In Victoria, all reporting to the reviewing HREC aligns with the guidance of the NHMRC Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods (2018) . In this guidance, the responsibility of reporting to the reviewing HREC is assigned to the sponsor of the research project. The sponsor may be an institution, investigator, collaborative group or commercial company.
Breach Forms found on DHHS Monitoring & Reporting Website (link on right hand side).
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 Human Research Ethics Committee (HREC).
This form must be completed by the sponsor when reporting a serious breach to the Human Research Ethics Committee (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 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.
This form must be completed when a third party (e.g. individual / institution) wishes to report a suspected breach of Good Clinical Practice or the protocol. This should be reported directly to the reviewing HREC without reporting through the sponsor.
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 Research Governance Officer (RGO) at the Principal Investigator's site.
The sponsor in collaboration with the site Principal Investigator should complete this form to report a non-serious breach - deviation.