Melbourne Genomics Establishing data governance in clinical genomics - - PowerPoint PPT Presentation

Melbourne Genomics

Ian Pham Data Governance Lead

Establishing data governance in clinical genomics

Melbourne Genomics Health Alliance

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Melbourne Genomics Health Alliance 3

Focused on implementing genomics in practice

Melbourne Genomics Health Alliance 4

Discovery Research Translational Research Implementation Routine Practice

Research Institutes and Universities Clinical Genetics Services and Hospitals Melbourne Genomics Health Alliance Australian Genomics Health Alliance

Approach

Melbourne Genomics Health Alliance 5

Evaluate the place of genomics in health care practice, by: (1) evaluating the process and outcomes of genomic tests in practice, and (2) establishing and applying a platform for health service research, program evaluation, economic evaluation and translational research in the use of genomics in health care. . Establish active relationships and participation in national and international initiatives with the aim

• f disseminating, communicating and

collaborating on the work of the Alliance and its implications. STREAM 5: NATIONAL AND INTERNATIONAL IMPACT STREAM 3: INNOVATION AND RAPID ADOPTION Develop and deploy systems to ensure patients have access to cutting-edge, high quality genomic testing that is cost-effective. STREAM 1: WORKFORCE DEVELOPMENT Build the literacy, skills and confidence of the clinical and diagnostic workforce in genomics, as relevant to each professional role STREAM 4: 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.

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DISEASE FLAGSHIPS Flagships are the mechanism through which genomic sequencing is provided to patients with defined clinical conditions or indications. Flagships will also be the means by which the workforce is developed, innovation is adopted,

• utcomes are evaluated and information systems

trialled, and underpin the five streams. STREAM 2: ASSESSING THE VALUE OF GENOMICS

Flagships

Melbourne Genomics Health Alliance

2014-2015

AML Childhood syndromes Focal epilepsy Hereditary colorectal cancer Hereditary neuropathy

2016-2018

Complex care Congenital deafness Dilated cardiomyopathy Immunology Advanced solid cancers Advanced lymphoma (non-Hodgkin)

2017-2019

Controlling superbugs Bone marrow failure Complex neurological and neurodegenerative diseases Genetic kidney disease Perinatal autopsy

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

Melbourne Genomics Health Alliance 8

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.

9 Melbourne Genomics Health Alliance

GenoVic

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• 8. Clinical Tools
• 13. Genomic Data Repository
• 14. Data Integration
• 5. Staff to

manage the data

People Policy & Process Technology

• 1. Standardised policy and

processes for data management & access (data governance)

• 11. Data Access Tools
• 12. Master

Patient Index

• 7. Identity & Access Management
• 2. Standardised

policy & processes for patient consent Electronic Orders and Results EMR (clinical data) LIMS (genomic sequencing data) Clinician Knowledge Clinical Decision Support Tools

• 9. Diagnostic Tools

Curation Tools Analysis (Pipeline) Tools

• 10. Patient Tools

Education Consent Results

• 6. Staff to

manage the technology

• 3. Standardised policy and

processes for test ordering & reporting

• 4. Change control process

Public variant curation data

Melbourne Genomics Health Alliance

Data Governance

Vision

‘We will support improvement in patient outcomes and disease prevention for Victorians through secure, ethical use and sharing

• f 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

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GenoVic implementation

Release 1

• Appointment of Data

Custodian/ Owner / Steward

• Data Sharing Agreement
• Data Access Policy
• Data Security Policy
• Priority data sets
• Data classification
• Information Model
• Maturity Assessment
• Data Quality Baseline
• Data Quality Plan
• Data Quality Assessment

Release 2

• Information Asset Register
• Information Asset Register

Procedures

• Information Architecture

Procedures

• Accountability
• Measurement
• Procedures

Release 3

• New data sets
• Accountability
• Expand metadata
• Measurement
• Procedures

Foundation

• Data Governance Framework
• Change Management
• Communications
• Information Architecture

Reference Group

• Roles and responsibilities

Pre-implementation Change Management Operationalise

Work to date

Melbourne Genomics Health Alliance 17

Data Governance Roles and Responsibilities

Melbourne Genomics Health Alliance 18

PROJECT CONTROL GROUP: Provides leadership, oversight and decision making for the management of information. DATA USER: Provides requirements and feedback Follows the rules when using the resource Alliance Data Governance Lead: Implements the rules on behalf of the custodian DATA GOVERNANCE OWNER: The CEO (or similar) for the Alliance Member Organisation has authority and accountability. ALLIANCE DATA CUSTODIAN : Defines and embraces the rules for the resource on behalf of the data steward

Delegates to Is accountable to Delegates to Is accountable to Provides strategic and policy direction Provides feedback to

DATA GOVERNANCE STEWARD, an Executive with responsibility with the organisation that has delegated authority.

