Case Western Reserve University
Institutional Biosafety Committee
Post Approval Monitoring Review Form
Principal Investigator: __________________________________________________
IBC Protocol Number:___________________________________________________
IBC Date of Expiration:__________________________________________________
IBC Amendment(s) Date(s) of Approval:____________________________________
Approved Agent(s):_____________________________________________________
Biosafety Level Designation:______________________________________________
Risk Group Designation:_________________________________________________
Safety/Incident Reporting (Summary):______________________________________
Laboratory Room Number(s):_____________________________________________
Reason for Review:______________________________________________________
Name of Reviewer(s): ___________________________________________________
Name(s) of Study Personnel:______________________________________________
Date of Review:_________________________________________________________
DISREGARD IF SELF-ASSESSMENT/FOR IBC USE
Date Report to PI:_______________________________________________________
Date of Follow-up (as Applicable):__________________________________________
Date Reported to IBC:____________________________________________________
Determination of Non-compliance: ________________________________________
Date Reported to OBA:___________________________________________________
CWRU IBC Version Dated July 9, 2015
Page 1 of 5
Case Western Reserve University
Institutional Biosafety Committee
Post Approval Monitoring Review Form
Application Review
1. Are the procedures proposed in the application still on going and congruent with the
application?
Yes  No  Not applicable
If no, recommended changes/action:___________________________________
2. Is the personnel list up to date and congruent with the application?
 Yes No
 Not applicable
If no, recommended changes/action:___________________________________
3. Are the locations listed in the application current and congruent with the
application?
 Yes  No  Not applicable
If no, recommended changes/action:___________________________________
4. Have all personnel completed the necessary training modules? (Verify with EH&S)
 Yes No
 Not applicable
If no, recommended changes/action:___________________________________
5. Have additional grants been issued to fund the protocol?
 Yes  No
 Not applicable
If yes, recommended changes/action:___________________________________
6. Are additional updates/changes to protocol required?
 Yes  No
 Not applicable
If yes, recommended changes/action:___________________________________
Other comments/notes:
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
CWRU IBC Version Dated July 9, 2015
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Case Western Reserve University
Institutional Biosafety Committee
Post Approval Monitoring Review Form
Safety Review
Date(s) of Laboratory Inspection (EH&S; IACUC):___________________________
Findings/Pending Resolution: _____________________________________________
7. Is the biosafety manual up-to-date and accessible in the lab?
 Yes  No  Not applicable
If no, recommended changes/action:___________________________________
8. Is the Exposure Control Plan (ECP) up-to-date and accessible in the lab?
 Yes  No  Not applicable
If no, recommended changes/action:___________________________________
9. Have biological safety cabinets been inspected and certified within the last 12
months?
 Yes  No  Not applicable
If no, recommended changes/action:___________________________________
10. Is biohazard signage present on the biological safety cabinet?
 Yes  No  Not applicable
If no, recommended changes/action:___________________________________
11. Is an inventory of infectious and recombinant agents well maintained and up to date?
Yes No
 Not applicable
If no, recommended changes/action:___________________________________
12. Have any safety/incident reports for infectious and recombinant agents occurred?
Yes No
 Not applicable
If yes/no, recommended changes/action:________________________________
13. Have these incidents been previously reported to the CWRU IBC?
Yes No
 Not applicable
If no, recommended changes/action:___________________________________
CWRU IBC Version Dated July 9, 2015
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Case Western Reserve University
Institutional Biosafety Committee
Post Approval Monitoring Review Form
Other comments/notes:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
Significant findings or deficiencies:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
Required actions to address findings or deficiencies to bring protocol back into compliance:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
Action plan to prevent recurrence of event(s) leading to significant deficiencies or findings:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
CWRU IBC Version Dated July 9, 2015
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Case Western Reserve University
Institutional Biosafety Committee
Post Approval Monitoring Review Form
Areas demonstrating excellence:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
Areas in need of improvement:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
Suggestions for improvement:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
_______________________________________________________________________
CWRU IBC Version Dated July 9, 2015
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