Monitoring Activities

As per the WA Health Research Governance and Single Ethical Review Standard Operating Procedures, a condition of ethical and institutional approval requires that the CPI/PI must seek and gain approval from WACHS' Research Governance Office and WACHS HREC (if this HREC provided ethics approval) for proposed amendments to the research project, which may affect the ethical, scientific or institutional acceptability of the research project. Additional requirements include annual reporting, timely notification of safety reports, and project closure reporting.

From 3 December 2018, researchers with projects operating within WA Health Services (including NMA projects) must complete and submit all monitoring forms and reports via RGS 

The following WA Health monitoring forms and reports are now built into the RGS and are available for use: 

  • Amendment Form (Ethics and Governance); 
  • Governance Only Amendment Form with additional Amended Budget Form; 
  • Safety Form; 
  • Progress Report; 
  • Site Final Report; 
  • Project Final Report; and 
  • Research Complaint Form (in the RGS side bar)

The RGS User Guides  and Help Wiki have been updated and contain information about how to complete a monitoring application via RGS. Presentations were conducted across WA Health during August 2018, slides from this presentation are available on RGS Research Education Page and a direct link to these slides is available via the following link - Navigating the RGS as a Researcher for Research Monitoring August 2018.

Amendments 

An amendment consists of a change made to the terms of the original ethics or governance application, the research team, the protocol, or any other supporting documentation after the study has started. An amendment will require ethical or governance review, or a combined review, depending on the nature of the amendment. 

For the addition of students who are either WA Health or non-WA Health research personnel, please ensure the WA Health Student Research and Confidentiality Declaration Form (for students affiliated with universities) is completed and submitted in conjunction with the amendment form via RGS.

Most administrative ethical amendments and all governance amendments will be reviewed out of session, however the HREC Chair reserves the right to request an amendment requiring ethical review be tabled at the next available HREC meeting for the full committee's review. 

Annual Progress Reports

Progress of research must be reported annually to the Lead HREC and all Research Governance Offices (for multi-centre research). Continuation of ethical approval and site authorisation for a research project will be contingent upon receipt of an annual progress reports.The due date for annual reports is one year from the date of final HREC approval date.

Final Report

At the conclusion of a research project at one or more sites the CPI must complete a Final Report (including the final results), within 30 calendar days of project completion. We encourage final publications and reports to be submitted in addition to the the completed WA Health Final Report Form.

Notification Forms

Reporting of adverse events, non-compliance, temporary halts or premature termination of projects should be submitted via RGS for ethical and governance review as soon as possible. 

Complaints

Reporting of complaints should be submitted as soon as possible via RGS under the Complaints section. The nature of the complaint will determine where it is lodge.

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