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Problems and pitfalls in a clinical research data management system.

R W Brower, H J ten Katen, G T Meester

    Computer Programs in Biomedicine
    |January 1, 1984
    PubMed
    Summary
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    Managing data for the Netherlands Coronary Surgery (NCS) study presented challenges. Effective quality control and data transfer are crucial for successful clinical research analysis.

    Area of Science:

    • Cardiovascular Surgery
    • Medical Informatics
    • Clinical Data Management

    Background:

    • The Netherlands Coronary Surgery (NCS) study collected extensive patient data.
    • The study involved 848 patients undergoing coronary artery surgery, with data collected pre- and post-operatively.

    Purpose of the Study:

    • To review the problems and pitfalls in establishing and managing a computerized data bank for the NCS study.
    • To highlight the importance of quality control and efficient data transfer in large-scale clinical studies.

    Main Methods:

    • Utilized 19 data forms, capturing up to 1142 variables per patient.
    • Focused on the challenges of data entry, storage, and retrieval in a complex surgical study.

    Main Results:

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    • Identified significant challenges in managing a large, multi-variable patient dataset.
    • Emphasized the critical need for robust data quality control measures.

    Conclusions:

    • Effective data management, including stringent quality control and efficient information transfer, is essential for the success of clinical studies like the NCS.
    • Lessons learned from the NCS data bank can inform future cardiovascular surgery research data management practices.