NIDCR Clinical Trial Planning Grant (R34)

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-Purpose. This FOA, issued by the National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health, will support clinical trial planning (R34) grants for the comprehensive planning, design and documentation of investigator-initiated Phase I, II, III, or IV interventional clinical trials. Interventional behavioral studies, sometimes referred to as Stage I, II, III or IV studies, are included. The R34 planning grant is designed to: (1) permit early peer review of the rationale for the proposed clinical trial; (2) permit early assessment of the design and implementation plans of the proposed trial; and (3) provide support for the development of a comprehensive clinical trial protocol and associated documents including a Manual of Procedures. The complete protocol and associated documents are required components of any subsequent clinical trial implementation (U01) application. The product of the R34 will be either an application for a clinical trial implementation cooperative agreement (U01) or a report summarizing the work completed and the reasons for not proceeding to a clinical trial implementation application. Pre-approval from the NIDCR is required for the submission of the R34 application. -Mechanism of Support. This FOA will utilize the NIDCR Clinical Trial Planning (R34) grant mechanism. -Funds Available and Anticipated Number of Awards. Awards issued under this FOA are contingent upon the availability of funds and the submission of meritorious applications.

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