An outline of data management in clinical research

Authors

  • Sunmeet Matkar Senior Executive, Arbor Biotech Pvt Ltd, Mumbai, India
  • Ajit Gangawane Faculty of Applied Sciences, Parul University, Limda, Waghodia Road, Vadodara, Gujarat-391760, India

DOI:

https://doi.org/10.18203/2349-3259.ijct20170302

Keywords:

Clinical research, Data management, Case report form

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.

Author Biography

Sunmeet Matkar, Senior Executive, Arbor Biotech Pvt Ltd, Mumbai, India

Senior Executive

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Published

2017-01-25

Issue

Section

Review Articles