Researchers, sponsors, and institutions are required to monitor and report safety events such as significant safety issues (SSIs), urgent safety measures (USMs), serious breaches, and adverse events in accordance with national guidelines.
It is essential that all Principal Investigators are aware of their reporting obligations and comply with these requirements.
For clinical trials, both sponsors and researchers have defined responsibilities for safety reporting, as outlined by the Therapeutic Goods Administration (TGA) and the National Health and Medical Research Council (NHMRC).
- TGA: Australian Clinical Trial Handbook
- NHMRC: Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods
Bayside Health Peninsula outline safety monitoring and reporting requirements in:
- Safety Monitoring and reporting in Clinical Trials Policy
- SOP 12- Safety Data Monitoring and Reporting Requirements for Clinical Trials Standard Operating Procedures for Clinical Trials
The type of reporting and reporting requirements are dependent on the nature of the event.
How do I notify the HREC of safety and adverse event reports for Single Site Projects?
The table below details the forms required for each type of event and the required submission timeframe. Aseparate research governance report is not required where the event has been reported to the Bayside Health (Peninsula) HREC.
| Event Type | ERM Report Form | Timeline | Submission Process |
| Annual Safety Report | Annual Safety Report (Sub-form of the HREA) | Annual | See below |
| Notification of an amendment due to safety information | Ethics Amendment Request or Project Notification Form[SS1] (Sub-form of the HREA) | As soon as possible without undue delay | See Amendments |
| Notification of a temporary halt or termination of a trial for safety reasons. | Ethics Amendment Request or Project Notification Form[SS2] (Sub-form of the HREA) | Within 15 calendar days | See Amendments |
| Serious Breach | Serious Breach Report VIC (Sub-form of the HREA) | Within 7 calendar days of confirming a serious breach has occurred | See below |
| Significant Safety Issues (SSIs) | Safety Report VIC (Sub-form of the HREA) | USM: Within 72 hours Not a USM: within 15 calendar days of the sponsor instigating or being made aware of the issue | See below |
| Suspected Breach | Suspected Breach Report VIC (Sub-form of the HREA) | As soon as practicable | See below |
| Urgent Safety Measure (USMs) | Safety Report VIC (Sub-form of the HREA) | Within 72 hours of becoming aware of the event | See below |
How do I submit these reports?
- All of the forms listed above are submitted via Ethical Review Manager (ERM). If you do not have an ERM account register here Login – ERM Applications.
- The Principal Investigator (PI) must also have an ERM account for electronic signature through ERM. The Applicant user guide to ERM provides comprehensive guidance on how to use ERM.
- Create the appropriate form as a sub-form of the HREA.
- Complete and upload any supporting documents.
- PI signs the form/request using ERM’s electronic signature process.
- Submit the form via ERM Applications only when all steps above are complete.
What documents do I need to submit?
Below is a list of the documents required for HREC submission. Incomplete applications will not be accepted for review.
All documents must have a version number and date (no draft documents or those with comments or tracked changes will be accepted as part of the submission).
Mandatory:
- Appropriate form as detailed above
Event Type Dependent:
- Any other documents that provide information related to the event.
How is my submission reviewed?
- The HREC meets monthly
- The documentation is reviewed by the Committee and their decision documented in the minutes.
- You will receive feedback via ERM within 7 days of the Committee meeting.
How do I notify safety and adverse event reports to the Office for Research for Multi- Site Projects?
Where Bayside Health (Peninsula) is NOT the Reviewing HREC report safety and adverse event reports according to the Reviewing HREC requirements:
The table below details the forms required to be submitted to the Office for Research for each type of event and the required submission timeframe.
| Event Type | ERM Report Form | Timeline |
| Annual Safety Report | Site Notification Form (SSA Sub-form) | Annual |
| Notification of an amendment due to safety information | Site Governance Amendment Request (SSA Sub-form) | As soon as practicable after HREC approval |
| Notification of a temporary halt or termination of a trial for safety reasons. | Site Notification Report (HREA Sub-form) | Within 15 calendar days |
| Serious Breach | Site Notification Form (SSA Sub-form) | Within 7 calendar days of confirming a serious breach has occurred |
| Significant Safety Issues (SSIs) | Site Notification Form (SSA Sub-form) | USM: Within 72 hours Not a USM: within 15 calendar days of the sponsor instigating or being made aware of the issue. |
| Suspected Breach | Site Notification Form (SSA Sub-form) | As soon as practicable |
| Suspected Unexpected Serious Adverse Reactions (SUSARs) – PH Site Only | Site Notification Form (SSA Sub-form) | within 72 hours of becoming aware of the event or change in status from SAE to SUSAR |
| Unanticipated Serious Adverse Device Effects (USADEs) – PH Site Only | Site Notification Form (SSA Sub-form) | within 72 hours of becoming aware of the event or change in status from SADE to USADE |
| Urgent Safety Measure (USMs) | Site Notification Form (SSA Sub-form) | Within 72 hours of becoming aware of the event |
How do I submit these documents to the Office for Research?
- Site Notifications and Site Governance Amendment Requests are submitted via Ethical Review Manager (ERM). If you do not have an ERM account register here Login – ERM Applications.
- The Principal Investigator (PI) must also have an ERM account for electronic signature through ERM. The Applicant user guide to ERM provides comprehensive guidance on how to use ERM.
- Create a Site Notification or a Site Governance Amendment Request as a sub-form of the Site Specific Assessment (SSA) on ERM. Complete and upload other documents that were submitted to the Reviewing HREC and their Acknowledgement.
- PI signs the request using ERM’s electronic signature process.
- Submit the Site Notification or Site Governance Amendment Request via ERM Applications only when all steps above are complete.
What documents do I need to submit?
Below is a list of the documents required for submission.
Mandatory:
- Site Notification Form or Site Governance Amendment Request
- Reviewing HREC Acknowledgement
- Documents submitted to Reviewing HREC
How is my submission reviewed?
- Site Notifications and Site Governance Amendment Requests Site are not subject to fixed deadlines.
- The Office for Research assesses the submission and liaises with the Principal Investigator or Study Coordinator.
- Feedback will be sent via ERM.
The following activities are not required to be reported to the Bayside Health Peninsula HREC or Office for Research:
- Single Serious Adverse Events (SAEs), Serious Adverse Reactions (SARs) and Adverse Events (AEs) that do not affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.
- External SUSARs or device/non-therapeutic good equivalents
- Six monthly line listings