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

Melbourne Health has developed guidelines for monitoring & reporting safety which comply with the NHMRC National Statement on Ethical Conduct in Human Research (2007), Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC, 2016),  the Australian Therapeutic Goods Administration, and 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 Safety Report Form 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.
Annual safety report

Melbourne Health has adopted the NHMRC's Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (2016) guideline.

This updated version has removed the requirement to submit individual reports of AEs, SAEs, external SUSARs/USADEs and six monthly line listings to institutions. Please refer to the information relating to line listings in the summary on page 3 and 'Note 1' on page 7.

Melbourne Health requires the sponsor to provide HRECs with an annual safety report. 

How to submit an annual safety report

  1. Download the Annual Safety Report from the Department of Health.
  2. Name the file and the subject of the email so that it includes:
  • the project number and/or HREC Reference number,
  • the type of document; and
  • the date it was sent

Example: 2017.999  HREC/17/MH/999 Safety Report 1 Jan 2017

  1. Submit the report by email to HrecCorrespondence@mh.org.au

Acknowledgement

  • You will receive an automatic email reply confirming receipt of the correspondence.
  • Any queries and the approval letter will be emailed to you by the Office for Research staff in due course.