This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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324
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Type:
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Invited
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Date/Time:
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Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
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Sponsor:
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Section for Statistical Programmers and Analysts
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Abstract - #306195 |
Title:
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Operational Data Sets to SDTM Data Sets: Narrowing the Gap, a Practical Review
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Author(s):
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Dan Crawford*+
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Companies:
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Octagon Research Solutions, Inc.
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Address:
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585 E. Swedesford Road, Wayne, PA, 19087,
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Keywords:
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CDISC ;
SDTM ;
ADaM ;
Data Standards
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Abstract:
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Historically, SDTM was never meant to be an operational database, it was created to be used in a data warehouse for FDA. A comprehensive review of the challenges the structure presents and how to overcome them when designing CRFs and databases will be investigated. Practical applications of how to narrow the gap when making the transition from operational datasets to submission compliant datasets will be also discussed. Similarly, SDTM and ADaM vary greatly in both structure and content; however both are needed when submitting to the FDA. An overview of both models will be explored, including the differences in structure, content, and the profile of reviewers at the agency who will utilize each data model.
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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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