Serious Breaches (Sponsor)
The NHMRC publication Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials involving Therapeutic Goods (2018) sets out the requirements for reporting serious breaches that occur in clinical trials.
A Serious Breach is a breach of GCP or the Protocol which 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 Royal Brisbane & Women’s Hospital Human Research Ethics Committee.
The submission must be completed by the sponsor when reporting a serious breach to the RBWH 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 to their site Research Governance Officer.
Suspected Breach report Form (Third Party)
A 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.
The submission 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 RBWH 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 ‘Breach – Serious or Suspected – Report Form (HREC) Qld’ in ERM.
The Chairperson of the RBWH HREC
- will review the impact on ongoing ethical acceptability of the research
- will review the management of the breach
- may provide ethical advice
- will assess the corrective and preventative action outlined in the report
Serious, Suspected, Non-Serious/Deviations
- Provide a Cover Letter addressed to the Chairperson, Royal Brisbane & Women’s Hospital Human Research Ethics Committee, clearly outlining the breach.
- In the original application (HREA) in ERM, ‘Create Sub-Form’, which is located in the Action Tiles. The Sub-Form to be selected is ‘Breach – Serious or Suspected – Report Form (HREC) Qld’. Please complete the applicable fields and upload the breach documentation into this Sub-Form. At Question 1d please identify whether this is a serious breach or a suspected breach. Once completed and the Sub-Form has been signed, please select ‘Submit’ in the Actions Tile.
- Once submitted via ERM, please send the breach documentation in an email to: RBWH-Ethics@health.qld.gov.au to allow HREC to confirm successful submission via ERM.