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Melbourne Genomics Health Alliance 1 Melbourne Genomics Health Alliance 3 Focused on Implementing Genomics in Practice

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Melbourne Genomics Health Alliance 1 Melbourne Genomics Health Alliance 3 Focused on Implementing Genomics in Practice Melbourne Genomics Establishing data governance in clinical genomics Ian Pham Data Governance Lead Melbourne Genomics Health Alliance 1 Melbourne Genomics Health Alliance 3 Focused on implementing genomics in practice Discovery Translational Implementation Routine Practice Research Research Research Institutes and Universities Australian Genomics Health Alliance Melbourne Genomics Health Alliance Clinical Genetics Services and Hospitals Melbourne Genomics Health Alliance 4 Approach STREAM 3: INNOVATION AND RAPID ADOPTION Develop and deploy systems to ensure patients STREAM 1: have access to cutting-edge, high quality genomic WORKFORCE DEVELOPMENT testing that is cost-effective. Build the literacy, skills and STREAM 5: NATIONAL AND confidence of the clinical and INTERNATIONAL IMPACT diagnostic workforce in genomics, as relevant to each Establish active relationships and participation in professional role national and international initiatives with the aim of disseminating, communicating and collaborating on the work of the Alliance and its implications. DISEASE FLAGSHIPS Flagships are the mechanism through which genomic sequencing is provided to patients with defined clinical conditions or indications. STREAM 2: ASSESSING THE VALUE Flagships will also be the means by which the OF GENOMICS workforce is developed, innovation is adopted, outcomes are evaluated and information systems Evaluate the place of genomics in health care trialled, and underpin the five streams. practice, by: (1) evaluating the process and outcomes of genomic tests in practice, and STREAM 4: ACCESS TO GENOMIC INFORMATION (2) establishing and applying a platform for Develop and implement a single set of standards, policies health service research, program evaluation, and procedures to support a common infrastructure for the economic evaluation and translational research management and use of genomic data by stakeholders in in the use of genomics in health care. Victoria. This stream will be the focus of the workshop. Melbourne Genomics Health Alliance 5 Flagships 2014-2015 2016-2018 2017-2019 AML Complex care Controlling superbugs Childhood syndromes Congenital deafness Bone marrow failure Focal epilepsy Dilated cardiomyopathy Complex neurological and Hereditary colorectal Immunology neurodegenerative diseases cancer Advanced solid cancers Genetic kidney disease Hereditary neuropathy Advanced lymphoma Perinatal autopsy (non-Hodgkin) Melbourne Genomics Health Alliance Outcomes to date 465 patients tested (and growing) Prototype systems used in NATA labs Patient data available to all members Evidence of cost-effectiveness for MSAC application $25M funding from NHMRC for AGHA led from Victoria 4 peer-reviewed publications, plus 6 under review International collaborations Presentations at major conferences in Europe, North America, Asia, Australia Melbourne Genomics Health Alliance | IMG meeting slides – 12 December 2016 7 Access to Genomic Information Develop and implement a single set of standards, policies and procedures to support a common infrastructure for the management and use of genomic data by stakeholders in Victoria. Melbourne Genomics Health Alliance 8 Melbourne Genomics Health Alliance 9 GenoVic Policy & Process People Technology 7. Identity & Access Management 1. Standardised policy and processes for data 8. Clinical Tools 9. Diagnostic Tools 10. Patient Tools 5. Staff to management & access Electronic manage the Clinician (data governance) Orders and Analysis Consent data Knowledge Results (Pipeline) Tools Results Clinical Decision Support Curation Tools Tools Education 2. Standardised policy & processes for patient consent 6. Staff to 11. Data Access Tools manage the technology 12. Master 13. Genomic Data Repository 3. Standardised policy and Patient Index processes for test ordering & reporting 14. Data Integration LIMS 4. Change control process EMR Public variant (genomic (clinical data) curation data sequencing data) Melbourne Genomics Health Alliance 10 Data Governance Vision ‘We will support improvement in patient outcomes and disease prevention for Victorians through secure, ethical use and sharing of reliable genomic information.’ Melbourne Genomics Health Alliance 12 Principles We all respect the rights of the patient and work collaboratively for better health outcomes through ensuring information is: • Secure • Used to its full extent • Fit-for-purpose • Valued Melbourne Genomics Health Alliance 13 Data Governance Framework Melbourne Genomics Health Alliance 14 Data Governance Framework – Implementation Plan Pre-implementation GenoVic implementation Foundation Release 1 • Data Governance Framework • Appointment of Data Release 2 Custodian/ Owner / Steward • Change Management • Data Sharing Agreement • Communications • Data Access Policy • Information Asset Register Release 3 • Information Architecture • Data Security Policy • Information Asset Register Procedures Reference Group • Priority data sets • Information Architecture • New data sets • Roles and responsibilities • Data classification Procedures • Accountability • Information Model • Expand metadata • Maturity Assessment • Accountability • Measurement • Data Quality Baseline • Measurement • Procedures • Data Quality Plan • Procedures • Data Quality Assessment Change Management Operationalise 15 Work to date Melbourne Genomics Health Alliance 17 Data Governance Roles and Responsibilities DATA GOVERNANCE OWNER: The CEO (or similar) for the Alliance Member Organisation has authority and accountability. Delegates to Is accountable to DATA GOVERNANCE STEWARD, an Executive with responsibility with the organisation that has delegated authority. Delegates to Is accountable to PROJECT CONTROL GROUP: Provides leadership, oversight and decision making for the management of information. ALLIANCE DATA CUSTODIAN : Defines and embraces the rules for the resource on behalf of the data steward Delegates to Is accountable to Provides feedback to Provides strategic and and strategic direction policy Provides Alliance Data Governance Lead: Implements the rules on behalf of DATA USER: Provides requirements and feedback the custodian Follows the rules when using the resource Melbourne Genomics Health Alliance 18 Information Architecture Reference Group • Alliance SME input • Member participation • Decision maker for information architecture • Review/endorsement of project deliverables • Monthly meetings Melbourne Genomics Health Alliance 19 Data Sharing Agreement • Supports strong ongoing collaboration • Contractually defines roles and data management processes • Ensures legal and ethical compliance • Enacts policies and procedures • Protects member IP and confidentiality Melbourne Genomics Health Alliance 20 Security Risk Assessment • Identify security risks • Risk analysis and rating • Risk treatment • Security control prioritisation Melbourne Genomics Health Alliance 21 What’s next? •Security Information implementation architecture Data Data quality management framework (incl metadata) Melbourne Genomics Health Alliance 23 Security implementation • Security control implementation plan • Information security policy, sub-policies and procedures • Data access and release policy • Data classification Melbourne Genomics Health Alliance 24 Information Architecture • Information architecture standards and principles • Information asset register • Information architecture standard operating procedures • Information models Melbourne Genomics Health Alliance 25 Data Quality Framework • Data quality framework and policy • Data profiling assessment • Data quality plans • Baseline metrics • Data quality Standard operating procedure Melbourne Genomics Health Alliance 26 Data Management (includes metadata) • Data lifecycle requirements and framework • Identify and prioritise datasets and metadata definitions • Standard operating procedures • Metadata policy and standards • Training material developed and delivered Melbourne Genomics Health Alliance 27 Data & Technology Team Melbourne Genomics Health Alliance 28 Melbourne Genomics – 2013-2015 CEOs/Leadership Ingrid Winship (Chair) AML CTP Information Systems Working Groups Louisa Di Pietro Andrew Roberts Paul Waring Patient-entered data tool Gareth Goodier (RMH) Heather Renton Ian Majewski Graham Taylor CPIPE / MG LOVD VLSCI Patient survey Christine Kilpatrick (RCH) Margaret Sahhar Seong Lin Khaw Tiffany Cowie Andrew Lonie Research access Stephen Smith (University of Melbourne) Janney Wale Francoise Merchinaud Sebastian Lunke Simon Sadedin Education symposium Doug Hilton (WEHI) Christine Walker Edward Chew Renata Marquis-Nicholson John-Paul Plazzer Evaluation Kathryn North (MCRI) Liat Watson Greg Corboy Charlotte Anderson CMT Information requirements Lynne Cobiac (CSIRO) Michael Christie Anthony Marty Monique Ryan Reporting Sue Forrest (AGRF) Clinical Interpretation Arthur Hsu Peter Georgeson Paul James Database users & Reporting Advisory Denis Bauer Tim Day VCGS Pipeline platform – Paul James (Chair) Harriet Dashnow Lynette Kiers Graham Taylor Damien Bruno Guido Grazioli Steering Group Adrienne Sexton Damien Bruno Paul Ekert Richard Sinnott James Angus (Chair) Steven Nasioulas – Monique Ryan CRC Glenn Tesla Julian Clark Belinda Chong Charlotte Slade Alex Boussioutas Clare Sloggett Project Team Sue Forrest Shannon Cowie Alison Trainer Finlay Macrae Clara Gaff (Exec Director) Melanie Smith Clinical Systems - MCRI & REDCAP Clara Gaff (Exec Director) Alison Trainer Trevor Lockett / David Hansen Genomics & Bioinformatics Advisory Clare Love Jane Halliday Tim
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