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Clinical Trials virtual tour

Clinical Trials virtual tour. HL7-IHE Demonstration HIMSS 2004. Meredith Nahm Director of Clinical Data Integration Duke Clinical Research Institute Durham, North Carolina. Presented by. High-level animated walkthrough Detailed view Application tools Standards and Profiles.

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Clinical Trials virtual tour

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  1. Clinical Trialsvirtual tour HL7-IHE Demonstration HIMSS 2004

  2. Meredith Nahm Director of Clinical Data Integration Duke Clinical Research Institute Durham, North Carolina Presented by

  3. High-level animated walkthrough Detailed view Application tools Standards and Profiles Virtual Tour

  4. Community Acquired Pneumonia Clinical Trial 250 Patients and 12 sites QT prolongation is a potential adverse event in the class of drugs under study Trial uses a Core Lab for Central reading of ECG’s Clinical Trial

  5. Clinical Trials: Integrating with patient care Adobe Berdy Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS Imaging aECG Arden CCOW CDA CT EUA LDM ODM PIX PSA RID RIM SDM SPL SWF V2 V3 Hospital PCP FDA Hospital Central Lab Core Lab Sponsor Patients seen at PCP, hospitals ECGs sent to Core Lab; annotated on site or at Core Lab

  6. Clinical Trials: Integrating with patient care Adobe Berdy Medical Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Medical Systems Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS Dictation Repository aECG Arden CCOW CDA CT EUA ODM PIX PSA RID RIM SDM SPL SWF V2 V3 Imaging Hospital PCP Query broker, trusted 3rd party FDA Hospital ? Registry Central Lab Core Lab Sponsor Sponsor identifies QT prolongation Requests additional documentation

  7. Clinical Trials: Integrating with patient care Adobe Berdy Medical Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Medical Systems Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS aECG Arden CCOW CDA CT EUA ODM PIX PSA RID RIM SDM SPL SWF V2 V3 Patients seen at PCP, hospitals ECGs sent to Core Lab; annotated on site or at Core Lab

  8. Clinical Trials: Integrating with patient care Adobe Berdy Medical Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Medical Systems Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS aECG Arden CCOW CDA CT EUA ODM PIX PSA RID RIM SDM SPL SWF V2 V3 Patients seen at PCP, hospitals ECGs sent to Core Lab; annotated on site or at Core Lab

  9. Clinical Trials: Integrating with patient care Adobe Berdy Medical Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Medical Systems Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS aECG Arden CCOW CDA CT EUA ODM PIX PSA RID RIM SDM SPL SWF V2 V3 Intervals for Analysis imported into Clinical Data Management System at Core Lab

  10. Clinical Trials: Integrating with patient care Adobe Berdy Medical Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Medical Systems Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS aECG Arden CCOW CDA CT EUA ODM PIX PSA RID RIM SDM SPL SWF V2 V3 Analysis data in ODM/SDM delivered to Sponsor Sponsor uses FDA Viewer to view waveforms

  11. Clinical Trials: Integrating with patient care Adobe Berdy Medical Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Medical Systems Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS aECG Arden CCOW CDA CT EUA ODM PIX PSA RID RIM SDM SPL SWF V2 V3 Sponsor identifies QT prolongation Polls registry through a Third Party Broker

  12. Clinical Trials: Integrating with patient care Adobe Berdy Medical Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Medical Systems Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS aECG Arden CCOW CDA CT EUA ODM PIX PSA RID RIM SDM SPL SWF V2 V3 Sponsor requests additional information Queries NIST registry, and obtains documents through a Third Party broker

  13. Clinical Trials: Integrating with patient care Adobe Berdy Medical Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Medical Systems Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS aECG Arden CCOW CDA CT EUA ODM PIX PSA RID RIM SDM SPL SWF V2 V3 Sponsor submits SDM data to the FDA Using HL7 v3 message and CDISC/HL7 standards

  14. Clinical Trials: Integrating with patient care Adobe Berdy Medical Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Medical Systems Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS aECG Arden CCOW CDA CT EUA ODM PIX PSA RID RIM SDM SPL SWF V2 V3 FDA uses Patient Profile Viewer and ECG Viewer To view SDM and waveform data

