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CDISC Technology

CDISC Technology. HITSP, 15 th October 2008 Dave Iberson-Hurst CDISC VP Technical Strategy. The Request. Current interchange formats (strengths and weaknesses)

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CDISC Technology

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  1. CDISC Technology HITSP, 15th October 2008 Dave Iberson-HurstCDISC VP Technical Strategy

  2. The Request • Current interchange formats (strengths and weaknesses) • Consider all healthcare information interchange architectures such as messaging, structured documents, health records and service oriented architectures • Consider transport and security • Relationship among your interchange formats, if multiple • XML now or in future plans • “Style Guide” of how information transformed into interchange format • Available tools, e.g., mappings or transforms • Supported architectures

  3. Overview

  4. CDISC The mission of CDISC is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.

  5. Technical Vision • Documented in Technical Road Map • http://www.cdisc.org/about/downloads/CDISC_Road_Map_Spring2008.pdf • Next version released Q4 2008/Q1 2009 • Will encompass • more integrated approach • improved process

  6. * Specification referenced via FDA Final Guidance

  7. The Foundation Stone Design Execute Analyse & Submit Protocol CDASH LAB SDTM(SEND) ADaM

  8. The Foundation Stone • Integrated standards • Protocol to Submission • The foundation stone • Then … • We can grow standards into other areas • The basis for the evolution of the CDISC products

  9. Key Principles

  10. Aligned With and By BRIDG Biomedical Research Integrated Domain Model (BRIDG) Protocol CDASH LAB SDTM (SEND) ADaM

  11. Same Concept, Same Meaning Biomedical Research Integrated Domain Model (BRIDG) Protocol CDASH LAB SDTM(SEND) ADaM

  12. BRIDG - What is it? The BRIDG model is an instance of a Domain Analysis Model (DAM). As such, it depicts a shared representation of the dynamic and static semantics of a particular domain-of-interest.

  13. The Revised, 2-layered (2-views) BRIDG Model Consistent levels of abstraction and explicitness in multiple sub-domain ‘Requirements Models’ Understandable to Domain Experts Sub-Domain 1 Sub-Domain 2 Sub-Domain 3 Sub-Domain 4 Sub-Domain 5 Consistent levels of standards-compliance and explicitness in a single ‘Analysis Model’ Unambiguously mappable to HL7 Reference Implementation Model Slide courtesy of Charlie Mead & John Speakman, NCI

  14. Use of BRIDG ApplicationDevelopment Message Development Data ExchangeStandards

  15. Alignment ApplicationDevelopment Message Development Data ExchangeStandards

  16. Quarter 2, 2009 Biomedical Research Integrated Domain Model (BRIDG) Protocol CDASH LAB SDTM (SEND)

  17. By The End of 2009 Biomedical Research Integrated Domain Model (BRIDG) Protocol CDASH LAB SDTM (SEND) ADaM

  18. Separation of Content and Transport • Key Items • BRIDG (broader audience via ISO) • Terminology • Consistently applied across all standards Protocol CDASH LAB SDTM (SEND) ADaM Transport

  19. Transport BRIDG Protocol CDASH LAB SDTM SEND) ADaM ODM & Extensions Define.xml SAS XPT

  20. Transport BRIDG Protocol CDASH LAB SDTM(SEND) ADaM ODM & Extensions HL7 V3

  21. Use of XML • CDISC • Operational Data Model • Laboratory Model • HL7 • HL7 Messages (FDA regulatory submission) • CDA being investigated

  22. Integrated with healthcare Medical Research Protocol CDASH LAB SDTM (SEND) ADaM Healthcare

  23. Integrated with Healthcare • Working with Integrating the Healthcare Enterprise (IHE) • HIMMS 2007, 2008 and 2009 • Retrieve Form for Data Capture (RFD) • Further (content) profiles being developed • CDASH • Protocol • RFD reached level of maturity • Ready for the next leap

  24. Integrated with Healthcare • Working with Integrating the Healthcare Enterprise (IHE) • HIMMS 2007, 2008 and 2009 • Retrieve Form for Data Capture (RFD) • Further (content) profiles being developed • CDASH • Protocol • RFD reached level of maturity • Ready for the next leap STOP PRESS! RFD Goes Live. First two subjects enrolled in a live study 15th December 2008

  25. FDA PDUFA IV IT Plan

  26. Target Clinical Data Flow Site Sponsor CDISC Content and Interchange Interchange: HL7 output file CDISC Content CDASH CDASH ODM Trial Design Sponsor Data Warehouse (ODM) Data Checker and Loader FDA Reviewers Review Tools Janus FDA/NCI Analytical Data Warehouse Site Data Archive (ODM) MedWatch AE Reports (ICSR)

  27. PDUFA IV IT Plan • Lists key CDISC projects • SDTM • CDISC HL7 • BRIDG • SEND • CDASH • ADaM • Links • http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-N-0352-bkg.pdf • http://www.accessdata.fda.gov/scripts/oc/ohrms/dailylist.cfm?yr=2008&mn=6&dy=30

  28. Summary

  29. Summary • Complete the “Foundation Stone” of content • Consistency across the CDISC standards • Stability of the CDISC standards • Evolution of the CDISC standards • Supported by CDISC XML and HL7 XML transport mechanisms • Linked to RIM 2009

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