Maintaining and reporting of adverse events and safety information in research will ensure that RMH complies with the NHMRC

RMH is required to comply with the requirements of the NHMRC National Statement on Ethical Conduct in Human Research (2007), the Australian Therapeutic Goods Administrationand the Victorian Managed Insurance Authority, maintaining and reporting of adverse events and safety information in clinical research.

Reporting adverse events

Report SAEs & SUSARs

This type of notification relates to SAEs and SUSARs which occur at RMH and/or at a site for which RMH is the lead HREC.

  • Only submit SAEs/SUSARs that are considered possibly related, probably related or definitely related to study conduct.
  • Submit all SAEs and SUSARs as soon as possible (ideally within 24 hours).
  • All SAEs and SUSARS need to be submitted using the appropriate Department of Health form.

How to report SAEs and SUSARs

  1. Download the appropriate form for your project from the Department of Health.
  2. Submit the form, signed by the principal investigator by emailing it to HREC Correspondence
  3. Name the file and the subject of the email so that it includes the project number, the type of document and the date it was sent (such as 2015.001 SUSAR 1 Jan 2015).

For SUSARs only

Also include the patient details and provide any supporting documents in the email. This will enable the Office for Research to report the events accurately to the insurers, VMIA.

Acknowledgement

  • An automatic email reply will be sent to you to confirm receipt of the correspondence.
  • Any queries and the approval letter will be emailed to you by the Office for Research staff in due course.
Submit summary safety report

This type of notification relates to summary adverse event reports including SUSAR line listings and annual adverse events report.

How to submit a summary safety report

  1. Complete and submit a SUSAR/USADE Line Listing Report signed by the principal investigator.
  2. Provide a sponsor statement outlining the impact of the summary safety report on the study conduct must be provided. 
    • If this statement is not provided by the sponsor then the PI must provide a statement outlining the impact of the summary safety report on the study.
    • If statement is not provided the documents will not be reviewed by the HREC.
  3. Submit the form by emailing it to HREC Correspondence
  4. Name the file and the subject of the email so that it includes the project number, the type of document and the date it was sent (such as 2015.001 SUSAR 1 Jan 2015).

Acknowledgement

  • An automatic email reply will be sent to you to confirm receipt of the correspondence.
  • Any queries and the approval letter will be emailed to you by the Office for Research staff in due course.