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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.