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Resource for Researchers You are here:HomeResearchResearchersResource for Researchers SAGE Quick Reference Guides for ALL TYPES of Submissions National Clinical Trial Governance Framework (NCTGF) resources National Ethics Guidelines and Resources Australian Clinical Trial Handbook (2018) Australian Code for the Responsible Conduct of Research (2018) Ethical Guidelines for Research with Aboriginal and Torres Strait Island Peoples (2018) DHHS Clinical Trials and Research Information ICH Guideline for Good Clinical Practice (2016) National Statement on Ethical Conduct in Human Research (2023) NHMRC Safety monitoring and reporting in clinical trials involving therapeutic goods (2016) NHMRC Research Governance Handbook SPIRIT Statement Guidance For Clinical Trial Protocols SPIRIT Checklist Ethics and Governance Submission Guidelines Ethics Submission Guide (2020) ERM User Guide (2020) Insurance Information for Clinical Trials (2021) Principal Investigator Roles in Single Site Research Projects Principal Investigator Roles in Multi Site Research Projects Statistical Consulting Centre (University of Melbourne) Victorian HPPs and IPPs Summary Victorian Specific Module (VSM) Guidelines VMIA Clinical Trials Risk and Insurance Guide (2018) Annual Progress Report Requirements Annual Progress Report Submission FAQs SVHM-Specific Guidelines SVHM Site-Specific Guidelines (2020) Addition of Research Alert on Patient Administration System (PAS) Addition of Research Alert on PAS - Quick Guide v2 (June 2024) Advertising Guidelines (2020) Breach Report Guidelines (2022) COVID-19 Attestation User Guide COVID-19 Generic Screening Tool COVID-19 Trial Activity Guidelines (2020) Digital Signature Guidelines (2025) Insurance for Clinical Trials Information and Guide (2020) Onsite Monitoring Guidelines (2022) Remote Monitoring Guidelines (2020) Verbal Consent Guidelines (2021) NT-proBNP for heart failure testing (2023) National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia (2021, updated 2023) Satellite, Recruitment & Service Site (2024) Satellite Site SOP (2024) Recruitment Site SOP (2024) Service Site SOP (2024) Requesting use of SVHM logo on research material from external organisations Tools for Researchers REDCap: REDCap Information Sheet (2021) Important note: SVHM REDCap does not support survey functionality to directly sent to external recipients. Consumer Resources: Is a clinical trial right for you - Participant Toolkit Biobank Facility for SVHM Researchers NRL Biobank Brochure Biobank Service Pricing for SVHM Investigator-Initiated Studies The St Vincent's Institute Biobank is managed by and housed at the National Serology Reference Laboratory (NRL, a division of SVI) on the St Vincent’s Hospital Melbourne campus. Other resources available from the Melbourne Academic Centre for Researchers (MACH) Website, including: MACH Omics Resource Directory Ethical conduct and practice in Indigenous health research Implementation Science Resource Directory MACH Clinical and Research Dataset Catalogue Teletrials Toolkit Investigator-Initiated Trials Toolkit UniMelb Methods and Implementation Support for Clinical and Health research Hub (MISCH) for BioStats, Health Economics and Informatics Support Standard Operating Procedures National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia (2021, updated 2023) SVHM Site-Specific SOPs Chapter 1. Values and Principles of Ethical Conduct 1.1 - Application of Values and Principles of Ethical Conduct Chapter 2. Risk, Benefit and Consent 2.1 - Assessment of Risks and Benefits 2.2 - Obtaining and Honouring Consent 2.3 - Qualifying or Waiving Conditions Chapter 3. Ethical Considerations Specific to Research Methods 3.1 - Qualitative Methods 3.2 - Databanks 3.3 - Interventions and Therapies 3.4 - Human Tissue Samples 3.5 - Human Genetics 3.6 - Human Stem Cells Chapter 4. Ethical Considerations Specific to Participants 4.1 Ethical Consideration Specific to Participants Chapter 5. Research Governance and Ethical Review 5.1 - Low Risk Research 5.2 - Composition of the Committee 5.3 - Appointment of HREC Members 5.4 - Induction of New HREC Members 5.5 - Responsibilities of HREC Members 5.6 - Training for HREC Members 5.7 - Documentation and Record Management 5.8 - Research Misconduct 5.9 - Making and Communicating Decisions 5.10 - Expert Opinion 5.11 - Minimising Duplication of Ethical Review 5.12 - Conflicts of Interest 5.13 - Monitoring of Approved Research 5.14 - Complaints Handling 5.15 - Timelines for Ethical Review 5.16 - Reporting and Accountability 5.17 - Fees and Charges 5.18 - Collaborative Research Groups 5.19 - Training Researchers 5.20 - Management of Research Data and Primary Materials 5.21 - Authorised Prescriber Endorsement 5.22 - Ionising Radiation 5.23 - Multisite Approval 5.24 - Insurance Indemnity Research Agreements and the VMIA 5.25 - Quality Assurance 5.26 - Safety Reporting 5.27 - Standard Operating Procedures