DOCUMENT | DOWNLOAD |
WESTERN HEALTH STRATEGY, POLICIES & GUIDELINES |
Best Research for Best Care - Research Strategic Plan 2021-2026 | Best Research for Best Care - Research Strategic Plan 2021-2026 |
2022 Arelene Wake Fellowship - Expression of Interest | 2022 Arelene Wake Fellowship - Expression of Interest |
Western Health Research Code of Conduct 2018 | Western Health Research Code of Conduct 2018.pdf |
Signature Delegation Guide | Research Signatures and Delegations Jun19 |
Western Health Research & Ethics Policy Jul18 | Research and Ethics Policy Jul18.doc |
Western Health Intellectual Property & Moral Rights Policy May19 | Intellectual Property & Moral Rights Policy May19 |
Western Health Data Management in Research Guideline | Data Management in Research Guideline OG-GC7 |
Western Health 21 CRF Part 11 Compliance Matrix | Western Health 21 CRF Part 11 Compliance Matrix |
WH STANDARD OPERATING PROCEDURES – GOOD CLINICAL PRACTICE (GCP) |
SOP1: Documentation of Investigational Site Qualifications, Adequacy of Resources and Training Records | SOP1: Documentation of Investigational Site Qualifications, Adequacy of Resources and Training Records |
SOP2: Study Site Master File and Essential Documents | SOP2: Study Site Master File and Essential Documents |
SOP3: Communication with HREC, Trial Sponsor and Insurer | SOP3: Communication with HREC, Trial Sponsor and Insurer |
SOP4: Protocol and Investigational Brochure Content, Design, Amendments & Compliance | SOP4: Protocol and Investigational Brochure Content, Design, Amendments & Compliance |
SOP5: Receipt and Handling of Investigational Product | SOP5: Receipt and Handling of Investigational Product |
SOP6: Informed Consent Procedures and Writing Patient Informed Consent Forms | SOP6: Informed Consent Procedures and Writing Patient Informed Consent Forms |
SOP7: Case Report Forms, Source Documents, Record Keeping and Archiving | SOP7: Case Report Forms, Source Documents, Record Keeping and Archiving |
SOP8: Site Initiation and Close-Out | SOP8: Site Initiation and Close-Out |
SOP9: TGA Notification and SAE Reporting Requirements | SOP9: TGA Notification and SAE Reporting Requirements |
SOP10: Investigator Responsibilities | SOP10: Investigator Responsibilities |
SOP11: Sponsor Responsibilities in Investigator Initiated Studies | SOP11: Sponsor Responsibilities in Investigator Initiated Studies |
SOP12: Handling and Shipping of Infectious Substances for Clinical Trials | SOP12: Handling and Shipping of Infectious Substances for Clinical Trials |
SOP13: Standard Operating Procedure Creation, Implementation and Revision | SOP13: Standard Operating Procedure Creation, Implementation and Revision |
Complete SOP ZIP file | Complete SOP ZIP file |
Word editable templates | GCP SOP Word editable templates.zip |
SOP GCP 001-013 Authorisation Signatures | SOP GCP 001-013 Authorisation Signatures
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NHMRC GUIDELINES |
National Statement on Ethical Conduct in Human Research (2007) (National Statement (2007)) | NHMRC National Statement (2007) updated 2018 |
Australian Code for the Responsible Conduct of Research (2018) effective 01 July 2019 | NHMRC Australian Code for the Responsible Conduct of Research |
Guide to Managing and Investigating Potential Breaches of the Australian Code for the Responsible Conduct of Research (2018) | Guide to Managing and Investigating Potential Breaches of the Australian Code for the Responsible Conduct of Research (2018) |
Authorship - Guide supporting the Australian Code | Authorship - Guide supporting the Australian Code |
Management of Data and Information in Research - Guide supporting the Australian Code | Management of Data and Information in Research - Guide supporting the Australian Code |
Peer Review - Guide supporting the Australian Code | Peer Review - Guide supporting the Australian Code |
Disclosure of interests and management of conflicts of interest - Guide supporting the Australian Code | Disclosure of interests and management of conflicts of interest - Guide supporting the Australian Code |
Supervision - Guide supporting the Australian Code | Supervision - Guide supporting the Australian Code |
Collaborative Research - Guide supporting the Australian Code | Collaborative Research - Guide supporting the Australian Code |
INVESTIGATOR-INITIATED CLINICAL TRIAL RESOURCES (VCCC & MACH) |
Investigator-Initiated Clinical Trial Resources (VCCC & MACH Partnership) | Investigator-Initiated Clinical Trials Resource Website |
THERAPEUTIC GOODS ADMINISTRATION |
ICH Guideline for Good Clinical Practice (Nov 2016) | Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) |
PRIVACY LEGISLATION IN AUSTRALIA |
Commonwealth Government Department or Agency |
Privacy Act 1988 | Privacy Act 1988 |
Australian Privacy Principles (APPs) | Australian Privacy Principles (APPs) |
Section 95 Guidelines | Section 95 Guidelines |
Victorian public of private sector health care service provider organisation which collects & handles health information in Victoria |
Privacy & Data Protection Act | Privacy & Data Protection Act 2014 |
Information Privacy Principles (IPPs) | Information Privacy Principles (IPPs) |
Health Records Act 2001 | Health Records Act 2001 |
Health Privacy Principles (HPPs) | Health Privacy Principles (HPPs) |
Statutory Guidelines on Research 2002 | Statutory Guidelines on Research 2002 |
Private Sector health care service provider (including individual medical practitioners) |
The Privacy Amendment (Privacy Section) Act 2000 | The Privacy Amendment (Privacy Section) Act 2000 |
Section 95A Guidelines | Section 95A Guidelines |
Victorian Managed Insurance Authority (VMIA) |