The requirements for adverse event reporting and monitoring are outlined below.
Clinical Trial Safety Monitoring and Reporting
The requirements for safety reporting and reporting for clinical trials are outlined on the Clinical Trials Research Governance Webpage
Clinical Trials Protocol Deviations and Serious Breaches
The requirements for protocol deviations and serious breach reporting in clinical trials are outlined on the Clinical Trials Research Governance Webpage
Reporting Adverse Events and Incidents for all other human research
Adverse events and incidents that occur while conducting a UNSW HREAP or HREC approved human research project which is not classified as a clinical trial are to be reported using the iRECS Portal.
Reports are to be submitted to the reviewing HREC as soon as possible after becoming aware of the event but within 7 days.