NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional)
NIDDK offers support for high-risk multi-center clinical studies through an implementation planning cooperative agreement (U34) to develop essential study elements.
This grant is no longer accepting proposals
National Institutes of Health has archived this opportunity.
Funder: National Institutes of Health
Due Dates: May 9, 2025 (Open date) | June 10, 2025 (Full application deadline) | February 11, 2026 (Full application deadline) | February 19, 2026 (FOA expiration)
Funding Amounts: Up to $225,000 in direct costs per year, maximum project period of 2 years.
Summary: Supports planning and preparation for high-risk, multi-center clinical studies on diseases within the NIDDK mission.
Key Information: Consultation with NIDDK scientific staff is strongly encouraged at least 12 weeks before submission.
Description
This opportunity supports investigator-initiated, high-risk multi-center clinical studies through a two-part process, beginning with an implementation planning cooperative agreement (U34). The U34 mechanism is designed to facilitate early peer review of the study's rationale and design, support the development of essential documents (such as study protocols and manuals of operations), and ensure comprehensive administrative planning before participant recruitment begins. The clinical study must be hypothesis-driven and focused on a disease area within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Only studies classified as "high-risk" (due to intervention or operational complexity) are eligible. Consultation with NIDDK staff is strongly encouraged to ensure alignment with institute priorities and appropriateness for this mechanism.
