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 Risk Form (Low Risk 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:
- Getting started in ERM
- Create a new project and transfer a project
- Create and transfer sub-forms
- How to assign access to forms using Roles+ and share roles
- How to complete signature requests in ERM
- Submit a form and respond to further information requests
Quick tips for applicants
The following Quick Tips give targeted advice on common questions regarding ERM as follows:
- Create an HREA application in ERM
- Creating SSAs for sites - by HREA owner
- Creating SSAs for sites - by SSA owner
- Upload documents in ERM
- Signature requests and submission in ERM
- Post approval and post authorisation sub forms
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@safercare.vic.gov.au
- 9am - 5pm AET, Monday - Friday
ERM technical support
- Infonetica Helpdesk
- 02 9037 8404
- helpdesk@infonetica.net
- 9am – 5pm AET, Monday – Friday
Downloads
