Safety monitoring & adverse events

The Barwon Health Human Research Ethics Committee (HREC), and the institutions it advises, are responsible for ensuring the safety of participants in clinical trials. In order to meet this responsibility, the Committee needs to receive sufficient and reliable information about the implications of adverse events or reactions.

Barwon Health is required to comply with the requirements of the NHMRC National Statement on Ethical Conduct in Human Researh (2007), Australian Therapeutic Goods Administration (TGA), and the Victorian Managed Insurance Agency (VMIA).

Maintaining and reporting of adverse events and safety information in clinical research

Please refer to the Barwon Health Guidelines for Research Monitoring and Reporting, found on the Guidelines and advice webpage, for a table summary on the reporting of Serious Adverse Events (SAEs), Unanticipated Serious Adverse Device Effect (USADEs), and Suspected Unexpected Serious Adverse Reactions (SUSARs), line listings, annual safety reports, investigator brochure updates, and protocol violations and deviations.

It is the responsibility of the Principal Investigator (PI) to review all Adverse Events (AEs) and safety reports coming to their notice and assess whether they contain information that should be drawn to the attention of the HREC or RGO.

Notification of SAEs and SUSARs

SAEs involving participants at Barwon Health (internal events) must be reported to the REGI Unit within 24 hours of occurrence.

Barwon Health requires only those SAEs and SUSARs that are deemed by the PI to be possibly, probably, or definitely related to study conduct, to be submitted.

Please submit one electronic copy of the appropriate form, signed by the PI, to regi@barwonhealth.org.au. All associated documentation regarding the event should also be provided in order for the HREC/RGO to assess the event. Please ensure files and email subjects are named as per the REGI Unit's Document Naming Guidelines.

Notification of summary safety reports

Summary safety reports must be accompanied by Sponsor or PI comment as to whether action is planned for the trial based on the report.

The Barwon Health HREC/RGO only wishes to receive safety line listings from Sponsors when the PI has determined the listing contains significant safety information that should be drawn to the attention of the HREC/RGO. In this instance, the listing must be submitted on the appropriate form to regi@barwonhealth.org.au, along with PI comment on the significance of the information, the possible impact on study participants, and action taken or recommended.

Annual safety reports and Data Monitoring Committee (DMC) reports, must include Sponsor and PI comment as to whether action is planned for the trial on the basis of the reports.

Please submit one electronic copy of the appropriate form, signed by the PI, to regi@barwonhealth.org.au. All associated documentation regarding the event should also be provided in order for the HREC/RGO to assess the event. Please ensure files and email subjects are named as per the REGI Unit's Document Naming Guidelines.

Adverse Event (AE) and safety reporting quicklinks

Traditional Owners

We, Barwon Health, acknowledge the Traditional Owners of the land, the Wadawurrung people of the Kulin Nation. We pay our respects to the Elders both past and present.