CDISC General Observation Class

**Semantic type:** Conceptual Entity

**Definition:** In the context of the Study Data Tabulation Model (SDTM), a higher level categorization of the subject-level observation domains. Most CDISC domains are assigned to one of three general observation classes: 1) The Interventions general observation class is a domain that captures investigational treatments, therapeutic treatments, and surgical procedures that are intentionally administered to the subject (usually for therapeutic purposes) either as specified by the study protocol (e.g., exposure), coincident with the study assessment period (e.g., concomitant medications), or other substances self-administered by the subject (such as alcohol, tobacco, or caffeine). 2) The Events general observation class captures occurrences or incidents independent of planned study evaluations occurring during the trial (e.g., "adverse events" or "disposition") or prior to the trial (e.g., "medical history"). 3) The Findings general observation class captures the observations resulting from planned evaluations such as observations made during a physical examination, laboratory tests, ECG testing, and sets of individual questions listed on questionnaires. (SDTM and SDTM Implementation Guide, www.CDISC.org)

**Synonyms:** - general observation class