Revising Your Study

Steps

  1. All submissions from UF and Shands researchers to WCG must include a copy of our UF Revision Cover Letter.  You must include the UF Revision Cover Letter with your submission to WCG to ensure:
    1. That the paperwork approved by WCG complies with UF specific requirements. For example- UF requires certain language in the Informed Consent form that WCG 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 WCG approval data back to specific UF proposals.


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

  2. If the protocol and/or Investigator Brochure have been revised, submit the revised paperwork to UF Health IDS Pharmacy prior to submitting it to WCG.  Send the revised protocol/IB either via email to IDS@shands.ufl.edu or campus mail to:

Susan Beltz, PharmD
Box 100316
Gainesville, FL 32610-0486