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NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional)
NIDDK supports investigator-initiated, high-risk multi-center (more than one center) clinical studies through a two-part process that may include an implementation planning cooperative agreement (U34).
The U34 is designed to:
1) Permit early peer review of the rationale for the proposed clinical study; 2) Permit assessment of the design and protocol of the proposed study; 3) Provide support for the development of documents needed for the conduct of the study, including a manual of operations; and 4) Support the development of other essential elements required for the conduct of the clinical study.
The proposed clinical study should be hypothesis-driven and focus on a disease in the mission of NIDDK.
Consultation with NIDDK scientific staff is strongly encouraged prior to the submission of the U34 application.
The U34 is designed to:
1) Permit early peer review of the rationale for the proposed clinical study; 2) Permit assessment of the design and protocol of the proposed study; 3) Provide support for the development of documents needed for the conduct of the study, including a manual of operations; and 4) Support the development of other essential elements required for the conduct of the clinical study.
The proposed clinical study should be hypothesis-driven and focus on a disease in the mission of NIDDK.
Consultation with NIDDK scientific staff is strongly encouraged prior to the submission of the U34 application.
Related Programs
Diabetes, Digestive, and Kidney Diseases Extramural Research
Department of Health and Human Services
Agency: Department of Health and Human Services
Office: National Institutes of Health
Estimated Funding: $0
Office: National Institutes of Health
Estimated Funding: $0
Who's Eligible
Relevant Nonprofit Program Categories
Obtain Full Opportunity Text:
https://grants.nih.gov/grants/guide/pa-files/PAR-25-090.html
Additional Information of Eligibility:
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U. S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U. S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Full Opportunity Web Address:
http://grants.nih.gov/grants/guide/pa-files/PAR-25-090.html
Contact:
Agency Email Description:
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Agency Email:
Date Posted:
2025-01-10
Application Due Date:
Archive Date:
2027-07-16
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