CLINICAL TRIALS AND RESEARCH

Ethical Review Manager

Guidance for the ERM System which is a paperless information management system for the entire life cycle of a research project

    Overview

    The Ethical Review Manager (ERM) website is used for applications and reports to Victorian public hospitals’ research offices.

    ERM is used for completion, submission and feedback on all Victorian:

    • Ethics applications
    • Research governance/site specific assessment (SSA) applications
    • Ethics post-approval forms
    • Research governance post-authorisation forms

    The ERM website is used by research applicants (researchers, trial coordinators, sponsors, Contract Research Organisations and others). It is also used by research office administrators and ethics committee members to manage the review, processing and approval/authorisation of all applications.

    An important feature of ERM is it ensures the entire life-cycle of a research project can be managed within the ERM system.

    ERM Guidance

    ERM is based on forms and an applicant creates a project and main form simultaneously. There is only one main form for each project:

    • Human Research Ethics Application (HREA)
    • Victorian Low/Negligible Risk Application (LNR VIC)
    • Quality Assurance Application (QA)
    • Minimal Dataset Form (MDF)
    • Legacy Application Replacement Form (LARF)

    The Site Specific Assessment (SSA) form is a sub-form of the main (ethics) form and both are linked in ERM.The Applicant user guide to ERM provides comprehensive guidance on how to use ERM and manage applications.

    Post ethics approval sub-forms

    ERM is used to create, complete, sign and submit post-approval forms. The available post-approval forms are:

    • Ethics Amendment Request
    • Safety Report
    • Annual Safety Report
    • Serious Breach Report
    • Suspected Breach Report
    • Project Progress Report
    • Project Final Report
    • Site Closure Report (for multisite projects only)
    • Project Notification form (for use regarding any other matters not covered in the above list)

    ERM Training Tools

    Training videos

    The following training videos are available for ERM users:

    Quick tips for applicants

    The following Quick Tips give targeted advice on common questions regarding ERM as follows:

    ERM Help

    Guidance, frequently asked questions (FAQs) and information documents are available in ERM - go to the Help area.

    Contact the Coordinating Office for Clinical Trial Research:

    • Phone: 0408 274 054 - General enquiries and ERM application advice
    • Phone: 0408 410 938 - Enquiries and ERM for Research Office administrators
    • Email: multisite.ethics@ecodev.vic.gov.au
    • 9am - 5pm AET, Monday - Friday

    ERM technical support

    pdf
    Applicant user guide to ERM
    (PDF File - 12.4 MB)
    Apr-2021
    pdf
    Create a Human Research Ethics Application (HREA) in ERM
    (PDF File - 357.7 KB)
    May-2021
    pdf
    Creating SSAs for sites - by HREA owner
    (PDF File - 237.3 KB)
    May-2021
    pdf
    Creating SSAs for sites - SSA owner
    (PDF File - 405.4 KB)
    May-2021
    pdf
    How to upload documents in ERM
    (PDF File - 377.2 KB)
    May-2021
    pdf
    Post approval and Post authorisation subforms in ERM
    (PDF File - 261.7 KB)
    May-2021
    pdf
    Signature requests and submission in ERM
    (PDF File - 347.4 KB)
    May-2021