Transcription of Strategies for Implementing SDTM and ADaM …
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Strategies for Implementing SDTM and ADaM …
Paper FC03 Strategies for Implementing sdtm and ADaM standards Susan J. Kenny, Maximum Likelihood Solutions, Inc and Octagon Research Solutions, Inc., Chapel Hill, NC Michael A. Litzsinger, SCHWARZ BIOSCIENCES, Inc., Research Triangle Park, NC ABSTRACT With the 2004 release of CDISC sdtm and ADaM standards , members of the pharmaceutical industry are all asking the same questions. How and when does the creation of sdtm files occur during the clinical trial process? What files should be used to create analysis files? How do I keep track of all of the data transformations? This presentation will offer some Strategies and considerations on how to implement CDISC standards within a pharmaceutical organization.
Paper FC03 Strategies for Implementing SDTM and ADaM Standards Susan J. Kenny, Maximum Likelihood Solutions, Inc and …
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