Unexpected-adverse-event-report-form-March-2016.docx (43.9 KB)

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Research Services
University of Tasmania
Private Bag 01
Hobart, Tasmania 7001
Tel: (03) 6226 7283
Fax: (03) 6226 7148
University of Tasmania
Animal Ethics Committee
UNEXPECTED ADVERSE EVENT
REPORTING FORM
animal.ethics@utas.edu.au
An unexpected adverse event impacts on the welfare of the animal and was not considered in the initial application. It
must be immediately reported to the University Veterinarian and the Animal Ethics Committee
1 - Details of the project
(Please type in the boxes provided).
Project No:
Title of approved project:
Responsible investigator:
Original approval date of the project:
2 - Please re-state the aims of the project in plain English:
3 – Date and time of the unexpected adverse event:
Date of the event:
Enter date.
Date of notification to the University
Veterinarian
Enter date.
Time of the
event:
Time of
notification to the
University
Veterinarian
Enter Time
Enter Time
4 - Where did the event occur?
Building/Site
Room/Area
Other (e.g. location of fieldwork)
Did the event occur at a UTAS facility?
Yes
/ No
5 – Details of the event
Briefly outline the event and the circumstances leading up to the event:
Probable cause of the event:
Impact of the event:
(both the immediate impact and any long term impact on research)
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Total number of mortalities or injuries which incurred out of the total population:
(include species details)
Autopsy details and findings:
(including autopsy personnel)
Remedial action taken:
How has this event been communicated to members of the Research team and others?
What procedures/practices need to be modified as a result of the event?
(Note: If a modification is necessary, an Application to modify an approved project form must be submitted)
Please sign and complete the declaration below, before emailing it to: animal.ethics@utas.edu.au Hard Copies are not required
DECLARATION
The outlined account represents a true and accurate description of the event as they relate to this approved
protocol.
Responsible Investigator or Nominee
Name of Investigator or Nominee:
Signature: .........................................................................
Date:
University Veterinarian
Name of University Veterinarian:
Signature: ..........................................................................
Date:
Comments:
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(Following table for completion by the Animal Ethics Committee)
Cause (tick all that apply)
Human Error
Equipment/Facility Failure
Experimental Procedure (includes adverse drug reactions but not incorrect
doses)
Uncontrollable event (e.g. adverse weather). Please provide details.
Action taken (tick all that apply):
Project Halted
Retraining of staff/investigators
Equipment/Facility Repair
Change to SOP
Change to Experimental Procedure
Other (please detail)
Severity
Low
Medium
High
Catastrophic
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