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REGULATORY CONSIDERATIONS IN CLINICAL DATA MANAGEMENT
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Clinical data management (CDM) is a major cross-functional vehicle in clinical trials to ensure high-quality data are captured by sites staff through paper case report form (CRF) or electronic case report form (eCRF) and available for early review. The integrity and quality of data being collected and transferred from study subjects to a clinical data management system (CDMS) must be monitored, maintained, and quantified to ensure a reliable and effective base for not only new drug application (NDA) submission and clinical science reports but also corporate clinical planning, decision-making, process improvement, and operational optimization. The gradually increasing use of electronic data-capturing (EDC) technology and eCRF to collect data in clinical trials has grown in recent years and has affected the activities of clinical research operations for industry sponsors, contract research organizations (CROs), and clinical sites. This article focuses on importance of Clinical data management in clinical researchddd