Study Breaches

In Victoria, all reporting to the reviewing Human Research Ethics Committee (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. 

Serious Breach report form (Sponsor) 

Serious Breach is a breach of Good Clinical Practice (GCP) 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 (e.g. individual / institution) wishes to report a suspected breach of GCP or the 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 GCP 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.

Click here for ERM Post Authorisation Submission Process Map

How to submit Serious Breach Reports

1. Complete and submit the relevant Breach Report Sub-Form (Serious Breach Report / Suspected Breach Report) to the reviewing HREC via Ethical Review Manager (ERM)
   
   Note: The Serious Breach Report can only be found under the HREA under Sub-Forms. If you do not have access to the HREA Form for your project, please contact the applicant listed under the HREA and request authorisation to access these forms
   
   
2. Download and submit a PDF copy of the ERM Breach Report to WH RGO via email: [email protected]. Provide a copy of the HREC acknowledgment if available.
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 41234 Serious Breach Report Form (Sponsor) 14Nov20). Refer to the Mandatory Electronic Naming Convention (download on right hand side links)
4. Acknowledgement and/or queries will be emailed to you by the Office for Research in due course.

How to submit Non-serious Breach/Deviation Report

1. Once the project has been selected, under the Project Tree click on "Site Specific Assessment (SSA) Vic – Western Health"
2. Click on "Create Sub Form' button on 'Actions' Panel on left of page and select 'Non-serious Breach/Deviation Report VIC)
3. Complete and submit via ERM.
4. Once the form is submitted, please email [email protected] to notify us of the submission of the Non-serious Breach and the associated HREC/ERM Reference Number.
5. 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 41234 Serious Breach Report Form (Sponsor) 14Nov20). Refer to the Mandatory Electronic Naming Convention (download on right hand side links)
6. Acknowledgement and/or queries will be emailed to you by the Office for Research in due course.