Electronic Data Capture-Study Implementation and Start-up

Web-based Electronic Data Capture is a mainstay of form-based data collection and management in clinical studies. This chapter reviews the implementation and start-up tasks for clinical studies using web-based EDC for form-based data collection and management (hereafter EDC.) Topics covered include designing, developing, testing, and implementing workflow and data flow in clinical studies using EDC systems. Topics of focus include data collection, work flow, and data flow associated with data collection and processing, data processing such as exchange, integration, cleaning, and coding in EDC systems, implementation at study sites including training and account management, and working with EDC system vendors. The chapter emphasizes common responsibilities of Clinical Data Management (CDM) professional in the implementation of an EDC application for a clinical study.