Humanitarian Use Devices Continuing Review Form

Annual Review Method: HUD – Full Board

INSTITUTIONAL REVIEW BOARD HUMANITARIAN USE DEVICES CONTINUING REVIEW FORM

A. GENERAL STUDY INFORMATION HUD Title: IRB #: Exemption Holder: Principal Investigator: Department: Person Completing this form: Phone: Email: Please return the following to the CMC IRB via email at: [email protected]  Completed Continuing Review Form in its entirety  Most recent safety report from the HDE holder  The three most recent consents

The IRB Office does not accept faxed copies.

B. STUDY STATUS YES NO 1. Have you ever used the above-referenced HUD under the approval granted by CMC IRB? *If No, please skip to number 3 2. How many times have you used the above-referenced HUD since the last renewal? 3. Considering your experience with the above-referenced HUD, it’s implantation to date and your review of outcomes, should changes be made to the informed consent, consent process, documentation or patient information sheet (if applicable)? *If Yes, please attach an explanation and your recommendations for change. 4. In your experience with the above-referenced HUD, has the relationship between study risks and benefits to patients become available or changed since the last renewal? *If Yes, please attach an explanation and any supporting documentation (if applicable) 5. Have there been any deaths, hospitalizations, or serious illness which have occurred and thought to be associated with the HUD that were not previously reported the IRB? *If Yes, please attach an explanation of events and whether or not in your opinion they were related, serious, or unexpected 6. Is there any new or other information available regarding the HUD or its use of which CMC’s IRB should be aware? *If Yes, please attach an explanation and any supporting documentation (if applicable)

I acknowledge that I have reviewed the information provided on this HUD Continuing Review Report and all attachments and I certify that the information provided is true and accurate to the best of my knowledge.

______Signature of Principal Investigator Date

Version date 01Sep2016