North Florida/South Georgia Veterans Health System
Human Research Protection Program (HRPP)
**NOTE: PLEASE CONTACT THE HRPP OFFICE FOR THE MOST CURRENT/UPDATED FORMS**
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All forms need to be typed, electronically signed (if required), and submitted via email to the HRPP staff. Your study IRB# should be noted in the subject line of ALL emails to the HRPP office staff. This will ensure proper sorting, filing, and accountability of study materials. Do not scan all forms together all forms are to be scanned separately. |
Adverse Events or Unanticipated Problems
Lisa Campbell, HRPP Administrator, 352-548-6000 ext. 105310
Navigate to:
New Study Continuing Review Revision Closure AE
ADVERSE EVENTS or
UNANTICIPATED PROBLEMS
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Please remember to submit your Adverse Event/Unanticipated Problems to the IRB and the HRPP Office at the same time. Please send a copy of the submission to Lisa Campbell, HRPP Administrator and copy Sofia Ortiz, HRPP Assistant on the email correspondence to ensure all deadlines are met.
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If the Unanticipated Problem or Adverse Event is RELATED or POSSIBLY RELATED to the research, it MUST BE REPORTED to the IRB within 5 working days of discovery.
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Please provide a copy of the Unanticipated Problem or Adverse Event to the HRPP Office within 5 working days of discovery as well.
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HRPP Cover Sheet - This form will give you a list of all forms needed and also serves as a checklist.
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IRB Approval Letter – (Following IRB review/determination)
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Adverse Event or Unanticipated Problem form (UFIRB)
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UFIRB Reportable Events Help process:
* VA is committed to protecting your privacy - please review our Privacy Policy.
In particular, please note that e-mail communication may not be secure against interception across the Internet. Please do not include sensitive information such as medical records or financial information, drug prescriptions, or your social security number.
