melbourne genomics health alliance · reference group roles and responsibilities pre-implementation...
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Melbourne Genomics
Ian Pham
Data Governance Lead
Establishing data governance in clinical genomics
Melbourne Genomics Health Alliance
1
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
of 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.
This stream will be the focus of the workshop.
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,
outcomes 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.
9Melbourne Genomics Health Alliance
GenoVic
10
8. Clinical Tools
13. Genomic Data Repository
14. Data Integration
5. Staff to
manage the
data
PeoplePolicy & 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 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
15
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 resourceAlliance 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 toIs accountable to
Delegates to Is accountable to
Pro
vid
es s
trate
gic
and p
olic
y d
irectio
n
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/LeadershipGareth Goodier (RMH)
Christine Kilpatrick (RCH)
Stephen Smith (University of Melbourne)
Doug Hilton (WEHI)
Kathryn North (MCRI)
Lynne Cobiac (CSIRO)
Sue Forrest (AGRF)
–Steering GroupJames Angus (Chair)
Julian Clark
Sue Forrest
Clara Gaff (Exec Director)
Trevor Lockett / David Hansen
Andrew Sinclair
Mike South
Paul Waring / Jon Emery
Ingrid Winship
–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
–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 SystemsCPIPE / 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
–
Working GroupsPatient-entered data tool
Patient survey
Research access
Education symposium
Evaluation
Information requirements
Reporting
Database users
Pipeline platform
–Project TeamClara 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 BoardCatherine 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)
–Executive Management CommitteeClara Gaff (Chair)David HansenAndrew SinclairRichard KingJulian ClarkFelicity ToppFergus KerrPeter McDougallIngrid WinshipSean GrimmondKirby SiemeringPaul Fennessy (DHHS observer)
–Advisory Groups Clinical Adoption Advisory
Fergus Kerr (Chair)Cate Kelly Sylvia Metcalfe Don CampbellLindsay GraysonMargaret Kelaher Noel CranswickJayesh Desai
Community Advisory
Jane Bell (Chair)Louisa Di PietroHeather RentonMargaret SahharJanney WaleChristine WalkerLiat Watson
Diagnostic Advisory
Richard King (Chair)Kirby SiemeringSebastian Lunke Melanie O’KeefeVivien VasicMichael ChristieAndrew FellowesSuzanne SvobodovaTony Papenfuss Simon SadedinPaul James
Information Management Advisory/GenoVic Project Control Group
David Hansen (Chair)Wayne Mather Rowan GronlundKevin EricksenTony Papenfuss Michael CarolanErminia SchiavoneKris JenkinsMike SouthAngela WattAndrew LonieClara GaffMalcolm Smart
–Flagships 2016-2018Congenital Deafness
David AmorLilian DownieValerie SungLibby SmithBibi GernerMatthew HunterKerryn SaundersNatasha BrownMelissa WakeRachel BurtJane HallidayZeffie PoulakisElizabeth Rose
Complex Care in Children
Sue WhiteZornitza StarkTiong TanAlison YeungMatthew HunterKatrina Harris
Dilated Cardiomyopathy
Paul JamesJay RamchandMatthew WallisDavid HareOmar Farouque
Immunology
Jo DouglassCharlotte SladeVanessa BryantJo SmartSara BarnesSeth MastersMimi TangIngrid WinshipZornitza Stark
Lymphoma
Stephen OpatMiles PrinceGareth GregoryMichael DickinsonEliza HawkesPiers Blombery
Solid Cancers
Jayesh DesaiKortnye SmithSophie BeckDong Anh Khuong QuongHui GanPaul EckertBen SolomonBen Markman
–Flagships 2017-2019Bone marrow failure
Piers BlomberyDavid RitchieFrancoise MechinaudAnthea GreewayAndrew GriggErica WoodPaddy Barbaro
Controlling Superbugs
Lindsay GraysonBen HowdenNorelle SherryJason KwongTony Korman
Caroline MarshallMark ChanMonica SlavinMarcel Leroi
Complex neurological
Patrick KwanSam BerkovicMartin DelatyckiDennis VelakoulisMichael FaheyMelanie BahloRick LeventerAmy Schneider
Genetic kidney disease
Catherine QuinlanSue WhiteZornitza StarkElla WilkinsMathew WallisDavid PowerKathy NichollsPeter Kerr
Perinatal autopsy
George McGillivrayJacqueline CollettIan SimpsonTrishe LeongJan PymanAlison YeungNatasha BrownSue WhiteSue Walker
–LaboratoriesCTP
Paul WaringGraham TaylorTiffany CowieSebastian LunkeRenata Marquis-NicholsonGreg Corboy
Michael ChristieArthur Hsu
VCGS
Graham TaylorDamien BrunoSteven NasioulasBelinda ChongShannon CowieMelanie SmithClare LoveChris Guest
AGRF
Sue ForrestKirby SiemeringMelanie O’KeefeMatthew TinningLavinia GordonRust TurakulovStephen Wilcox
–Information SystemsCPIPE / MG LOVD VLSCI
Andrew LonieSimon SadedinJohn-Paul PlazzerCharlotte AndersonAnthony MartyPeter GeorgesonMichael MiltonJuny KesumadewiGayle PhilipsDenis BauerHarriet DashnowGuido GrazioliRichard SinnottGlenn TeslaClare Sloggett
Clinical Systems - MCRI & REDCAP
Jane HallidaySusan DonathLeanne MillsRoss DunnLuke StephensBIOGRIDMaureen TurnerLeon HefferAlice Johnstone
–Working GroupsPatient-entered data toolPatient surveyResearch accessEducation symposiumEvaluationInformation requirementsReportingDatabase usersPipeline platformCuration tool pilot evaluatorsCuration tool RFQ evaluatorsAnalysis tool user groupCuration tool user groupInformation architecture reference group
–Genetic Counsellors
Gemma BrettEmma CreedAnna JarmolowiczIvan MaccioccaEllie PrawerGiulia ValenteKirsty West
Health Economics
Khurshid AlamDeborah SchofieldRupendra Shrestha
Melbourne Genomics Health Alliance Program Team
Thank you