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Each study must include 1 standardized set of observations in a specific structure; this is the Demographics domain described here. Demographics is the parent domain for all other observations for subjects and should be identified with the domain code of "DM". The DM domain describes the essential characteristics of the study subjects, and is used by reviewers for selecting subsets of subjects for analysis. The DM domain, as with other datasets, includes identifiers, a topic variable, timing variables, and qualifiers. See the implementation guides referenced in Section 1.2, Implementation Advice for this Model, for further guidance regarding use of additional identifier and timing variables.

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