NIDDK Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34)

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NIDDK supports investigator-initiated, multi-center (three or more sites) 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 a clinical study. The proposed clinical study should be hypothesis-driven and focus on a disease relevant to the mission of NIDDK. Consultation with NIDDK Scientific/Research staff is strongly encouraged prior to the submission of the U34 application.

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