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An interactive clinical data system

W A Keller, M A Winblad, M L Sutter

    Journal of Medical Systems
    |February 1, 1982
    PubMed
    Summary
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    A new clinical data system is being developed to improve data availability and reduce errors. This system streamlines data entry and reporting for clinical research professionals.

    Area of Science:

    • Clinical data management
    • Biostatistics
    • Information systems in healthcare

    Background:

    • Traditional clinical data systems often involve significant time lags between patient visits and data availability.
    • Data entry errors and extensive training requirements are common challenges in clinical data management.
    • The need for specialized programming and complex data handling hinders efficient clinical research.

    Purpose of the Study:

    • To develop an advanced clinical data system at the Upjohn Company.
    • To minimize the time lag from patient visit to data availability.
    • To reduce data entry errors and training requirements for system users.

    Main Methods:

    • System design emphasizes generality for study monitors and biostatisticians.

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  • Incorporates pre-entry data editing and simplified form design.
  • Allows direct entry of textual responses, reducing the need for coding and special programs.
  • Utilizes interactive subsystems for study description, program generation, database updates, and ad hoc reporting.
  • Implementation is based on a database management system on an IBM 370/148 under VM/CMS.

    • Main Results:

    • Anticipates a significant reduction in the time lag for data availability.
    • Aims to decrease data entry errors through enhanced editing capabilities.
    • Expected to lower the training burden for users of the clinical data system.
    • Provides flexibility for diverse study needs and user roles.

    Conclusions:

    • The developed clinical data system offers a more efficient and accurate approach to managing clinical trial data.
    • The system's design promotes user-friendliness and reduces reliance on specialized programming.
    • Expected to enhance the overall productivity and reliability of clinical research data management.