Electronic Data Capture-Selecting an EDC System

Web-based Electronic data capture (EDC) has become the preferred method for capture of key-entered data in clinical studies. This chapter reviews the considerations for selecting an EDC system including evaluation of systems and vendors, user requirements, an process change, as well as initial implementation of systems within organizations. The goal of system selection is to assure that organizational needs are identified and documented and ultimately that the desired functionality is available and appropriately supports clinical studies conducted by the organization. Multiple roles on study teams use the EDC system and should be involved in software selection and initial implementation.