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NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

National Institutes of Health

This notice of funding opportunity (NOFO) encourages applications for implementation of investigator-initiated, milestone driven clinical trials that need enhanced oversight, and as applicable, include mechanistic studies. Mechanistic work in clinical trials may be of great value because it promotes

Funding
See official notice
Deadline
July 6, 2029
Status
OPEN
Category
Health & Medical
Opens
June 16, 2026
Directory link check
October 27, 2026

About this opportunity

This notice of funding opportunity (NOFO) encourages applications for implementation of investigator-initiated, milestone driven clinical trials that need enhanced oversight, and as applicable, include mechanistic studies. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities. Support is available for clinical trials up to 5 years, as well as for extended clinical trials of 6- or 7-years. Investigators are encouraged to visit this NIH website for additional information about the overall mission and research areas of NIAID.Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation Cooperative Agreement (U01) application. In accordance with NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered.

Eligibility recorded

Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility. Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant types

Focus areas

Health

Recorded notice evidence

What to verify for NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

Applicant evidence

  • Applicant type: State governments
  • Applicant type: County governments
  • Applicant type: City or township governments
  • Applicant type: Special district governments
  • Applicant type: Independent school districts
  • Applicant type: Public and state-controlled institutions of higher education
  • Applicant type: Federally recognized tribal governments
  • Applicant type: Public housing authorities and Indian housing authorities

Opportunity boundaries

  • Recorded funding: See official notice
  • Recorded deadline: July 6, 2029; confirm the closing time.
  • Recorded focus: Health
Fields to verify directly: funding amount. A missing directory value does not remove a restriction.
Connect every eligibility claim, registration, attachment and deadline to the current notice. Open the specific official notice →

Application checklist

How to evaluate and apply for NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

Use this record for discovery, then connect every requirement and date to the current official notice and its amendments.

Recorded applicant fit

State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and state-controlled institutions of higher education

Recorded geography

No structured geographic scope is recorded.

Recorded deadline

July 6, 2029 — confirm the closing time.

Eligibility summary: Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility. Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Recorded focus: Health

1Confirm fitMatch entity type, location, project scope, exclusions and cost share.
2Read the noticeCollect amendments, budget rules, attachments and portal instructions.
3Plan timingRecord the funder’s time zone, registrations and internal review dates.
4Submit officiallyUse the funder’s route and save the submission confirmation.

Official sources

Directory link check: October 27, 2026. Always recheck the live notice before relying on it.

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