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Research

Safety Reporting

When safety reports are required

There are three types of safety reporting for research. The type you use will depend on your circumstances. The circumstances are:

  • Reporting incidents, hazards and near misses in RiskMan.These are defined in our Incident Management Policy (OPPIC Document ID 12624) and Incident Management Procedure (OPPIC Document ID 2292) on the Pulse;
  • Safety reporting for research where there is no TGA CTN/CTA notification. Submit a safety report immediately to Austin Health using this link.
  • Safety reporting for research where there is TGA CTN/CTA notifications. Submit safety reports in accordance with the tables below.

Safety reporting to Ethics

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

Submit Austin Health Safety Report Form here
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

Safety reporting to Austin Health Office for Research (when the event happened at Austin Health)

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

Submit Austin Health Safety Report Form here
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

Safety Reports no longer required to be submitted

  • Reports made to the Human Research Ethics Committee (HREC):

· 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)

  • At a site level (e.g., RGO):

· 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.

Definitions

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 – meets the definition of a serious adverse event
Related – resulted from administration of the trial intervention
Unexpected – the event is not described in the protocol as an expected occurrence
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:·
results in death;
is life-threatening;
requires in-patient hospitalisation or prolongation of existing hospitalisation;
results in a persistent or significant disability/incapacity;
is a congenital anomaly/birth defect; or
is a medically important event or reaction.
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;
The safety or rights of a trial participant, or
The reliability and robustness of the general data