Research & Ethics

Governance 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

• Level of Risk Checklist (DOC, 36KB)
• Quality Assurance / Audit Registration Form (DOC, 143KB)

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 (available within relevant section on page)  

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 (available within relevant section on page)  
• Material Transfer Agreement (DOC, 190KB)

Case Reports

• Case Report Form Consent Form Template (DOC 114KB)

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, 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

• Cardiology
• Diagnostic Imaging
• General Service
• Health Information
• Lung Function
• Pathology
• Pharmacy

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