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Abstract Details
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Activity Number:
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428
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Type:
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Roundtables
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Date/Time:
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Wednesday, August 1, 2012 : 7:00 AM to 8:15 AM
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Sponsor:
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Section for Statistical Programmers and Analysts
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| Abstract - #306077 |
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Title:
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Preparing to Share CDISC Data: A Discussion of How to Best Conduct (and Document) Review of SDTM and ADaM Data
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Author(s):
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Steven R Kirby*+
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Companies:
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ViroPharma Inc.
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Address:
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730 Stockton, Exton, PA, , USA
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Keywords:
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SDTM ;
ADaM ;
REVIEW ;
FDA ;
CDISC ;
VALIDATION
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Abstract:
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For effective downstream use, CDISC SDTM and ADaM data must be comprehensive, consistent with source information and in conformance with the specific standard applied. The group will discuss CDISC data review with an emphasis on the scope of review, when that review is best conducted, and how to usefully document that review for a variety of downstream consumers including the FDA
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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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