| 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 |
| 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) |
