title: Piloting the EHR4CR feasibility platform across Europe.
abstract: BACKGROUND
  Pharmaceutical clinical trials are primarily conducted across many countries, yet recruitment numbers are frequently not met in time. Electronic health records store large amounts of potentially useful data that could aid in this process. The EHR4CR project aims at re-using EHR data for clinical research purposes.
  
  
  OBJECTIVE
  To evaluate whether the protocol feasibility platform produced by the Electronic Health Records for Clinical Research (EHR4CR) project can be installed and set up in accordance with local technical and governance requirements to execute protocol feasibility queries uniformly across national borders.
  
  
  METHODS
  We installed specifically engineered software and warehouses at local sites. Approvals for data access and usage of the platform were acquired and terminology mapping of local site codes to central platform codes were performed. A test data set, or real EHR data where approvals were in place, were loaded into data warehouses. Test feasibility queries were created on a central component of the platform and sent to the local components at eleven university hospitals.
  
  
  RESULTS
  To use real, de-identified EHR data we obtained permissions and approvals from 'data controllers' and ethics committees. Through the platform we were able to create feasibility queries, distribute them to eleven university hospitals and retrieve aggregated patient counts of both test data and de-identified EHR data.
  
  
  CONCLUSIONS
  It is possible to install a uniform piece of software in different university hospitals in five European countries and configure it to the requirements of the local networks, while complying with local data protection regulations. We were also able set up ETL processes and data warehouses, to re-use EHR data for feasibility queries distributed over the EHR4CR platform.
authors: Justin Doods, Institute of Medical Informatics, University of Münster, Albert-Schweitzer-Campus 1, Gebäude A11, 48149 Münster, Germany, E-mail: Justin.Doods@uni-muenster.de.
authors: J
authors: J
authors: Doods
authors: R
authors: R
authors: Bache
authors: M
authors: M
authors: McGilchrist
authors: C
authors: C
authors: Daniel
authors: M
authors: M
authors: Dugas
authors: F
authors: F
authors: Fritz
mesh_terms: D003628:Database Management Systems; D057286:Electronic Health Records; D005240:Feasibility Studies; D006801:Humans; D018579:Patient Selection; D010865:Pilot Projects; D058028:Research Report; D012984:Software
keywords: Protocol feasibility; clinical research; clinical trials; electronic health records; secondary use