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
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, workflow 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) professionals in the implementation of an EDC application for a clinical study. Keywords: EDC 1) Learning ObjectivesAfter reading this chapter, the reader should understand:• the regulatory basis for practices in EDC study implementation and start-up • similarities and differences between paper and webbased data collection • basic and common features of fields, forms, and form groupings in EDC systems • common dynamic workflow and data flow options within web-based EDC systems • special considerations for data processing when using web-based EDC • common steps in system set-up and testing • methods for managing system access and privileges • common practices for training clinical investigational sites in the use of EDC • considerations and business models for using vendorhosted EDC systems
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