1 / 21

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.

aletta
Télécharger la présentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related