Forms - RCH Ethics Department

FORMS

Initial Application

• Application Coversheet
• Short Application Form (Negligible Risk Research & Clinical Audit)
• RCH Information Statements & Consent forms
• Application Forms
  • National Ethics Application Form (NEAF)
  • DHS Common Application Form (CAF)
• Information statements
  • Tracing letter
  • Recruitment letter 
  • Permission to contact form
  • Permission to contact a possible participant (family member)
  • Permission to contact a possible participant (friend)
• Radiation Review Coversheet
• Protocol
  • Protocol Guidance (all studies)
  • Annotated Protocol Template (drug trials only)
  • Empty Protocol Template (drug trials only)
  • Clinical Research Development Office (CRDO) (For more guidance & protocol templates) 

Pre-submission (Peer) Review

• Pre-submission (Peer) Review Process
• Pre-submission (Peer) Review Proforma  

For Clinical Trials

• CTN form   
• Clinical Trial Research Agreement (CTRA) coversheet 
• Standard CTRAs (VMIA Website)
• Medicines Australia Indemnity Form
• Medicines Australia HREC Review Only Indemnity Form
• Guidance for Registering a Clinical Trial

Existing Applications  

• Annual report 
• Final report
• Renewal form (now part of the Annual Report) 
• Modification form 
• Change of Investigator Form (for addition/removal of investigators only)
• Serious Adverse Event forms
  • Single SAE form
  • Periodic SAE form 

Monitoring & Auditing

• Monitoring Form (for reference only)

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• FAQs
• New Applications
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