North Florida/South Georgia Veterans Health System
Human Research Protection Program (HRPP) Office
Revision Submissions to the VA
**All approved study revision inquires shall be addressed to Sofia Ortiz.
**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. |
Please provide (1) COMPLETE electronic copy of the revision packet (VA and IRB forms), with signatures, to the HRPP Office via email to:
Sofia Ortiz, HRPP Assistant, 352-548-6000 ext. 104925
Please remember that all revisions must be submitted to the IRB first for review and approval, with the exception of making changes to the HIPAA authorization. The IRB does not review or approve the authorization, therefore all changes to the HIPAA Authorization need to be submitted to the HRPP office for review and approval first. All IRB approved revisions MUST be submitted via a revision packet of required VA forms to the HRPP office to ensure the study file is current and up to date.
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New Study Continuing Review Revision Closure AE
Revisions
If revision changes the study safety evaluation, a separate revision will also need to be submitted to the Safety Committee.
**Please contact Chris Johnston for guiance on the safety evaluation changes
Was there a change in Principal Investigator’s?:
If there is a change of Principal Investigator’s (this revision MUST be approved by the R&D after IRB approval is received). You will need to update and submit all newly updated VA documents in the new VA Principal Investigator’s name:
1. Medical Center Support form
2. Abstract
3. Conflict of Interest - The Conflict of Interest (COI) form is also required with all new studies and with continuing reviews.
4. One of the following is required for each person on the study:Scope of Practice or clinical privileges
5. CITI training completion report (for Gainesville #573) visit the CITI Program
6. Research and Development Investigator Info sheet (Page 18) - IF this is a newly assigned investigator to the VA a (Page 18) must be completed. IF your unsure if this form has previously been submitted please contact the HRPP staff for guidance.
7. Safety Amendment, New Safety Evaluation, Safety Coversheet – please see the safety website for additional information.
8. HRPP coversheet
Adding New Staff:
If adding someone to your approved study you will need to also submit the following documents:
~HRPP coversheet
Safety Amendment:
~New Safety Evaluation, Safety Coversheet
* 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. |
