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Jozef Aerts - XML4Pharma. CDASH, electronic medical records and ODM – status update. The Standards. ODM: standard for clinical data CDASH: standardized Forms - SDTM EHR “standards”: HL7: Continuity of Care Document (CCD) OpenEHR. The challenge. Can we integrate EHR and EDC systems ?

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Jozef aerts xml4pharma

Jozef Aerts - XML4Pharma

CDASH, electronic medical records and ODM – status update


The standards
The Standards

  • ODM: standard for clinical data

  • CDASH: standardized Forms - SDTM

  • EHR “standards”:

    • HL7: Continuity of Care Document (CCD)

    • OpenEHR


The challenge
The challenge

  • Can we integrate EHR and EDC systems ?

    • Physicians/Investigators only need to use 1 system

    • eCRFs are prepopulated with EHR data


It is not only a technical problem
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


Ihe i ntegrating the h ealthcare e nterprise
IHE: Integrating the Healthcare Enterprise

  • Defines “Integration Profiles”

  • Brings SDOs, vendors, developers and users together

  • Organizes “Connectathons”

    • 2009: Vienna, Chicago




Retrieve form for data capture profile rfd clinical research data capture profile crd
“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


The rfd and crd ingredients
The RFD and CRD “Ingredients”

  • HL7 “Continuity of Care Document”

    • HL7-v3 message in XML

    • Generated from CDA

  • CDISC ODM 1.3

  • CDASH

  • XForms


The integration team the geeks
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



Cdash odm metadata a cdash form in odm
CDASH - ODM Metadata(a CDASH form in ODM)


The missing link
The missing link ...

  • Must be vendor-neutral

  • Must be EHR-neutral

    • Not limited to CCD

  • Must match with CDASH


The solution odm cdash clinicaldata prepopdata
The solution:ODM-CDASH ClinicalData“PrepopData”




The european situation
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


Rfd and crd profiles for openehr
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



The prepopdata intermediate
The “PrepopData”(intermediate)



Cdisc and ehr jozef s strong opinions
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



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