title: Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Institute of Medical Informatics, University of Münster, Münster, 48149, Germany. philipp.bruland@uni-muenster.de.
authors.forename: Philipp
authors.identifier: 0000-0001-6939-7630
authors.initials: P
authors.lastname: Bruland
authors.affiliation: University of Dundee, Dundee, DD2 4BF, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: McGilchrist
authors.affiliation: Département d'Informatique Hospitalière, AP-HP, Hôpital Européen Georges Pompidou, Paris, 75015, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Zapletal
authors.affiliation: CHIME, Institute of Health Informatics, University College London, London, NW1 2DA, UK.
authors.forename: Dionisio
authors.initials: D
authors.lastname: Acosta
authors.affiliation: Previously Bayer Healthcare, Building K9, Leverkusen, 51368, Germany.
authors.forename: Johann
authors.initials: J
authors.lastname: Proeve
authors.affiliation: Novartis Pharma AG, Basel, 4002, Switzerland.
authors.forename: Scott
authors.initials: S
authors.lastname: Askin
authors.affiliation: Chair of Medical Informatics, University of Erlangen/Nuremberg, Erlangen, 91054, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Ganslandt
authors.affiliation: Institute of Medical Informatics, University of Münster, Münster, 48149, Germany.
authors.forename: Justin
authors.initials: J
authors.lastname: Doods
authors.affiliation: Institute of Medical Informatics, University of Münster, Münster, 48149, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Dugas
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D035843:Biomedical Research / Q000379:methods / Q000706:statistics & numerical data; D002986:Clinical Trials as Topic / Q000379:methods / Q000706:statistics & numerical data*; D065709:Common Data Elements; D057286:Electronic Health Records / Q000706:statistics & numerical data*; D005060:Europe; D066275:Health Information Exchange / Q000706:statistics & numerical data; D006753:Hospital Records / Q000706:statistics & numerical data; D006801:Humans; D008490:Medical Informatics / Q000379:methods / Q000706:statistics & numerical data*; D012107:Research Design
keywords: Clinical trials; Common data elements; Data quality; Electronic health records; Metadata; Secondary use