NIDCR Clinical Trial Implementation Cooperative Agreement (U01)

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-Purpose. This FOA issued by the National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health, will support investigator-initiated Phase I, II, III, or IV clinical trial cooperative agreement applications only from NIDCR Clinical Trial Planning (R34) grant awardees (see PAR-08-195 for information about NIDCR Clinical Trial Planning Grants) unless an exception is granted. Each clinical trial implementation application will use the PHS 398 grant application with special instructions and will include a final draft of the clinical trial protocol, the Clinical Investigators Brochure or equivalent, and a Manual of Procedures resulting from the R34 grant. These documents must meet all National Institutes of Health (NIH), Food and Drug Administration (FDA), and Office of Human Research Protections (OHRP) requirements. All awards will be made as cooperative agreements.-Mechanism of Support. This FOA will utilize the NIH single project (U01) cooperative agreement award grant mechanism. -Funds Available and Anticipated Number of Awards. Because the nature and scope of the proposed research will vary between applications, 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 relevance of the proposed trial to the NIDCR mission and strategic plan, trial complexity, anticipated duration, and associated operational trial proposed costs.

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