Abstract #301843

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JSM 2002 Abstract #301843
Activity Number: 34
Type: Topic Contributed
Date/Time: Sunday, August 11, 2002 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section*
Abstract - #301843
Title: Harnessing The Power Of Analysis Databases: The Necessity Of Appropriate Software
Author(s): Juliet Allen*+
Affiliation(s): Rho, Inc.
Address: 100 Eastowne Drive, Chapel Hill, North Carolina, 27514,
Keywords: Analysis Database ; Clinical Trials ; Software ; Metadata
Abstract:

Access, manipulation, management, and storage of data in an Analysis Database for clinical trials are critical. Data are useless without the means to organize them efficiently for easy access by a diverse team of researchers and study personnel--from statisticians to investigators, from company executives to medical writers. The complex nature of Analysis Databases requires appropriate, powerful, software tools to make the data readily available for review, analyses, reports, and submissions. These tools must also facilitate understanding the database by providing straightforward access to the metadata documentation that describe the data and their sources. This presentation will focus on the appropriate development of software for Analysis Databases. Discussion will include design and execution of levels of data access (including static and dynamic reports), and the importance and unique issues surrounding metadata documentation. These issues will be illustrated with an example.

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Revised March 2002