Safety Monitoring and Reporting
In November 2016, the National Health and Medical Research Council (NHMRC) released new guidance on Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (the Guidance). The Guidance replaces the 2009 Australian Health Ethics Committee (AHEC) Position Statement on safety reporting. The Guidance will streamline clinical trial safety reporting and monitoring for Australia. NSW Public Health Organisations (PHOs), including Concord Hospital, have been implementing the new safety reporting guidelines from 3 October 2017.
The new reporting requirements have been implemented for new clinical trial applications and existing clinical trials with ethical approval and governance authorisation; and for therapeutic goods and non-therapeutic goods trials.
Any of the above arising from the site and any research-related events that meet the definition of an incident should be submitted by the investigator to the local RGO.
The safety monitoring and reporting responsibilities of the Sponsor, Coordinating Principal Investigator, and Principal Investigator to the HREC and RGO are outlined in the below tables and flowcharts. Reporting forms are available below as well as in Forms and Templates:
NB: The below tables only show the events that should be reported to the HREC and RGO. For further details on the safety monitoring/reporting responsibilities of the HREC, Principal Investigator, TGA, Institution and the Sponsor please refer to the guidelines.
Summary of safety notifications (therapeutic goods trials)
Reporting pathway for therapeutic good trials
Summary of safety notifications (non-therapeutic goods trials)
Reporting pathway for non-therapeutic good trials
Office for Health and Medical Research (OHMR) Links
SERIOUS BREACHES IN CLINICAL TRIALS
Serious breaches should be reported in accordance with NHMRC Guidelines document: Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods 2018.
A 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 trial participant, or
The NHMRC guidelines does not use the terms Protocol Deviation or Protocol Violation
Serious breaches should be reported to the reviewing HREC, usually by the Sponsor within 72 calendar days of confirming a serious breach has occurred. The HREC will review the serious breach to evaluate its impact on the continued ethical acceptability of the study and to satisfy itself that the serious breach is managed appropriately.
It is the responsibility of the Principal Investigator to (i) report any suspected breach to the sponsor within 72 hours of becoming aware of it and (ii) to report to their institution (via the Research Governance Officer) within 72 hours any serious breach that has been confirmed by the sponsor as occurring at their site.