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- USUBJID for observations about individual humans or animals who are study subjects.
- POOLID for observations about a group of human or animal study subjects which cannot be attributed to individual subjects.
- SPDEVID in certain domains for a study in which devices are subjects of the study subjects.
- SPTOBID for observations about tobacco products which are subjects of the subjects of in vitro studiesresearch.
- GTREFID for observations about sources of information that serve as subjects in genetic toxicology testing performed in vitro (GT domain only).
SDTM datasets that represent data about study subjects are of 2 types: general observation class datasets and special-purpose datasets. General observation class domains conform to general structures for 1 of 3 classes: findings, events, and interventions. The data for a study would study would generally include multiple domains in each general observation class. In contrast to general observation class models on which individual domains can be based, special-purpose domains are specified completely. do not to conform to a common structure and may make use of variables that do not appear elsewhere in SDTM.
Domains based on the general observation classes are specified in SDTM implementation guides (see Section 1.2, Implementation Advice for this Model).
Each study subject domain dataset is distinguished by a unique 2-character code.
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