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.

This Notice of Funding Opportunity (NOFO) requires a Plan for Enhancing Diverse Perspectives (PEDP).

Key Dates

Open Date: 5/9/2025

Letter of Intent Due Date: Not applicable.

Application Due Date: June 10, 2025