Implementation of electronic data capture systems: barriers and solutions.
Although increasing in pace, the conversion to Electronic Data Capture (EDC) has been a slow progression. The use of EDC systems should confer improved data integrity, cost savings and a shorter time to study database closure. This will reduce the time to market and cost of new medications. With the current sentiment of the industry suggesting the cost analysis has been accepted to be in favor of EDC, the likely limitation to disseminated use is an inability to implement these systems. If the leadership at the sponsor, clinical research organization and investigator site is cognizant of the barriers to implementation, they can anticipate and mitigate them prior to the users becoming disgruntled and resistant to the new method of data capture. Once understood, barriers such as user input, technical support, user motivation, regulatory requirements, communication with users, timing of implementation, software installation, graphical user interface, identification of bridgers, patient participation, availability of technology, and costs can be better addressed at the beginning of the implementation process and successfully averted. This review discusses these barriers and potential solutions that can assist the clinical trial industry in achieving more wide-spread EDC use and the resulting improvement in operating efficiencies.
Welker
James A
JA
University of Maryland School of Medicine, and Franklin Square Clinical Research Center, Franklin Square Hospital Center, 9000 Franklin Square Drive, Baltimore MD 21237, USA. jimwelker@hotmail.com
D002986:Clinical Trials as Topic; D003142:Communication; D003625:Data Collection / Q000191:economics / Q000379:methods*; D004059:Diffusion of Innovation; D001330:Electronic Data Processing / Q000191:economics; D006801:Humans; D009042:Motivation; D010358:Patient Participation; D014584:User-Computer Interface