Forms Library
General Forms/Documents & Guides
- Compliant Tax Invoice
- Fee schedule
- Electronic Naming Convention
- Statement of Approval Form
- WH Curriculum Vitae Template
- WH Researcher Code of Conduct (2023)
- WH Letterhead Template - 404
- WH Logo
- ERM Applicant User Guide - DHHS
- ERM Applicant User Training - DHHS - Zip required
- Guide: How to add Clinical Trial Note on EMR
- QA Submissions Process Map
- SSA Governance Submission Process Map
- LREP Submissions Process Map
- Post Authorisation ERM Submission Process Map
- Post Authorisation ERM Submissions Guide
- Progress Report SSA Submission Summary Guide
- Progress Report QA LR Submission Summary Guide
- Research Agreement Review and Endorsement Process Map - 404
- WH Start-up Checklist
- WH Investigator File Folder Setup Guide
External Researchers & Monitors
- Honorary Researcher Appointment Eligibility Flowchart
- Honorary Researcher Appointment Form - 404
- Pre-Employment Immunisation Form - 404
- Approval to Examine Medical Records (External Monitor only)
- How to Create a New Network Access Account for Monitors/CRAs
- EMR WeLearn Registration Instructions
Research Agreements
- Medicines Australia Clinical Trial Research Agreements
- WH Research Collaboration Agreement
- WH Memorandum of Understanding
- MACH Agreement
Medical Imaging Forms
- Victorian Medical Physics Risk Assessment Form
- Medical Imaging Application Flow Chart
- Medical Imaging Clinical Trial Application Form
- Schedule of Investigations for Research Medical Imaging
High Risk SSA Research Governance
- Research Governance Cover Letter and Checklist
- Site Specific Assessment (SSA) Form (Ethics Review Manager)
- WH Site Specific Investigator Declaration Signature Form
- WH PICF Site Specific Requirements
- Medicines Australia Standard Form of Indemnity
- eClinical Trial Notification (TGA website)
Low Risk SSA Research Governance
- LR Research Governance Cover Letter and Checklist - 404
- Site Specific Assessment (SSA) Form (Ethical Review Manager)
Quality Assurance Forms
- QA MRR Level of Risk Checklist
- QA Clinical Quality AUDIT Protocol Template
- QA MRR Evaluation Protocol Template
- QA PICF Template
- WH QA Change of Personnel Form
LREP Low & Minimal Risk Forms
- LR Site Specific Assessment (LR SSA) Form
- Investigator Declaration Signature Page
- LR Protocol Template
- LR PICF Template
LREP Post Approval Amendments
- LREP Amendment Request 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
Pathology Forms
Databank Registration
SSA Post Approval Amendments
SSA Self-Audit Form
SSA Study Breach
- Non-serious Breach – Deviation Report (ERM)
- Serious Breach Report Form (Sponsor) (ERM)
- Covid-19 Temporary Non-Serious Breach-Deviation Report Form
University SSA Research Governance
- Research Governance Cover Letter and Checklist - 404
- WH Site Specific Assessment Form REx
- WH Investigator Details (Page for Duplication)
Statistical Support Resources