Key messages

  • A Human Research Ethics Committee (HREC) is responsible for monitoring the ethical conduct and safety of an approved research project.
  • A site Research Governance Officer (RGO) is responsible for monitoring the site conduct of an authorised research project.
  • Ethical Review Manager (ERM) is used for reporting in Victoria.
     

Post-approval reporting

For the duration of an approved research project, the reviewing Human Research Ethics Committee (HREC) is responsible for monitoring the ethical conduct and safety of the research.  This involves verification that the conduct of the research conforms to the approved project.

In Victoria, all reporting to the reviewing HREC aligns with the guidance of the National Health and Medical Research Council (NHMRC) – Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC, 2016). In this guidance, the of safety responsibility of reporting to the reviewing HREC is assigned to the sponsor of the research project. The sponsor may be an institution, investigator, collaborative group or commercial company. 

Reporting to the Human Research Ethics Committee (HREC)

For information on post-approval reporting requirements, refer to the Monitoring and Reporting Matrix.

In Victoria, all post-approval report forms are completed using the Ethical Review Manager (ERM) website. Refer to the Applicant User Guide to ERM for information on using ERM.

The Coordinating Principal Investigator (multi-site project) or Principal Investigator (single-site project) and the sponsor have reporting responsibilities to a Victorian HREC.

These are:

  • Report on an approved research project using the forms available in ERM:
    • Ethics Amendment Request
    • Project Progress Report
    • Project Final Report
    • Safety Report
    • Annual Safety Report
    • Serious Breach Report
    • Suspected Breach Report
    • Site Closure Report (one site closing from a multi-site project) 
    • Project Notification Form
  • Complete the required reporting form(s) for the research project (single-site or multi-site project)
  • Submit the required reporting form(s) to the reviewing HREC.

Post-authorisation reporting

The site Research Governance Officer (RGO) is responsible for monitoring the conduct of the research project at their site.

Reporting to the site RGO

For information on post-authorisation reporting requirements, refer  RGO to the Monitoring and Reporting Matrix.

In Victoria, all post-authorisation report forms are completed using the Ethical Review Manager (ERM) website. Refer to the Applicant User Guide to ERM for information on using ERM.

Each site Principal Investigator has responsibility to:

  • Report to the site RGO according to local policy using the forms available in ERM:
    • Site Governance Amendment Request
    • Site Progress Report
    • Non-serious Breach/Deviation Report
    • Site Audit Report
    • Complaint Report
    • Site Notification Form
  • Complete the required reporting form(s) for the site
  • Submit the required reporting form(s) to the site RGO.