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Pre-Award

IRB

IRB-01

IRB-01 is the institutional review board for UF faculty, staff, and students who conduct or participate in medical research of human subjects. Questions can be directed to the IRB staff at the following email address: IRBSubmission@jax.ufl.edu

WIRB

The Western IRB (WIRB) is a contracted central IRB that reviews industry sponsored trials involving FDA regulated drugs or devices. College of Medicine faculty and staff are required to utilize WIRB.

Single IRB (sIRB)

Single IRB (sIRB) review occurs when research is being conducted at multiple universities/institutions but only a single IRB reviews and approves the research for multiple sites.

Funded Projects

UFIRST

UFIRST is the agreement, proposal and award management system of the University of Florida. UFIRST is mandatory for the entry and routing of proposal and agreements managed by DSP. UFIRST allows transparent tracking throughout the lifecycle of the award from proposal development to proposal submission to award negotiation, set up and management.

Agreements – Agreements are created in UFIRST for industry sponsored clinical research involving human subjects. Confidentiality/non-disclosure agreements (CDAs) and clinical trial agreements (CTAs) are negotiated by the Office of Research Affairs.

  • Create an agreement in UFIRST and contact ora@jax.ufl.edu to begin the negotiation process. The department is responsible for negotiating the budget.
  • Required documents for CTAs:
    • CTA Checklist (need digital copy or link)
    • ICF Checklist (need a digital copy or link)
    • WIRB Certificate of Action

Proposals – Proposals are submitted for a non-industry funded research study. Use the smart forms in UFIRST to create your proposal. Refer to the UFIRST Toolkits for detailed information on creating and submitting a proposal.

Awards – The Office of Research Affairs will coordinate fund creation within UFIRST upon completion of an executed clinical trial agreement or confirmation of a funded proposal. You will then be able to manage your award(s) within UFIRST.

Once your study is funded and uploaded into the awards section, you will need to complete the following forms:

  • CMS Billing Verification Form (F:\common\Researcher Manual & Resources Committee\CMS Billing Verification Form and Medicare Coverage Analysis\CMS Billing Verification Form)
  • Institutional Research Start-Up Forms (Click "Ok", "Read Only", "Save As" to Edit. Submit to Darin Morse)

Other Funding Resources

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