---
_id: '11746'
abstract:
- lang: eng
  text: "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."
article_number: '205520761877767'
author:
- first_name: Archana
  full_name: Tapuria, Archana
  last_name: Tapuria
- first_name: Philipp
  full_name: Bruland, Philipp
  id: '75847'
  last_name: Bruland
  orcid: 0000-0001-6939-7630
- first_name: Brendan
  full_name: Delaney, Brendan
  last_name: Delaney
- first_name: Dipak
  full_name: Kalra, Dipak
  last_name: Kalra
- first_name: Vasa
  full_name: Curcin, Vasa
  last_name: Curcin
citation:
  ama: Tapuria A, Bruland P, Delaney B, Kalra D, Curcin V. Comparison and transformation
    between CDISC ODM and EN13606 EHR standards in connecting EHR data with clinical
    trial research data. <i>Digital health</i>. 2018;4. doi:<a href="https://doi.org/10.1177/2055207618777676">10.1177/2055207618777676</a>
  apa: Tapuria, A., Bruland, P., Delaney, B., Kalra, D., &#38; Curcin, V. (2018).
    Comparison and transformation between CDISC ODM and EN13606 EHR standards in connecting
    EHR data with clinical trial research data. <i>Digital Health</i>, <i>4</i>, Article
    205520761877767. <a href="https://doi.org/10.1177/2055207618777676">https://doi.org/10.1177/2055207618777676</a>
  bjps: <b>Tapuria A <i>et al.</i></b> (2018) Comparison and Transformation between
    CDISC ODM and EN13606 EHR Standards in Connecting EHR Data with Clinical Trial
    Research Data. <i>Digital health</i> <b>4</b>.
  chicago: Tapuria, Archana, Philipp Bruland, Brendan Delaney, Dipak Kalra, and Vasa
    Curcin. “Comparison and Transformation between CDISC ODM and EN13606 EHR Standards
    in Connecting EHR Data with Clinical Trial Research Data.” <i>Digital Health</i>
    4 (2018). <a href="https://doi.org/10.1177/2055207618777676">https://doi.org/10.1177/2055207618777676</a>.
  chicago-de: Tapuria, Archana, Philipp Bruland, Brendan Delaney, Dipak Kalra und
    Vasa Curcin. 2018. Comparison and transformation between CDISC ODM and EN13606
    EHR standards in connecting EHR data with clinical trial research data. <i>Digital
    health</i> 4. doi:<a href="https://doi.org/10.1177/2055207618777676">10.1177/2055207618777676</a>,
    .
  din1505-2-1: '<span style="font-variant:small-caps;">Tapuria, Archana</span> ; <span
    style="font-variant:small-caps;">Bruland, Philipp</span> ; <span style="font-variant:small-caps;">Delaney,
    Brendan</span> ; <span style="font-variant:small-caps;">Kalra, Dipak</span> ;
    <span style="font-variant:small-caps;">Curcin, Vasa</span>: Comparison and transformation
    between CDISC ODM and EN13606 EHR standards in connecting EHR data with clinical
    trial research data. In: <i>Digital health</i> Bd. 4. Thousand Oaks, Calif. [u.a.]
    , SAGE Publications (2018)'
  havard: A. Tapuria, P. Bruland, B. Delaney, D. Kalra, V. Curcin, Comparison and
    transformation between CDISC ODM and EN13606 EHR standards in connecting EHR data
    with clinical trial research data, Digital Health. 4 (2018).
  ieee: 'A. Tapuria, P. Bruland, B. Delaney, D. Kalra, and V. Curcin, “Comparison
    and transformation between CDISC ODM and EN13606 EHR standards in connecting EHR
    data with clinical trial research data,” <i>Digital health</i>, vol. 4, Art. no.
    205520761877767, 2018, doi: <a href="https://doi.org/10.1177/2055207618777676">10.1177/2055207618777676</a>.'
  mla: Tapuria, Archana, et al. “Comparison and Transformation between CDISC ODM and
    EN13606 EHR Standards in Connecting EHR Data with Clinical Trial Research Data.”
    <i>Digital Health</i>, vol. 4, 205520761877767, 2018, <a href="https://doi.org/10.1177/2055207618777676">https://doi.org/10.1177/2055207618777676</a>.
  short: A. Tapuria, P. Bruland, B. Delaney, D. Kalra, V. Curcin, Digital Health 4
    (2018).
  ufg: '<b>Tapuria, Archana u. a.</b>: Comparison and transformation between CDISC
    ODM and EN13606 EHR standards in connecting EHR data with clinical trial research
    data, in: <i>Digital health</i> 4 (2018).'
  van: Tapuria A, Bruland P, Delaney B, Kalra D, Curcin V. Comparison and transformation
    between CDISC ODM and EN13606 EHR standards in connecting EHR data with clinical
    trial research data. Digital health. 2018;4.
date_created: 2024-07-18T13:34:20Z
date_updated: 2024-07-18T13:36:34Z
department:
- _id: DEP5024
doi: 10.1177/2055207618777676
extern: '1'
external_id:
  pmid:
  - '29942639'
intvolume: '         4'
keyword:
- EN13606
- Operational data model
- clinical archetypes
- electronic health records
- interoperability.
language:
- iso: eng
place: 'Thousand Oaks, Calif. [u.a.] '
pmid: '1'
publication: Digital health
publication_identifier:
  eissn:
  - 2055-2076
publication_status: published
publisher: SAGE Publications
status: public
title: Comparison and transformation between CDISC ODM and EN13606 EHR standards in
  connecting EHR data with clinical trial research data
type: scientific_journal_article
user_id: '83781'
volume: 4
year: '2018'
...