melbourne genomics health alliance · reference group roles and responsibilities pre-implementation...

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


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


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


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


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


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.’


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


Data Governance Framework


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

Data Governance Roles and Responsibilities


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


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


Security Risk Assessment

• Identify security risks

• Risk analysis and rating

• Risk treatment

• Security control prioritisation


What’s next?


•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


Information Architecture

• Information architecture standards and principles

• Information asset register

• Information architecture standard operating procedures

• Information models


Data Quality Framework

• Data quality framework and policy

• Data profiling assessment

• Data quality plans

• Baseline metrics

• Data quality Standard operating procedure


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


Data & Technology Team


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

melbourne genomics health alliance · reference group roles and responsibilities pre-implementation...

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