Delegates to Is accountable to

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?

Melbourne Genomics Health Alliance 23

• Security

implementation Information architecture Data quality framework Data management (incl metadata)

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

Melbourne Genomics Health Alliance | Document Name Here 29

CEOs/Leadership

Gareth Goodier (RMH) Christine Kilpatrick (RCH) Stephen Smith (University of Melbourne) Doug Hilton (WEHI) Kathryn North (MCRI) Lynne Cobiac (CSIRO) Sue Forrest (AGRF)

–

Steering Group

James Angus (Chair) Julian Clark Sue Forrest Clara Gaff (Exec Director) Trevor Lockett / David Hansen Andrew Sinclair Mike South Paul Waring / Jon Emery Ingrid Winship

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Advisory Groups

Information Management Advisory David Hansen (Chair) Terry Brennan Ken Doig Rowan Gronlund Andrew Lonie Fernando Martin-Sanchez Wayne Mather Emeline Ramos Brenda White Community Advisory Ingrid Winship (Chair) Louisa Di Pietro Heather Renton Margaret Sahhar Janney Wale Christine Walker Liat Watson Clinical Interpretation & Reporting Advisory Paul James (Chair) Damien Bruno Paul Ekert Monique Ryan Charlotte Slade Alison Trainer Genomics & Bioinformatics Advisory Graham Taylor / Alicia Oshlack (Chair) Melanie Bahlo Denis Bauer Paul James Andrew Lonie Simon Sadedin Kirby Siemering Data Access Advisory Yousef Kowsar Kurt Lackovic Steven Manos Candice McGregor Owen O’Neill Gayle Philip Bernie Pope Melissa Southey Advanced Users Group

–

Flagships

AML Andrew Roberts Ian Majewski Seong Lin Khaw Francoise Merchinaud Edward Chew CMT Monique Ryan Paul James Tim Day Lynette Kiers Adrienne Sexton CRC Alex Boussioutas Finlay Macrae Alison Trainer Ingrid Winship Michael Bogwitz CS Sue White Zornitza Stark Tiong Tan Paul Ekert Christiane Theda David Amor Maie Walsh Patrick Yap Epilepsy Patrick Kwan Terry O’Brien Ingrid Scheffer Piero Perucca Paul James

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Laboratories

CTP Paul Waring Graham Taylor Tiffany Cowie Sebastian Lunke Renata Marquis-Nicholson Greg Corboy Michael Christie Arthur Hsu VCGS Graham Taylor Damien Bruno Steven Nasioulas Belinda Chong Shannon Cowie Melanie Smith Clare Love Chris Guest AGRF Sue Forrest Kirby Siemering Melanie O’Keefe Matthew Tinning Lavinia Gordon Rust Turakulov Stephen Wilcox

–

Information Systems

CPIPE / MG LOVD VLSCI Andrew Lonie Simon Sadedin John-Paul Plazzer Charlotte Anderson Anthony Marty Peter Georgeson Denis Bauer Harriet Dashnow Guido Grazioli Richard Sinnott Glenn Tesla Clare Sloggett Clinical Systems - MCRI & REDCAP Jane Halliday Susan Donath Leanne Mills Ross Dunn Luke Stephens BIOGRID Maureen Turner Leon Heffer Alice Johnstone

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Working Groups

Patient-entered data tool Patient survey Research access Education symposium Evaluation Information requirements Reporting Database users Pipeline platform

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Project Team

Clara Gaff (Exec Director) Tim Bakker (Info Mgmt) Michele Cook (Admin) Ivan Macciocca (Clinical) Karen Meehan (Comms) Natalie Thorne (Bioinf) Evaluation Team Emily Forbes Melissa Martyn Nessie Mupfeki Bill Wilson Genetic Counsellors Gemma Brett Emma Creed Ella Wilkins Health Economics Khurshid Alam Deborah Schofield Rupendra Shrestha

Melbourne Genomics – 2016-2019

Melbourne Genomics Health Alliance | Document Name Here 30

Alliance Board

Catherine Walter (Chair) Christine Kilpatrick (RMH) Andrew Stripp (Monash Health) Dale Fisher (PeterMac) Christine Kilpatrick (RCH) Shitij Kapur (UoM) Doug Hilton (WEHI) Kathryn North (MCRI) Rob Grenfell (CSIRO) Irene Kourtis (AGRF) Sue Shilbury (Austin Health) Anna Burgess (DHHS observer)

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Executive Management Committee

