Research & Ethics

Quality Assurance and Audit Activities

• Level of Risk Checklist
• Quality Assurance / Clinical Audit Registration Form

Low or Negligible Risk Research

• Level of Risk Checklist
• Low Risk Application Form
• Fee Notification Advice (refer to fee schedule)
• Confidentiality Agreement (Non-Eastern Health employees accessing identified data)
• Participant Information and Consent Forms (select most appropriate template from Sections 4 & 8)

Research requiring full Ethics Committee Review

• Online Forms (National Ethics Application Form and Site Specific Assessment)
• Victorian Specific Module
• Section 4 - Use of Ionising Radiation
• Fee Notification Advice (refer to fee schedule)
• Confidentiality Agreement (Non-Eastern Health employees accessing identified data)
• Participant Information and Consent Forms (select most appropriate template from Sections 4 & 8)
• Material Transfer Agreement

Post Approval Submissions

• Amendment Request Form
• Change of Personnel Form
• Fee Notification Advice (protocol amendments and Investigator's Brochure updates)
• Progress Report (submit via email to ethics@easternhealth.org.au)
• Final Report (submit via email to ethics@easternhealth.org.au)
• Protocol Deviation or Violation Report
• Safety Report (Site)
• Annual Safety Report (Sponsor)
• Confidentiality Agreement (Non-Eastern Health employees accessing identified data)
• Complaints Report Form

Local Guidelines

• Health Information Services (HIS) Retrieval Fees
• Human research ethics committee - terms of reference
• Pharmacy Fee Schedule for Sponsored Clinical Trials
• Research policy
• Standard operating procedures (SOP) - scientific ethical review
• Standard operating procedures (SOP) - governance review
• Writing guidelines

External Resources

• Australian Code for the Responsible Conduct of Research
• 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