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 ensure:
    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. That the submission has an Institutional number: a unique UF identifier that allows UF to map WIRB approval data back to specific UF proposals.

     

  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, PharmDBox 100316

    Gainesville, FL 32610-0486

    IDS@shands.ufl.edu

    Shands Pharmacy Cover Letter (revision)

*Note: sometimes sponsors complete the paperwork and submit it to WIRB on your behalf. It is incumbent upon the PI to ensure that the UF cover letter is included with the submission.