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There are three types of safety reporting for research. The type you use will depend on your circumstances. The circumstances are:
Type of event |
Who Reports |
When |
How |
---|---|---|---|
Significant Safety Issues (SSI) implemented as an urgent Safety Measure (USM) |
Sponsor through the Coordinating Principal Investigator (CPI) |
Within 72 hours after the sponsor becoming aware of the event |
|
Significant Safety Issues (SSI) NOT implemented as an Urgent Safety Measure | Sponsor through the CPI | Within 15 days of the sponsor becoming aware of the SSI | Submit Austin Health Safety Report Form here |
Investigator Brochure updates/Addenda | Sponsor through the CPI | As and when updates are generated | Via amendment in ERM |
Annual Safety Reports | Sponsor through the CPI | Can accompany the annual progress report or when provided by the sponsor annually. The Executive Summary of the DSUR/DSMB or IB on the sponsor's template can serve as the Annual Safety Report. |
Via annual report form |
Serious Breach | Sponsor through the CPI | Within 7 calendar days of confirming a serious breach has occurred | Submit Austin Health Safety Report Form here |
Type of event |
Who reports |
When |
How |
---|---|---|---|
Significant Safety Issues (SSI) when it happened at Austin Health |
Austin Health Principal Investigator |
No later than 72 hours after the PI becoming aware of the safety events |
|
Suspected Unexpected Serious Adverse Events (SUSARs) and Unanticipated Serious Adverse Device Effects (USADEs) | Austin Health Principal Investigator | No later than 72 hours after the PI becoming aware of the safety events | Submit Austin Health Safety Report Form here |
· Individual reports of SUSARs (that do not result in an SSI) or 6 monthly line listings
· Individual reports of USADEs (that do not result in an SSI)
· DSMB Reports (that do not result in an SSI)
· Single Serious Adverse Events (SAEs)
· Serious Adverse Reactions (SARs)
· Adverse Events (AEs) that do not affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.
· Annual Safety Reports
· DSMB Reports
For roles and responsibilities, including how to document in site files etc… Please see the Process maps located on the Murdoch Children’s Research Institute webpage.
Term |
Definition |
---|---|
Significant Safety Issues (SSI) |
A safety issue that could adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial. |
Urgent Safety Measure (USM) | A measure required to be taken in order to eliminate an immediate hazard to a participant's health or safety |
Suspected Unexpected Serious Adverse Events (SUSARs) | An adverse reaction that is both serious and unexpected |
Unanticipated Serious Adverse Device Effects (USADEs) | A serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current version of the risk analysis report (and/or Investigator's Brochure/Instructions for Use). |
Unexpected & Related SAEs (URSAE) |
An adverse event that is: |
Serious Adverse Event (SAE) |
A Serious Adverse Event is defined as any untoward medical occurrence in a clinical trial or other clinical research project that:· |
Adverse Event (AE) |
Any untoward medical occurrence in a clinical trial participant receiving a trial intervention that does not necessarily have a causal relationship with this intervention |
Serious Breach |
A breach of Good Clinical Practice or the protocol that is likely to affect to a significant degree; |