Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)
ID: 357669Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/357669

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-25-029.html
Timeline
    Description

    The National Institutes of Health (NIH) has announced a Notice of Funding Opportunity (NOFO) for the establishment of a Clinical Coordinating Center (CCC) to support multi-site investigator-initiated clinical trials under the UG3/UH3 cooperative agreement mechanism. This initiative aims to facilitate trials focused on efficacy, comparative effectiveness, and implementation research, particularly those that address health disparities and promote community engagement. Eligible applicants include a diverse range of organizations, such as academic institutions, nonprofit entities, and tribal governments, with applications required to detail project management, participant recruitment strategies, and a Plan for Enhancing Diverse Perspectives (PEDP). The application period opens on January 11, 2025, with a submission deadline of September 11, 2025, and interested parties can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-25-029-Full-Announcement.html
    PAR-25-029.html
    The Department of Health and Human Services, through the National Institutes of Health (NIH), has released a Notice of Funding Opportunity (NOFO) for the development of a Clinical Coordinating Center (CCC) aimed at supporting multi-site investigator-initiated clinical trials under the UG3/UH3 cooperative agreement format. This initiative focuses on trials that address efficacy, comparative effectiveness, and implementation research, with an emphasis on reducing health disparities and promoting community engagement. Applications should detail project management plans, participant recruitment strategies, and a Plan for Enhancing Diverse Perspectives (PEDP). The funding opportunity encourages innovative trial designs and aligns with the research priorities of the National Heart, Lung, and Blood Institute (NHLBI). Key dates include an application opening on January 11, 2025, with the project expected to commence no later than February 2025. Eligible applicants span a wide range of academic, nonprofit, and for-profit organizations. Submission guidelines emphasize adherence to application instructions, preparatory consultations with NHLBI staff, and compliance with diversity and community engagement initiatives. The NOFO underlines the need for collaborative applications between the CCC and Data Coordinating Center (DCC), ensuring a comprehensive approach to clinical trial management.
    Similar Opportunities
    Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for the development of a Clinical Coordinating Center (CCC) to support multi-site investigator-initiated clinical trials under the UG3/UH3 activity codes. This initiative aims to foster innovative trial designs relevant to the National Heart, Lung, and Blood Institute's (NHLBI) research mission, requiring comprehensive project plans that address participant recruitment, milestone achievements, and strategies for enhancing community engagement and diversity. The funding mechanism is bi-phasic and necessitates simultaneous applications for both a CCC and a collaborating Data Coordinating Center (DCC), emphasizing strong project management and a commitment to minimizing health disparities. Interested applicants must submit their proposals by September 11, 2025, and can reach out to the NIH OER Webmaster at OERWebmaster03@od.nih.gov for further inquiries. More details can be found in the full announcement at http://grants.nih.gov/grants/guide/pa-files/PAR-22-192.html.
    Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for cooperative agreements to establish a Clinical Coordinating Center (CCC) for multi-site, investigator-initiated clinical trials focused on the effects of natural products, such as botanicals and dietary supplements. Applicants are required to develop a comprehensive scientific and operational plan for the clinical trial, including project management, participant recruitment, and performance milestones, while also submitting a companion Data Coordinating Center (DCC) application. This initiative aims to generate robust clinical data to inform integrative health approaches and public health strategies, with applications opening on January 20, 2025, and closing on July 14, 2026. For further details, interested parties can contact NIH Grants Information at grantsinfo@nih.gov or visit the opportunity's webpage at https://grants.nih.gov/grants/guide/pa-files/PAR-24-312.html.
    Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), is offering a funding opportunity for the establishment of a Clinical Coordinating Center (CCC) to support multi-site investigator-initiated clinical trials focused on mind and body interventions. Applicants are required to develop comprehensive plans that include project management, participant recruitment, and data analysis, while collaborating with a corresponding Data Coordinating Center (DCC) to ensure the trials are scientifically robust and aligned with NCCIH's research priorities. This initiative aims to explore the efficacy and effectiveness of complementary health approaches, emphasizing the inclusion of diverse populations and the necessity for a detailed plan to enhance diversity in research teams and subjects. Interested applicants must submit their proposals by January 20, 2025, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries. For more details, please refer to the full announcement available at https://grants.nih.gov/grants/guide/pa-files/PAR-24-275.html.
    Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for the establishment of a Clinical Coordinating Center (CCC) to support multi-site investigator-initiated clinical trials focused on natural products, such as botanicals and dietary supplements. Applicants are required to submit a comprehensive plan detailing project management, participant recruitment, and clinical trial execution, while also ensuring alignment with NIH standards. This initiative emphasizes the importance of evidence-based research in natural products and mandates the submission of a corresponding Data Coordinating Center (DCC) proposal to oversee data management and analysis. Interested applicants should note that the application deadline is July 15, 2026, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries. For additional details, applicants can refer to the full announcement available at https://grants.nih.gov/grants/guide/pa-files/PAR-24-123.html.
