The requirements for adverse event reporting and monitoring are outlined below.
The requirements for safety reporting and reporting for clinical trials are outlined on the Clinical Trials Research Governance Webpage
The requirements for protocol deviations and serious breach reporting in clinical trials are outlined on the Clinical Trials Research Governance Webpage
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 UNSW Adverse Event or Incident Event Report Form.
Reports are to be submitted to the reviewing HREC as soon as possible after becoming aware of the event but within 7 days. Reports are to be sent via email to email@example.com