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Clinical data management (CDM) is an indispensable part of clinical research. CDM activities lead to the collection of reliable, high-quality and statistically sound data generating from the clinical trials. Clinical trial data are important for the drug and medical device development processing pharmaceutical companies to examine and evaluate the efficacy and safety of the new medical product in human volunteers. The results of the clinical trial studies generate the most product. Several practices in CDM including CRF annotation, case report form (CRF) designing, data extraction, data entry, data validation, database designing, database locking, discrepancy management and medical coding are evaluated for quality checks at regular intervals during clinical trial.

KEYWORDS:  Clinical trial, Clinical data management, Data capture, Clinical Management Process, Factors