Best Research for Best Care - Research Strategic Plan 2021-2026
Western Health Clinical Trials Governance Framework 2023
Western Health Clinical Trials Governance Framework Diagram
Western Health Research Code of Conduct 2023
Western Health Research, Ethics and Governance Policy
Western Health Research, Ethics and Governance Procedure
Western Health as Study Sponsor for Clinical Trials
Research Risk Register
Consumer Feedback Management Policy
Consumer Feedback Management Procedure
Consumer and Community Involvement Training and Resources by external providers
Data Management in Research Guideline
Aboriginal and Torres Strait Islander Peoples Recruited into Research
Western Health Intellectual Property & Moral Rights Policy Aug2022
Western Health 21 CRF Part 11 Compliance Matrix
SOP1: Documentation of Investigational Site Qualifications, Adequacy of Resources and Training Records
SOP2: Study Site Master File and Essential Documents
SOP3: Communication with HREC, Trial Sponsor and Insurer
SOP4: Protocol and Investigational Brochure Content, Design, Amendments & Compliance
SOP5: Receipt and Handling of Investigational Product
SOP6: Informed Consent Procedures and Writing Patient Informed Consent Forms
SOP7: Case Report Forms, Source Documents, Record Keeping and Archiving
SOP8: Site Initiation and Close-Out
SOP9: TGA Notification and SAE Reporting Requirements
SOP10: Investigator Responsibilities
SOP11: Sponsor Responsibilities in Investigator Initiated Studies
SOP12: Handling and Shipping of Infectious Substances for Clinical Trials
SOP13: Standard Operating Procedure Creation, Implementation and Revision
NHMRC GUIDELINES
Investigator-Initiated Clinical Trial Resources (VCCC & MACH Partnership)
ICH Guideline for Good Clinical Practice (Nov 2016)
PRIVACY LEGISLATION IN AUSTRALIA
In the case of a life threatening emergency, call 000.
Emergency