Clinical data management: Tools and regulations

Authors

  • Namrata Malik*, Neha Jain , Upendra Nagaich Author

Keywords:

Clinical data management, Medical Coding, Clinical Data Interchange Standards Consortium (CDISC)

Abstract

Clinical data management (CDM) is that process in research which helps us to create high quality and statistically
correct data from clinical trials. It helps us to reduce the manual work load as well as saves time and energy. There
are certain members who are involved with CDM process, which helps to maintain the standards of process; those
members should be highly qualified and experienced. Various processes involve in CDM process are CRFreporting, data entry, data collection, data validation, discrepancy management, database locking, and medical
coding. CDM process involves certain rules and regulation which need to be followed. There is an increase demand
to improve certain regulations to stay ahead of competition by the means of capitalisation of product. It is the duty of
CDM professionals to meet the demands of standards and protocols to maintain the quality of data and to adjust with
the changing technology. This topic basically gives the overview of certain tools, standards and responsibilities in
CDM.

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Published

2018-03-30

Issue

Section

Articles

How to Cite

Clinical data management: Tools and regulations. (2018). International Journal of Pharmacy and Life Sciences, 9(3), 5767-5771. https://ijplsjournal.com/index.php/ijpls/article/view/453

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