Safety reporting

St Vincent’s Hospital Research Office

Updated Safety Reporting – 31 October 2017

As of October 3, 2017, the NSW OHMR has formally accepted the updated NHMRC Safety Reporting Guidance.   This will now align with national and international standards.    This is effective now, and applies to new and existing trials.

 

A summary of Safety Notifications and Safety Reporting Pathways for all trials, further information and FAQs a can be found at:

https://www.medicalresearch.nsw.gov.au/clinical-trial-safety-monitoring/

 

The new policy can be found at:

http://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2017_039.pdf

 

What changes to reporting requirements have been made?

Fewer reports are required, and all safety reporting to the HREC and/or RGO is the responsibility of the sponsor of the trial.

HRECs will no longer receive: Single case AEs, SAE/SARs and 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.  Significant safety issues can be reported in the Significant Safety Issue Form (the use of which is mandated by OHMR).  Annual Safety reports can be reported in the Annual Progress Report or as a summary of the most recently updated Investigator’s Brochure or DSUR/DSMB report on the sponsor’s template.

The Significant Safety Issue Form (SSI) can be found on the OHMR Safety Reporting Webpage.

Once completed, the SSI form must be submitted via REGIS.

  • A significant safety issue (SSI) is a safety issue that could adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.
  • If an SAE/SAR/SUSAR meets the definition of an SSI, it will be reported to the HREC/RGO through that reporting mechanism.
  • SSIs that have been implemented as an urgent safety measure1 should be reported within 72 hours of the sponsor becoming aware of the issue.
  • All other SSIs should be reported within 15 calendar days of the sponsor becoming aware of the issue.

1A measure required to be taken in order to eliminate an immediate hazard to a participant’s health or safety.

RGOs will no longer receive: Single case AEs, SAE/SARs and external SUSARs or device/non-therapeutic good equivalents or six monthly line listings.

RGOs will receive: All significant safety issues (SSIs), any local SUSARs/USADEs/URSAEs and any research-related events that meet the definition of an incident. 

Local SUSARs/USADEs/URSAEs can be reported in the Local SUSAR/USADE/URSAE Notification Form (the use of which is mandated by the OHMR) and this can be found on the OHMR Safety Reporting Webpage.

Once completed the SUSAR/USADE/URSAE Notification Form must be submitted as a governance amendment in the study SSA/STE project via REGIS.

In trials where St Vincent’s Hospital is the sponsor the sponsor’s reporting responsibility is delegated by the St Vincent’s Hospital CEO to the Coordinating Principal Investigator or Principal Investigator.   It is the responsibility of the CPI/PI to ensure compliance with NHMRC and OHMR policy and guidance.

Where the sponsor is another entity- for example, a University, you should seek guidance from that institution.   It is likely that the delegation will be to the Principal Investigator.

Incident reporting for Medical Devices

In addition to the requirements of the HREC and Research Governance Officer, safety incidents involving medical devices may require notification to the Australian Therapeutic Goods Administration (TGA). Please refer to the TGA website for information relating to the medical device incident reporting and investigation scheme at https://www.tga.gov.au/medical-devices-safety