Research Ethics and Governance Safety Reporting procedure has recently been updated!
As per the updated Safety Reporting procedure, SUSARs are no longer accepted via RiskMan. Please report SUSARs via the Site Notification Form on Ethical Review Manager (ERM).
(Updated November 2025)
Safety Reporting Summary for Commercially Sponsored Studies
Safety Reporting Summary for Investigator Initiated Studies
Research Ethics and Governance – Safety Reporting Guidelines
Monash Health has adopted the NHMRC “Safety monitoring and reporting in clinical trials involving therapeutic goods” Position Statement (November 2016) available here
Sponsors must also abide by the TGA “Pharmacovigilance responsibilities of medicine sponsors” Australian recommendations and requirements (September 2017) available at here
