- 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 1 July 2024.
Restructured fees commenced and are valid from 1 July 2024.
Changes to previous fees relate to Patient Information Consent Forms and Clinical Trial Research Agreements (CTRA) Amendments.
From this date, the below new Fee Notification Forms (FNA) must be used, and there will now be 2 forms, one for New Submissions and another for subsequent Post Approval actions. Use of obsolete forms will be returned after this date.
- 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, 43KB)
Please note all Low and Negligible Risk Applications are now to be submitted via Ethical Review Manager (ERM) only. Please refer to ERM directions above, Obsolete forms will be returned
- 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, 43KB)
(All relevant documents are to be submitted to [email protected])
- 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, 46 KB)
- Change of Personnel Form (DOC, 62KB)
- Confidentiality Agreement (DOC, 38KB) (non-Eastern Health employees accessing identified data)
1. Research Support Services Request Forms
2. Guidance
- Health Information Services (HIS) Retrieval Fees
- Human Research Ethics Committee – Terms of Reference (PDF, 431KB)
- Pharmacy Fee Schedule for Sponsored Clinical Trials (PDF, 400KB)
- Research Policy (PDF, 370KB)
- Writing guidelines (PDF, 287KB)
Standard Operating Procedures (SOP) – Are being updated for 2024 and will be available shortly. If you have any urgent questions, please contact our office [email protected]
- Australian Code for the Responsible Conduct of Research, (PDF, 193KB), (DOC, 67KB)
- Medical Technology Association of Australia
- National Statement on Ethical Conduct in Human Research 2023|NHMRC
- 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)