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Activity Number:
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34
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Type:
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Topic Contributed
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Date/Time:
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Sunday, August 11, 2002 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section*
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| Abstract - #301842 |
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Title:
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The Self-Documenting Database
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Author(s):
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Karen Wade*+
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Affiliation(s):
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Rho, Inc.
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Address:
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100 Eastowne Drive, Chapel Hill, North Carolina, 27514,
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Keywords:
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Analysis Database ; Clinical Trials ; Metadata
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Abstract:
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No matter how valuable the data, an analysis database is useless unless people can efficiently access the data. Good documentation guides a variety of users through the database and helps them seek answers. But what is good documentation? Medical writers, statisticians, and regulatory reviewers may all answer this question differently, because each has different objectives. This paper: a) explores the types and structures of documentation that various users need; b) emphasizes that good documentation is more than a detailed description of the data and database structure. Good database documentation is the result of a dynamic and scientific process that is often more difficult and time-consuming than manipulating the data into the database; c) discusses the types of details that must be documented in an analysis database of clinical data; d) offers solutions to a set of typical problems that often prevent these details from being well-documented; e) illustrates with examples including a description of a fully self-documenting database that is far easier to use than the typical binder of study documents.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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