1. Research Governance Toolkit The journey thus far Bill Karanatsios 20 May 2010

2. VMIA VMIA is the insurer and risk management advisor for the state of Victoria. The VMIA aims to protect the interests of the State of Victoria through the TCOR concept and via the facilitation of a number of key projects.

3. VMIA Key projects within the clinical research arena: –National Clinical Trial Agreements –FTIH Guidelines –13 SOPs for ICH-GCP Compliance –Research Governance Toolkit –VMIA CTN Guidelines

4. Research Governance Toolkit Commencement Date: 19 August 2008 Proposed Launch Date: 2 June 2010 Project Owner: Bill Karanatsios Aim: to draw on the collective VMIA client base experience and IP to construct the elements of the RGT to be used by the collective

5. RESEARCH GOVERNANCE GOVERNANCE TOOLKIT TOOLKIT FOR VICTORIAN PUBLIC HOSPITALS AND VMIA INSURED MEDICAL RESEARCH INSTITUTES

6. “The Research Governance Toolkit has been developed to assist Victorian Public entities engaged in the conduct of clinical research with the establishment of research governance. The RGT is intended to provide the appropriate guidance and provision of essential tools in the form of templates, proformas or SOPs that will facilitate good research governance practice. ”

7. The RGT Elements ETHICSINDUCTIONRISKLEGALFINANCE TISSUE & DATA IP SOPs Guidelines/Templates Policy Proformas Training Module

8. Research Ethics The National Statement on Ethical Conduct in Human Research (2007) sets out the establishment of HRECs, their reviewing practices, the monitoring of such decision making and the conduct of the approved research itself. Bernice DaviesBarwon Health Jill DavisAustin Health Lisa NelsonNucleus Network Suzanne Hasthorpe Department of Human Services Andrea JohanessenSt Vincent's Hospital LeeAnne ClavarinoPeninsula Health Peter Disler Bendigo Health Care Group Angela WattMelbourne Health Rowan FrewAlfred Health Jeremy Kenner Peter MacCallum Cancer Centre Paul KomesaroffAlfred Health Angela HenjakAlfred Health Lai Wan ReidEastern Health Louise SillarWestern Health Deb DellSouthern Health

9. Research Ethics Introduction5 Recommended recruitment strategies for HREC members6 Monitoring Human Research Policy7 Key Performance Indicators for HRECs and Research Administration Governance Units13 Allocation of research to different levels of review18 Models of Ethics Review21 Handling research-related complaints24 Conflict of interest - research-related activities28 Template for HREC Report to Institution30 Template for reporting HREC review waiver of requirement for consent31 APPENDIX 1: HREC Terms of Reference Template32 APPENDIX 2: CTA HREC Mutual Acceptance Submissions36 APPENDIX 3: Recognised Prior Review Guidelines - Peter MacCallum Cancer Institute 39 APPENDIX 4: Low Risk Research Review Procedures - Melbourne Health41 APPENDIX 5: Human Ethics Advisory Groups (HEAGS) - University of Melbourne 42 APPENDIX 6: Low Risk Research Application Form - Alfred Health44 APPENDIX 7: Melbourne Health QA Guidelines52 APPENDIX 8: Approval of a Quality Assurance Project Application Form54 APPENDIX 9: Criteria for Allocation of Research to Different Levels of Review - Checklist63 APPENDIX A: HREC Spokesperson Project Review64 APPENDIX B: Project Summary Report For Ethics Committee67 APPENDIX C: Template for HREC Report to Institution69 APPENDIX D: Waiver of the Requirement for Consent72

12. Induction, Training and Accreditation In order to perform good quality research the individuals and teams engaged in research must have access to appropriate training and guidelines Andy GiddyNucleus Network Denise ByrneSt Vincent's Hospital Angela Gray (MH)Melbourne Health Marianne Hundling Peter MacCallum Cancer Centre John McNeilAlfred Health Jill DavisAustin Health Robyn LichterNucleus Network Rowan FrewAlfred Health

13. Induction, Training and Accreditation Clinical Research Stakeholdersp73 Introductionp74 KPIs for induction, training and accreditation of Research Governance Offices, Departments/Teams and Researchers p75 Research Governance Office New Starter Checklistp77 Research Governance Office Accreditation Checklistp79 Research Governance Office Checklist – ACHS Accreditationp83 Research Governance Office Audit Checklist – Researcherp91

14. Induction, Training and Accreditation(1) Research Team – New team Checklist p93 New Researcher Checklist p95 Researcher Self-Accreditation Checklist p97 Investigator Self-Accreditation Checklist for Clinical Trials p99 VMIA requirements for drug & device trials under CTN schemep102 APPENDIX 1: Checklist for induction, training and accreditation - Research Governance Office p104 APPENDIX 2: Checklist for induction, training and accreditation - Department/Team p105 APPENDIX 3: Checklist for induction, training and accreditation - Researcher

