Serious Adverse Events, SUSARS

 

Guidelines for reporting SAEs/SUSARs

The Barwon Health Cover letter is required for reporting of events  (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 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 links below to download the relevant proforma 

 SAE and SUSAR reporting .doc (56 KB)

 

 Report IB_product info.doc (37 KB) 

 

 

 

 

 

  

 Report PROTOCOL violation.doc (41 KB)

 

 BH SOP SAE reporting final.doc (174 KB)

 

 

: : EVENTS
Walk and Talk Organ Donation
1/23/2012


Palliative Care conference 'Continuing Conversations'
1/23/2012


Blokes Day Out 2012
11/3/2011

Blokes Day Out: Friday 23 March - Sunday 1 April, 2012.

Find out more about how you can get involved.