Adverse Events – SAE – SUSAR – SSI – USM

Monash Health has adopted the NHMRC “Safety monitoring and reporting in clinical trials involving therapeutic goods” Position Statement (November 2016) available at https://www.nhmrc.gov.au/guidelines-publications/eh59

Sponsors must also abide by the TGA “Pharmacovigilance responsibilities of medicine sponsors” Australian recommendations and requirements (September 2017) available at https://www.tga.gov.au/publication/pharmacovigilance-responsibilities-medicine-sponsors

Coordinating Principal Investigators (CPI) or Principal Investigators (PI) must submit to the Sponsor:

• Safety critical Adverse Events (AE) or Adverse Events (SAE) as per the protocol
• Urgent Safety Measures (USM) instigated by the PI in accordance with the study protocol and the Sponsors reporting documentation

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.

Sponsors must submit to Coordinating Principal Investigators (CPI) or Principal Investigators (PI):

• Significant Safety Issues (SSI) reported as either Urgent Safety Measures (USM), amendments or as a temporary halt/early termination of a trial.
• SUSARs arising from the site
• USADEs arising from the site
• Investigator Brochure updates
• SUSAR or Line Listings only if required by the Sponsor’s global Standard Operating Procedures

Sponsors must submit to the Human Research Ethics Committee (HREC)

• Significant Safety Issues (SSI) reported as either Urgent Safety Measures (USM), amendments or as a temporary halt/early termination of a trial
• Annual Safety Reports
• Investigator Brochure updates
• Submissions Must include:
  • Monash Health local reference number
  • HREC Number
  • Title of Project
  • Coordinating Principal Investigator or local Principal Investigator 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

Sponsors must submit to the Therapeutic Goods Administration (TGA).

• SUSARs (Australian Sites)
• Significant Safety Issues (SSI) reported as either Urgent Safety Measures (USM), notifications or as a temporary halt/early termination of a trial

Coordinating Principal Investigators (CPI) or Principal Investigators (PI), once advised by the Sponsor, must submit to the Institution (Research Support Services):

• Significant Safety Issues (SSI) reported as either Urgent Safety Measures (USM), amendments or as a temporary halt/early termination of a trial
• SUSARs arising from the site
• USADEs arising from the site

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:

• NHMRC “Safety monitoring and reporting in clinical trials involving therapeutic goods” Position Statement (November 2016) available at:  https://www.nhmrc.gov.au/guidelines-publications/eh59
• Safety Reports must be emailed to research@monashhealth.org
• TGA “Pharmacovigilance responsibilities of medicine sponsors” Australian recommendations and requirements (September 2017) available at: https://www.tga.gov.au/publication/pharmacovigilance-responsibilities-medicine-sponsors

Safety Reporting Summary Flow Charts