title: NOR-DMARD data management: implementation of data capture from electronic health records.
abstract: OBJECTIVE
  The use of electronic health records (EHR) is an essential part of modern health care, and electronic data capture (EDC) has become essential for managing clinical trials. Usually, these two entities are independent of each other, and transfer from one system to another is done manually. Our aim was to develop a method to capture data directly from the EHR system and transfer them into an EDC system for the NORwegian Disease-Modifying Anti-Rheumatic Drugs (NOR-DMARD) registry.
  
  
  METHODS
  All rheumatology departments contributing to NOR-DMARD had implemented a structured EHR system. Data are extracted locally and securely transferred to the study data management once a month. The study data management then parse the data into a readable format for the EDC and import the data. Once the data is in the EDC, they are available to all authorized researchers and downloadable in a preferred format.
  
  
  RESULTS
  From May 2012 to August 2014 almost 6400 visits in 3400 patients treated with biologics have been successfully registered in the EDC system. Previously, NOR-DMARD used standard paper-based case report forms (CRFs), with a substantial cost for data entry. Setting up and maintaining the EDC system required some investments, but the amount saved from avoiding paper handling has made the shift into EDC profitable. In addition to this, gains have been made in administration and data quality.
  
  
  CONCLUSIONS
  The transition from paper and pencil format to a fully electronic data management system in NOR-DMARD has had obvious advantages regarding feasibility, cost, data quality and accessibility of the data.
authors.affiliation: Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway. inge.christoffer.olsen@gmail.com.
authors.forename: I C
authors.initials: IC
authors.lastname: Olsen
authors.forename: E A
authors.initials: EA
authors.lastname: Haavardsholm
authors.forename: E
authors.initials: E
authors.lastname: Moholt
authors.forename: T K
authors.initials: TK
authors.lastname: Kvien
authors.forename: E
authors.initials: E
authors.lastname: Lie
mesh_terms: D022126:Access to Information; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D057225:Data Mining; D057286:Electronic Health Records / Q000191:economics / Q000592:standards*; D006801:Humans; D016247:Information Storage and Retrieval / Q000191:economics / Q000592:standards*; D008498:Medical Record Linkage / Q000592:standards*; D009664:Norway / Q000453:epidemiology; D010043:Outcome and Process Assessment, Health Care / Q000191:economics / Q000592:standards*; D012042:Registries / Q000592:standards*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents