Page History

Observations about study subjects are normally represented in a series of domains. A domain is defined as a collection of logically related observations with a common topic. The logic of the relationship may pertain to the scientific subject matter of the data or to its role in the trial. For example, "Subject 101 had an adverse event of mild nausea starting on study day 6" is an observation belonging to the Adverse Events (AE) domain in a clinical trial.

The entity that is the subject of a study varies across studies. The SDTM variable that represents an observation about a study subject or a group of study subjects can be

• USUBJID for observations about humans or animals who are study subjects
• POOLID for observations about a group of study subjects which cannot be attributed to individual subjects
• SPDEVID in certain domains for a study in which devices are study subjects
• SPTOBID for observations about tobacco products which are the subjects of in vitro studies
  

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 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. 

...