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Reengineering a Database for Clinical Trials Management: Lessons for System Architects

This paper describes the process of enhancing Trial/DB, a database system for clinical studies management. The system's enhancements have been driven by the need to maximize the effectiveness of developer personnel in supporting numerous and diverse users, of study designers in setting up new s...

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Published in:Controlled clinical trials 2000-10, Vol.21 (5), p.440-461
Main Authors: Brandt, Cynthia A, Nadkarni, Prakash, Marenco, Luis, Karras, Bryant T, Lu, Charles, Schacter, Lee, Fisk, John M, Miller, Perry L
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container_end_page 461
container_issue 5
container_start_page 440
container_title Controlled clinical trials
container_volume 21
creator Brandt, Cynthia A
Nadkarni, Prakash
Marenco, Luis
Karras, Bryant T
Lu, Charles
Schacter, Lee
Fisk, John M
Miller, Perry L
description This paper describes the process of enhancing Trial/DB, a database system for clinical studies management. The system's enhancements have been driven by the need to maximize the effectiveness of developer personnel in supporting numerous and diverse users, of study designers in setting up new studies, and of administrators in managing ongoing studies. Trial/DB was originally designed to work over a local area network within a single institution, and basic architectural changes were necessary to make it work over the internet efficiently as well as securely. Further, as its use spread to diverse communities of users, changes were made to let the processes of study design and project management adapt to the working styles of the principal investigators and administrators for each study. The lessons learned in the process should prove instructive for system architects as well as managers of electronic patient record systems. Control Clin Trials 2000;21:440–461
doi_str_mv 10.1016/S0197-2456(00)00070-2
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source ScienceDirect Freedom Collection 2022-2024
subjects Biological and medical sciences
Clinical trial. Drug monitoring
Clinical trials
Clinical Trials as Topic
Database Management Systems
Databases as Topic
General pharmacology
Medical sciences
Pharmacology. Drug treatments
relational database systems
World Wide Web database applications
title Reengineering a Database for Clinical Trials Management: Lessons for System Architects
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