CALHN Safety Guidelines
The CALHN Safety Monitoring and Reporting of Serious Breaches of Good Clinical Practice of the Protocol for Trials Involving Therapeutic Goods guideline describes the regulatory and good practice requirements. The document sets a framework to define the roles and responsibilities of trial sponsors, investigators, the HREC, and the institution to ensure a consistent approach to safety monitoring and reporting across CALHN. Information on what sponsors should no longer report is available here.
Significant Safety Issue (SSI)
A safety issue that could adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.
Without undue delay and no later than 72 hours of becoming aware of the event, the Principal Investigator (PI) must report to the institution all SSI’s occurring at local site and SSI’s occurring at an external site implemented as an USM, as an amendment or as a temporary halt/early termination of a trial.
Within 72 hours, the sponsor must notify the Human Research Ethics Committee (HREC) of a SSI implemented as an Urgent USM, as an amendment or as a temporary halt/early termination of a trial. All other SSIs must be notified within 15 days of the sponsor instigating or being made aware of the issue.
Suspected Unexpected Serious Adverse Reaction (SUSAR)
An adverse reaction that is both serious and unexpected. Within 72 hours of becoming aware of the event, the PI must report to the institution all SUSARs arising from a local site.
Unanticipated Serious Adverse Device Effect (USADE)
A serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current version of the risk analysis report. Within 72 hours of becoming aware of the event, the PI must report to the institution all USADEs arising from a local site.
Sponsor Annual Safety Reporting
The sponsor is required to provide the lead HREC with an annual safety report including a clear summary of the evolving safety profile of the trial. This report should allow the lead HREC to assess whether ongoing safety monitoring is being conducted appropriately and that the trial’s safety monitoring plans are being followed and where necessary, are being adapted to take into account new findings as the trial progresses.
The annual safety report should generally include:
- A brief description and analysis of new and relevant findings.
- For Investigational Medicinal Products IMPs and Investigational Medical Devices (IMD) not on the Australian Register of Therapeutic Goods, a brief analysis of the safety profile of the IMP or IMD and its implications for participants taking into account all available safety data and the results of relevant clinical or non-clinical studies.
- A brief discussion of the implications of the safety data to the trial’s risk-benefit ratio.
- A description of any measures taken or proposed to minimise risks.
The Executive Summary of safety information produced for international regulators, such as a Development Safety Update Report (DSUR), may serve as the annual safety report sent to the lead HREC (a full DSUR is not required). The timing of the annual safety report may be aligned with the reporting cycles of global companies or aligned with the annual progress report sent to the HREC.
Please note: Where CALHN is not the lead HREC, no Annual Safety Report is required.