Reporting of Adverse Events

The Alfred Research & Ethics Unit

Reporting of adverse events

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.

Notification of SAEs

Researchers are obliged to notify the Ethics Manager within 24 hours of all serious or unexpected adverse events relating to participants in approved research projects at Bayside Health. Reports involving participants in project sites outside Bayside Health must be submitted to the Ethics Office as soon as possible.

Serious adverse events that the chief researcher deems possibly, probably or definitely related to a study drug or procedure will need to be referred to the Hospital insurers. The Ethics Office will provide contact names and addresses for this purpose.

Commercial sponsors will instruct researchers on SAE reporting requirements.

For researcher-initiated projects, SAEs related to drugs or devices are to be reported to the Therapeutic Goods Administration (TGA).

An Adverse Events Report Form must be submitted with each report or group of reports. This form must be completed and signed by the chief 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. You will be sent an acknowledgement of receipt by return email.

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

[^Top]

This page was last modified on 25/08/08

URL: http://www.alfredresearch.org/ethics/adverse.htm