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Electronic Data Capture (EDC) has become a common a proven tool for data collection and management in clinical trials. Thus, understanding the principles and methods for EDC use has become a major component of clinical data management (CDM) professional practice. This chapter focuses on using the EDC system and accruing data to support study conduct, maintaining an EDC system during a study, and concluding active data collection through database lock. The regulatory basis for minimum standard and recommended best practices are discussed.

Electronic Data Capture-Study Conduct, Maintenance and Closeout