Safety and adverse event reports

Monitoring and reporting

The RMH has guidelines for monitoring & reporting safety, which comply with the NHMRC Guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods November 2016 (the Guidance), National Statement on Ethical Conduct in Human Research 2007 (Updated 2018) (The National Statement), the Australian Therapeutic Goods Administration, and the Victorian Managed Insurance Authority, maintaining and reporting of adverse events and safety information in clinical research.

It is essential that all Principal Investigators are familiar and comply with the requirements of the Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods.

Reporting time frames

Reporting time frames are defined in the Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC, 2016).

Researchers should also comply with RMH policy and procedures for reporting adverse events including:

• MH18 Research Policy
• MH19 Risk Management Policy
• MH19.02 Incident Reporting
• MH14.08 Adverse Drug Documentation and Reporting
• PCY08.03 Assessing and Processing Reported Adverse Drug Events

Instructions for reporting adverse events

How to submit Safety & Adverse Event reports

1. For guidance on your reporting requirement, review the "What do I report?" section below.
2. Download and complete the safety reports relevant to your circumstance
   • Annual Safety Report
   • Safety Report
   • If you choose to submit the report via ERM, ensure to download a copy, and then follow step 3 below.
3. Complete the email template at ressafety@mh.org.au and attach the relevant report
   • 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
   • An automatic email reply will be sent to you to confirm receipt of the correspondence by the Office for Research
   • Acknowledgement/queries will be emailed to you by the Office for Research in due course

What do I report?

RMH investigators reporting to the Office for Research

Investigators should report the following safety information only for participants at RMH sites to the Office for Research:

• All SSIs reported as USM, as amendments or as a temporary halt/early termination of a trial
• SUSARs/USADEs that are considered possibly related, probably related or definitely related to study conduct

Investigator reporting to the sponsor

Investigators should report the following safety information to the Sponsor as per the Sponsor's protocols:

• SAEs as defined in the protocol
• Any occurrences of congenital abnormality/birth defect arising from any pregnancy of a participant (or partner)
• USMs instigated by the site
• Safety critical events as defined in the protocol

Sponsor reporting to the RMH HREC

• SSIs reported as USMs, as amendments or as a temporary halt/early termination of a trial
• Annual Safety Reports
• Investigator Brochure updates and interim addenda (submitted as an amendment)

Sponsor reporting to site investigator

• SSIs reported as USMs as amendments or as a temporary halt/early termination of a trial
• All SSIs that adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial
• Investigator Brochure updates and interim addenda
• SUSAR/line listings (only if required by the sponsor’s global SOPs)

Note: RMH investigators are not required to review safety report from other sites.

Sponsor* reporting to the Therapeutic Goods Administration (TGA)

• All SUSARs occurring in Australian participants
• All SSIs that adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial