Page History

...

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 completelydo 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).

...