Safety Reporting

Last Updated 5th January 2018

NHMRC Safety Reporting

In November 2016, NHMRC released new guidance on Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (the Guidance). The Guidance replaces the 2009 Australian Health Ethics Committee (AHEC) Position Statement on safety reporting. The NSW Office for Health and Medical Research (OHMR) fully supports implementation of the Guidance, which will streamline clinical trial safety reporting and monitoring for Australia. Researchers and Sponsors are asked to adopt the new safety reporting guidelines from 18th September 2017. The NSW Health Policy can be accessed here

KEY CHANGES
• HRECs will no longer receive: Single case Adverse Events (AEs), Serious Adverse Events (SAEs)/Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs)* or device/non-therapeutic good trial equivalents or six monthly line listings.

• HRECs will receive: All significant safety issues, annual safety reports and investigator’s brochure updates. These will be submitted to the HREC by the Sponsor (or their delegate).

• Research Governance Officers (RGO) will receive: All significant safety issues (SSIs), any local SUSARs/ Unanticipated Serious Adverse Device Effects (USADEs)/ Unexpected and Related Serious Adverse Event (URSAEs) arising from the site and any research-related events that meet the definition of an incident. These will be submitted by the investigator to the local RGO.

The safety monitoring and reporting responsibilities of the Sponsor, Coordinating Principal Investigator, and Principal Investigator to the HREC and RGO are outlined in the below tables and flowcharts. Reporting forms are available here:
• Significant Safety Issue (SSI) notification form

• SUSAR/USADE/URSAE notification form

• SAE reporting form (if a SAE needs to be sent to the RGO)

NB: The below tables only show the events that should be reported to the HREC and RGO, For further details on the safety monitoring/reporting responsibilities of the HREC, Principal Investigator, TGA, Institution and Sponsor please refer to the guidelines here.

 Summary of safety notifications to the HREC and RGO (therapeutic goods trials)

Reporting pathway for therapeutic good trials

Summary of notifications to the HREC and RGO (non-therapeutic goods trials)

  Reporting pathway for non-therapeutic good trials

Definitions
• Adverse Event: Any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and that does not necessarily have a causal relationship with this treatment.
• Adverse Reaction: Any untoward and unintended response to an investigational medicinal product related to any dose administered. All adverse events judged by either the reporting investigator or the sponsor as having a reasonable possibility of a causal relationship to an investigational medicinal product would qualify as adverse reactions.
• Suspected Unexpected Serious Adverse Reaction (SUSAR): 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).
• Urgent Safety Measure (USM): A measure required to be taken in order to eliminate an immediate hazard to a participant’s health or safety.
• Significant Safety Issue (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.
• 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.

Office for Health and Medical Research (OHMR) Links

• Safety Reporting and Monitoring for Clinical Trial

• Summary of Safety Notifications and Safety Reporting Pathways for all trials

• Frequently asked questions (FAQS) – Safety Monitoring and Reporting

SERIOUS BREACHES IN CLINICAL TRIALS

Serious breaches should be reported in accordance with NHMRC Guidelines document:  Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods 2018.

A serious breach is 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 data generated in a clinical trial.

The NHMRC guidelines does not use the terms Protocol Deviation or Protocol Violation

Serious breaches should be reported to the reviewing HREC, usually by the Sponsor within 72 calendar days of confirming a serious breach has occurred. The HREC will review the serious breach to evaluate its impact on the continued ethical acceptability of the study and to satisfy itself that the serious breach is managed appropriately.

It is the responsibility of the Principal Investigator to (i) report any suspected breach to the sponsor within 72 hours of becoming aware of it and (ii) to report to their institution (via the Research Governance Officer) within 72 hours any serious breach that has been confirmed by the sponsor as occurring at their site.