NHLBI Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required) is sponsored by NIH NHLBI. Supports clinical coordinating centers for multi-site investigator-initiated clinical trials in HLBS disorders.

Opportunity Listing - Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required) Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required) Agency: National Institutes of Health Assistance Listings: 93. 837 -- Cardiovascular Diseases Research 93. 838 -- Lung Diseases Research 93.

839 -- Blood Diseases and Resources Research 93. 233 -- National Center on Sleep Disorders Research 93. 840 -- Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders Last Updated: March 18, 2026 View version history on Grants.

gov 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.

Public and state institutions of higher education Independent school districts Private institutions of higher education City or township governments Special district governments Public and Indian housing authorities Federally recognized Native American tribal governments Nonprofits non-higher education with 501(c)(3) Other Native American tribal organizations Nonprofits non-higher education without 501(c)(3) For-profit organizations other than small businesses 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. Grantor contact information Division of Cardiovascular Sciences NHLBIDCVSClinical@mail. nih.

gov NHLBIDCVSClinical@mail. nih. gov NHLBIDCVSClinical@mail.

nih. gov File name Description Last updated PAR-27-012-Full-Announcement. html PAR-27-012-Full-Announcement.

html Mar 18, 2026 12:46 PM UTC Link to additional information Closing: November 2, 2028 Funding opportunity number : Cost sharing or matching requirement : Funding instrument type : Opportunity Category Explanation : Category of Funding Activity :