Human Gene Transfer Closure Notification

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Human Gene Transfer
Closure Notification Form
IBC Use Only
Registration # _________
THIS APPLICATION MUST BE TYPEWRITTEN
*Principal Investigators must use this form to notify the IBC of their impending protocol closure. Timely
submittal of this form allows update of records required by granting and regulatory agencies, and will permit
continued use of biological agents without interruption during the transition.
1.
2.
3.
4.
Principal Investigator:
Department/Division:
Office Address:
Lab Address:
M.D. [ ] Ph.D. [ ] Other:
Email:
Phone:
Phone:
5. List any personnel and students approved by the IBC that will remain to work on these experiments
during the transition. Attach an additional sheet if needed.
Name
Job Title
Lab Address
Phone Number
6. Project Title:
7. IBC Registration Number (located on approval letter):
8. Identify the Building and Room Number where the experiments have been conducted:
9. Study Closure Date:
10.
11.
12.
13.
Are there still patients enrolled in this study?
YES
NO
If yes, have all doses of the study drug/agent been administered?
Is the study still ongoing at other sites?
YES
NO
If yes, what is the status of patient enrollment at those sites?
14. Have there been any
unexpected adverse events
associated with the use of this
study drug/agent?
YES
15. If yes, were these reported
to the:
IBC
Date:
IRB
Date:
NIH
Date:
University of Utah IBC
HGT Closure Notification
Page 1 of 2
YES
NO
NO
04/07/2015
16. Is there still study drug/agent on site?
YES
NO
17. Are there decontamination procedures in place for disposal of unused or remaining agent(s)?
YES
NO
18. If yes, where will the product/agent be disposed?
ONSITE
19. If onsite, provide documentation of how it will be disposed:
20. If offsite, please provide:
OFFSITE
Where it will be disposed:
How it will be disposed:
21. Please attach the most recent report from the Data and Safety Monitoring Board (DSMB).
22. I certify that all herein provided information, and any subsequent information submitted in
connection with this application, is accurate and complete.
Principal Investigator (signature/date):_____________________________________________________
Send a copy of completed forms to the following individual:
Biosafety Officer
University of Utah
Environmental Health and Safety
Bldg. 605
Telephone: 801-581-6590
FAX: 801-585-7240
e-mail [email protected]
University of Utah IBC
HGT Closure Notification
Page 2 of 2
04/07/2015
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