Serious Adverse Events, SUSARS

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 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