Clinical data management system

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Clinical Data Management System (CDMS)

Clinical Data Management System (CDMS) /ˈklɪnɪkəl deɪtə ˈmænɪdʒmənt ˈsɪstəm/ is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data.

Etymology

The term "Clinical Data Management System" is derived from the purpose of the system. "Clinical" refers to the clinical trial process which involves tests and observations in medicine and health. "Data Management" refers to the process of collecting, storing, and using data securely, efficiently, and cost-effectively. The "System" refers to the software or tool used to manage the data.

Related Terms

  • Clinical Trial: A research study performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention.
  • Case Report Form (CRF): A specialized document in clinical research.
  • Data Management: The process of ingesting, storing, organizing and maintaining the data created and collected by an organization.
  • Clinical Research: A branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use.

Function

A Clinical Data Management System is designed to provide a high level of functionality while maintaining a high degree of user-friendliness. The system is used to manage patient data in a clinical trial and it can be made to adapt to any study design. The CDMS can be used to:

  • Design CRF
  • Annotate CRF
  • Perform data entry
  • Perform clinical data management
  • Generate reports

Benefits

The use of a Clinical Data Management System can:

  • Improve data quality
  • Reduce data handling errors
  • Provide secure data storage
  • Improve data accessibility
  • Increase efficiency in data collection

External links

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