIH policy (effective May 1, 2025).
Unit fits — one characterization, each unit's own rules
| Physical Sciences & Engineering (demo) | 90 strong | technical depth: central; funds data infrastructure |
| IPPRA | 58 good | peripheral portfolio topic: public_health; signature methods: community engaged; social/behavioral work is minor; funds data/survey infrastructure; biomedical core — IPPRA health lane is communication/crisis/policy (capped) |
| Tom Love Innovation Hub | 15 none | deep-tech content; no commercialization signal |
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.
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.
Apply
View on Grants.gov → CONTACT: National Institutes of Health <NHLBIDCVSClinical@mail.nih.gov>
Proposal brief SEE AN EXAMPLE →
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