Adverse Events and Safety Reporting
Reporting of adverse events
Any unexpected adverse events or complications that occur anytime during the conduct of a research study or during the follow up period after the research must be reported to the Research Ethics & Integrity office. These matters must be reported promptly via email to humanethicscommittee@canberra.edu.au.
The following information must be provided:
- Chief Investigator and Ethics approval details
- Description of the adverse event
- Date and site of adverse event
- Impact on participants
- Immediate actions taken to mitigate harm and risk to participants
- Actions required to reduce the risk of recurrence
Failure to report adverse events promptly may result in the withdrawal of the Ethics approval.