Research & Ethics

ERM (Ethics Review Manager) Submissions  

• Ethics Review Manager (ERM) (New Governance/Ethics Submissions, formerly Online Forms)

Fees

• Fee Notification Advice (Current as of April 2018) 
  

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
• Confidentiality Agreement (Non-Eastern Health employees accessing identified data)
• Participant Information and Consent Forms (select most appropriate template from Sections 5) 

Research requiring full Ethics Committee Review

• Victorian Specific Module
• Section 4 - Use of Ionising Radiation
• Confidentiality Agreement (Non-Eastern Health employees accessing identified data)
• Participant Information and Consent Forms (select most appropriate template from Sections 5)  
• Material Transfer Agreement

Post Approval Submissions

• Amendment Request Form
• Change of Personnel Form
• Progress Report (submit via email to ethics@easternhealth.org.au)
• Final Report (submit via email to ethics@easternhealth.org.au)
• Breach Report Forms (formerly protocol deviation/violation form)
• Safety Report (Site)
• Annual Safety Report (Sponsor)
• 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
• 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, (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