Steve Walker, CIO, UK Biobank NCRI Genetic Variation

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Steve Walker, CIO, UK Biobank NCRI Genetic
Variation Cancer WorkshopLondon 03 February
2006
UK Biobank Implementation and Roll Out
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Contents

• About UK Biobank
• Introduction
• Objectives, Organisation and Approach
• Systems Solutions and Standards
• Scope
• Development Approach
• High Level Architectures
• Current Status of the Project

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Approach Participants

• Invite 500,000 people in age range 40-69 to
  participate
• Dedicated Assessment Centres throughout UK
• Explicit broad consent
• Detailed lifestyle and health questionnaire
• Physical Measurements
• Collection of blood and urine samples
• Follow Up
• Participants health for 20-30 years with
  information from multiple sources
• Medical records and biological samples
• Environmental information

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Organisation of the Project

• Funded for recruitment phase
• Registered charity and limited company
• Chief Executive Prof Rory Collins (Oxford)
• Core team of based near Stockport - site of
  laboratories, archives and secure information
  centre
• Close working with Oxford CTSU
• 6 Regional Collaborating Centres involving 22
  universities

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Principles Behind the I.T. Strategy

• Systems .. resilient .. secure .. ensure the
  confidentiality of participant information at all
  times
• Security of individual systems and the overall
  systems architecture .. independently tested and
  proved
• UK Biobank information systems will comply with
  all relevant legislation e.g. the Data Protection
  Act
• Where relevant UK Biobank data structures will be
  based on (international) standards
• The objective is to develop a data resource that
  will serve a project lasting twenty to thirty
  years
• Complete audit trails for all data at the most
  detailed level
• Built in support for quality assurance

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The UK Biobank Data Resource
UK Biobank Assessment Centre
UK Biobank Lab Archive
NHS Records
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Recruitment Services
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Assessment Centre Systems
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In Clinic Activity
60 90 minutes
Registration
Informed Consent
Self-Administered Touchscreen Questionnaire
Urine Sample
Physical Measurements
Interviewer Questionnaire
Blood Sample
Exit Interview
Integrated IT Systems
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Touchscreen Questionnaire
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Interviewer Questionnaire

Approx. 50 questions
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Measurements

• Height Sitting and Standing
• Weight and Body Impedance
• Hip and Waist Size
• Resting Pulse
• Blood Pressure
• Grip Strength
• Spirometry - Vital Capacity FEV1

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Core Systems
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Principles of Operation

• Messaging environment
• One way movement of sensitive data (inwards)
• Repository is never directly or indirectly
  connected to external systems
• Directly attributable data (e.g. Name, NHS
  Number) separated from clinical/characteristic
  data (e.g. Consent, Height, Lifestyle etc)
• Organisational/functional separation of
  Identifiers and Clinical Data on a need-to-know
  basis. Each unit has its own Participant
  Identifier.
• Pre-Clinic (Recruitment/Booking)
• Assessment
• Laboratory (Lab specific sample grouper)
• Follow Up Health Record - Primary Care, Secondary
  Care, Registries

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Systems Architecture
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Why Standards Based ?

• Future proofing - HL7 (and HTB) will evolve to
  meet new requirements
• Potential to develop multi-study research
  platforms
• Access to international skill base and
  intelligence HL7 community, NHS, suppliers,
  potential end users
• Desire to minimise in-house development
• Consistent approach for the whole life of the
  study
• UKB involvement in the EU Work Programme
  Harmonising Data Standards for Biobanking

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Why Health Level 7 (HL7) ?

• International standard for health-related data
• Fit with emerging UK health systems standards
• Fits all current UKB requirements
• UKB can influence HL7 for future requirements
  (and influence is stronger working with Oracle)

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Why XML ?

• HL7 mandated standard
• Platform independent
• XML is standards compliant (ISO 10646)
• Human readable
• Extensible
• Easy programmatic access
• Enforces data formats

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Why Oracle HTB ?

• Options put to Board (Dec 2004)
• IBM (dB2, Websphere etc) the IBM report
• In-House development (SQL server, .Net)
• Oracle HTB/in-house and add-ons
• Why HTB ?
• HL7 out of the box
• Oracle application suite and other solutions e.g.
  research and analysis
• Industrial strength business model
• Consistent platform to support whole study
• Java development tools
• Reduced lock in and less risk than home grown
• Value for money

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Current Status
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The Integrated Pilot - 1

• Clinic in the centre of Altrincham, Cheshire
• Aim is to recruit 2-3,000 people over two months
  (lt100 people/day)
• 4 PCTs, gt400,000 population
• MREC approval received January 2006
• NHS approval for UKB use of data

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The Integrated Pilot - 2

• Full systems and processes test for main study
• Call centre and invitation systems and services
  in place
• Laboratory, archives and LIMS in place
• 1st invitations sent 13 February
• Integrated clinic data collection systems
  complete 18 February
• Final clinical staff training 27 February
• 1st participant 06 March 2006

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Next Steps

• Pilot evaluation May 2006
• International review July 2006
• Full scale recruitment to start September 2006
• Up to 15 concurrent assessment centres
• Flexible operation hours and locations
• 1,500 people/day ?

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www.ukbiobank.ac.uk