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
It is the responsibility of the Sponsor to review these safety reports (with Data Safety Monitoring Board [DSMB] or equivalent oversight) to determine if a Significant Safety Issue (SSI) or Suspected Unexpected Serious Adverse Reaction (SUSAR) or Unanticipated Serious Adverse Device Effect (USADE) has occurred.
On the Department of Health and Human Services templates available at: https://www2.health.vic.gov.au/about/clinical-trials-and-research/clinical-trial-research/monitoring-reporting
Please note that for Investigator Initiated studies, the Institution takes the role of the sponsor and the Principal Investigator is responsible for timely submission of documentation.
All definitions and time lines for reporting are in accordance with: