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The SDTM has been designed to accommodate the broadest range of human and nonclinical study data in a standardized manner. This document describes the basic concepts and general structure of the model. Individual Implementation Guides (IGs) have been created to provide specific recommendations for numerous domains of data commonly collected in human, nonclinical, and medical device studies, identifying which variables from a general observation class may apply.  

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These IGs also describe basic assumptions and business rules, and provide numerous examples for mapping data to the standard format. Sponsors wishing to represent data in the standard formats should consult the IGs before preparing datasets based on the SDTM. The following implementation guides have been published by CDISC:

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