Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)
Grant Opportunity Analysis
The National Institutes of Health, through NHLBI, is seeking applications for a Clinical Coordinating Center to support investigator-initiated multi-site clinical trials under a cooperative agreement. The work includes developing and conducting the coordinating center for efficacy, comparative effectiveness, pragmatic, and dissemination and implementation science trials, with responsibilities for project management, subject recruitment and retention, milestone tracking, scientific conduct, and dissemination of results. The award uses a bi-phasic UG3/UH3 structure with a one-year development phase followed by a four- to six-year execution phase, and applications must be paired with a collaborating Data Coordinating Center submission on the same due date. The opportunity closes on November 2, 2028, and applicants are encouraged to contact NHLBIDCVSClinical@mail.nih.gov before submitting.
Eligible Applicants
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.