National Institutes of Health · Department of Health and Human Services
Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)
Key facts
- Deadline
- Opens Nov 16, 2026 · due about Feb 16, 2027 Estimate, not confirmed by the funder ?
- Award size
- Not stated: see the official notice
- Match ?
- Not required · Work out your budget and match
- Who can apply
- Nonprofit without 501(c)(3), Larger business, Public college or university, School district, State government, Small business, Special district (utility, fire, etc.), Tribal government, County government, City or town government, Tribal organization, Nonprofit with 501(c)(3), Private college or university, and others named in the official notice
- Where
- Anywhere in the U.S., including Tennessee
Opening soon: the funder has announced this grant, but you can't apply yet. Use the time to get ready and check whether it fits.
Before you apply: federal grants require an active SAM.gov registration (Unique Entity ID) and a Grants.gov account. Registration is free but can take weeks, so start now, not when the deadline is close. Get-ready checklist
How this fits you
- Available in Blount County (nationwide program)
- No match required
- Past Tennessee awards on file: 286
Tell us who you are to see whether you're eligible.
Official notice: https://simpler.grants.gov/opportunity/23a356f5-2b12-4891-a251-d01db68c7582 · Printed from grantme.click/grants/9f23d00c-3901-4dea-a73e-56b70a33ad38
View on Grants.gov Add dates to my calendar
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About this grant
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, from the official notice
Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;Non-domestic (non-U.S.) Entities (Foreign Institutions).
Writing the need statement? Blount County facts with citations.
Who in Tennessee has won this program
78 awards to Tennessee groups in 2 counties since 1977 · 0 in Blount County. Largest shown:
| Past winner | Where | Amount | Fiscal year |
|---|---|---|---|
| Vanderbilt University Medical Center | Nashville, Davidson County | $34.7M spent that year | 2025 |
| St Jude Children's Research Hospital Inc | Memphis, Shelby County | $28.2M | 1997 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $24.7M | 2014 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $21.8M | 2012 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $21.6M | 2010 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $19.2M spent that year | 2025 |
| Vanderbilt University | Nashville, Davidson County | $15.5M | 2014 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $12.3M | 2016 |
| University of Tennessee | Memphis, Shelby County | $11.3M | 1977 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $8.1M | 2022 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $7.1M | 2019 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $6.8M | 2007 |
Source: Federal Audit Clearinghouse, USAspending.gov. Past awards show who this program funds. They don't guarantee future awards.
Tennessee groups that got this money through a state agency or another organization
This federal money also reaches local groups as pass-through grants. 208 pass-through grants on file · 0 in Blount County. Largest shown:
| Past winner | Where | Through | Amount | Fiscal year |
|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville, Davidson County | Trustees of Boston University | $4.6M | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Research Triangle Institute | $3.6M spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Regents of the University of Michigan | $3.4M | 2025 |
| Vanderbilt University | Nashville, Davidson County | Vanderbilt University Medical Center | $1.3M | 2023 |
| Vanderbilt University | Nashville, Davidson County | Purdue University | $1.2M | 2024 |
| Vanderbilt University Medical Center | Nashville, Davidson County | University of Michigan | $1.1M spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Regents of the University of California, San Francisco, the | $1M | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Yale Univ | $938K | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Research Triangle Institute | $936K spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | The Children's Hospital of Philadelphia | $810K | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | University of Pittsburgh - of the Commonwealth System of Higher Education | $764K | 2026 |
| St Jude Children's Research Hospital Inc | Memphis, Shelby County | Icahn School of Medicine at Mount Sinai | $763K | 2024 |
Source: USAspending.gov pass-through reports (the first recipient reports each one of $30,000 or more).
About the federal program
National Center on Sleep Disorders Research
Program number 93.233 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Project grant
How applications are judged
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the importance of the problem the proposed research will address; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation of the proposed research; (5) the potential of the proposed research for commercial application; (6) the appropriateness of the budget requested; (7) the adequacy and suitability of the facilities and research environment; (8) the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will be evaluated; and (9) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or...
Match
None required (federal program listing).
About the federal program
Cardiovascular Diseases Research
Program number 93.837 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Project grant
How applications are judged
The major elements in evaluating proposals include assessments of: (1) the scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) the soundness and technical merit of the proposed approach; (2) the importance of the problem the proposed research will address; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation of the proposed research; (5) the potential of the proposed research for commercial application; (6) the appropriateness of the budget requested; (7) the adequacy and suitability of the facilities and research environment; and (8) the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will be evaluated; and (9) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or...
Match
None required (federal program listing).
About the federal program
Lung Diseases Research
Program number 93.838 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Project grant
How applications are judged
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the importance of the problem the proposed research will address; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the scientific, technical, or technological innovation of the proposed research; (5) the potential of the proposed research for commercial application; (6) the appropriateness of the budget requested; (7) the adequacy and suitability of the facilities and research environment; (8) the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will be evaluated; and (9) where applicable, the adequacy of assurances detailing the proposed means for (a)...
Match
None required (federal program listing).
About the federal program
Blood Diseases and Resources Research, also called “Division of Blood Diseases and Resources (DBDR)”
Program number 93.839 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Project grant
How applications are judged
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the importance of the problem the proposed research will address; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation of the proposed research; (5) the potential of the proposed research for commercial application; (6) the appropriateness of the budget requested; (7) the adequacy and suitability of the facilities and research environment; (8) the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will be evaluated; and (9) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or...
Match
None required (federal program listing).
About the federal program
Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders
Program number 93.840 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Project grant
How applications are judged
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2)the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the importance of the problem the proposed research will address; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation of the proposed research; (5) the potential of the proposed research for commercial application; (6) the appropriateness of the budget requested; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I...
Match
None required (federal program listing).