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Governance/RGO Fees
- Fee Notification Advice (DOC, 42.8KB) (Current as of March 2023)
These fees are for EH Research/Ethics/Governance fees, only, they are unrelated to Site, Start Up, Pharmacy, Patient fees etc. These fees are for review and not for approval, please refer to the correct section of CTRA where applicable. Overdue fees will incur sanctions on the research and potentially other research related to the sponsor and/or research group
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)
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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.
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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.
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)
- EH Research Protocol Template (DOC, 43KB)
Research Requiring Review Greater Than Low Risk
- 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)
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 ethics@easternhealth.org.au along with any supporting documents.
Clinical Quality Registry Application Form (DOC, 57KB)
Post Approval Submissions
(All relevant documents are to be submitted to ethics@easternhealth.org.au)
- 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)
Monash Partners
1. Research Support Services Request Forms
2. Guidance
- Biospecimens Addendum
- Legal Guidance Repository
- Research Collaboration Agreement
- Site Specific Addendum
Local Guidelines
- 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 ethics@easternhealth.org.au
External Resources
- 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)
Good Clinical Practice (GCP)
If you have an interest in GCP training please contact our office for further information ethics@easternhealth.org.au
- Posted
- Last Modified: Monday, March 27, 2023
Eastern Health is committed to ensuring the communities we service receive care that is responsive to their cultural and language needs.
Eastern Health acknowledges the Traditional Owners of the land on which its services operate, and pays respect to their Elders past, present and emerging. Eastern Health is committed to achieving equality in health status between Aboriginal and Torres Strait Islander peoples and non-indigenous Australians.
Eastern Health strives to be an inclusive healthcare service.
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