DOI: http://dx.doi.org/10.18203/2349-3259.ijct20170302

An outline of data management in clinical research

Sunmeet Matkar, Ajit Gangawane

Abstract


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. Several studies suggest that such data helps in extreme reduction in time from drug development processes to the marketing stage. 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. In recent times, the huge gap about improvements of the CDM standards for meeting the regulatory requirements remains to be filled. Fulfilling these requirements will help the clinical trial sector to stay ahead of the game. The current article accentuates the practices followed and activities involved in CDM. Therefore, it enables the reader an outline of management of data in the clinical research.


Keywords


Clinical research, Data management, Case report form

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References


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