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Revising Your Study

Steps

  1. All submissions from UF and Shands researchers to WIRB must include a copy of our UF Cover Letter.

    You must include the UF Cover Letter with your submission to WIRB to insure:

    1. That the paperwork approved by WIRB complies with UF specific requirements. For example- UF requires certain language in the Informed Consent form that WIRB does not necessarily require in consent forms for other institutions. Of considerable importance is that the Consent includes our local language for (a) payment related to injuries and (b) HIPAA authorizations.
    2. That UF and it’s research related offices are properly notified about the status of your research.
    3. New WIRB Submission Requirement

      Beginning May 9th, 2012, all University of Florida study submissions to Western IRB (WIRB) will require provision of an “Institutional Number.” This institutional number is a unique UF identifier that will allow UF to map WIRB approval data back to specific UF proposals. This new WIRB requirement applies to all submissions – new and continuing.

      How Do I get the Institutional Number for my Study?

      UF will be using the Research Administration and Compliance (RAC)# as the Institutional Number. Since November 2009, the RAC# has been provided on the RAC Financial Language Assessment (FLA) form on the right-side of the study information box at the top of the FLA form. Labels for this number varied slightly over time; some older FLAs labeled this number “PS Proposal #” or “RAC Logbook #”. FLAs will now include the label “Institutional /RAC#.”

      For older, continuing studies that have never had a FLA issued, the Institutional Number can be obtained from the RAC office via COM-RESEARCH-ADMIN-COMP-L@LISTS.UFL.EDU. Be sure to include the following information in the request:

      PI Name and UFID

      Study Title

      PeopleSoft Proposal number (if applicable)

      WIRB number

    Failure to complete and include our UF coverletter can result in compliance issues for you later, the least of which may be having to revise your paperwork and resubmit to WIRB (which will obviously include a fee).

    Note: sometimes sponsors complete the paperwork and submit it to WIRB on your behalf. It is incumbent upon you, the PI, to insure that the UF cover letter is included with the submission. The administration is not likely to absolve you in a compliance situation if your excuse is “the sponsor submitted it for me.”

  2. If the protocol and/or Investigator Brochure has been revised, submit the revised paperwork to Pharmacy prior to submitting it to WIRB. Complete and print the Pharmacy revision cover letter, enclose a copy of the protocol and Investigator Brochure, and mail to:

    HSC Susan Beltz, PharmD

    Box 100316

    Gainesville, FL 32610-0486

    IDS@shands.ufl.edu

    Shands Pharmacy Cover Letter (revision)

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