NIDDK Multi-Center Clinical Study Implementation Planning Grants (U34)

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Purpose. NIDDK supports investigator-initiated, multi-center (three or more sites) clinical studies exclusively through a two-part process that includes an implementation planning (U34) grant. The U34 planning grant 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 a clinical study. Completion of the required products of a U34 grant is a prerequisite for submission of a multi-center clinical study cooperative agreement (U01) application, which will support the actual conduct of the study. Pre-approval from NIDDK will be required for submission of an U34 application. Mechanism of Support. This FOA will utilize the U34 grant mechanism. Funds Available and Anticipated Number of Awards. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received.

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