NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)
Open Posted
- Opportunity number
- PAR-27-064
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Category
-
- Health
- Eligible applicants
-
- Non-501(c)(3) Nonprofits
- Other
- State Governments
- Independent School Districts
- Tribal Governments (Federally Recognized)
- Higher Education Inst. (Private)
- Special District Governments
- County Governments
- Tribal Organizations (Not Federally Recognized)
- For Profit Organizations
- Public or Indian Housing Auth.
- 501(c)(3) Nonprofits
- Small Businesses
- City/Township Governments
- Higher Education Inst. (Public)
- Points of contact
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institute of Allergy and Infectious Diseases (NIAID) seeks applicants for the Clinical Trial Implementation Cooperative Agreement (U01) program to fund investigator-initiated, milestone-driven, high-risk clinical trials with enhanced oversight, including mechanistic studies, with applications due July 5, 2029. Only one clinical trial may be proposed per application.
Eligible applicants include non-501(c)(3) nonprofits, 501(c)(3) nonprofits, for-profit organizations, small businesses, state and local governments, tribal governments and organizations, special district governments, higher education institutions (public and private), independent school districts, and public or Indian housing authorities. Non-domestic entities and foreign components of U.S. organizations are eligible.
The program supports clinical trials lasting up to 5 years, with extended support available for 6- or 7-year trials. Funded activities include conduct, completion, and analysis of the clinical trial; training of study personnel; enrollment and recruitment of study subjects; data collection, clinical data management, and quality control; investigational product costs; laboratory work and data analyses; study management and oversight; post-trial activities; and regulatory activities and site monitoring.
Applications undergo peer review based on scientific merit and general significance, technical adequacy of experimental design, investigator competency, adequacy of facilities and resources, appropriateness of budget components, and relevance to program objectives. The program operates under CFDA 93.855 (Allergy and Infectious Diseases Research), with statutory authority from Sections 301 and 405 of the Public Health Service Act and Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.
Synopsis
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
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.
Files
| File | Type | Posted |
|---|---|---|
| PKG00293320.pdf | ||
| PAR-27-064-Full-Announcement.html | HTML file |
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