Serious Adverse Event Reporting

Notifying the Human Research Ethics Committee

The Research Directorate must comply with the requirements of both the NHMRC National Statement on Ethical Conduct in Human Research (2007) and the VMIA (Melbourne Health Service's insurers), regarding disclosure of relevant events.

The requirement of the Melbourne Health Research Directorate and the Human Research Ethics Committee (HREC) is that the following reports be submitted:

All serious adverse event reports and safety updates circulated to researchers by the sponsoring company (which the responsible principal researcher believes may in any way impact upon patients for whom the Melbourne Health HREC is responsible); and

All reports of events occurring to patients of Melbourne and/or Western Health for research projects that have been approved by HREC, which are possibly related to the trial or which result in a change to the Participant Information and Consent Form or the conduct of the trial. Serious adverse events occurring to patients of Melbourne or Western Health must be notified within 24 hours.

Reports of events not within these categories need not be submitted and should simply be filed on the site file.

An Adverse Event Form (Form 14) is to be submitted with each report. Please note that the Form must be accompanied by the detailed SAE report describing the actual incident (where applicable). The form should be completed and signed by the principal researcher. Incomplete forms will be returned to researchers without acknowledgment.

Identification of individual reports

Some sponsors of clinical trials request unique identification of each adverse event report. If this is the case, a Report/Control Number should be provided on the Adverse Events Report Form and this number will be quoted in any further correspondence between the researcher and HREC. The Report/Control Number covers either a single report or a batch of reports. Where an individual report is to be identified in a batch of reports, this may be referred to by the patient identifier.

Acknowledgment of receipt

Acknowledgment of receipt of adverse event reports will be forwarded following review of the adverse event report material by the scientific spokesperson for the project and formal confirmation of notification by the full HREC at its next meeting.

SERIOUS ADVERSE EVENT DEFINITION:

Any untoward medical occurrence that:

 results in death;
 is life-threatening;
 requires in-patient hospitalisation or prolongation of existing hospitalisation;
 results in a persistent or significant disability/incapacity; or
 is a congenital anomaly/birth defect.

Source: NHMRC National Statement on Ethical Conduct in Human Research (2007)