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- Title
Clinical data management: Tools and regulations.
- Authors
Malik, Namrata; Jain, Neha; Nagaich, Upendra
- 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.
- Subjects
CLINICAL trials; MEDICAL databases; MEDICAL coding; MEDICAL economics; ACQUISITION of data
- Publication
International Journal of Pharmacy & Life Sciences, 2018, Vol 9, Issue 3, p5767
- ISSN
0976-7126
- Publication type
Article