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.
Safety reporting for clinical trials
Unless otherwise stipulated in the approval letter, for externally-sponsored clinical trials being conducted at Metro North the NHMRC Guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods applies to safety monitoring and reporting for clinical trials involving therapeutic products.
What should be reported to the HREC?
- Urgent Safety Measures (USMs) instigated by the Site or Sponsor within 72 hours of becoming aware of the event
Report an Urgent Safety Measure to the Metro North RGO
All other Significant Safety Issues (SSIs) should be notified within 15 calendar days of the sponsor instigating or being made aware of the issue
- An annual safety report including a clear summary of the evolving safety profile of the trial
- Investigator Brochure amendments
- Data Safety Monitoring Board (DSMB) reports
What should be reported to the RGO?
- Urgent Safety Measures (USMs) instigated by the Site or Sponsor within 72 hours of becoming aware of the event
Report an Urgent Safety Measure to the Metro North RGO
- Suspected Unexpected Serious Adverse Reactions (SUSARs) or Unanticipated Serious Adverse Device Effects (USADEs) arising from the local site, 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 within 72 hours of becoming aware of the event
- An annual safety report including a clear summary of the evolving safety profile of the trial
- Investigator Brochure amendments
- Data Safety Monitoring Board (DSMB) reports
What should NOT be reported to the HREC or RGO?
- 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 at MetroNorthResearch-ClinicalTrials@health.qld.gov.au.