Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)
Status: Forecasted
Posted date: March 18, 2026
Archive date: January 2, 2029
Close date: November 2, 2028
Opportunity ID: 358851
Opportunity number: PAR-27-012
Opportunity category: Discretionary
Agency name: National Institutes of Health
Agency code: HHS-NIH11
Award floor: $0
Award ceiling: $0
Cost sharing required: No
Funding Instrument Types
- Cooperative Agreement
Category of Funding Activity
- Health
Eligible Applicants
- City or township governments
- County governments
- For-profit organizations other than small businesses
- Independent school districts
- 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
- Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education
- Others
- Private institutions of higher education
- Public and State controlled institutions of higher education
- Public housing authorities/Indian housing authorities
- Small businesses
- Special district governments
- State governments
Categories (use these for quoted searches)
- agency_code:hhs_nih11
- category_of_funding_activity:health
- cost_sharing_or_matching_requirement:false
- eligible_applicants:city_or_township_governments
- eligible_applicants:county_governments
- eligible_applicants:for_profit_organizations_other_than_small_businesses
- eligible_applicants:independent_school_districts
- eligible_applicants:native_american_tribal_governments_federally_recognized
- eligible_applicants:native_american_tribal_organizations_other_than_federally_recognized_tribal_governments
- eligible_applicants:nonprofits_having_a_501_c_3_status_with_the_irs_other_than_institutions_of_higher_education
- eligible_applicants:nonprofits_that_do_not_have_a_501_c_3_status_with_the_irs_other_than_institutions_of_higher_education
- eligible_applicants:others
- eligible_applicants:private_institutions_of_higher_education
- eligible_applicants:public_and_state_controlled_institutions_of_higher_education
- eligible_applicants:public_housing_authoritiesindian_housing_authorities
- eligible_applicants:small_businesses
- eligible_applicants:special_district_governments
- eligible_applicants:state_governments
- funding_instrument_type:cooperative_agreement
- opportunity_category:discretionary
- status:forecasted
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.