Data Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative U24 Clinical Trial Required)

---

Description

This opportunity funds a Data Coordinating Center (DCC) to support multi-site, investigator-initiated clinical trials of mind and body interventions, such as those for chronic pain, depression, or anxiety. The DCC will work in close collaboration with a Clinical Coordinating Center (CCC) to provide overall project coordination, administrative support, data management, and biostatistical expertise for Phase III and later-stage trials. The DCC must be independent from the CCC and is responsible for ensuring the integrity of data collection, intervention delivery, and study blinding across multiple sites.

The DCC will contribute to study design, adverse event monitoring, randomization, interim data reporting, statistical analyses, and dissemination of results. The program is milestone-driven and performance-based, with continued funding contingent on meeting agreed-upon milestones.

---

Due Dates

• June 20, 2025: New, Renewal, Resubmission, Revision applications due
• July 14, 2025: AIDS-related applications due
• February 20, 2026: New, Renewal, Resubmission, Revision applications due
• March 17, 2026: AIDS-related applications due
• June 22, 2026: New, Renewal, Resubmission, Revision applications due
• July 14, 2026: AIDS-related applications due

All applications are due by 5:00 PM local time of the applicant organization. The final expiration date is July 15, 2026.

---

Funding Amount

• Budget: No specific budget limit; budgets must reflect the actual needs of the proposed project.
• Project Period: Up to 5 years is standard; up to 7 years may be requested with strong justification.
• Note: If the combined direct costs of the DCC and CCC exceed $500,000 in any year, prior approval from NCCIH is required.

---

Eligibility

Eligible applicants include:

• Public and private institutions of higher education
• Nonprofits (with or without 501(c)(3) status)
• For-profit organizations (including small businesses)
• State, county, city, township, and special district governments
• Native American tribal governments and organizations
• Independent school districts
• Public housing authorities/Indian housing authorities
• Faith-based and community-based organizations
• Regional organizations
• U.S. territories and possessions
• Eligible agencies of the federal government

Restrictions:

• Non-domestic (non-U.S.) entities and non-U.S. components of U.S. organizations are not eligible to apply.
• Foreign components (e.g., collaborators or consultants) are allowed, but not foreign sites.

---

Application Process

• Companion Application Required: You must submit a DCC application in parallel with a CCC application (see PAR-24-275). Both must be submitted on the same due date.
• Plan for Enhancing Diverse Perspectives (PEDP): A PEDP is required and will be evaluated during peer review. Applications lacking a PEDP will be withdrawn.
• Project Management Plan: Must be included as an attachment (max 3 pages).
• Milestone Plan: Must be included as an attachment (max 5 pages).
• Clinical Trial Experience Table: Required (max 3 pages).
• Budget: Must be synchronized with the CCC budget and include all relevant costs (e.g., DSMB meetings, data sharing, publication).
• Registrations: Applicant organizations must be registered in SAM, eRA Commons, and Grants.gov. All PDs/PIs must have eRA Commons accounts.
• Submission: Applications must be submitted electronically via ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.

For full instructions, see the NIH Application Guide and the full funding announcement.

---

Additional Information

• Milestone-Driven: Continued funding is contingent on meeting annual milestones.
• Clinical Trial Requirements: Only applications proposing clinical trials are accepted.
• Data Management and Sharing: A Data Management and Sharing Plan is required.
• Oversight: An independent Data and Safety Monitoring Board (DSMB) is required.
• No Cost Sharing: Cost sharing is not required.
• Award Administration: Cooperative agreement mechanism (U24) with substantial NIH involvement.

---

External Links

• NIH Funding Opportunity Announcement (PAR-24-276)
• NCCIH Mission and Priorities
• Companion CCC Funding Opportunity (PAR-24-275)
• NIH Application Guide
• Apply via Grants.gov
• NCCIH Policy for Large Budget Clinical Trials
• NIH Data Management and Sharing Policy

---

Contact Information

---