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Web-based data management for a phase II clinical trial in ALS
Authors:
Richard Buchsbaum a;
Petra Kaufmann b;
Alexandra I. Barsdorf b;
Rachel Arbing a;
Jacqueline Montes b;
John L. P. Thompson ab; For The Qals Study Group
| Affiliations: | a Department of Biostatistics, Mailman School of Public Health, |
| b Department of Neurology, College of Physicians and Surgeons, Columbia University, New York, NY, USA |
DOI:
10.1080/17482960802378998
Publication Frequency:
6 issues per year
Published in:
Amyotrophic Lateral Sclerosis
First Published on:
09 September 2008
Subject:
Neurology;
Formats available:
HTML
(English)
:
PDF
(English)
Previously published as:
Amyotrophic Lateral Sclerosis and other Neuron Disorders
(1466-0822,
1471-180X)
until 2006
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Abstract
The objective was to report on the creation, features and performance of a web-based data management system for a two-stage phase II randomized clinical trial of Co-Enzyme Q10 in ALS. We created a relatively comprehensive web-based data system that provided electronic data entry; patient management utilities; adverse event reporting, safety monitoring, and invoice generation; and standardized coding for medications and adverse events. In stage 1, clinical sites submitted 7207 forms reporting on 105 patients followed for 10 months. Less than 0.7% of submitted forms contained errors. At the time of the delivery of the analysis data set, only four errors remained unresolved. Data were available quickly, with a median time from event to data posting of two days. The data set was locked and the analysis data set produced nine days after the final patient visit. A survey of trial personnel yielded generally positive feedback, with 75% of respondents wishing to use a similar system in the future. Given sufficient resources, a comprehensive web-based data management system can meet the need for clean, available data in clinical trials in ALS and similar diseases, and can contribute significantly to their efficient execution.
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| Keywords: Clinical trial; data management; web; EDC; ALS |
| view references (13) |


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