Safety and Adverse Event Reporting

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Safety and Adverse Event Reporting

The Therapeutic Goods Administration definition of a serious adverse event is:
Any untoward medical occurrence that at any dose:

  • Results in death,
  • Is life-threatening, (NOTE: The term "life-threatening" in the definition of "serious" refers to an event/reaction in which the patient was at risk of death at the time of the event/reaction; it does not refer to an event/reaction which hypothetically might have caused death if it were more severe)
  • Requires inpatient hospitalisation or prolongation of existing hospitalisation,
  • Results in persistent or significant disability/incapacity,
  • Is a congenital anomaly/birth defect, or;
  • Is a medically important event or reaction.

For more information on adverse events, click here to download the TGA’s Australian Clinical Trials Handbook

A SUSAR (Suspected Unexpected Serious Adverse Reaction) is an adverse reaction that is both unexpected (not consistent with the applicable product information) and also meets the definition of a Serious Adverse Event/Reaction.
An USADE (Unanticipated Serious Adverse Device Effect) is any serious adverse effect on health or safety, any life-threatening problem or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the application; or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

Serious Adverse Events/ SUSAR/USADE

NH HREC Approval:
All ‘possibly, probably, definitely related to the investigational product or procedurally related (device trials)’ AND/OR ‘possibly or definitely considered to have material impact’ serious adverse events should be submitted for review within 24 hours of the event or as soon as possible thereafter.

All other SAE/SUSAR/USADE can be reported within 15 days. 

Lead HREC Approval: Concurrent submission to the HREC and the research governance office should occur. The RGO does not require the lead HREC approval unless the event impacts on the overall conduct of the trial or the patients enrolled.  All ‘possibly, probably, definitely related to the investigational product or procedurally related (device trials)’ AND/OR ‘possibly or definitely considered to have material impact’ serious adverse events that occur to patients from Northern Health should be concurrently submitted to the research governance office for review.

All other SAE SAE/SUSAR/USADE can be reported within 15 days. 

Click on the link and scroll to the bottom of the page to download the AE & SAE Report template.