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Governance/RGO Fees
- 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 registered on ERM) (Section 12).
- 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.
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.
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)
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)
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)
- Complaints Report Form
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, 430KB)
- Pharmacy Fee Schedule for Sponsored Clinical Trials (PDF, 400KB)
- Research Policy (PDF, 370KB)
- Standard operating procedures (SOP) - scientific ethical review (PDF, 700KB)
- Standard operating procedures (SOP) - governance review (PDF, 430KB)
- Writing guidelines
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
- Note For Guidance Good Clinical Practice
- Medicines Australia (CTRA templates)
- Victorian Managed Insurance Authority (VMIA)
- Clinical Trial Notification Scheme
- Posted
- Last Modified: Friday, May 27, 2022
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 is an inclusive healthcare service.
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