Adverse Event and Safety Reporting and Monitoring of Human Research

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

 

 

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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

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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 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 humanethics@unsw.edu.au 

 

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