Page History

...

The primary purpose of the SDTM is to represent data about study subjects (e.g., such as humans, animals, or medical devices). The SDTM includes a general model for representing data in 3 "general observation" classes. Within those classes, data are grouped by topic into domains, represented in separate datasets. The 3 general observation classes (i.e., Interventions, Events, Findings) are described further in Section 3.1, The General Observation Classes. Additional special-purpose datasets about individuals are described in Section 3.2, Special-purpose Domains.

Studies sometimes include data about "associated persons" who are not study subjects; these data are represented in domains based on the domains used to represent data about study subjects. The structure of these domains is described in Section 4, Associated Persons Data.

The SDTM also includes a set of tables for representing data at the study level. These datasets are specified in Section 5, Study-level Data.

...