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Healthcare Link Initiatives: Bridging Clinical Research and Healthcare

Healthcare Link Initiatives: Bridging Clinical Research and Healthcare. May 29, 2008 Bay Area Users’ Group Landen Bain CDISC Liaison to Healthcare. Submission Standards Protocol Representation Critical Path Initiative. WHO International Clinical Trial Registry Platform.

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Healthcare Link Initiatives: Bridging Clinical Research and Healthcare

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  1. Healthcare Link Initiatives: Bridging Clinical Research and Healthcare May 29, 2008 Bay Area Users’ Group Landen Bain CDISC Liaison to Healthcare

  2. Submission Standards • Protocol Representation • Critical Path Initiative WHO International Clinical Trial Registry Platform • Liaison Status to ISO/TAG215 • Submitted CDISC Standard • as New Work Item Terminology BRIDG • Protocol Representation w/ • elements mapped to EudraCT • Discussing all CDISC projects PhRMA EFPIA C D A S H NIH / DCRI • Shared Information • Business Case • CDASH • IA Project • eSubmissions Data Collection Stds (FDA Critical Path) • Integration Profile • Healthcare Link Demo CV/ TB Data Stds

  3. Healthcare Link Relationships

  4. (e)Source Documents EHR Circa 1998 ….. data conception (e)CRFs Healthcare Delivery Clinical Research eSource auto reconciliation

  5. Patient Care World Single Source 2003 Clinical Research World • An industry initiative that has successfully • demonstrated clinical information interoperability • between physician clinical systems (EHR) • and pharmaceutical clinical trials systems • based on open standards. • Duke Medical Center, Duke Clinical Research Institute, • CDISC, Novartis, Merck, J&J, Microsoft JAMIA article to be published.

  6. Integrating the Healthcare Enterprise • IHE is a collaborative initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. IHE promotes the coordinated use of established standards such as DICOM and HL7 (and CDISC!). • THE FOUR STEPS OF THE IHE PROCESS • Identify Interoperability Problems. • Specify Integration Profiles. • Test Systems at the Connectathon and Demonstrate at the Interoperability Showcase at HIMSS. • Publish Integration Statements for use in RFPs.

  7. Integrating the Healthcare Enterprise • IHE is a collaborative initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. IHE promotes the coordinated use of established standards such as DICOM and HL7 (and CDISC!). • THE FOUR STEPS OF THE IHE PROCESS • Identify Interoperability Problems. • Specify Integration Profiles. • Test Systems at the Connectathon and Demonstrate at the Interoperability Showcase at HIMSS. • Publish Integration Statements for use in RFPs. 1. Identify Interoperability Problem

  8. Retrieve Form for Data Capture Integrating the Healthcare Enterprise • IHE is a collaborative initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. IHE promotes the coordinated use of established standards such as DICOM and HL7 (and CDISC!). • THE FOUR STEPS OF THE IHE PROCESS • Identify Interoperability Problems. • Specify Integration Profiles. • Test Systems at the Connectathon and Demonstrate at the Interoperability Showcase at HIMSS. • Publish Integration Statements for use in RFPs. 2. Specify Integration Profiles

  9. Integrating the Healthcare Enterprise • IHE is a collaborative initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. IHE promotes the coordinated use of established standards such as DICOM and HL7 (and CDISC!). • THE FOUR STEPS OF THE IHE PROCESS • Identify Interoperability Problems. • Specify Integration Profiles. • Test Systems at the Connectathon and Demonstrate at the Interoperability Showcase at HIMSS. • Publish Integration Statements for use in RFPs. 3. Test Systems at the Connectathon and Demonstrate at the HIMSS Interoperability Showcase.

  10. Healthcare Link Technology

  11. Healthcare Medical Research EHR Protocol Form Manager Form Filler Healthcare Link Data Archiver Data Receiver • RFD’s Four Actors enable: • Visual integration of eCRF into the EHR • Creation of an eSource document independent of the EHR • Integration of workflow while maintaining separation of data

  12. ASTER is mentioned twice: p. 7 & p. 20 p. 7, note 12: “CDISC has developed a tool that converts source data from a clinical information system to a format that can be transmitted to regulatory authorities to report clinical trial adverse events. “

  13. Current paper-based practice. Healthcare Research Physician/investigator photo-copies a page out of medical record, eyeballs it, edits it, derives needed data for submission, and files it as a paper source document. The chain of custody is severed at that point, and the source is now the paper copy, not the original from the paper chart. How RFD mimics the paper flow. 1. Electronic ‘photocopy’ of a medical summary (CCD) routed to Form Mgr 4. Investigator eyeballs form, verifies copy, edits, submits data, and saves as eSource, cutting chain of custody. Form Filler Form Mgr 2. Form Mgr ‘pastes’ the ‘photocopy’ into the form. 3. Form with ‘photocopy’ of EHR data returned to EHR

  14. IHE Grouping Model: Bind content creators and consumers to a single integration profile transaction Content Profile: Clinical Trial Data Content Creator HL7 CDA Medical Summary (CCD) Mapping Content Consumer Standard CRF ODM/CDASH CCD In CDASHOut Form Manager Form Filler Retrieve Form Transaction Integration Profile: RFD

  15. RFD: A Disruptive Innovation “Two paradigmatic trajectories of progress interact.” http://www.12manage.com/methods_christensen_disruptive_innovation.html

  16. Strength through collaboration. lbain@cdisc.org

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