Amendments and Safety Reports

All reports about the ongoing conduct of approved research projects must be submitted online in the Research Governance Service. Monitoring reports include:

  • Amendments: Modifying the study protocol or documents (e.g., participant information sheet and consent form), extending the HREC approval period, adding a new study site or changing personnel
     
  • Reports of significant safety events or protocol breaches occurring at a site covered by the HREC approval
     
  • Reports of the suspension or early termination of a project
     
  • Submitting an annual or final report.

If you have any questions about monitoring/reporting requirements for research, please contact the Research Hub Administrative Officer via EMHS.REG@health.wa.gov.au, quoting the project’s Research Governance Service number (#).

Following submission in Research Governance Service, researchers will receive acknowledgement or approval notification via the Research Governance Service. The nature and time of the approval or acknowledgement depends on the type of report.

Last Updated: 08/05/2019