JSM 2005 - Toronto

Abstract #302868

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 200
Type: Contributed
Date/Time: Monday, August 8, 2005 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #302868
Title: A Randomization Design Software for Clinical Trial
Author(s): Chunshen Pan*+ and Juan He and Corinne Campanella and Tat Chan
Companies: Biovail Contract Research and Biovail Contract Research and Biovail Contract Research and Biovail Corporation
Address: 460 Comstock Road, Toronto, ON, M1L 4S4, Canada
Keywords: Randomization ; Clinical trial ; Software
Abstract:

Subject/patient randomization design is an important step before a clinical trial. The software for such design will make this process standard and convenient. This software is designed to generate the protocol-specific randomization schemes. It covers a variety of common randomization designs, including parallel design, two-way replicate design, and crossover designs through two to five way. This software is composed of two parts: the front end is an interface written with Visual Basic and the back end is a database with Microsoft Access. The interface allows users to input necessary information such as the protocol number, randomization version number, and the number of subjects and alternates (if applicable). Users can select the sequence set by default, random, or manual selection. A panel in the right side of the interface will display the randomization results for check. The database is tabulated, a set of data automatically created, and saved through the Randomization program.


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Revised March 2005