15. Induction,Training & Accreditation ( 2) Training Modules Module 1 – National Statement of Ethical Conduct in Human Research Module 2 – Clinical Research Site SOPs Module 3 – VMIA CTN Guidelines Module 4 – ACHS Standards Module 5 – To describe the process to access TGA unapproved therapeutic goods (drugs and devices) Module 6 – Privacy – Overview of Privacy Law requirements for governance of research programs Training Module 7 – Radiation

18. Research Finance Management Having in place the appropriate tools to administer financial transactions intended for research purposes should facilitate better financial administration, better provision of accountability and assist with the institute’s annual reporting requirements David Rees (SVI)St Vincent's Institute Katerina Canellopoulos (MH)Melbourne Health Sianna PanagiotopoulosAustin Health Marie Luci Clinical Trials Australia Patricia Molloy (Eastern)Eastern Health

19. Research Finance Management Introductionp123 Recommended clauses for Clinical Trial/Research Agreementp125 Research Grant Financial Managementp126 Summary of Financial Positionp129 Hospital Foundation Review of Research Funding Application Checklist p131

20. Legal & Insurance Introductionp109 Version Control Coversheetp110 Contract creation, approval and execution SOPp111 Clinical Trial Preparation Agreementp114 Deed of Variationp117 Checklist for Participant Information & Informed Consent p118 Standard wording for research involving collection of drug use Information p119 Register of Research Ethics Compliance p120 APPENDIX 1: Flow Chart p122

21. Data &Tissue Management Research involving human tissue must observe the fundamental ethical principle of respect for tissue donor, including the provision of full information, consent, professional removal of samples and secure storage of the tissue to maintain confidentiality and privacy. Lisa DevereuxPeterMac Bradley CrammondMonash Kordula DunscombeAlfred Health Carmel MuroneLudwig Institute Anthony Penington Bernard O'Brien Institute

22. Data &Tissue Management Introductionp135 Policy: Use of Human Tissue in Researchp136 Establishment of Data/Biobank Checklistp140 Databank access request for research purposesp142 Use of cadaveric tissue for researchp144 APPENDIX 1: Acknowledgement and Authorshipp149

23. Intellectual Property & Publication Effective administration, protection and utilisation of an organisation’s Intellectual Property can provide important financial benefits to that organisation and thus can offset the substantial costs of an organisation’s investment in its research activity and contribute enormously towards its financial viability, reputation and ongoing success. Jacqueline BarrySt Vincent's Hospital Tony MasonSt Vincent's Institute Robert MerrielMelbourne Health Shari LofthousePeter MacCallum Heather GallicioAlfred Health Fiona NelmsBaker Institute

24. Intellectual Property & Publication Introductionp151 Intellectual Property Policy p152 Review of Material Transfer Agreements p165 Material Transfer Deedp167 Non Disclosure Agreement (NDA/ Creation, Review and Execution)p175 Guidelines for Determining Authorshipp181 Evidencing Inventorshipp183 Invention Disclosurep186 Guidelines for Determining Authorshipp181 Evidencing Inventorshipp183 Invention Disclosurep186 APPENDIX 1: Standard Terms and Conditions on Intellectual Propertyp159 APPENDIX 2: Flow Chartp178 APPENDIX 3: Standard NDA Template Non Disclosure Agreementp179

25. Research Risk Management By definition “risk management’ describes the activities an organisation undertakes to manage the “effect of uncertainty on its objectives’. Equally as important however, it should be about seizing opportunities as well. Leanne TobyVMIA Virginia LeopoldSt Vincent's Institute Kathryn FrowenSouthern Health Rosemary FrenchBurnet Institute Janine Peterson (RWH) Royal Women's Hospital Eva Booth (Austin)Austin Health John McNeil (Alfred)Alfred Health Robin Luber (NN)Nucleus Network Jack BeeverBarwon Health

26. Research Risk Management How to use the Research Risk Management Guidep189 Tools and Templatesp190 Risk Management Glossaryp191 Risk Management Process – AS 4360:2004p194 Risk Management Policy and Procedurep195 Risk Management Framework Checklistp196 Opportunities for identifying risks in Research Organisationsp198 Risk reporting by category sample onlyp199 Sample research ‘risks’ and ‘risk categories’ 1 p200

27. Research Risk Management(2) Risk Summary Heat Map samples onlyp204 Risk Assessment template sample onlyp205 Risk Register template sample only p206 An Introduction to ‘Risk Management’ Powerpoint p207

28. RGT The challenges –The scope of works for the project were considerable given the allocated timeframe –Not mandating strongly a specific template for submitting work packages –The natural evolution of legislation or standards over the allocated project period –The ever evolving clinical trial landscape –Proof reading & final sign off.

29. The Launch RGT to be made officially available 2 nd of June Each VMIA insured healthcare & medical research entity involved in research will receive: a hardcopy of the RGT a CD with: –a complete PDF and word version Each institute must protect the version control of their own RGT