---
res:
  bibo_abstract:
  - "Objectives: Integrating Electronic Health Record (EHR) systems into the field
    of clinical trials still contains several challenges and obstacles. Heterogeneous
    standards and specifications are used to represent healthcare and clinical trial
    information. Therefore, this work investigates the mapping and data interoperability
    between healthcare and research standards: EN13606 used for the EHRs and the Clinical
    Data Interchange Standards Consortium Operational Data Model (CDISC ODM) used
    for clinical research.\r\n\r\nMethods: Based on the specifications of CDISC ODM
    1.3.2 and EN13606, a mapping between the structure and components of both standards
    has been performed. Archetype Definition Language (ADL) forms built with the EN13606
    editor were transformed to ODM XML and reviewed. As a proof of concept, clinical
    sample data has been transformed into ODM and imported into an electronic data
    capture system. Reverse transformation from ODM to ADL has also been performed
    and finally reviewed concerning map-ability.\r\n\r\nResults: The mapping between
    EN13606 and CDISC ODM shows the similarities and differences between the components
    and overall record structure of the two standards. An EN13606 archetype corresponds
    with a group of items within CDISC ODM. Transformations of element names, descriptions,
    different languages, datatypes, cardinality, optionality, units, value range and
    terminology codes are possible from EN13606 to CDISC ODM and vice versa.\r\n\r\nConclusion:
    It is feasible to map data elements between EN13606 and CDISC ODM and transformation
    of forms between ADL and ODM XML format is possible with only minor limitations.
    EN13606 can accommodate clinical information in a more structured manner with
    more constraints, whereas CDISC ODM is more suitable and specific for clinical
    trials and studies. It is feasible to transform EHR data in the EN13606 form to
    ODM to transfer it into research database. The attempt to use EN13606 to build
    a study protocol (that was already built with CDISC ODM) also suggests the possibility
    of using EN13606 standard in place of CDISC ODM if needed to avoid transformations.@eng"
  bibo_authorlist:
  - foaf_Person:
      foaf_givenName: Archana
      foaf_name: Tapuria, Archana
      foaf_surname: Tapuria
  - foaf_Person:
      foaf_givenName: Philipp
      foaf_name: Bruland, Philipp
      foaf_surname: Bruland
      foaf_workInfoHomepage: http://www.librecat.org/personId=75847
    orcid: 0000-0001-6939-7630
  - foaf_Person:
      foaf_givenName: Brendan
      foaf_name: Delaney, Brendan
      foaf_surname: Delaney
  - foaf_Person:
      foaf_givenName: Dipak
      foaf_name: Kalra, Dipak
      foaf_surname: Kalra
  - foaf_Person:
      foaf_givenName: Vasa
      foaf_name: Curcin, Vasa
      foaf_surname: Curcin
  bibo_doi: 10.1177/2055207618777676
  bibo_volume: 4
  dct_date: 2018^xs_gYear
  dct_isPartOf:
  - http://id.crossref.org/issn/2055-2076
  dct_language: eng
  dct_publisher: SAGE Publications@
  dct_subject:
  - EN13606
  - Operational data model
  - clinical archetypes
  - electronic health records
  - interoperability.
  dct_title: Comparison and transformation between CDISC ODM and EN13606 EHR standards
    in connecting EHR data with clinical trial research data@
  fabio_hasPubmedId: '29942639'
...