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    NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)

    Funding for observational studies and biomarker validation requiring prospective data/biospecimen collection or analysis from prior NIDCR grants.

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    Funder: National Institutes of Health

    Due Dates: June 5, 2025 (New) | July 5, 2025 (Renewal/Resubmission/Revision) | September 7, 2025 (AIDS) | October 5, 2025 (New) | November 5, 2025 (Renewal/Resubmission/Revision) | January 7, 2026 (AIDS) | February 5, 2026 (New) | March 5, 2026 (Renewal/Resubmission/Revision) | May 7, 2026 (AIDS)

    Funding Amounts: No budget cap; budgets must reflect actual project needs. Project period up to 5 years.

    Summary: Supports investigator-initiated observational or biomarker validation studies requiring prospective data/biospecimen collection or analysis of previously collected NIDCR data/biospecimens.

    Key Information: Clinical trials are not allowed; contact NIDCR if requesting ≥$500,000 direct costs in any year.


    Description

    This opportunity, offered by the National Institute of Dental and Craniofacial Research (NIDCR) at NIH, supports investigator-initiated prospective observational studies or biomarker validation studies. Projects must require either the prospective collection of data and/or biospecimens, or continued analysis of data/biospecimens collected under a previous NIDCR cooperative agreement. The mechanism is a U01 cooperative agreement, which involves substantial NIH programmatic involvement.

    The program aims to generate high-quality data to advance understanding, prevention, diagnosis, and treatment of dental, oral, and craniofacial diseases and disorders. Both large-scale observational studies and advanced biomarker validation efforts are eligible, provided they do not meet the NIH definition of a clinical trial.


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