Natural Product Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 14, 2026
Can you apply?
This grant is for research institutions, academic medical centers, and nonprofit research organizations seeking to establish or maintain a Data Coordinating Center (DCC) for multi-site natural product clinical trials. The grant supports collaborative U24 awards specifically designed to facilitate coordination, management, and analysis of data from multiple clinical trial sites investigating natural products. Eligible applicants include academic institutions, hospital systems, research centers, and other research organizations capable of managing complex multi-site clinical trial data infrastructure. The geographic scope is nationwide, supporting U.S.-based research institutions. Activities supported include data management systems development, quality assurance and monitoring, statistical analysis support, regulatory documentation coordination, and collaborative infrastructure to ensure data integrity across distributed trial sites.
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Program description
This Notice of Funding Opportunity (NOFO), utilizing the U24 grant funding mechanism, encourages applications for a collaborating Data Coordinating Center (DCC) application that accompanies an investigator-initiated multi-site clinical trial (Phase Ill and beyond) application submitted underTEMP-26943. The DCC application must be specific to the collaborating Clinical Coordinating Center (CCC) application. The objective of the DCC application is to propose a comprehensive plan that provides overall project coordination, and administrative, data management, and biostatistical support for the proposed clinical trial. Both a DCC application and a corresponding CCC application need to be submitted simultaneously for consideration by NCCIH.
Trials for which this NOFO applies must be relevant to the research mission of the NCCIH and considered a high priority by the Center. For additional information about the mission, strategic vision, and research priorities of the NCCIH, applicants are encouraged to consult the NCCIH website: (http://www.nccih.nih.gov).
Applicants are strongly encouraged to contact the appropriate Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this NOFO.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- NIH Form SF-424 (R&R) application package
- Project Narrative (Research Strategy section detailing data coordinating center operations)
- Detailed Budget and Budget Justification
- Biosketches for all key personnel (NIH format)
- Institutional Commitment and Facilities documents
- Letters of Support/Commitment from participating clinical trial sites
- Data Management Plan with Quality Assurance protocols
- Regulatory Compliance documentation (HIPAA, FDA compliance approach)
- Organization's Tax-Exempt Status documentation (if applicable)
- Conflict of Interest disclosures
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.213 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$22,367,527
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$21,646,919
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$19,236,131
-
$17,730,528
-
$15,036,701
-
$14,473,882
-
$12,748,932
-
$11,956,053
-
$11,225,697
-
$10,919,780
Top States by Funding
- CA 13 awards $83.5M
- MA 13 awards $80.2M
- WA 8 awards $69.9M
- NC 7 awards $53.8M
- NY 6 awards $40.0M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.213). How funding has trended year over year.
| 2024 | $240,178,154 | |
| 2025 | $232,899,116 | |
| 2026 est. | $2,655,626 |
FAQ
Who is eligible to apply for this U24 Data Coordinating Center grant?
Academic medical centers, research institutions, nonprofit research organizations, and similar entities with established research infrastructure and experience in multi-site clinical trials are eligible. The applicant institution must have capacity to serve as the central coordinating hub for multiple clinical trial sites.
What is the typical funding range for a U24 Data Coordinating Center award?
U24 awards for clinical trial coordination typically range from $500,000 to over $2 million annually, depending on the complexity and number of participating sites. Budget should reflect realistic costs for staffing, infrastructure, and data management systems.
What types of activities are supported by this grant?
Supported activities include establishing and maintaining data management systems, conducting quality assurance across sites, managing regulatory documentation, providing statistical support, coordinating site communications, and ensuring data security and compliance with HIPAA and FDA regulations.
What makes a competitive application for a Data Coordinating Center grant?
Competitive applications demonstrate prior experience with multi-site trial coordination, clear data management protocols, experienced personnel, strong collaborative relationships with trial sites, and feasibility of managing large complex datasets while maintaining data quality and regulatory compliance.
When is the application deadline and what is the timeline?
The application deadline is July 14, 2026. Applications typically undergo peer review over several months, with funding decisions announced approximately 6-8 months after submission. Planning and preparation should begin well in advance.
💡 Tips for applicants
- Emphasize your institution's prior experience with multi-site clinical trials and data management infrastructure. Reviewers will scrutinize your track record with complex coordinating center work.
- Develop detailed data management and quality assurance plans that specify how you will standardize data collection across multiple sites and ensure compliance with FDA and HIPAA requirements.
- Include letters of commitment from all participating clinical trial sites demonstrating their agreement to use your coordinating center services and their confidence in your leadership.
- Budget realistically for personnel with specific expertise in clinical data management, biostatistics, regulatory affairs, and informatics. Highlight key staff with relevant doctoral degrees and publications.
- Propose a clear communication and governance structure that shows how you will coordinate efficiently with multiple sites, resolve data issues, and maintain scientific integrity throughout the trial.
⚠️ Common mistakes
Applications often fail due to underestimating the complexity of multi-site data coordination and proposing insufficient staffing or budget. Many applicants lack detailed descriptions of their data quality assurance protocols or fail to adequately address regulatory compliance and data security measures. Weak letters of commitment from participating trial sites or unclear roles and responsibilities among coordinating center staff can also lead to rejection.
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