Reporting of Adverse Events

The Alfred Research & Ethics Unit

Reporting of adverse events
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Serious Adverse Events (SAEs)

A Serious Adverse Event is defined as any untoward medical occurrence that at any dose:

results in death;

is life-threatening;

requires in-patient hospitalisation or prolongation of existing hospitalisation;

results in a persistent or significant disability/incapacity;

is a congenital anomaly/birth defect; or

is a medically important event or reaction.

Source: National Statement on Ethical Conduct in Human Research 2007.

An event should be considered unexpected if the nature, severity or frequency of that event is not consistent with the information in the Investigator’s Brochure if the product or device being trialled is unapproved or if it is not documented in the current Australian Product Information if the product is approved for marketing.

Reporting of adverse events

Reporting to the Ethics Committee
The NHMRC Australian Health Ethics Committee (AHEC) Position Statement on Monitoring and Reporting of Safety for Clinical Trials Involving Therapeutic Products sets out requirements for the reporting of adverse events in accordance with the National Statement on Ethical Conduct in Human Research (2007). The Alfred Hospital Ethics Committee has adopted the requirements set out in the Position Statement with some minor refinements, as detailed in the Alfred Hospital Ethics Committee Safety Monitoring and Reporting Requirements. The Adverse Event Flow Chart provides an easy reference for researchers. Please read all three documents.

An Adverse Events Report Form must be submitted with each report or group of reports. This form must be completed and signed by the principal researcher.

Please submit a hard copy of the form and reports to the Ethics Manager. Please also email the completed form to Eve Kovesdy on e.kovesdy@alfred.org.au. An acknowledgement of receipt will be sent by return email.

If the Ethics Committee requires subsequent action, researchers will be notified by further email.

Reporting to the insurers
If the event is possibly, probably or definitely related to a study drug or procedure, it will need to be referred to the Hospital insurers in case a claim is subsequently made against Alfred Health. The Ethics Office will instruct researchers on how to do this.

Reporting to sponsors
Commercial sponsors will instruct researchers on their adverse event reporting requirements.

Reporting to the TGA
For researcher-initiated projects, serious adverse events related to drugs or devices are to be reported to the Therapeutic Goods Administration (TGA)

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