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.