Clinical Trial Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Oct 18, 2026
Can you apply?
This grant is for researchers and research institutions seeking to conduct clinical trials on musculoskeletal, rheumatologic, and immunologic diseases under the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Eligible applicants include nonprofit organizations, for-profit organizations, state and local governments, academic institutions, and tribal organizations with demonstrated research capability. The UG3/UH3 cooperative agreement structure provides two phases: a UG3 planning phase (typically 1 year) to refine protocols and obtain regulatory approvals, followed by a UH3 implementation phase (typically 3 years) to conduct the clinical trial. Applicants must have institutional resources, experienced research teams, and commitment to rigorous clinical trial execution. This program supports clinical research that will advance understanding and treatment of NIAMS-relevant conditions through properly designed and conducted trials.
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Program description
This NIAMS Clinical Trial Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) PAR, a re-issue of PAR-24-208, was re-issued as a result of the Simplifying Review of Research Project Grant Applications [link: https://grants.nih.gov/policy-and-compliance/policy-topics/peer-review/simplifying-review].
The Simplified Review changes in Section V. Application Review Information of the funding opportunity are the only changes that have been made. All other aspects of this funding opportunity remain the same.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (R&R) Application for Federal Assistance
- Project narrative (research strategy, including background, significance, innovation, approach, timeline)
- Detailed budget with justification (including direct and F&A costs for both UG3 and projected UH3)
- Biographical sketches of Key Personnel (limit 2-3 pages per person)
- Letters of support from clinical sites and Data Safety Monitoring Board members
- Institutional support letter confirming IRB and research infrastructure
- IRB protocol or documentation of plan to obtain IRB approval
- DSMB charter or plan for Data Safety Monitoring Board
- Curriculum vitae or biosketch for study coordinator and trial management staff
- Preliminary data supporting trial feasibility (if available)
- Other support documentation showing current/pending funding on related projects
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.846 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$63,962,483
-
$60,038,896
-
$34,166,872
-
$28,848,731
-
$24,598,295
-
$21,654,386
-
$21,510,846
-
$20,225,012
-
$17,794,329
-
$16,915,106
Top States by Funding
- MA 17 awards $143.1M
- CA 14 awards $133.2M
- NC 5 awards $127.9M
- NY 14 awards $127.4M
- PA 11 awards $104.1M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.846). How funding has trended year over year.
| 2018 | $476,478,975 | |
| 2019 | $490,084,446 | |
| 2020 | $505,547,334 | |
| 2021 | $509,241,630 | |
| 2022 | $499,786,367 | |
| 2023 | $548,439,000 | |
| 2024 est. | $545,593,000 | |
| 2025 est. | $541,712,000 |
FAQ
Who can apply for this cooperative agreement?
Research institutions, universities, nonprofits, for-profits, state and local governments, and tribal organizations with institutional support for clinical research. Applicants must have IRB approval capability and adequate research infrastructure.
What is the UG3/UH3 structure?
The UG3 phase (typically 1 year) focuses on trial preparation, protocol refinement, and regulatory approvals. Upon successful completion and competitively peer-reviewed progress, the UH3 phase (typically 3 years) supports the actual clinical trial implementation.
What types of clinical trials are supported?
Trials must address musculoskeletal, rheumatologic, or immunologic diseases within NIAMS scope. Phase II and Phase III trials are typical. Trials must be prospective, have clearly defined outcomes, and follow rigorous study design principles.
How competitive is this program?
Very competitive. NIAMS receives many applications. Strong scientific innovation, experienced team composition, demonstrated feasibility, and preliminary data significantly improve competitiveness. Clear regulatory pathway and realistic timelines are essential.
What is the typical funding range?
Funding varies based on trial complexity and scope, typically ranging from $500,000 to $2+ million per year depending on phase and trial requirements. Budget must align with proposed scope.
💡 Tips for applicants
- Build a strong multidisciplinary team: Include clinicians, biostatisticians, data managers, and outcome measurement experts. Peer reviewers assess team capability heavily.
- Demonstrate feasibility: Include preliminary data, enrollment projections with letters of support from clinical sites, and realistic timeline. Show you can actually enroll and retain participants.
- Align with NIAMS mission: Clearly position your trial within musculoskeletal, rheumatologic, or immunologic disease scope. Review recent NIAMS-funded trials for context.
- Plan for regulatory success: Work with your IRB early. Address Data Safety Monitoring Board (DSMB) composition, adverse event reporting, and protocol amendment procedures in advance.
- Use the UG3 phase strategically: Treat the planning year as your opportunity to nail down enrollment pathways, refine inclusion/exclusion criteria, and solve anticipated operational challenges before expensive trial startup.
⚠️ Common mistakes
Many applications fail due to weak enrollment feasibility—reviewers want documented commitment from clinical sites and realistic patient numbers, not optimistic projections. Second, insufficient detail on trial operations and data management can sink an otherwise strong science proposal; specify exactly how you'll handle recruitment, retention, protocol adherence monitoring, and data quality. Finally, misalignment with NIAMS disease scope or proposing trials that don't clearly advance clinical practice in these areas leads to low priority scores.
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