Forms Library

 

LREP Quality Assurance Forms

• QA Clinical Quality AUDIT Protocol Template
• QA NRR Evaluation Protocol Template
• QA PICF Template

LREP Low & Negligible Risk Forms

• LREP LNR Cover Letter Template
• HREA Form (Ethics Review Manager)
• Investigator Declaration Signature Page
• Victorian Specific Module
• LNR Protocol Template
• LNR PICF Template

LREP Post Approval Amendments

• LREP Amendment Request Form
• WH Change of Personnel Form
• WH Investigator Details (Page for Duplication)
• LREP Protocol Deviation/Violation Report Form
• LREP AE/SAE Report Form
• Covid-19 Temporary Non-Serious Breach-Deviation Report Form

LREP Progress Reports

• LREP Progress Report Form

Pathology Forms

• Pathology Approval Process Flowchart
• Pathology documents (WH Intranet access only)

Databank Registration

• Databank Registration Form
• WH Data Management in Research (Guideline)

SSA Post Approval Amendments

• Amendment Request Form (DHHS)
• Amendment Research Form (Ethics Review Manager)
• Safety Report
• Annual Safety Report Form

SSA Progress Reports

• Progress Report – Project Form (HREC)
• Progress Report – Site Form (RGO)
• WH Self-Audit Form

SSA Study Breach

• Non-serious Breach – Deviation Report
• Serious Breach Report Form (Sponsor)
• Suspected Breach Report Form (Third Party)
• Covid-19 Temporary Non-Serious Breach-Deviation Report Form

University SSA Research Governance

• Research Governance Cover Letter and Checklist
• WH Site Specific Assessment Form REx
• WH Investigator Details (Page for Duplication)