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).
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Reporting Requirements |
Types of Adverse Event/Reaction |
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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
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‘Local ‘Serious Adverse Events (SAEs) |
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Provide to HREC |
Expected adverse reactions
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Provide to HREC |
Suspected Unexpected Serious Adverse Reactions (SUSARs) occurring in Australia |
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Provide to HREC quarterly with comments re planned action or if no action planned
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All SUSARs (Australian and international)
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Provide to HREC Annual summary of all SAEs .More frequent reporting if requested by HREC, e.g. in early phase trial
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SAE summary
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Click on the link below to download the Serious Adverse Event Report Local/Non Local cover letter proforma.
Serious Adverse Event report
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