In this section
Safety reporting for clinical trials must follow the
2016 NHMRC Guidance: Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods
Additional requirements for post approval monitoring at Victorian public health sites are also available from the
Victorian Department of Health and Human Services website.
For research that is either ethically approved by the RCH HREC, or where RCH has issued governance authorisation only, the following reporting structure applies:
Type of Report
Terminology defined in the below Frequently asked questions
RCH ethics within 72 hours of study staff becoming aware of the SSI using the
Safety Report Form via
Please refer to the
Safety Reporting Timelines table for Investigational Medicinal Products (IMPs) and Investigational Medical Devices (IMDs).
Annual Safety Reports are only required for any study which involves the use of an investigational product i.e. when an investigational product is being provided to the participants as part of the study.
All reports for RCH ethics and governance must be submitted via
ERM and signed by the CPI or PI.
Clinical Research Development Office (CRDO)
have guidance available for
with the following documents: Standard Operating Procedures for safety monitoring and reporting, Safety Report Form and Safety Assessment, Documentation and Reporting Process Maps. Information can be found
A significant safety issue, also known as an SSI, is a safety issue that could adversely affect the safety of participants or materially affect the continued ethical acceptability or conduct of the trial related to the trial intervention.
An urgent safety measure is a measure that needs to be taken to eliminate an immediate hazard to a participant’s health or safety related to the trial intervention. Note: this type of significant safety issue can be instigated by either the investigator or sponsor and can be implemented
before seeking approval from HREC’s or institutions.
An annual safety report should include a:
For investigator initial trials, the annual safety report should be completed and submitted at the same time as the annual progress report.
For commercially sponsored trials, 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 HRECs via
ERM. A 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.
An adverse event (AE) is any untoward medical occurrence to a participant which does not necessarily have a causal relationship with the treatment. It is expected that sponsors, or PIs when the study is investigator initiated, collect and periodically analyse AE data.
A SUSAR is an SAE for which there is some degree of probability that the event is related to the study drug and the adverse reaction is unexpected. That is, the nature or severity of which is not consistent with the applicable product information. SUSARs can be defined and reported as SSIs, with the timeliness of reporting dependent on whether the event meets the definition of an urgent safety event.
SUSARs must be reported to the Therapeutic Goods Administration (TGA) and to the local research governance office. For commercially sponsored studies the commercial sponsor may take on this responsibility, however for Investigator driven studies SUSAR reporting is the
Principal Investigator's responsibility.
A Suspected Unexpected Serious Adverse Reaction
(SUSAR) or Unanticipated Serious Adverse Device Effect (USADE) that affected a
participant at a site in Victoria must also be notified to the Victorian Managed
Insurance Authority (VMIA). Submit a copy of the Suspected Unexpected Serious Adverse
Reaction Form to VMIA, at the same time it is submitted to the responsible
Human Research Ethics Committee for the clinical trial.
The sponsor is responsible for reporting all fatal or life-threatening unexpected adverse drug reactions to the TGA as soon as possible, but no later than 7 days. All other serious, or unexpected adverse drug reactions should be reported no later than 15 days.
Additional information on safety reporting can be found via the
TGA Clinical Trials webpage.