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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
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