title: Design of case report forms based on a public metadata registry: re-use of data elements to improve compatibility of data.
abstract: Clinical trials use many case report forms (CRFs) per patient. Because of the astronomical number of potential CRFs, data element re-use at the design stage is attractive to foster compatibility of data from different trials. The objective of this work is to assess the technical feasibility of a CRF editor with connection to a public metadata registry (MDR) to support data element re-use.
  
  
  
  Based on the Medical Data Models portal, an ISO/IEC 11179-compliant MDR was implemented and connected to a web-based CRF editor. Three use cases were implemented: re-use at the form, item group and data element levels.
  
  
  
  CRF design with data element re-use from a public MDR is feasible. A prototypic system is available. The main limitation of the system is the amount of available MDR content.
authors.affiliation: Institute of Medical Informatics, University of Münster, Albert-Schweitzer-Campus 1, A11, D-48149, Münster, Germany. dugas@uni-muenster.de.|European Research Centre for information systems (ERCIS), Leonardo-Campus 3, 48149, Münster, Germany. dugas@uni-muenster.de.
authors.forename: Martin
authors.identifier: 0000-0001-9740-0788
authors.initials: M
authors.lastname: Dugas
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D016208:Databases, Factual; D004282:Documentation; D057286:Electronic Health Records; D005240:Feasibility Studies; D005568:Forms and Records Control; D006801:Humans; D016247:Information Storage and Retrieval / Q000379:methods*; D000071253:Metadata; D012042:Registries; D012107:Research Design
keywords: CDISC ODM; CRF; Data element re-use; ISO/IEC 11179; Information infrastructure; MDR