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Pivot/Remote: a distributed database for remote data entry in multi-center clinical trials

S B Higgins1, K Jiang, W D Plummer

  • 1Division of Biomedical Engineering and Computing, Vanderbilt University, Nashville, TN 37232 USA.

Medinfo. MEDINFO
|January 1, 1995
PubMed
Summary
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This study introduces Pivot/Remote, an electronic data capture system for clinical trials that eliminates paper case report forms (CRFs). It streamlines data collection in intensive care units (ICUs) by using bedside laptop computers and a distributed database.

Area of Science:

  • Clinical Trial Data Management
  • Intensive Care Unit (ICU) Research
  • Electronic Data Capture (EDC) Systems

Background:

  • Multi-center clinical trials, especially in ICUs, face challenges with timely and accurate data collection due to the acute nature of patient illnesses.
  • Traditional paper-based remote data entry (RDE) systems require manual transcription and dual verification, increasing effort, expense, and potential for errors.
  • Existing RDE systems often fail to fully leverage automatic data checking capabilities, necessitating extensive monitoring to ensure data integrity.

Purpose of the Study:

  • To develop and evaluate an innovative RDE system, Pivot/Remote, that eliminates the need for paper case report forms (CRFs).
  • To create a distributed database system for clinical trials that resides partially at clinical centers (CCs) and the data coordinating center (DCC).
  • To improve the efficiency and accuracy of data collection and management in multi-center clinical trials, particularly in intensive care settings.

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Main Methods:

  • Developed Pivot/Remote, an RDE system utilizing bedside laptop computers with a graphical user interface (GUI) that mimics paper CRFs.
  • Implemented a distributed database architecture where data resides at both CCs and the DCC, with data logically moving upon monitoring.
  • Incorporated features such as automatic edit checks, calculations (e.g., APACHE II score), trended data display, audit trails, and electronic security locks.

Main Results:

  • Pivot/Remote successfully eliminates paper-based CRFs, enabling direct bedside data entry with equivalent time to paper forms.
  • The system performs automatic data validation, including temporal logic and range checks, and calculates key scores in real-time.
  • The distributed database and audit trail features streamline data management, minimize dual database issues, and enhance data integrity.

Conclusions:

  • Pivot/Remote offers a significant advancement in clinical trial data collection by leveraging electronic CRFs and a distributed database.
  • The system enhances data accuracy, reduces the burden of data monitoring, and improves efficiency in intensive care unit clinical trials.
  • This innovative approach simplifies data management and ensures that clinical center personnel remain involved until data verification is complete.