Lessons on the Metadata Approach. Dave Iberson- Hurst 9 th April 2014 CDISC Euro Interchange 2014

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2 Lessons on the Metadata Approach Dave Iberson- Hurst 9 th April 2014 CDISC Euro Interchange

3 Experience Human beings, who are almost unique in having the ability to learn from the experience of others, are also remarkable for their apparent disinclinakon to do so. Douglas Adams Experience is the name everyone gives to his mistakes. Oscar Wilde 3

4 Vision What is it we after trying to achieve? Find the same tests across several studies Study Programme Visit Data Context Subject Timing 4

5 InformaKon Flow & Big Picture Design Study Build Study Capture Tabulate Analyse Submit Protocol / SAP Study Design and Capture System Configura?on Raw Data Data Sets (SDTM) Analysis Data Sets (ADaM) CSR Pa?ent Profiles Submission FDA Annotated CRF Define.xml Organisa?on Content Defini?on Based on Standards (e.g. CRF defini?ons, extra terminology etc.) Standards (CDISC [CDASH, SDTM, ADaM, Terminology], MedDRA, WHO Drug ) 5

6 Islands of Metadata Protocol Writing Study Build Data Capture Individually- managed islands of defini9ons The defini9ons overlap The same defini9on will be different in the different islands Tabulations Analysis Datasets 6

7 Building Blocks I Rule Item Group Form Variable Domain QuesKon Text Panel Code List Item Value Set Code List 7

8 Building Blocks II Rule Item Group Form Variable Domain QuesKon Text Panel Code List Item Value Set Code List 8

9 A Common Model? SDM.xml define.xml ODM Study ID Protocol ADaM SDTM 9

10 Concepts Standardized Results VSPOS= C71148,C62122,SITTING C71148,C62166,STANDING C71148,C62167,SUPINE Body Position? VSORRES=Captured Data Value Result VSTESTCD=C66741,C49677,HR VSTEST=C67153,C49677,Heart Rate HR Units VSORRESU=C66770,C49673,BEATS/MIN Category Sub Category Baseline? Derived? Flags etc Timing Info Date & Time Visit Study Day Test Code Test Name 10

11 CRF Define Once, Use Many TABULATION Value Method LocaKon Units Correct mapping V S T E S T C D V S L O C CRF Capturing HR Shared terminology for response: SITTING, STANDING, SUPINE Set the correct test code 11

12 ConKnuum & Traceability Capture Process (CRF) Analysis Dataset Tabulation Dataset How I want to see it The data & definitions 12

13 CDISC SHARE DefiniKon PDF Version today This is from the Diabetes TA dra`, metadata seckon SHARE would provide this electronically in the future Saves a lot of work as scope (coverage of TA area) increases 13

14 AutomaKon How much should we aim for? 100% is not sensible Need repeatable manual intervenkon at each stage Allows for complex cases to be accommodated 14

15 VisualisaKon VisualizaKons and making it real for the users Business objects such as Generic CRFs Domains SpecificaKons Study acrf Make the content understandable to the business users 15

16 CommunicaKon The Why & What is in it for me Extends the why standards discussion to why metadata based processing Also includes the how does it work discussion Study versus OrganizaKon needs You can never do enough Repeat, repeat & repeat again 16

17 ExpectaKons 17

18 Study Build V1 V2 V3 V4 Assessment 1 Assessment 2 New VS Screening VS X X X X X New Content Response Time Capture Systems Visit 1 Visit 3,4 Annotated CRF Build Time SDTM Metadata Weight Blood Pressure Heart Rate Define.xml 18

19 Tools Metadata must be useable by the business Demands that tools are integrated This needs a Model Control of key tools, e.g. MDR Take small steps A single master as the source of definikons 19

20 Flexibility Need to retain flexibility and the ability to respond to new demands and needs Capability OperaKonal needs Metadata content Control of tools Response of vendors 20

21 Version Management I Sponsor metadata Terminology Business objects V1 V4 Concepts Forms V4 V2 Domains V3 V1 CDISC metadata V6 Concepts Terminology Rate of change, e.g. CDISC terminology quarterly SDTM IG and now 3.2 Current latest versus studies that use previous versions Level of management 21

22 Version Management II 28 March December 2014 C48251: Submission Value PROTOCOL VIOLATION - > PROTOCOL DEVIATION 22

23 Training You will need to do some training Repeat. It does not always make sense the first Kme 23

24 Shi`ing of Effort Effort Note: Illustra?ve not defini?ve! Automa9on and Metadata shigs effort to the start of a study Time 24

25 Benefit Concept Reuse SDTM Automa?on % Reuse 80% % Reuse 90% Studies Studies 25

26 Summary A vision of where you are heading and why Pay aoenkon to the data flow Remove the islands of definikons Have a model Use concepts and benefit from the TA work Automate but allow manual fixes/updates, maintain flexibility Take small steps Visualise the metadata Pay aoenkon to the study build process & single source of truth Single master and use the metadata within the business Pay aoenkon to version management & governance Beware of the shi` in where effort is needed as well as skills & training Measure benefit 26

27 Contact And More InformaKon dave.iberson- Blog Post 27

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