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

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 (concurrently to the HREC and Northern Health Office for Research & Ethics) 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.  

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