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 emailed or electronically signed by the principal
researcher.
Please
email the completed form to
research@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)