---
_id: '11745'
abstract:
- lang: eng
  text: "Background: Data capture is one of the most expensive phases during the conduct
    of a clinical trial and the increasing use of electronic health records (EHR)
    offers significant savings to clinical research. To facilitate these secondary
    uses of routinely collected patient data, it is beneficial to know what data elements
    are captured in clinical trials. Therefore our aim here is to determine the most
    commonly used data elements in clinical trials and their availability in hospital
    EHR systems.\r\n\r\nMethods: Case report forms for 23 clinical trials in differing
    disease areas were analyzed. Through an iterative and consensus-based process
    of medical informatics professionals from academia and trial experts from the
    European pharmaceutical industry, data elements were compiled for all disease
    areas and with special focus on the reporting of adverse events. Afterwards, data
    elements were identified and statistics acquired from hospital sites providing
    data to the EHR4CR project.\r\n\r\nResults: The analysis identified 133 unique
    data elements. Fifty elements were congruent with a published data inventory for
    patient recruitment and 83 new elements were identified for clinical trial execution,
    including adverse event reporting. Demographic and laboratory elements lead the
    list of available elements in hospitals EHR systems. For the reporting of serious
    adverse events only very few elements could be identified in the patient records.\r\n\r\nConclusions:
    Common data elements in clinical trials have been identified and their availability
    in hospital systems elucidated. Several elements, often those related to reimbursement,
    are frequently available whereas more specialized elements are ranked at the bottom
    of the data inventory list. Hospitals that want to obtain the benefits of reusing
    data for research from their EHR are now able to prioritize their efforts based
    on this common data element list."
article_number: '159'
author:
- first_name: Philipp
  full_name: Bruland, Philipp
  id: '75847'
  last_name: Bruland
  orcid: 0000-0001-6939-7630
- first_name: Mark
  full_name: McGilchrist, Mark
  last_name: McGilchrist
- first_name: Eric
  full_name: Zapletal, Eric
  last_name: Zapletal
- first_name: Dionisio
  full_name: Acosta, Dionisio
  last_name: Acosta
- first_name: Johann
  full_name: Proeve, Johann
  last_name: Proeve
- first_name: Scott
  full_name: Askin, Scott
  last_name: Askin
- first_name: Thomas
  full_name: Ganslandt, Thomas
  last_name: Ganslandt
- first_name: Justin
  full_name: Doods, Justin
  last_name: Doods
- first_name: Martin
  full_name: Dugas, Martin
  last_name: Dugas
citation:
  ama: Bruland P, McGilchrist M, Zapletal E, et al. Common data elements for secondary
    use of electronic health record data for clinical trial execution and serious
    adverse event reporting. <i>BMC Medical Research Methodology</i>. 2016;16(1).
    doi:<a href="https://doi.org/10.1186/s12874-016-0259-3">10.1186/s12874-016-0259-3</a>
  apa: Bruland, P., McGilchrist, M., Zapletal, E., Acosta, D., Proeve, J., Askin,
    S., Ganslandt, T., Doods, J., &#38; Dugas, M. (2016). Common data elements for
    secondary use of electronic health record data for clinical trial execution and
    serious adverse event reporting. <i>BMC Medical Research Methodology</i>, <i>16</i>(1),
    Article 159. <a href="https://doi.org/10.1186/s12874-016-0259-3">https://doi.org/10.1186/s12874-016-0259-3</a>
  bjps: <b>Bruland P <i>et al.</i></b> (2016) Common Data Elements for Secondary Use
    of Electronic Health Record Data for Clinical Trial Execution and Serious Adverse
    Event Reporting. <i>BMC Medical Research Methodology</i> <b>16</b>.
  chicago: Bruland, Philipp, Mark McGilchrist, Eric Zapletal, Dionisio Acosta, Johann
    Proeve, Scott Askin, Thomas Ganslandt, Justin Doods, and Martin Dugas. “Common
    Data Elements for Secondary Use of Electronic Health Record Data for Clinical
    Trial Execution and Serious Adverse Event Reporting.” <i>BMC Medical Research
    Methodology</i> 16, no. 1 (2016). <a href="https://doi.org/10.1186/s12874-016-0259-3">https://doi.org/10.1186/s12874-016-0259-3</a>.
  chicago-de: Bruland, Philipp, Mark McGilchrist, Eric Zapletal, Dionisio Acosta,
    Johann Proeve, Scott Askin, Thomas Ganslandt, Justin Doods und Martin Dugas. 2016.
