Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)

Background
This Notice of Funding Opportunity (NOFO) is issued by the National Institutes of Health (NIH), specifically the National Heart, Lung, and Blood Institute (NHLBI). The mission of the NHLBI is to foster research and training in cardiovascular, lung, and blood diseases.

The goal of this NOFO is to support applications for the development and conduct of a Clinical Coordinating Center (CCC) for multi-site investigator-initiated clinical trials that may include efficacy, comparative effectiveness, pragmatic, and dissemination and implementation science trials. Innovative trial designs are encouraged, with a focus on addressing health outcomes within the U.S. population.

Grant Details
The CCC application must present a scientific rationale for the clinical trial along with a comprehensive scientific and operational plan. Key tasks include: project management; subject recruitment and retention; performance milestones; scientific conduct of the trial; dissemination of results; and strategies for increasing community engagement throughout the intervention's design, implementation, and sustainability phases.

The application must also detail plans to close gaps in health outcomes within the U.S. population. Both CCC and collaborating Data Coordinating Center (DCC) applications must be submitted simultaneously for consideration.

Eligibility Requirements
Eligible applicants include higher education institutions (public or private), nonprofits, for-profit organizations (including small businesses), local governments, state governments, Indian/Native American tribal governments, faith-based organizations, regional organizations, foreign organizations/international collaborations, and other entities as specified. Applicants are encouraged to consult with NHLBI contacts prior to submission.

Period of Performance
The project period for the UG3 phase will be up to 1 year followed by a UH3 phase expected to last 4 years. With strong justification, up to 6 years may be requested for the UH3 phase.

Grant Value
The total value of the grant is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are not limited but should reflect actual project needs.