- Fee Notification Advice (DOC, 84KB) (Current as of August 2021)
ERM (Ethical Review Manager) Submissions
- 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.
Level of Research Risk (A guide to the pathway your activity may take)
Quality Assurance and Audit Activities
All Quality Assurance and Audit Activities are now submitted only via Ethical Review Manager (ERM), previous form is now obsolete and cannot be accepted. Information regarding ERM, including new accounts and use can be located above under ERM (Ethical Review Manager) Submissions.
For all QA submissions please use the QA Protocol template.
Low or Negligible Risk Research
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)
Clinical Quality Registry
A Clinical Registry is a structured collection of data, including clinical outcomes and process measures, for a defined clinical condition. A Clinical Quality Registry is larger in scale and likely to be state wide, national or international in scope.
This Clinical Quality Registry Application Form is to be completed by external parties and/or Eastern Health clinical staff regardless of the size and scope of the Registry. The completed form is to be emailed to firstname.lastname@example.org along with any supporting documents.
Post Approval Submissions
(All relevant documents are to be submitted to email@example.com)
- 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 (Site) (DOC, 38KB)
- Change of Personnel Form (DOC, 62KB)
- 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, 400KB)
- Research Policy (PDF, 370KB)
- Writing guidelines (PDF, 287KB)
Standard Operating Procedures (SOP) – Are being updated for September 2022 and will be available shortly. If you have any urgent questions, please contact our office firstname.lastname@example.org
- 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
- 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
- Victorian Clinical Trial Education (V-CTEC)
- Last Modified: Wednesday, September 21, 2022