Electronic Data Capture-Selecting an EDC System

Abstract

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, and 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 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. 1) Learning ObjectivesAfter reading this chapter, the reader should understand• The regulatory basis for practices in selecting an EDC system • Common requirements and functionality domains of EDC systems • Key domains and criteria for pre-selection evaluation of EDC systems • Process impact and redesign considerations at evaluation and selection time • Initial system implementation within an organization * P4CDM, US

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