title: Electronic case report forms and electronic data capture within clinical trials and pharmacoepidemiology.
abstract: OBJECTIVE
  Researchers in clinical and pharmacoepidemiology fields have adopted information technology (IT) and electronic data capture, but these remain underused despite the benefits. This review discusses electronic case report forms and electronic data capture, specifically within pharmacoepidemiology and clinical research.
  
  
  METHODS
  The review used PubMed and the Institute of Electrical and Electronic Engineers library. Search terms used were agreed by the authors and documented. PubMed is medical and health based, whereas Institute of Electrical and Electronic Engineers is technology based. The review focuses on electronic case report forms and electronic data capture, but briefly considers other relevant topics; consent, ethics and security.
  
  
  RESULTS
  There were 1126 papers found using the search terms. Manual filtering and reviewing of abstracts further condensed this number to 136 relevant manuscripts. The papers were further categorized: 17 contained study data; 40 observational data; 27 anecdotal data; 47 covering methodology or design of systems; one case study; one literature review; two feasibility studies; and one cost analysis.
  
  
  CONCLUSIONS
  Electronic case report forms, electronic data capture and IT in general are viewed with enthusiasm and are seen as a cost-effective means of improving research efficiency, educating participants and improving trial recruitment, provided concerns about how data will be protected from misuse can be addressed. Clear operational guidelines and best practises are key for healthcare providers, and researchers adopting IT, and further work is needed on improving integration of new technologies with current systems. A robust method of evaluation for technical innovation is required.
authors.affiliation: Ninewells Hospital and Medical School, University of Dundee, Dundee, UK.
authors.forename: David A
authors.initials: DA
authors.lastname: Rorie
authors.affiliation: Ninewells Hospital and Medical School, University of Dundee, Dundee, UK.
authors.forename: Robert W V
authors.initials: RWV
authors.lastname: Flynn
authors.affiliation: Ninewells Hospital and Medical School, University of Dundee, Dundee, UK.
authors.forename: Kerr
authors.initials: K
authors.lastname: Grieve
authors.affiliation: Ninewells Hospital and Medical School, University of Dundee, Dundee, UK.
authors.forename: Alexander
authors.initials: A
authors.lastname: Doney
authors.affiliation: Ninewells Hospital and Medical School, University of Dundee, Dundee, UK.
authors.forename: Isla
authors.initials: I
authors.lastname: Mackenzie
authors.affiliation: Ninewells Hospital and Medical School, University of Dundee, Dundee, UK.
authors.forename: Thomas M
authors.initials: TM
authors.lastname: MacDonald
authors.affiliation: Ninewells Hospital and Medical School, University of Dundee, Dundee, UK.
authors.forename: Amy
authors.initials: A
authors.lastname: Rogers
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D003625:Data Collection / Q000379:methods*; D057286:Electronic Health Records; D006801:Humans; D000073256:Information Technology; D017891:Pharmacoepidemiology / Q000379:methods*
keywords: electronic case report form; electronic data capture