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:______
Application Review
1. Are the procedures proposed in the application still on going and congruent with the application?
rYes r No r Not applicable
If no, recommended changes/action:______
2. Is the personnel list up to date and congruent with the application?
r Yes rNo r Not applicable
If no, recommended changes/action:______
3. Are the locations listed in the application current and congruent with the application?
r Yes r No r Not applicable
If no, recommended changes/action:______
4. Have all personnel completed the necessary training modules? (Verify with EH&S)
r Yes rNo r Not applicable
If no, recommended changes/action:______
5. Have additional grants been issued to fund the protocol?
r Yes r No r Not applicable
If yes, recommended changes/action:______
6. Are additional updates/changes to protocol required?
r Yes r No r Not applicable
If yes, recommended changes/action:______
Other comments/notes:
______
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?
r Yes r No r Not applicable
If no, recommended changes/action:______
8. Is the Exposure Control Plan (ECP) up-to-date and accessible in the lab?
r Yes r No r Not applicable
If no, recommended changes/action:______
9. Have biological safety cabinets been inspected and certified within the last 12 months?
r Yes r No r Not applicable
If no, recommended changes/action:______
10. Is biohazard signage present on the biological safety cabinet?
r Yes r No r Not applicable
If no, recommended changes/action:______
11. Is an inventory of infectious and recombinant agents well maintained and up to date?
rYes rNo r Not applicable
If no, recommended changes/action:______
12. Have any safety/incident reports for infectious and recombinant agents occurred?
rYes rNo r Not applicable
If yes/no, recommended changes/action:______
13. Have these incidents been previously reported to the CWRU IBC?
rYes rNo r Not applicable
If no, recommended changes/action:______
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:
______
Areas demonstrating excellence:
______
Areas in need of improvement:
______
Suggestions for improvement:
______
CWRU IBC Version Dated July 9, 2015
Page 2 of 5