Serious Breach is a breach of Good Clinical Practice or the protocol that is likely to affect to a significant degree the safety or rights of a research participant or the reliability and robustness of the data generated in the research project.
In Victoria, all reporting to the reviewing HREC aligns with the guidance of the NHMRC Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC, 2016).
In this guidance, the responsibility of reporting to the reviewing Human Research Ethics Committee (HREC) is assigned to the sponsor of the research project.
The sponsor may be an institution, investigator, collaborative group or commercial company.
How to submit serious breaches
- Complete and submit the appropriate Breach Report:
- Submit a copy of the Breach Report via the email template to: 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 (for example, 2024.NNN-Serious Breach Report Form- Sponsor-1 March 2023)
- An automatic email reply will be sent to you to confirm that the Office for Research has received the correspondence
- Acknowledgement and queries will be emailed to you by the Office for Research in due course
What are the different types of breach reports?
Serious Breach report form (Sponsor)
Serious Breach is a breach of Good Clinical Practice or the protocol that is likely to affect to a significant degree the safety or rights of a research participant or the reliability and robustness of the data generated in the research project.
Serious breaches must be notified to the reviewing HREC.
This form must be completed by the sponsor when reporting a serious breach to the HREC or when a sponsor is providing additional/follow-up information following notification by an individual/institution of a confirmed serious breach.
Serious breaches at a site should also be reported by the site Principal Investigator (PI) to their site Research Governance Officer (RGO) using this form.
Suspected Breach report form (Third Party)
Suspected Breach is a report that is judged by the reporter as a possible serious breach but has yet to be formally confirmed as a serious breach by the sponsor.
Serious breaches must be notified to the reviewing HREC.
This form must be completed when a third party (for example, individual/institution) wishes to report a suspected breach of Good Clinical Practice or protocol. This should be reported directly to the reviewing HREC without reporting through the sponsor.
Non-serious Breach - Deviation report
A deviation is any breach, divergence or departure from the requirements of Good Clinical Practice or the clinical trial protocol and does not have a significant impact on the continued safety or rights of participants or the reliability and robustness of the data generated in the clinical trial. Deviations that are considered to be a serious breach should be reported using the Serious Breach Report Form (Sponsor).
To fulfil ICH-GCP requirements any deviations are to be reported to the sponsor. Not all deviations require reporting to the reviewing HREC but sites should decide according to site policy. A copy of this report should be provided to the RGO at the PI’s site.
The sponsor in collaboration with the site PI should complete this form to report a non-serious breach - deviation.