OpportunityTitle: NIDCR Clinical Trial Implementation or Biomarker Clinical Evaluation Study Cooperative Agreement (U01)
AdditionalInformationOnEligibility: Other Eligible Applicants include the following:  Alaska Native and Native Hawaiian Serving Institutions; Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.  Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Description: 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 or biomarker evaluation studies that require prospective collection of clinical outcomes and clinical specimens. All applicants must have received an NIDCR Clinical Trial Planning (R34) award to plan the proposed cooperative agreement study (see PAR-11-338 for information about NIDCR Clinical Trial or Biomarker Clinical Evaluation Study Planning Grants). NIDCR may consider an exception. A unique application is required for each proposed study, and must include a final draft of the study protocol, a Manual of Procedures and other supporting materials such as the Investigators Brochure. 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.
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GrantorContactText: NIH OER Webmaster&lt;br/&gt;FBOWebmaster@OD.NIH.GOV&lt;br/&gt;