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

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-Purpose. NIDDK supports investigator-initiated, multi-center clinical studies 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/protocol of the proposed study; (3) provide support for the development of a complete study protocol and associated documents 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. -Mechanism of Support. This Funding Opportunity Announcement (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. Although the financial plans of the Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

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