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Safety reporting for clinical trials

​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) No later than 72 hours after the sponsor becoming aware of the event Word icon SSI Notification Form or sponsor template, submitted via 'safety form' in Regis.
Significant Safety Issues (SSI) NOT implemented as an Urgent Safety Measure (USM) Sponsor through the CPI Within 15 days of the sponsor becoming aware of the SSI. Word icon SSI Notification Form or sponsor template, submitted via 'safety form' in Regis.
Investigator Brochure updates/Addenda Sponsor through the CPI As and when updates are generated. Submitted as a general amendment in Regis.
Annual Safety Report 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.

If accompanying the milestone report, click on the milestone tab within the ethics application in Regis and attach the report.

If not accompanying milestone report, submit via 'safety form' in Regis.

 

 

Research Governance: 

 

Type of event Who reports When How
Significant Safety Issues (SSI) – When the ethics application is in REGIS. Principal Investigator (PI) No Later than 72 hours after the PI becoming aware of the safety event.

No action required.

Once the HREC has approved the SSI Notification Form or Sponsor Template Safety Notification Form in REGIS this will be automatically sent to all sites in REGIS.

Significant Safety Issues (SSI) – When the ethics application is not in REGIS.

 

Principal Investigator (PI) No Later than 72 hours after the PI becoming aware of the safety event.

The Word icon SSI Notification Form or Sponsor Template Safety Notification Form and HREC Acknowledgment must be submitted via REGIS.

Go to 'Projects' section and select the site (STE) application. Select the 'Reporting Local Safety Events to the Institution' tab and select the form; 'SSI from approving HREC (external to REGIS).'

Suspected Unexpected Serious Adverse Events (SUSARs) and Unanticipated Serious Adverse Device Effects(USADEs) occurring at site. Principal Investigator (PI) No Later than 72 hours after the PI becoming aware of the safety event.

The SUSAR/USADE/URSAE Word icon Notification Form must be submitted via REGIS.

Go to 'Projects' section and select the site (STE) application.  Select the 'Reporting Local Safety Events to the Institution' tab and select the form 'Local Safety Event.'

 

  • The following reports are no longer required by human research (ethics) or research governance;

single case AEs, SAE/SARs and SUSARs or device/non-therapeutic good trial equivalents or six monthly line listings.

  • For research where NSLHD is acting as the sponsor, it is the responsibility of the PI to ensure compliance with the above guidance.

 

Definitions:

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.

 

References and related documents:

Chevron PDF icon Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations policy External Link

Chevron Clinical Trial Monitoring & Safety External Link

Chevron Safety monitoring and reporting in clinical trials involving therapeutic goods  External Link

Chevron Guidance for Safety Monitoring and Reporting in Clinical Trials External Link