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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 2.1 How To Determine Where Data Belong, section 2.7 Standards for Collection, and  and section 2.8 Standards for Collection

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