Serious Adverse Events

Guidelines for reporting SAEs/SUSARs

The Barwon Health Serious Adverse Event Report Local/Non Local Cover letter is required for reporting of SAE’s (see link below).

Reporting Requirements	Types of Adverse Event/Reaction
All local SAE’s must be reported to the HREC and at times RISKMAN. NB more serious (eg. death or an event initiating a change of protocol) must be reported within 24 hours: initial email advice is accepted	‘Local ‘Serious Adverse Events (SAEs)
Provide to HREC	Expected adverse reactions
Provide to HREC	Suspected Unexpected Serious Adverse Reactions (SUSARs) occurring in Australia
Provide to HREC quarterly with comments re planned action or if no action planned	All SUSARs (Australian and international)
Provide to HREC Annual summary of all SAEs .More frequent reporting if requested by HREC, e.g. in early phase trial	SAE summary

Click on the link below to download the Serious Adverse Event Report Local/Non Local cover letter proforma.