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PhUSE 2008 Manchester 2008-10-12 / 2008-10-15 Michael Knoessl

PhUSE 2008 Manchester 2008-10-12 / 2008-10-15 Michael Knoessl. Implementing CDISC at Boehringer Ingelheim. B.C. Before CDISC. CDISC – Impact. 2004 – 07 – 21. According to CDISC. Motivation and Target. Approach: Design Example. Results: Enhancing SDTM. Agenda. Motivation.

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PhUSE 2008 Manchester 2008-10-12 / 2008-10-15 Michael Knoessl

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  1. PhUSE 2008Manchester 2008-10-12 / 2008-10-15Michael Knoessl Implementing CDISC at Boehringer Ingelheim Michael Knoessl

  2. B.C. Before CDISC CDISC – Impact • 2004 – 07 – 21 According to CDISC Michael Knoessl

  3. Motivation and Target Approach: Design Example Results: Enhancing SDTM Agenda Michael Knoessl

  4. Motivation • Issue:analyses on pooled databases (PDB) are increasing • Need:all clinical data of a project/substance available inone standardized structure for all clinical data • Task:investigate the CDISC data standardsfor usability for analysis & reporting Michael Knoessl

  5. Implementing CDISC at BI I C B I Motivation • need for efficient pooled databases (PDB) • need to submit data in CDISC standard Michael Knoessl

  6. Target • design and implementation of a • CLINICAL DATA MODEL • based on CDISC principles Michael Knoessl

  7. Target • CLINICAL DATA MODEL • corporate wide across trials, projects, substances • integralpart of the in-house clinical data business process • operational for single trials and pooled databases (PDB) • data quality check • Analysis Data Set (ADaM / ADS) creation • ad hoc analysis • CDISC principles of SDTM, ADaM, ODM, CT Michael Knoessl

  8. Motivation and Target Approach: Design Example Results: Enhancing SDTM Agenda Michael Knoessl

  9. Phase IIItrial Phase IItrial XD – Diagnostic Assessments XR – Central Assessments YT – Bleeding Events AE – Adverse Events EX – Exposure SE – Subject Elements TA – Trial Arms DM – Demographics Efficacy(SDTM Domains: XD, XR, YT) Safety (SDTM Domains: AE) Exposure(SDTM Domains: EX, SE, TA, TE, DM) Design Example - Objective test operability of CDISC SDTM Michael Knoessl

  10. SDTM+ Design Example - Methodology O*Cviews SDTM AnalysisData Sets detailed comparison SDTM vs. SDTM+ analyse transformation SDTM+ to SDTM Michael Knoessl

  11. Strive for the Goal O*Cviews SDTM AnalysisData Sets Clinical Data Model SDTM+ Michael Knoessl

  12. Motivation and Target Approach: Design Example Results: Enhancing SDTM Agenda Michael Knoessl

  13. Identified Plus + Michael Knoessl

  14. Identified Plus + Michael Knoessl

  15. SDTM domain 1 O*C view 1 SDTM domain 2 O*C view 2 SDTM domain 3 Deriveddata Mapping: O*C  SDTM no 1:1 relationship CRF/O*C : SDTM domain  carefully define mapping rules Michael Knoessl

  16. Additional Results • Variable renaming is exception - rule is complex transformations • CDISC SDTM does not cover all analysis & reporting relevant data •  additional records e.g. IE •  additional domains e.g. efficacy • CT - Controlled Terminology • consistency between variable and content • pooling requirement • CDISC CT does not provide sufficient cover yet • define BI CT to comply with CDISC CT •  consolidation of existing GLIB formats Michael Knoessl

  17. Overall Risks and Benefits - Risks - Benefits … Current Standards … Processes, Systems - Current Standards - Global Library - Macros - Clinical Data Flow - Systems (O*C, LSH) - External Data- Legacy Data … Compliance - Functions / Roles - SOPs and Guidelines - Training - Validation … Resources, Commitment - other BI Initiatives - Effort and Cost - Organisation Impact on … Michael Knoessl

  18. Phase IIItrial Phase IItrial XD – Diagnostic Assessments XR – Central Assessments YT – Bleeding Events AE – Adverse Events EX – Exposure SE – Subject Elements TA – Trial Arms DM – Demographics Efficacy(SDTM Domains: XD, XR, YT) Safety (SDTM Domains: AE) Exposure(SDTM Domains: EX, SE, TA, TE, DM) Design Example - Objective test operability of CDISC SDTM Michael Knoessl

  19. Operability of CDISC SDTM ? Michael Knoessl

  20. Benefit of Enhanced SDTM Clinical Data Model - creation of pooled databases (PDB) - facilitate analysis & reporting Michael Knoessl

  21. define. The Goal O*Cviews SDTM AnalysisData Sets Clinical Data Model SDTM+ Michael Knoessl

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