Safety Notifications and reporting pathways for clinical trials
SESLHD HREC and Research Governance follow the NSW Health Policy Directive: Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations PD2026_002.
SESLHD HREC
Require the following safety related items:
-
Significant Safety Issues (SSI) (submitted via REGIS)
-
Investigator Brochure updates (submitted as a general amendment in REGIS)
-
Annual Safety Report (often the Executive Summary of the DSUR serves as the annual safety report. This can be submitted with your REGIS annual report or at any other time)
Do not require the following reports:
-
Single case AEs, SAE/SARs and SUSARs (or device/non-therapeutic good trial equivalents)
-
Six monthly line listings.
SESLHD RGO
Require
-
All Significant Safety Issues (SSI) (See REGIS guide on reporting).
-
All SUSARs/USADEs occurring at a SESLHD site (See REGIS guide on reporting). Summary tables of the reporting requirements can be found below.
Any clinical incidents should be reported in accordance with NSW Health Policy Directive PD2020_047.
For guidance on how an incident arising from a clinical trial is identified, reported, and managed in a Health Service Organisation (HSO), please see fact sheet from the Australian Commission on Safety and Quality in Health Care.
Therapeutic Goods Trials: Trials investigating the safety and/or effectiveness of medicines, biologicals or medical devices.
Non-Therapeutic Goods Trials: Trials other than a Therapeutic Goods Trial (e.g. radiotherapy, surgery, psychotherapy trials).
Suspected Unexpected Serious Adverse Reaction (SUSAR): An adverse reaction that is both serious and unexpected.
Unanticipated Serious Adverse Device Effects (USADEs): 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 (and/or Investigator’s Brochure/Instructions for Use).
Urgent Safety Measure (USM): A measure required to be taken in order to eliminate an immediate hazard to a participant’s health or safety.
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.
Unexpected & Related SAEs (URSAE): An adverse event that is:
- Serious – meets the definition of a serious adverse event
- Related – resulted from administration of the trial intervention
- Unexpected – the event is not described in the protocol as an expected occurrence.
Summary Table
|
Type of event |
Who reports |
To whom |
When | How |
|---|---|---|---|---|
|
Significant Safety Issue (SSI) implemented as an Urgent Safety Measure (USM) |
Sponsor |
Lead HREC (and all investigators participating in the study) |
Within 72 hours of the sponsor becoming aware of the SSI |
SSI Notification Form via REGIS |
|
Significant Safety Issue (SSI) not implemented as an Urgent Safety Measure (USM) |
Sponsor |
Lead HREC (and all investigators participating in the study) |
Within 15 days of the sponsor becoming aware of the SSI |
SSI Notification Form via REGIS |
|
All Significant Safety Issues (SSIs) |
Principal Investigator (PI) |
RGO for the site where the event occurred |
Within 72 hours of the PI becoming aware of the SSI |
SSI Notification Form via REGIS |
|
Suspected Unexpected Serious Adverse Events (SUSARs) and Unanticipated Serious Adverse Device Effects (USADEs) occurring at the site |
Principal Investigator (PI) |
RGO for the site where the event occurred |
Within 72 hours of the PI becoming aware of the event |
Local Safety Event Notification Form via REGIS |
|
Investigator’s Brochure Updates/Addenda |
Sponsor |
Lead HREC |
As and when updates are generated |
Amendment or as part of an annual progress/annual safety report via REGIS |
|
Annual Safety Report |
Coordinating Principal Investigator or Sponsor |
Lead HREC |
Within annual progress report sent to the HREC or aligned with the safety reporting cycles of global companies |
Annual Progress Report via REGIS |
|
Type of event |
Who reports |
To whom |
When | How |
|---|---|---|---|---|
|
Significant Safety Issue (SSI) implemented as an Urgent Safety Measure (USM) |
Sponsor |
Lead HREC (and all investigators participating in the study) |
Within 72 hours of the sponsor becoming aware of the USM |
SSI Notification Form via REGIS |
|
Significant Safety Issue (SSI) not implemented as an Urgent Safety Measure (USM) |
Sponsor |
Lead HREC (and all investigators participating in the study) |
Within 15 days of the sponsor becoming aware of the SSI |
SSI Notification Form via REGIS |
|
All Significant Safety Issues (SSIs) |
Principal Investigator (PI) |
RGO for the site where the event occurred |
Within 72 hours of the PI becoming aware of the SSI |
SSI Notification Form via REGIS |
|
Unexpected & Related Serious Adverse Event (URSAEs) occurring at the site |
Principal Investigator (PI) |
RGO for the site where the event occurred |
Within 72 hours of the PI becoming aware of the event |
Local Safety Event Notification Form via REGIS |
|
Annual Safety Report |
Coordinating Principal Investigator or Sponsor |
Lead HREC |
Annually (within the annual progress report) |
Annual Progress Report via REGIS |
Please refer to the Clinical Trial Safety Reporting Quick Reference Guides under 'Applicants' on the how-to page of the REGIS website. Note there are separate guides for HREC and RGO.
SESLHD HREC and Research Governance follow the NHMRC Guideline: Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods. The information in this section is adapted from this guideline.
Note:
Good Clinical Practice (GCP) requires all deviations to be reported to the trial sponsor. Sponsors have primary responsibility for determining whether any suspected breach meets the definition of a serious breach. Serious breaches are the small sub-set of deviations that 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.
Report to SESLHD HREC
- All serious breaches within 7 calendar days of confirming the breach has occurred (See REGIS guide on reporting).
- Follow up reports when required
Report to SESLHD Research Governance / RGO
- Serious breaches occurring at a SESLHD site (See REGIS guide on reporting).
Not required by SESLHD HREC or RGO
- Protocol deviations that do not meet the definition of a serious breach (Sponsors have primary responsibility for determining whether any suspected breach meets the definition of a serious breach).
Please see Appendix IV of the NHMRC guideline for examples of reports that were confirmed as serious breaches and reports confirmed not to be serious breaches.
How does a serious breach differ from a significant safety issue (SSI)?
The definitions significant safety issue and serious breach are similar; however, they differ by virtue of the fact that a serious breach only results from a deviation of the protocol or GCP whereas a SSI may arise in a trial without any such deviation occurring. In addition, the serious breach reporting system enables the escalation of issues concerning both participant safety and data reliability.
Clinical Incidents
Any clinical incidents should be reported in accordance with NSW Health Policy Directive PD2020_047.
For guidance on how an incident arising from a clinical trial is identified, reported, and managed in a Health Service Organisation (HSO), please see fact sheet from the Australian Commission on Safety and Quality in Health Care.