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SDTM variables can be classified into 5 major roles:

  • Identifier variables, 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, 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 ; variable metadata attributes are as described in Section 2.2, Table Structure.

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

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