    Common data elements for secondary use of electronic health record data for clinical
    trial execution and serious adverse event reporting. <i>BMC Medical Research Methodology</i>
    16, Nr. 1. doi:<a href="https://doi.org/10.1186/s12874-016-0259-3">10.1186/s12874-016-0259-3</a>,
    .
  din1505-2-1: '<span style="font-variant:small-caps;"><span style="font-variant:small-caps;">Bruland,
    Philipp</span> ; <span style="font-variant:small-caps;">McGilchrist, Mark</span>
    ; <span style="font-variant:small-caps;">Zapletal, Eric</span> ; <span style="font-variant:small-caps;">Acosta,
    Dionisio</span> ; <span style="font-variant:small-caps;">Proeve, Johann</span>
    ; <span style="font-variant:small-caps;">Askin, Scott</span> ; <span style="font-variant:small-caps;">Ganslandt,
    Thomas</span> ; <span style="font-variant:small-caps;">Doods, Justin</span> ;
    u. a.</span>: Common data elements for secondary use of electronic health record
    data for clinical trial execution and serious adverse event reporting. In: <i>BMC
    Medical Research Methodology</i> Bd. 16. London, Springer Science and Business
    Media LLC (2016), Nr. 1'
  havard: P. Bruland, M. McGilchrist, E. Zapletal, D. Acosta, J. Proeve, S. Askin,
    T. Ganslandt, J. Doods, M. Dugas, Common data elements for secondary use of electronic
    health record data for clinical trial execution and serious adverse event reporting,
    BMC Medical Research Methodology. 16 (2016).
  ieee: 'P. Bruland <i>et al.</i>, “Common data elements for secondary use of electronic
    health record data for clinical trial execution and serious adverse event reporting,”
    <i>BMC Medical Research Methodology</i>, vol. 16, no. 1, Art. no. 159, 2016, doi:
    <a href="https://doi.org/10.1186/s12874-016-0259-3">10.1186/s12874-016-0259-3</a>.'
  mla: Bruland, Philipp, et al. “Common Data Elements for Secondary Use of Electronic
    Health Record Data for Clinical Trial Execution and Serious Adverse Event Reporting.”
    <i>BMC Medical Research Methodology</i>, vol. 16, no. 1, 159, 2016, <a href="https://doi.org/10.1186/s12874-016-0259-3">https://doi.org/10.1186/s12874-016-0259-3</a>.
  short: P. Bruland, M. McGilchrist, E. Zapletal, D. Acosta, J. Proeve, S. Askin,
    T. Ganslandt, J. Doods, M. Dugas, BMC Medical Research Methodology 16 (2016).
  ufg: '<b>Bruland, Philipp u. a.</b>: Common data elements for secondary use of electronic
    health record data for clinical trial execution and serious adverse event reporting,
    in: <i>BMC Medical Research Methodology</i> 16 (2016), H. 1.'
  van: Bruland P, McGilchrist M, Zapletal E, Acosta D, Proeve J, Askin S, et al. Common
    data elements for secondary use of electronic health record data for clinical
    trial execution and serious adverse event reporting. BMC Medical Research Methodology.
    2016;16(1).
date_created: 2024-07-18T13:31:36Z
date_updated: 2024-07-18T13:33:42Z
department:
- _id: DEP5024
doi: 10.1186/s12874-016-0259-3
extern: '1'
intvolume: '        16'
issue: '1'
keyword:
- Clinical trials
- Common data elements
- Data quality
- Electronic health records
- Metadata
- Secondary use
language:
- iso: eng
place: London
publication: BMC Medical Research Methodology
publication_identifier:
  issn:
  - 1471-2288
publication_status: published
publisher: Springer Science and Business Media LLC
status: public
title: Common data elements for secondary use of electronic health record data for
  clinical trial execution and serious adverse event reporting
type: scientific_journal_article
user_id: '83781'
volume: 16
year: '2016'
...