    Natural Product Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for the Natural Product Multi-Site Clinical Trial Data Coordinating Center (DCC) through a cooperative agreement mechanism. This initiative invites applications for a DCC that will collaborate with a Clinical Coordinating Center (CCC) to conduct multi-site clinical trials focused on the efficacy and effectiveness of natural products, requiring simultaneous submission of both applications. The program emphasizes the importance of maintaining data integrity, promoting diversity in participant recruitment, and achieving specific milestones for continued funding, while also necessitating a Plan for Enhancing Diverse Perspectives (PEDP) to ensure inclusivity in research. Interested applicants can find more information and application details on the NIH grants website, with a submission deadline of July 14, 2026, and a contact email for inquiries at grantsinfo@nih.gov.
    Data Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative U24 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), is inviting applications for a Data Coordinating Center (DCC) to support multi-site, investigator-initiated clinical trials focused on mind and body interventions. The DCC will be responsible for project coordination, administrative support, data management, and biostatistical analysis for Phase III clinical trials, and must be submitted alongside a Clinical Coordinating Center (CCC) proposal. This initiative is crucial for advancing research in complementary and integrative health strategies that address public health challenges, emphasizing participant diversity and data integrity. Interested applicants should note that the application deadline is January 20, 2025, with a funding period of up to 7 years, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for the Data Coordinating Center (DCC) for multi-site investigator-initiated clinical trials under funding opportunity PAR-22-193. This initiative aims to support trials that evaluate efficacy, comparative effectiveness, and implementation strategies relevant to the mission of the National Heart, Lung, and Blood Institute (NHLBI), emphasizing collaboration with a Clinical Coordinating Center (CCC). The DCC will be responsible for comprehensive project coordination, data management, and biostatistical support, ensuring adherence to participant safety and diverse population recruitment. Interested applicants must submit both DCC and CCC applications concurrently by September 11, 2025, and can seek early consultation with NIH staff for guidance. For further details, applicants can contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov or visit the additional information link at http://grants.nih.gov/grants/guide/pa-files/PAR-22-193.html.
    NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a Notice of Funding Opportunity (NOFO) for the NIAID Clinical Trial Implementation Cooperative Agreement (U01), aimed at supporting high-risk clinical trials that enhance the understanding of human diseases. This funding opportunity encourages applications for investigator-initiated, milestone-driven clinical trials, with each application permitted to propose only one clinical trial that must demonstrate a hypothesis-driven approach. The initiative emphasizes the importance of mechanistic studies within clinical trials and requires a robust plan for managing trial complexity and participant safety. Interested applicants can find additional details and guidelines at the provided NIH link, with the earliest submission date set for April 12, 2024, and the application deadline on January 13, 2027. For inquiries, applicants may contact NIH Grants Information at grantsinfo@nih.gov.
    Limited Competition: Research Centers in Minority Institutions (RCMI) Coordinating Center (U24 - Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a limited competition federal grant opportunity titled "Research Centers in Minority Institutions (RCMI) Coordinating Center," aimed at establishing a national coordinating center to enhance research capacity at RCMI institutions. The center will facilitate collaboration among approximately 22 RCMI Specialized Centers, focusing on securing extramural funding and fostering environments conducive to successful research careers, particularly in addressing health disparities affecting minority populations. This initiative is crucial for promoting high-quality biomedical, behavioral, and clinical research while supporting investigators from underrepresented backgrounds. The total funding available for this opportunity is $3.5 million, with applications due by January 25, 2025. Interested applicants can find more information and contact NIH Grants Information at grantsinfo@nih.gov for inquiries.
    NIAMS Clinical Trial Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity for the NIAMS Clinical Trial Implementation Cooperative Agreement (UG3/UH3), aimed at supporting interventional clinical trials focused on rheumatic, musculoskeletal, and skin diseases. This initiative encompasses a two-phase approach, where the UG3 phase involves trial preparation and the UH3 phase focuses on trial execution, contingent upon meeting specific milestones. The program emphasizes the importance of developing clinical protocols, obtaining IRB approval, and securing necessary resources, while also promoting health equity by engaging individuals with lived experience in the research process. Interested applicants can apply for funding up to $250,000 for the UG3 phase, with a closing date for submissions set for March 4, 2027. For further inquiries, applicants may contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information link at https://grants.nih.gov/grants/guide/pa-files/PAR-24-208.html.