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Adverse Events

Adverse Events

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Notifying the PAH Human Research Ethics Committee

 

It is a requirement of the Therapeutic Goods Association and the NHMRC that all serious and unexpected adverse events (SAEs) be reported by investigators to the HREC.

 

Serious Adverse Events MUST be reported for ALL protocols including student projects.

 

Definition: Serious adverse event (SAE)

Any untoward medical occurrence that:

• results in death;
• is life-threatening;
• requires in-patient 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

Source: NHMRC's National Statement on Ethical Conduct in Human Research 2007 (Glossary).

 

SAEs include all of the above events irrespective of whether they occur during drug trials or other types of research projects.

 

The PAH HREC has developed templates for the reporting of SAEs to both assist researchers and to aid the HREC in assessing how important these events are in relation to the welfare of research participants and the continuation of the study.  These forms have been designed to be printed on Queensland Health Letterhead.

 

The Principal Investigator at this site is required to sign the form before submission to the HREC to indicate they have viewed the SAE and considered, in his/her expert opinion, whether the event/s is/are related/not related to the study.

 

PAH Onsite SAEs:

SAEs on site at the PAH should be reported to the Ethics Secretariat as soon as practicable using the On-site SAE Form (1 original + 15 copies).

 

External SAEs (not at PAH):

All external serious adverse events are to be submitted monthly by the next closing date for submissions using the External SAE Form (1 original + 1 copy).

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