| Safety and Adverse Event Reporting |
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Notifying the Human Research Ethics Committee
Melbourne Health is required to comply with the requirements of the NHMRC National Statement on Ethical Conduct in Human Research (2007), the Australian Therapeutic Goods Administration and the Victorian Managed Insurance Authority, maintaining and reporting of adverse events and safety information in clinical research.
Melbourne Health has issued the Guidelines for Monitoring and Reporting of Safety in Clinical Trials and Other Clinical Research
An Adverse Event Report form is to be submitted with each report requiring notification to a Melbourne Health HREC. Please note that the form must be accompanied by a detailed 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.
All researchers are expected to be familiar with Melbourne Health's Monitoring and Reporting of Safety Guidelines and to abide by them at all times.
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 to researchers after review of the relevant material by the HREC scientific spokesperson for the project and formal noting of the information by the full HREC.
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)
Guidelines for Monitoring and Safety for Clinical Trials Involving Therapeutic Products and Other Clinical Research
These guidelines have been developed to clearly set out the roles and responsibilities of Melbourne Health (MH), its Human Research Ethics Committees, investigators and sponsors, and the processes in place in relation to monitoring and reporting reports of adverse events, including serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs), involving clinical trials for which MH, or a MH HREC, is responsible. | 
