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Federal Clinical Trials

The UF federally negotiated Other Sponsored Research (OSA) F&A Rate may be used for human clinical studies that meet ALL of the following conditions:

  • Prime funding from a federal entity, including flow-through funding from an external sponsor to UF.
  • Protocol or research orders are prescribed and controlled by the sponsor or the prime agency:
    • The local UF principal investigator (PI) does not have scientific freedoms generally understood to be a part of fundamental and/or basic research projects.
    • Generally these protocols follow a clinical calendar, prescribing visits, data and order tissue/sample collections.
    • These studies may include observational or data-collection-only studies without analytical reports provided to the funding source.
  • The compensation for these studies are driven by milestones or deliverables, such as:
    • Enrollment or accrual (per case reimbursement language or capitation language)
        • Also sometimes referred to as “completely enrolled subjects”
        • Generally as a protocol site, UF is permitted only a finite number of enrollment slots
    • Payment Fact Sheets from DHHS/NIH divisions, such as the National Cancer Institutes – National Clinical Trials Network – Cooperative Groups, such as ECOG-ACRIN, SWOG, NRG, Alliance, or COG.
    • Upon completion of “case report forms” commonly called CRF’s or eCRF’s

If the UF PI has control over the scope of work and experimental design or if the UF PI must submit analytical reports on the study data and results, the federal research rate would apply.  Clinical and research studies funded by nonfederal sources will follow UF’s standard F&A policy.

Addendum (list of Federal Cooperative clinical trial groups for support in determining appropriateness of the application of this policy):

NCI Clinical Trials Groups

  • COG (Children’s Oncology Group)
  • NRG (consolidation of NSABP, RTOG, and GOG)
  • ALLIANCE (consolidation of ACOSOG, NCCTG, and CALGB)
  • SWOG

For clinical studies using animal subjects, the appropriate federal negotiated rates are used, most common being on campus research. See details on definitions of clinical trials and allowability in section 3 of F&A Directives and Procedures.