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Abstract Details
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Activity Number:
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60
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Type:
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Topic Contributed
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Date/Time:
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Sunday, July 31, 2011 : 4:00 PM to 5:50 PM
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Sponsor:
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Section for Statistical Programmers and Analysts
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| Abstract - #300629 |
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Title:
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The Art of Writing Statistical Analysis Plan and Associated Pitfalls
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Author(s):
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Carmen Elena Arteaga*+
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Companies:
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Pfizer Inc.
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Address:
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320 A 4th Street, Palisades Park, NJ, 07650,
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Keywords:
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SAP ;
Outsourcing Programming ;
CRO/FSP
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Abstract:
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In the current industry environment, outsourcing the programming work has become the norm. This requires of re-assessing the role of the statistician and his/her relationship with the CRO or FSP programmer. In this new environment, designated programmers with knowledge of the therapeutic area are mostly non-existing. Thus, a clear link between the database and the SAP is a must, and the statistical analysis plan (SAP) plays a greater role than before. Best practices and common pitfalls experiences should be examined and considered when writing the SAP.
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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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