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.
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This page was last modified on
25/08/08
URL: http://www.alfredresearch.org/ethics/adverse.htm
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