Steve Walker (CIO, UK Biobank) UK Biobank – IT Systems from Design to Delivery

1. Steve Walker (CIO, UK Biobank) UK Biobank – IT Systems from Design to Delivery

2. Contents • Introduction • About UK Biobank • Objectives and Approach • Timescales • Systems Solutions and Standards • Scope • Requirements Definition • Development Approach • High Level Architectures • HL7 and HTB

3. Introduction My responsibilities include: • Information Systems & Data Management • To build the infrastructure that will become the UK Biobank data resource • Programme & Project Planning • Complex interdependencies • Green field project • Recruitment Services • How to ensure that 500,000 people want to and can participate in the project

4. Approach & Rationale

5. Approach – Participants • Invite 500,000 people in age range 40-69 to participate • Dedicated Assessment Centres throughout UK: • About 15 concurrently • 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

6. 16,200,000 People in Age Range Regional Sampling Frames Participant Identification Participant Invitation Participant Consent 500,000 (3%) Participants The Recruitment Funnel Central & GP • UK Biobank Cohort • Generalisable to • UK Population • aged 45-69. • Cohort stratification criteria; • Age; • Gender; • Ethnic Minorities; • Other Minority Groups; • Socio-economic Status Response Rate: 30%?

7. Scientific Rationale - 1 • Largest prospective cohort project yet undertaken • Combines robust epidemiological tools with the new biological technologies to: • Study the underlying mechanisms of disease • Identify markers of disease and disease progression • Identify genetic, environmental and/or lifestyle factorspredicting, pre-disposing or affecting disease onset or prognosis • Allowing existing studies to be carried out with increased power and new questions to be asked

8. Scientific Rationale - 2 • The project is large enough that sufficient incident cases of major diseases will occur in the population to yield informative data on nested subsets. • The UK Biobank will be a resource for prospective studies with benefits of: • Accuracy of assessment of environmental exposures against retrospective studies • Modification of environmental exposures after first presentation • Psycho-social factors and mental health Doll and Hill’s paper on their prospective study on smoking and lung cancer was published 50 years ago – BMJ 1954;228:1451-55

9. Organisation of the Project • Funded for recruitment phase • Registered charity and limited company • Acting Chief Executive Dr Tim Peakman • Core team of 18 people based at Manchester University • Site of laboratories, storage and secure information centre • 6 Regional Collaborating Centres involving 22 universities

10. Programme Milestones in 2005

11. Systems Solutions & Standards

12. Measurements e.g. Height Weight Respiratory Function Sight Hearing Blood Pressure Results Biochemistry Haematology Advanced testing Questionnaire e.g. Diet Circumstances Family History Employment Smoking Alcohol Lifestyle Medications Cognitive Function Health Hospital Records In & Day Patients ICD-10/ICD-9 (Diagnoses) OPCS4 (procedure) Primary Diagnosis Main Operation GP Health Record Symptoms Diagnoses Referrals Medications Procedures The UK Biobank Resource UK Biobank Assessment Centre UK Biobank Lab & Archive NHS Records

13. Overall Systems Architecture Recruitment Services

14. Post Room Call Centre Clinic Secure Database GP RCC Sample Frame RCC UKB Recruitment Services

15. Assessment Centre Systems

16. 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

17. Samples Collected from Each Participant Spray-dried K2EDTA (plastic) Acid citrate dextrose additives (ACD) Clot activator and gel for serum separation Plastic Conical Urinalysis F/Ox • 750 participants per day • 3,750 tubes of blood • 750 tubes of urine • 14 million 1ml tubes • 10 million 50ul tubes 4.5 10 10 10 10 8 Glucose 40C Transport RT Transport 40C Transport RT Transport Plasma, Buffy coat, DNA (FTA),RBCs, cell counts Plasma, Buffy coat, PBLs, Serum blood chemistry Urine Metabolites Bioanalytes

18. Current Status of IT Systems • Initial core hardware platform installed - IBM • Applications and database installed this week – Oracle and Linux • Process definition and data modelling on-going (BPMN standard) • Thermo Nautilus LIMS being configured • Assessment Centre • Applications v1 delivered and v2 commissioned • Hardware procurement almost complete - Dell • Recruitment Services systems being specified

19. Particular IT Challenges • Everything is new – there are no legacy systems • Timescales • Breadth of scope • Scale • Balancing: • Cost • Usability • Security – not negotiable (EGC review next week) • Not “over-complicating” …. but it is complicated ! • We are not building an openmulti-user system

20. www.ukbiobank.ac.uk