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Electronic Data Capture-Study Conduct, Maintenance and Closeout
Author(s) -
Olivia Montaño,
Maxine Pestronk,
Derek Johnson,
Muthamma Muthanna,
Denise Redkar-Brown,
Ralph Russo,
David Eade,
Meredith Zozus,
Shweta Kerkar
Publication year - 2021
Publication title -
journal of the society for clinical data management
Language(s) - English
Resource type - Journals
ISSN - 2694-1473
DOI - 10.47912/jscdm.31
Subject(s) - data collection , electronic data capture , automatic identification and data capture , data management , computer science , best practice , database , operating system , statistics , mathematics , management , economics
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.

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