OpportunityTitle: NIDCR Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant (R34)
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: The NIDCR will support R34 grants for the planning and design of clinical trials or biomarker clinical evaluation studies. The R34 grant award will provide support for activities that include, but are not limited to: the establishment of the research team; the development of the clinical protocol and Clinical Investigators Brochure (or equivalent); the development of tools for data management, safety and operational oversight of the research; the definition of recruitment strategies; and all essential elements of the study such as a Manual of Procedures for the clinical trial or biomarker clinical evaluation study, or a draft of the manualized behavioral, community, or services intervention. (See Scope for more detail.) The Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant is not designed for the collection of preliminary data (clinical or pre-clinical), or the collection of prospective data to support the rationale for a clinical trial or study.
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