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

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 ?  Physicians/Investigators only need to use 1 system  eCRFs are prepopulated with EHR data

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: Integrating the Healthcare Enterprise Defines “Integration Profiles” Brings SDOs, vendors, developers and users together Organizes “Connectathons”  2009: Vienna, Chicago

The IHE Process

IHE Connectathon

“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” HL7 “Continuity of Care Document”  HL7-v3 message in XML  Generated from CDA CDISC ODM 1.3 CDASH XForms

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

Continuation of Care Document (CCD)

CDASH - ODM Metadata (a CDASH form in ODM)

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 process

The result

The European situation CEN 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 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 source: OpenEHR extract

The “PrepopData” (intermediate)

The result: prefilled eCRF

CDISC and EHR Jozef's strong opinions CDISC thinks too US-centric There is more in the world than HL7 HL7 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 other first result: ISO datatypes CDISC should have the same relationship with CEN-TC251 as it has with HL7

Europeans: raise your voice !