Amendments and Safety Reports

All reports about the ongoing conduct of approved research projects must be submitted online in the RGS (Research Governance Service.) 

• It is the responsibility of the Coordinating Principal Investigator (CPI) to submit monitoring reports to the HREC.
• It is the responsibility of the EMHS site Principal Investigator to submit monitoring reports and provide updates to the EMHS Research Governance (RG) office.

Monitoring reports include:

• Amendments: modifying the study of 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. 
• Annual Progress Reports submitted to the HREC and site/s RG office. 
• Site Final Reports submitted to the sire/s RG office on project completion. 
• Project Final Reports submitted to the HREC on project completion.

HREC Monitoring Report Queries

For further information or support with HREC monitoring and/or reporting requirements for research, please contact the Central Office for Research Ethics (CORE) at hrec@health.wa.gov.au or (08) 9222 4214, quoting the projects RGS number. 

EMHS Site Monitoring Report Queries

For further information or support with monitoring and/or reporting requirements for an EMHS site, please contact the Research Hub at EMHS.REG@health.wa.gov.au, quoting the project's Research Governance Service (RGS) number. 

Research Audit Program

EMHS strives to achieve excellence in research and part of maintaining a high standard is the regular auditing of selected approved projects. Auditing of approved projects is a necessary component of the overall monitoring of health research. 

The research audit program aims to: 

• Review how research is being conducted. 
• Detect, correct and prevent potential problems that may compromise the safety and wellbeing of participants, and
• Ensure the integrity and success of research projects undertaken with EMHS. 

The audit program is designed to be collaborative and supportive, with broad, generalisable learnings guiding research, education, planning and policy, and process reviews. 

Resources