- Ethical Review Manager (ERM) (New Governance/Ethics Submissions, formerly Online Forms)
- For ERM assistance please refer to https://www.clinicaltrialsandresearch.vic.gov.au/ethical-review-manager where you will find help, training and a copy of the Application User Guide which will take you through ERM including:
- Creation of New ERM Accounts (Section 1)
- New and Post Approval Submissions
- Legacy Application Replacement Form (LARF – For studies not already registered on ERM) Section 12). Essentially all studies are, or will need, to be registered on ERM
- Progress Reporting (Section 15)
- Annual and Final Reporting of research is to be submitted via ERM only, previous forms are now obsolete and cannot be accepted. Assistance with reporting can be found within Section 15 of the Applicant User Guide.
- The Eastern Health Office of Research and Ethics are users of ERM, as applicants are, we are not the developers, owners or control ERM, so any technical or user issues, need to be to directed here Ethical Review Manager – Clinical Trials and Research under ERM Help. This includes, but is not limited to (a) Signing up to ERM (b) Unable to access (c) “I can’t see my project” etc. Our office cannot see anything during the actual application process, only once it is submitted.
Fee Structure as of 01 March 2026.
Restructured fees commenced and are effective from 1st March 2026.
From this date, the below new Fee Notification Forms (FNA) must be used. Please choose the correct form depending on the sponsor’s type. Remittance Advice (i.e., proof of payment) must be provided with submission (new or amendment). Use of obsolete forms will be returned after this date.
Authorised Prescriber (DOC,55KB)
Collaborative Study (DOC,59KB)
- Confidentiality Agreement (DOC, 38KB) (Non-Eastern Health employees accessing identified data)
- Participant Information and Consent Forms (available within relevant section on page)
- Material Transfer Agreement (DOC, 58.5KB)
- EH Research Protocol Template (DOC, 46KB)
- Confidentiality Agreement (DOC, 38KB) (Non-Eastern Health employees accessing identified data)
- Participant Information and Consent Forms (available within relevant section on page)
- EH Research Protocol Template (DOC, 46KB)
- Annual and Final Progress Reporting of research must now be submitted via Ethical Review Manager (ERM) only, refer to section above headed: ERM (Ethical Review Manager) Submissions
- Safety Reporting Form (DOC, 47KB)
- EH Change of Personnel Form (DOC, 88KB)
- Confidentiality Agreement (DOC, 38KB) (non-Eastern Health employees accessing identified data)
- Health Information Services (HIS) Retrieval Fees
- Human Research Ethics Committee – Terms of Reference (PDF, 431KB)
- Pharmacy Fee Schedule for Sponsored Clinical Trials (PDF, 2MB)
- Research Policy (PDF, 87KB)
- Writing guidelines (PDF, 287KB)
Standard Operating Procedures (SOP) – Have been updated as of 2024 and are available here Information For The General Public | Eastern Health
- Australian Code for the Responsible Conduct of Research, (PDF, 193KB), (DOC, 67KB)
- Medical Technology Association of Australia
- Australian Clinical Trial Handbook
- Medicines Australia (CTRA templates)
- Victorian Managed Insurance Authority (VMIA)
- Clinical Trial Notification Scheme
- Australian Clinical Trials Website
- Victorian Clinical Trials and Researchers Website
- Australian Clinical Trials Education Centre (A-CTEC)