Clara Gaff (Chair) David Hansen Andrew Sinclair Richard King Julian Clark Felicity Topp Fergus Kerr Peter McDougall Ingrid Winship Sean Grimmond Kirby Siemering Paul Fennessy (DHHS observer)

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Advisory Groups

Clinical Adoption Advisory Fergus Kerr (Chair) Cate Kelly Sylvia Metcalfe Don Campbell Lindsay Grayson Margaret Kelaher Noel Cranswick Jayesh Desai Community Advisory Jane Bell (Chair) Louisa Di Pietro Heather Renton Margaret Sahhar Janney Wale Christine Walker Liat Watson Diagnostic Advisory Richard King (Chair) Kirby Siemering Sebastian Lunke Melanie O’Keefe Vivien Vasic Michael Christie Andrew Fellowes Suzanne Svobodova Tony Papenfuss Simon Sadedin Paul James Information Management Advisory/GenoVic Project Control Group David Hansen (Chair) Wayne Mather Rowan Gronlund Kevin Ericksen Tony Papenfuss Michael Carolan Erminia Schiavone Kris Jenkins Mike South Angela Watt Andrew Lonie Clara Gaff Malcolm Smart

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Flagships 2016-2018

Congenital Deafness David Amor Lilian Downie Valerie Sung Libby Smith Bibi Gerner Matthew Hunter Kerryn Saunders Natasha Brown Melissa Wake Rachel Burt Jane Halliday Zeffie Poulakis Elizabeth Rose Complex Care in Children Sue White Zornitza Stark Tiong Tan Alison Yeung Matthew Hunter Katrina Harris Dilated Cardiomyopathy Paul James Jay Ramchand Matthew Wallis David Hare Omar Farouque Immunology Jo Douglass Charlotte Slade Vanessa Bryant Jo Smart Sara Barnes Seth Masters Mimi Tang Ingrid Winship Zornitza Stark Lymphoma Stephen Opat Miles Prince Gareth Gregory Michael Dickinson Eliza Hawkes Piers Blombery Solid Cancers Jayesh Desai Kortnye Smith Sophie Beck Dong Anh Khuong Quong Hui Gan Paul Eckert Ben Solomon Ben Markman

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Flagships 2017-2019

Bone marrow failure Piers Blombery David Ritchie Francoise Mechinaud Anthea Greeway Andrew Grigg Erica Wood Paddy Barbaro Controlling Superbugs Lindsay Grayson Ben Howden Norelle Sherry Jason Kwong Tony Korman Caroline Marshall Mark Chan Monica Slavin Marcel Leroi Complex neurological Patrick Kwan Sam Berkovic Martin Delatycki Dennis Velakoulis Michael Fahey Melanie Bahlo Rick Leventer Amy Schneider Genetic kidney disease Catherine Quinlan Sue White Zornitza Stark Ella Wilkins Mathew Wallis David Power Kathy Nicholls Peter Kerr Perinatal autopsy George McGillivray Jacqueline Collett Ian Simpson Trishe Leong Jan Pyman Alison Yeung Natasha Brown Sue White Sue Walker

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Laboratories

CTP Paul Waring Graham Taylor Tiffany Cowie Sebastian Lunke Renata Marquis-Nicholson Greg Corboy Michael Christie Arthur Hsu VCGS Graham Taylor Damien Bruno Steven Nasioulas Belinda Chong Shannon Cowie Melanie Smith Clare Love Chris Guest AGRF Sue Forrest Kirby Siemering Melanie O’Keefe Matthew Tinning Lavinia Gordon Rust Turakulov Stephen Wilcox

–

Information Systems

CPIPE / MG LOVD VLSCI Andrew Lonie Simon Sadedin John-Paul Plazzer Charlotte Anderson Anthony Marty Peter Georgeson Michael Milton Juny Kesumadewi Gayle Philips Denis Bauer Harriet Dashnow Guido Grazioli Richard Sinnott Glenn Tesla Clare Sloggett Clinical Systems - MCRI & REDCAP Jane Halliday Susan Donath Leanne Mills Ross Dunn Luke Stephens BIOGRID Maureen Turner Leon Heffer Alice Johnstone

–

Working Groups

Patient-entered data tool Patient survey Research access Education symposium Evaluation Information requirements Reporting Database users Pipeline platform Curation tool pilot evaluators Curation tool RFQ evaluators Analysis tool user group Curation tool user group Information architecture reference group

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Genetic Counsellors Gemma Brett Emma Creed Anna Jarmolowicz Ivan Macciocca Ellie Prawer Giulia Valente Kirsty West Health Economics Khurshid Alam Deborah Schofield Rupendra Shrestha

Melbourne Genomics Health Alliance Program Team

Thank you