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BRIDG Activities, Clinical Data Elements and the role of MDR

BRIDG Activities, Clinical Data Elements and the role of MDR. Basel, 21. March 2008 Mark Regenass, Isabelle de Zegher, Peter Spiers, Saurin Mehta, Mitra Rocca. Key question. How to develop and maintain an internal data element registry Supporting data integration

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BRIDG Activities, Clinical Data Elements and the role of MDR

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  1. BRIDG Activities, Clinical Data Elements and the role of MDR Basel, 21. March 2008 Mark Regenass, Isabelle de Zegher, Peter Spiers, Saurin Mehta, Mitra Rocca

  2. Key question • How to develop and maintain an internal data element registry • Supporting data integration • Supporting SDTM submissions

  3. Three strategic decisions • Specify the set of data elements for Novartis Development analogous to SDTM data elements (extend SDTM for Novartis). • Use a ISO 11179 MDR1)-based system to register the data elements with. • Introduce an Analysis Model for Novartis Development analogous to the BRIDG2) model mapping the data elements to unambiguously defined concepts. • ISO/IEC 11179, Information Technology -- Metadata registries (MDR) • Biomedical Research Integrated Domain Group 3 | BRIDG Activity, CDE & MDR | Mark Regenass | 21.03.2008

  4. 1 - Specify DE analogue to SDTM 4 | BRIDG Activity, CDE & MDR | Mark Regenass | 21.03.2008

  5. Extend SDTM for Novartis => SDTM++ Additional attributes per DE Additional DE’s per Domain 5 | BRIDG Activity, CDE & MDR | Mark Regenass | 21.03.2008

  6. 2 - Register DEs in an MDR Values Elements • ... • Republic of Cyprus • Czech Republic • Kingdom of Denmark • Republic of Djibouti • Commonwealth of Dominica • Dominican Republic • ... Set of Value Meanings • Meaning Country Representation Implementation Permissible Values ... CY Republic of Cyprus CZ Czech Republic DK Kingdom of Denmark DJ Republic of Djibouti DM Commonwealth of Dominica DO DominicanRepublic ... APPLICATION A Cntry:varchar(2) ... 0022 Republic of Cyprus 0023 Czech Republic 0024 Kingdom of Denmark 0025 Republic of Djibouti 0026 Commonwealth of Dominica 0027 DominicanRepublic ... Codes/Ranges/… Data type APPLICATION B Cntry:number(4,0) 6 | BRIDG Activity, CDE & MDR | Mark Regenass | 21.03.2008

  7. 3 - Build a Domain Analysis Model analogous to BRIDG Domain Analysis Model A shared view of the semantics defining a domain of interest 7 | BRIDG Activity, CDE & MDR | Mark Regenass | 21.03.2008

  8. L S I O Harmonization AM – Global Requirements Gathering • Requirements Engineering per Project BRS SRS BRS SRS BRS SRS BRS: Business Requirements Specification SRS: System Requirements Specification • Global Requirements Engineering • Business Requirements Specifications are obligated to harmonize their project analysis models with the global analysis model Analysis Model based on BRIDG BRS SRS BRS SRS BRS SRS 8 | BRIDG Activity, CDE & MDR | Mark Regenass | 21.03.2008

  9. Part of BRIDG is “generic” These elements define business semantics precisely, explicitly and clearly. These elements provide structures that can be used to further specify semantics mainly activities and observation results generic precise 9 | BRIDG Activity, CDE & MDR | Mark Regenass | 21.03.2008

  10. Mapping DE to BRIDG Release 1.1 USUBJID SEX SUBJID AGE STUDYID TEDUR QSORRES VSORRES VSORRESU EXLOT MHTERM CMTRT LBORRES VSTEST CMCAT VSPOS SUROUTE SUDOSE 10 | BRIDG Activity, CDE & MDR | Mark Regenass | 21.03.2008

  11. Percentage share (mapping DE to BRIDG 1.1) RFSTDTC STUDYID DMDTC USUBJID CMTRT SUBJID CMDECOD SITEID Precise ~ 42% EXDOSE INVID EXDOSU BRTHDTC Generic ~58% SUROUTE AGE SUDUR AGEU MHTERM SEX MHDECOD LOT MHDTC VISIT EGPOS VISITDY … … EGORRES EPOCH 11 | BRIDG Activity, CDE & MDR | Mark Regenass | 21.03.2008

  12. “Precise” – dedicated sets of value meaning HL7 Data Type TS: Point in Time CD: Concept Descriptor A reference to a concept defined in a code system BRTHDTC SEX • female • male • non-binary & neuter DE to attribute mapping is 1:1 12 | BRIDG Activity, CDE & MDR | Mark Regenass | 21.03.2008

  13. “Generic” – multiple sets of value meanings • Values for VSTESTCD • WEIGHT - Body weight • HEIGHT - Body height • SYSBP - Systolic blood pressure • PULSE - Pulse rate • … VSTESTCD = HEIGHT VSORRES = 182 VSORRESU = cm • Values for EGTESTCD • VRATE - Ventricular rate • PR - PR Interval • QRS - QRS Interval • QT - QT Interval • QTABN - QT Abnormalities • … EGTESTCD = PR EGORRES = 1091 • Values for LBTESTCD • ALP - Alkaline Phosphatase Measurement • ALB - Albumin Measurement • AST - Aspertate Armintransferase • RBC - Erythrocyte Count • PT - Prothrombin Time • … EGORRESU = msec LBTESTCD = WBC HL7 Data Type PQ: Physical Quantity A dimensioned quantity expressing the result of measuring (value AND unit) LBORRES = 6548 LBORRESU = µl^-1 More than one DE mapto one attribute One attribute has several value domains 13 | BRIDG Activity, CDE & MDR | Mark Regenass | 21.03.2008

  14. Registering in MDR – “precise” zone BRIDG DE SEX • female • male • non-binary & neuter MDR F - female M - male N - non-binary & neuter 14 | BRIDG Activity, CDE & MDR | Mark Regenass | 21.03.2008

  15. Registering in MDR – “generic” zone BRIDG DE EGTESTCD VSTESTCD LBTESTCD A reference to a concept defined in a code system MDR • WEIGHT - Body weight • HEIGHT - Body height • SYSBP - Systolic blood pressure • PULSE - Pulse rate • … • VRATE - Ventricular rate • PR - PR Interval • QRS - QRS Interval • QT - QT Interval • QTABN - QT Abnormalities • … • ALP - Alkaline Phosphatase Msrmnt • ALB - Albumin Measurement • AST - Aspertate Armintransferase • RBC - Erythrocyte Count • PT - Prothrombin Time • … 15 | BRIDG Activity, CDE & MDR | Mark Regenass | 21.03.2008

  16. Conclusion • SDTM needs to be extended to fully cover the need of data element definition from data collection onwards. • Use of BRIDG as a source for unambiguous data element concepts requires 2 different types of mapping: • “precise”: one-to-one mapping between a DE and a BRIDG concept; business semantics precisely, explicitly and clearly defined. • “generic”: many DE fit within a single BRIDG concept, this BRIDG concept is providing structure to further specify semantics (mainly to define specific activities and observation results). • An ISO 11179 based MDR can cover all requirements for data element registration only when applied with some flexibility.

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