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Abstract Details
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Activity Number:
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270
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Type:
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Invited
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Date/Time:
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Tuesday, July 31, 2012 : 8:30 AM to 10:20 AM
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Sponsor:
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Section for Statistical Programmers and Analysts
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| Abstract - #303597 |
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Title:
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The Interaction Between CDISC and a Metadata-Driven Process
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Author(s):
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Dan Crawford*+
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Companies:
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Octagon Research Solutions
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Address:
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585 East Swedesford Road, Suite 300, Wayne, PA, 19087,
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Keywords:
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Metadata ;
CDISC ;
SDTM ;
ADAM
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Abstract:
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CDISC standards are being adopted by companies of all sizes within the pharmaceutical industry. The FDA has been receiving submissions in increasing numbers for both SDTM and ADaM. With the adoption and maturation of the CDISC standards - how do we organize, maintain and govern these standards? What role does metadata play?
This presentation will cover the meaning and value of metadata (structural and semantic). The presenter will discuss how organizations can maximize the value of using CDISC standards through metadata-driven processing across the clinical data lifecycle. The presentation will also focus on identifying and explaining metadata-driven processes at critical points in the clinical data lifecycle along with the key characteristics of a Metadata Registry application: - Store metadata - Manage metadata - Govern metadata
The emerging CDISC SHARE metadata registry, its content and metadata model will also be discussed.
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Authors who are presenting talks have a * after their name.
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