Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 15, 2026
Can you apply?
This grant is for researchers leading large, complex clinical trials at one or multiple sites. NIH will accept efficacy, effectiveness, pragmatic, and implementation research trials. Decentralized and virtual trials are eligible if they meet NIH's clinical trial definition. Your institution must align with participating NIH Institute or Center (IC) research priorities.
The two-phase structure requires a startup phase (UG3, up to 2 years) followed by a full implementation phase (UH3, up to 5 years). Successful UG3 projects transition to UH3 funding. Applicants must demonstrate capacity for trial coordination, data management, and biostatistical support.
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Key dates
- Jul 1, 2026 Applications open
- Feb 16, 2027 Application deadline in 215 days
- Oct 1, 2027 Award announced
- Dec 1, 2027 Project start
Program description
The NIH intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications to develop and implement investigator-initiated multi-site clinical trials, including efficacy, effectiveness, pragmatic, and/or implementation research clinical trials. Applications that propose a large and/or complex clinical trial conducted at either a single site or at multiple locations but without physical clinical sites (e.g., decentralized or virtual trials) may also be eligible. Proposed trials must be relevant to the research mission of the participating ICs and meet the NIH definition of a clinical trial (see NOT-OD-15-015 and NOT-OD-26-032). The objective of the application is to present 1) the scientific rationale as well as a comprehensive scientific and operational plan for the trial, and 2) a comprehensive plan to provide overall project coordination, administration, data management, and biostatistical support for the clinical trial.
Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize a bi-phasic (UG3/UH3), milestone-driven mechanism consisting of a start-up phase up to 2 years (UG3) and a full enrollment and clinical trial implementation phase up to 5 years (UH3), for a total award duration of up to 7 years. A UG3 project that meets its milestones will be administratively considered for transition to the UH3 award. Investigators with expertise and insights into this area are encouraged to begin to consider applying for this NOFO.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (federal application form)
- Project Narrative (including scientific rationale and operational plan)
- Budget and Budget Justification
- Biographical sketches of key personnel
- Data management and biostatistics plan
- Letters of support from collaborating sites (if multi-site)
Program contact
- 👤 National Heart, Lung, and Blood Institute (NHLBI)
- 📧 NHLBIDCVSClinical@mail.nih.gov
- 📞 Please contact via e-mail.
Funding track record
Recent awards under CFDA 93.840 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$9,471,643
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$8,728,007
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$7,692,108
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$4,748,073
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$4,329,292
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$3,974,800
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$3,945,932
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$3,945,135
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$3,943,028
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$3,868,722
Top States by Funding
- MA 7 awards $24.6M
- NY 5 awards $17.8M
- WA 5 awards $16.2M
- CA 8 awards $14.1M
- PA 6 awards $14.0M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.840). How funding has trended year over year.
| 2024 | $68,908,737 | |
| 2025 | $72,174,672 |
FAQ
What type of clinical trials are eligible?
Efficacy, effectiveness, pragmatic, and implementation research trials. Decentralized and virtual trials qualify if they meet NIH clinical trial definitions.
Do I need cost-sharing funds?
No. Cost sharing is not required for this grant.
How does the UG3/UH3 mechanism work?
UG3 funds trial development and planning for up to 2 years. Meeting milestones leads to UH3 funding for enrollment and implementation up to 5 years.
What is the total project duration?
Up to 7 years total—combining UG3 and UH3 phases.
What must my application include?
Scientific rationale, comprehensive trial plan, and detailed plans for coordination, administration, data management, and biostatistics.
💡 Tips for applicants
- Start planning now. Applications aren't being solicited yet, so use this time to build collaborative partnerships and finalize your trial design.
- Emphasize your team's trial management capacity. Include experienced coordinators, biostatisticians, and data managers in your plan.
- Align your research question with the priorities of participating NIH Institutes and Centers. Review their strategic plans.
- Detail your data management and biostatistical infrastructure. Reviewers want to see robust systems for large, complex trials.
- If proposing a decentralized trial, clearly explain how you'll maintain scientific rigor and participant safety without physical sites.
⚠️ Common mistakes
Weak trial coordination plan—reviewers reject applications lacking detail on data management, biostatistics, or site management. Misalignment with IC priorities—ensure your trial directly supports a participating IC's research agenda. Insufficient preliminary evidence—provide strong justification for your trial's scientific need and feasibility.
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