CLINICAL TRIALS AND RESEARCH

Monitoring and Reporting

Monitoring and verifying the ethical conduct and safety of an approved research project

    Post-ethics 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 (2016) . In this guidance, the safety monitoring and 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.

    Investigator responsibilities

    The Coordinating Principal Investigator (multi-site project) or Principal Investigator (single-site project) and the sponsor have reporting responsibilities to a Victorian HREC. Reporting forms for an approved project are available as subforms 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 and submit the required reporting form(s) to the reviewing HREC.

    Post-authorisation reporting

    Reporting to the Research Governance Officer

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

    For information on post-authorisation reporting requirements, refer 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.

    Investigator responsibilities

    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 and submit the required reporting form(s) to the site RGO.

    pdf
    Monitoring and Reporting Matrix
    This matrix is designed to assist investigators, HREC Coordinators and Research Governance Officers. It provides information on reporting requirements for multi-centre human research projects taking place in Australia. (MS Excel Document - 444.3 KB)
    May-2021