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Most subject-level observations collected during the study should be represented according to one of the 3 SDTM general observation classes, and the Special-purpose domains which represent data that do not fit any of the general observation classes Given this, referring to both the CDASH Model when applicable and the SDTM is highly recommended when using domains to support understanding of intended scope and to inform extensions and creation of custom domains when needed.  Also see section See also Section 2.1, How To Determine Where Data Belong, section Section 2.7, Standards for Collection, and section Section 2.8, Standards for Collection.

The examples in this section illustrate how to represent various aspects of studies involving a tobacco product using the Clinical Data Acquisition Standards Harmonization (CDASH) model, and the Study Data Tabulation Model (SDTM), including:

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