OpportunityTitle: NIDCR Clinical Trial or Biomarker Clinical Validation Study Planning Grant (R34)
AdditionalInformationOnEligibility: Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); 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); Non-domestic (non-U.S.) Entities (Foreign Organizations); 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 validation studies. This Funding Opportunity Announcement (FOA) will support activities to develop: the draft clinical protocol; the Clinical Investigators Brochure (or equivalent) if needed; tools for data and quality management, safety and operational oversight plans; recruitment and retention strategies; the study team; and other essential documents such as a draft Manual of Procedures that are necessary for the subsequent clinical trial or biomarker clinical validation study. The Clinical Trial or Biomarker Clinical Validation Study Planning Grant is not designed for the collection of preliminary data on the efficacy of the intervention (clinical or pre-clinical), or the collection of prospective data to support the rationale for a clinical trial or study. Evaluation of the potential subject population to determine its eligibility for participation in the future trial or biomarker validation study is allowed but not required. Planning grant activities for behavioral and social interventions may include pilot testing of the intervention during the R34 phase, thus a separate FOA (PAR-14-342) will support these types of interventional trials.
GrantorContactEmailDescription: If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster
GrantorContactText: NIH OER Webmaster &lt;br/&gt;FBOWebmaster@OD.NIH.GOV &lt;br/&gt;