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NIAMS Clinical Trial Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

US · US National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), HHS grant open #PAR-25-141
Response due Mar 04, 2027 · 00:00 UTC

Summary

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a component of the National Institutes of Health (NIH), is soliciting applications for a Clinical Trial Implementation Cooperative Agreement under the UG3/UH3 funding mechanism. This two-phase award structure (UG3: planning/feasibility; UH3: implementation) requires a clinical trial as a core component. The opportunity is intended to support the design, planning, and full execution of clinical trials relevant to NIAMS mission areas, which include arthritis, musculoskeletal, and skin diseases.

What they want

Applicants must propose and conduct a clinical trial within the scope of NIAMS research priorities (arthritis, musculoskeletal diseases, and skin diseases). The UG3 phase covers trial planning, protocol finalization, infrastructure setup, and feasibility assessments. Upon meeting UG3 milestones, awardees transition to the UH3 phase for full clinical trial implementation. As a cooperative agreement, NIH staff will have substantial programmatic involvement throughout both phases.
Deliverables
  • UG3 phase milestone completion report and feasibility assessment
  • Finalized clinical trial protocol
  • Full clinical trial implementation under UH3 phase
  • Progress reports as required by NIH cooperative agreement terms
Technical requirements
  • Clinical trial must be required and central to the proposed research
  • Two-phase structure: UG3 (planning/feasibility) must be completed before transitioning to UH3 (implementation)
  • Substantial NIH programmatic involvement as a cooperative agreement
  • Research scope must align with NIAMS mission areas: arthritis, musculoskeletal, and skin diseases

How they evaluate

Submission: Grants.gov electronic submission portal (PAR-25-141)

Eligibility & certifications

SAM.gov registration (for institutional applicants)NIH Human Subjects research complianceInstitutional Review Board (IRB) approvalCompliance with NIH Grants Policy Statement

Risks & flags

  • Opportunity number PAR-25-141 suggests a Program Announcement with Review, which may have relatively focused eligibility criteria tailored to NIAMS grantee community
  • Multi-year open window (Dec 2024 – Mar 2027) with rolling submissions may favor established NIH-funded research teams with existing infrastructure
  • UG3/UH3 phased mechanism and milestone-based transition adds complexity that may disadvantage new entrants unfamiliar with NIH cooperative agreement structures

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541714
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

NIAMS Clinical Trial Implementation Cooper…
Due Mar 04
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