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

HHS-NIH11 PAR-25-029

Posted: Dec 11, 2024 12:00:00 AM EST

Closes: 01/11/2026

Description

This Notice of Funding Opportunity (NOFO) supports applications to develop and implement a Clinical Coordinating Center (CCC) for investigator-initiated multi-site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. 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 that encourages applications for a collaborating Data Coordinating Center (PAR-22-193). 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. 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.

Synopsis

This Notice of Funding Opportunity (NOFO) supports applications to develop and implement a Clinical Coordinating Center (CCC) for investigator-initiated multi-site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. 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 that encourages applications for a collaborating Data Coordinating Center (PAR-22-193). 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. 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.

Eligibility

Eligible Applicants:

Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments For profit organizations other than small businesses Small businesses Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education City or township governments Public and State controlled institutions of higher education Others (see text field entitled "Additional Information on Eligibility" for clarification) Independent school districts County governments Public housing authorities/Indian housing authorities

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

Funding Activity Categories

Health

CFDA Numbers

93.233 - National Center on Sleep Disorders Research
93.837 - Cardiovascular Diseases Research
93.838 - Lung Diseases Research
93.839 - Blood Diseases and Resources Research
93.840 - Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders

Contact Information

Agency: National Institutes of Health

Contact: National Institutes of Health

Email: grantsinfo@nih.gov

Phone: 301-402-2541

NIH Grants Information
grantsinfo@nih.gov

Additional Information

Document Type: synopsis

Opportunity Category: Discretionary

Version: 2

Last Updated: May 21, 2025 11:22:53 AM EDT

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