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Governance Fees
- Fee Notification Advice (DOC, 82KB) (Current as of August 2020)
ERM (Ethics Review Manager) Submissions
- Ethics Review Manager (ERM) (New Governance/Ethics Submissions, formerly Online Forms)
Quality Assurance and Audit Activities
Low or Negligible Risk Research
- Level of Risk Checklist (DOC, 112KB)
- Confidentiality Agreement (DOC, 143KB) (Non-Eastern Health employees accessing identified data)
- Participant Information and Consent Forms (select most appropriate template from Sections 5)
Research Requiring Review Greater Than Low Risk
- Section 4 - Use of Ionising Radiation (DOC, 207KB)
- Confidentiality Agreement (DOC, 143KB) (Non-Eastern Health employees accessing identified data)
- Participant Information and Consent Forms (select most appropriate template from Sections 5)
- Material Transfer Agreement (DOC, 190KB)
Case Reports
Post Approval Submissions
(All relevant documents are to be submitted to ethics@easternhealth.org.au)
- Progress Reporting Form (Annual or Final) (DOC, 100KB)
- Safety Reporting Form (Site) (DOC, 62KB)
- Change of Personnel Form (DOC, 163KB)
- Confidentiality Agreement (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
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