Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)

HHS-NIH11 PAR-22-193

Posted: Jul 12, 2022 12:00:00 AM EDT

Closes: 01/11/2026

Description

This Funding Opportunity Announcement (FOA) supports applications for a collaborating Data Coordinating Center (DCC) for investigator-initiated multi-site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. Trials for which this FOA 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 FOA will utilize a cooperative agreement mechanism of award and runs in parallel with a companion FOA (PAR-22-NNN) that encourages applications for a collaborating Clinical Coordinating Center (CCC). The objective of the DCC application is to present a comprehensive plan to provide overall project coordination, administration, data management, and biostatistical support for the clinical trial proposed in the collaborating CCC application.Both a DCC application and a collaborating CCC application must be submitted on the same application due date for consideration by NHLBI.

Synopsis

This Funding Opportunity Announcement (FOA) supports applications for a collaborating Data Coordinating Center (DCC) for investigator-initiated multi-site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. Trials for which this FOA 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 FOA will utilize a cooperative agreement mechanism of award and runs in parallel with a companion FOA (PAR-22-NNN) that encourages applications for a collaborating Clinical Coordinating Center (CCC). The objective of the DCC application is to present a comprehensive plan to provide overall project coordination, administration, data management, and biostatistical support for the clinical trial proposed in the collaborating CCC application.Both a DCC application and a collaborating CCC application must be submitted on the same application due date for consideration by NHLBI.

Eligibility

Eligible Applicants:

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

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: OERWebmaster03@od.nih.gov

Phone: 301-402-2541

NIH OER Webmaster
OERWebmaster03@od.nih.gov

Additional Information

Document Type: synopsis

Opportunity Category: Discretionary

Version: 2

Last Updated: May 21, 2025 11:32:05 AM EDT

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