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SDTM variables can be classified into 5 major roles:

• Identifier variables, 

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  showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key SDTM-793

  such  such as those that identify the study, the subject involved in the study, the domain, and the sequence number of the record;
• Topic variables, which specify the focus of the observation (e.g., the name of a lab test);
• Timing variables, which describe the timing of an observation (e.g., start date, end date);
• Qualifier variables,

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  showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key SDTM-794

  which  which include additional illustrative text or numeric values that describe the results or additional traits of the observation (e.g., units, descriptive adjectives); and
• Rule variables, which describe the conditions for starting, ending, branching, or looping in the Trial Design model.

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The SDTM includes variable metadata for the standard variables as described in Section 2.2, Table Structure. 

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All datasets for data about individuals and for data about a study include the variable DOMAIN, which is populated with a code

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that code that should be used in the dataset name. Some relationship datasets include the variable RDOMAIN, to describe a relationship to a domain for data about individuals. The Comments special-purpose domain includes the variable RDOMAIN, but other special-purpose domains do not. The Device-subject Relationships dataset includes the variable DOMAIN, but other study reference datasets do not.  JirashowSummaryfalseserverIssue Tracker (JIRA)serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45keySDTM-796

The SDTM is structured so that data can be represented in SAS v5 transport files, the file format accepted by the US Food and Drug Administration (FDA) and other regulatory authorities. This imposes certain restrictions on variables. Note that the SDTM type specified in this document is either character or numeric, as these are the only types supported by SAS v5 transport files. Define-XML provides more descriptive data types (e.g., integer, float, date, datetime); see the Define-XML specification for information about how to represent SDTM types using Define-XML data types.

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