  15. Clinical Trials: Integrating with patient care Adobe Berdy Medical Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Medical Systems Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS Dictation Repository aECG Arden CCOW CDA CT EUA ODM PIX PSA RID RIM SDM SPL SWF V2 V3 Imaging Hospital PCP Query broker, trusted 3rd party FDA Hospital Repository ? Registry Central Lab Core Lab Sponsor Patients seen at PCP, hospitals ECGs sent to Core Lab, Sponsor and FDA

  16. Special thanks to • Mallinckrodt Institute of Radiology • Patient Identifier Cross Referencing (PIX) server • Fred Behlen, Laitek Technologies • DICOM SR to CDA transformation • The SIMI Group • State Department of Health application • Michael Palmer, Zurich Biotech • SAS to ODM conversion • NorthEast Monitoring • Corelab software integrating aECGs • CSS Informatics • FDA Patient Profile Viewer • AMPS • FDA aECG Viewer • Amnon Shabo, IBM Haifa • Sample CDA Botulism Case Report • Data Conversion Labs • Sample Structured Product Labeling transformation

  17. Demo Executive Committee • HL7 • Karen Van Hentenryck, HL7 Associate Director • Landen Bain, Co-chair, HL7 Marketing Committee • IHE • Joyce Sensmeier, HIMSS • Chris Carr, RSNA

  18. Invitation to Tour • Guided Tours start on the quarter hour • Self-guided Tours anytime • Maps available at Reception • Complete a tour, win a prize • Get each location initialled by participant • Go to reception with completed map • Enter a business card to win • HL7 Working Group Registration (drawing 1/day) • HIMSS 2005 Registration (drawing 1/week)

  19. Start Start Continuity of Care Tour Start Clinical Trials Tour Patient Safety Tour Public Health Tour Start PIX Patient Identifier Cross Referencing (V2)1, 11 PSA Patient Synchronized Application (CCOW) 1, 14, 18,28, 29, 30, RID Retrieve Information for Display1,8, 10,11,15,18,29, 30 RIM Reference Information Model (V3)2, 4,6, 7, 9, 10, 11, 12, 13, 16,19,20,21, 22, 23, 24, 25, 26, 27,32 SDS Submissions Data Standard (CDISC)20, 21 SPL Structured Product Label (CDA)19 SWF Scheduled Work Flow (V2, DICOM)1,2,3,29,31 V2 Version 2 messaging1,5,6, 8, 9,11,12,17,18,22,25,26,32 V3 Version 3 messaging 4,9,10,11,16,19,20,21,22,24,27,32 aECG Annotated ECG (V3)4, 16, 19, 20,21, 27 Arden Arden Syntax Medical Logic Modules 17, 19, 26 CCOW Clinical Context Object Workgroup1,14, 15, 17, 18, 28, 29, 30 CDA Clinical Document Architecture (RIM)2, 6, 7, 9, 10, 11, 12, 13, 20, 22, 23, 24, 25, 26, 32 CT Integration Profile for Consistent Time1, 2, 18, 30 EUA Enterprise User Authentication (Kerberos)1, 2, 14, 18, 28, 30 Integration Profiles: 1, 2, 3, 6, 8, 10, 11, 14, 15, 18, 28, 29, 30, 31 LDM Lab Data Model (V3, CDISC)20 ODM Operational Data Model (CDISC)20, 21 Walking Tour Tour Guide HL7-IHE Interoperability Demonstration Booth 4638 GE CWeb • Take A Tour, Win A Prize! • Get a stamp at every stop on a tour • Take stamped Tour Guide to receptionist • Enter to win a Prize! • -HL7 Registration or • -HIMSS 2005 Registration GE RA600 1 2 Kodak Carefx/GE 3 4 GE Solar Mortara ACP/FDA 19 15 14 5 GE MUSE DigitalInfuzion Misys 16 Guided tours on the quarter hour; Self-guided tours any time 20 18 17 AISLE 6 MS InfoPath Dictaphone GE ED Eclipsys 7 C L A S S R O O M DCRI 8 21 Berdy SNOMED Soarian Siemens OL T H E A T E R Philips Adobe 9 CommerceNet 13 CDC/UCDavis MS BTS 23 24 25 26 27 Kryptiq 22 12 10 31 32 30 29 28 Raining Data 11 Ximis Epic NIST Sentillion INFINITT GE CPortal AISLE

  20. Thank you • Questions? • Tours starting now • This presentation will be available on www.rsna.org/IHE/hl7ihedemo

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