WH STANDARD OPER ATING 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
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| SOP2: Study Site Master File and Essential Documents | SOP2: Study Site Master File and Essential Documents
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| 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
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| SOP5: Receipt and Handling of Investigational Product | SOP5: Receipt and Handling of Investigational Product
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| SOP6: Informed Consent Procedures and Writing Patient Informed Consent Forms | SOP6: Informed Consent Procedures and Writing Patient Informed Consent Forms
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| SOP7: Case Report Forms, Source Documents, Record Keeping and Archiving | SOP7: Case Report Forms, Source Documents, Record Keeping and Archiving
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| SOP8: Site Initiation and Close-Out | SOP8: Site Initiation and Close-Out
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| SOP9: TGA Notification and SAE Reporting Requirements | SOP9: TGA Notification and SAE Reporting Requirements
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| SOP10: Investigator Responsibilities | SOP10: Investigator Responsibilities
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| SOP11: Sponsor Responsibilities in Investigator Initiated Studies | SOP11: Sponsor Responsibilities in Investigator Initiated Studies
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| SOP12: Handling and Shipping of Infectious Substances for Clinical Trials | SOP12: Handling and Shipping of Infectious Substances for Clinical Trials
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| SOP13: Standard Operating Procedure Creation, Implementation and Revision | SOP13: Standard Operating Procedure Creation, Implementation and Revision
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| NHMRC GUIDELINES | |
| National Statement on Ethical Conduct in Human Research (2023) (National Statement (2023) | NHMRC National Statement 2023
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| 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 |
| National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia | National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia |
| INVESTIGATOR-INITIATED CLINICAL TRIAL RESOURCES (VCCC & MACH) |
| Investigator-Initiated Clinical Trial Resources (VCCC & MACH Partnership) | Investigator-Initiated Clinical Trials Resource Website |
THERAPEUTIC GOODS ADMINISTRATION
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| 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 G uidelines |
| Victorian Managed Insurance Authority (VMIA) |
| Clinical Trials - Insurance and Risk Management Guidelines July 2022 | VMIA Clinical Trials Guidelines
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