forecasted
Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)
National Institutes of Health · PAR-27-125
See source for award amount
Not specified
Native American tribal governments (Federally recognized), City or township governments, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Special district governments, State governments, County governments, Public and State controlled institutions of higher education, Others (see text field entitled "Additional Information on Eligibility" for clarification), Public housing authorities/Indian housing authorities, For profit organizations other than small businesses, Private institutions of higher education, Independent school districts, Small businesses
Geographic eligibility and all attachment-specific conditions require review of the original announcement.
Eligibility details
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).
Matching funds & resources
Source matching-funds field: Not Required.
Matching funds and leveraged resources are different requirements. Read the description and reviewed rules below before determining resource commitments.
About this opportunity
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.
Funding geography: Not specified — review source. A funder’s address does not establish eligibility.
Review original source ↗Funding instrument: Cooperative Agreement. Issuing jurisdiction: Federal. This is not a geographic eligibility determination.
Source fields and evidence
id: 363025
Source ↗ · id
opportunityNumber: PAR-27-125
Source ↗ · opportunityNumber
opportunityTitle: Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)
Source ↗ · opportunityTitle
revision: 0
Source ↗ · revision
agencyDetails: {"code":"NIH","seed":"HHS-NIH11","agencyName":"National Institutes of Health","agencyCode":"HHS-NIH11","topAgencyCode":"HHS"}
Source ↗ · agencyDetails
owningAgencyCode: HHS-NIH11
Source ↗ · owningAgencyCode
cfdas: [{"id":434390,"opportunityId":363025,"cfdaNumber":"93.233","programTitle":"National Center on Sleep Disorders Research"},{"id":434391,"opportunityId":363025,"cfdaNumber":"93.837","programTitle":"Cardiovascular Diseases Research"},{"id":434393,"opportunityId":363025,"cfdaNumber":"93.838","programTitle":"Lung Diseases Research"},{"id":434389,"opportunityId":363025,"cfdaNumber":"93.839","programTitle":"Blood Diseases and Resources Research"},{"id":434392,"opportunityId":363025,"cfdaNumber":"93.840","programTitle":"Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders"}]
Source ↗ · cfdas
forecastDesc: <p>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. </p><p>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. </p>
Source ↗ · forecastDesc
applicantTypes: [{"id":"07","description":"Native American tribal governments (Federally recognized)"},{"id":"02","description":"City or township governments"},{"id":"11","description":"Native American tribal organizations (other than Federally recognized tribal governments)"},{"id":"12","description":"Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"13","description":"Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"04","description":"Special district governments"},{"id":"00","description":"State governments"},{"id":"01","description":"County governments"},{"id":"06","description":"Public and State controlled institutions of higher education"},{"id":"25","description":"Others (see text field entitled \"Additional Information on Eligibility\" for clarification)"},{"id":"08","description":"Public housing authorities/Indian housing authorities"},{"id":"22","description":"For profit organizations other than small businesses"},{"id":"20","description":"Private institutions of higher education"},{"id":"05","description":"Independent school districts"},{"id":"23","description":"Small businesses"}]
Source ↗ · applicantTypes
applicantEligibilityDesc: 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).
Source ↗ · applicantEligibilityDesc
fundingInstruments: [{"id":"CA","description":"Cooperative Agreement"}]
Source ↗ · fundingInstruments
fundingActivityCategories: [{"id":"HL","description":"Health"}]
Source ↗ · fundingActivityCategories
costSharing: false
Source ↗ · costSharing
lastUpdatedDate: Jul 01, 2026 10:46:02 AM EDT
Source ↗ · lastUpdatedDate
status: forecasted
Source ↗ · oppHits[id=363025].oppStatus
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