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CDASH, electronic medical records and ODM

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CDASH, electronic medical records and ODM status update Jozef Aerts - XML4Pharma The Standards ODM: standard for clinical data CDASH: standardized Forms - SDTM ... – PowerPoint PPT presentation

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Title: CDASH, electronic medical records and ODM


1
CDASH, electronic medical records and ODM
status update
  • Jozef Aerts - XML4Pharma

2
The Standards
  • ODM standard for clinical data
  • CDASH standardized Forms - SDTM
  • EHR standards
  • HL7 Continuity of Care Document (CCD)
  • OpenEHR

3
The challenge
  • Can we integrate EHR and EDC systems ?
  • Physicians/Investigators only need to use 1
    system
  • eCRFs are prepopulated with EHR data

4
It is not only a technical problem
  • EHR vendors are not interested in EDC
  • niche market
  • 21 CFR Part 11
  • EDC vendors are afraid of EHR
  • too big world
  • complex

5
IHE Integrating the Healthcare Enterprise
  • Defines Integration Profiles
  • Brings SDOs, vendors, developers and users
    together
  • Organizes Connectathons
  • 2009 Vienna, Chicago

6
The IHE Process
7
IHE Connectathon
8
Retrieve Form for Data Capture profile
(RFD)Clinical Research Data Capture profile
(CRD)
  • Retrieve data from an EHR system
  • Populate eCRF with EHR data
  • within EHR system
  • or within EDC system
  • Submit completed form
  • to EDC system
  • or to EHR system

9
The RFD and CRD Ingredients
  • HL7 Continuity of Care Document
  • HL7-v3 message in XML
  • Generated from CDA
  • CDISC ODM 1.3
  • CDASH
  • XForms

10
The integration team(the geeks)
  • Kevin Powel Cerner
  • John Gedeon Cerner
  • Daemon Whittenburg - Greenway Medical
  • Jason Colquitt Greenway Medical
  • Andrew Fowler XClinical
  • Gary Walker Quintiles
  • Chris Connor Phoenix Data Systems
  • Rhonda Facile CDISC
  • Jozef Aerts XML4Pharma

11
(No Transcript)
12
Continuation of Care Document(CCD)
13
CDASH - ODM Metadata(a CDASH form in ODM)
14
The missing link ...
  • Must be vendor-neutral
  • Must be EHR-neutral
  • Not limited to CCD
  • Must match with CDASH

15
The solutionODM-CDASH ClinicalDataPrepopData
16
The process
17
The result
18
The European situation
  • CEN 13606 for EHR extracts
  • HL7-v3-XML does not comply
  • OpenEHR extracts comply
  • CDISC, IHE and HL7 are US-centric
  • IHE-RFD should be extended to other EHR
    standards than HL7

19
RFD and CRD-profiles for OpenEHR
  • XSLT stylesheet for OpenEHR to PrepopData has
    been developed
  • Trying to interest OpenEHR vendors for demo
    application
  • CDISC seems to be open for integration with
    non-HL7 systems

20
The source OpenEHR extract
21
The PrepopData(intermediate)
22
The result prefilled eCRF
23
CDISC and EHRJozef's strong opinions
  • CDISC thinks too US-centric
  • There is more in the world than HL7HL7 is not
    the only SDO in Healthcare
  • HL7-v3-XML is not the best basis for
    EHR(HL7-v3-XML datatypes rejected by CEN)
  • CEN, ISO, HL7 do talk to each otherfirst result
    ISO-21090 datatypes
  • CDISC should have the same relationship with
    CEN-TC251 as it has with HL7

24
Europeans raise your voice !
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