Reporting adverse events2024-10-14T14:40:04+10:00

Reporting adverse events 

Safety reporting and adverse events

While undertaking a research project, researchers have an obligation to both the participants and to the Human Research Ethics Committee (HREC) and research governance office to provide reporting and monitoring, including reporting of adverse events.

Unless otherwise stipulated in the approval letter, externally-sponsored clinical trials conducted at Metro North must comply with the NHMRC Guidance for safety monitoring and reporting for clinical trials involving therapeutic products.

 

Urgent Safety Measures (USMs)

All Urgent Safety Measures (USMs) instigated by the Site or Sponsor must be reported within 72 hours of becoming aware of the event. USMs are notified directly to the reviewing HREC and Metro North research governance.

Report a USM to the Metro North HREC

Email: MetroNorthResearch-Ethics@health.qld.gov.au

Phone: (07) 3646 5280

Report a USM to Metro North research governance

Email: MetroNorthResearch-RGO@health.qld.gov.au

Phone: (07) 3647 9550

All other safety reporting

All other safety reporting for clinical trials, including annual safety reports and reporting of adverse events, are submitted to the reviewing HREC and Metro North research governance via ERM.

Report to the HREC

Safety and adverse event reporting requirements for the Metro North (or reviewing) HREC include:

  • All Significant Safety Issues (SSIs). Must be notified to the Metro North (or reviewing) HREC within 15 calendar days of the sponsor instigating or being made aware of the issue.
  • Annual safety report, including a clear summary of the evolving safety profile of the trial
  • Investigator Brochure amendments
  • Data Safety Monitoring Board (DSMB) reports

Submit a safety report to the Metro North HREC

Report to Metro North research governance

Safety and adverse event reporting requirements for Metro North research governance include:

  • Suspected Unexpected Serious Adverse Reactions (SUSARs) or Unanticipated Serious Adverse Device Effects (USADEs) arising from the local site. Must be reported within 72 hours of becoming aware of the event or change in status from SAE to SUSAR
  • All other SSI that result in temporary halt, amendment or early termination of a trial. Must be reported within 72 hours of becoming aware of the event
  • Annual safety report, including a clear summary of the evolving safety profile of the trial
  • Investigator Brochure amendments
  • Data Safety Monitoring Board (DSMB) reports

Submit a safety report to Metro North research governance

What should not be reported to the HREC or RGO?

The following activities are not required to be reported to the reviewing HREC or research governance office:

  • Single Serious Adverse Events (SAEs), Serious Adverse Reactions (SARs) and Adverse Events (AEs) that do not affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.
  • External SUSARs or device/non-therapeutic good equivalents
  • Six monthly line listings

Safety reporting for Metro North sponsored clinical trials

For studies where Metro North is the sponsor, please notify all safety events for all sites for which Metro North is responsible through to the study sponsor via Metro North Research.

MetroNorthResearch-ClinicalTrials@health.qld.gov.au

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