title: ODM2CDA and CDA2ODM: tools to convert documentation forms between EDC and EHR systems.
abstract: BACKGROUND
  Clinical trials apply standards approved by regulatory agencies for Electronic Data Capture (EDC). Operational Data Model (ODM) from Clinical Data Interchange Standards Consortium (CDISC) is commonly used. Electronic Health Record (EHR) systems for patient care predominantly apply HL7 standards, specifically Clinical Document Architecture (CDA). In recent years more and more patient data is processed in electronic form.
  
  
  RESULTS
  An open source reference implementation was designed and implemented to convert forms between ODM and CDA format. There are limitations of this conversion method due to different scope and design of ODM and CDA. Specifically, CDA has a multi-level hierarchical structure and CDA nodes can contain both XML values and XML attributes.
  
  
  CONCLUSIONS
  Automated transformation of ODM files to CDA and vice versa is technically feasible in principle.
authors.affiliation: Institute of Medical Informatics, University of Münster, Albert-Schweitzer-Campus 1, A11, D-48149, Münster, Germany. dugas@uni-muenster.de.
authors.forename: Martin
authors.initials: M
authors.lastname: Dugas
mesh_terms: D004282:Documentation / Q000592:standards*; D057286:Electronic Health Records / Q000592:standards*; D006801:Humans