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New domain specifications may be created when domain specifications in this guide don't exist

The General Observation Classes - SDTMIG v3.4 - Wiki (cdisc.org)

Most subject-level observations collected during the study should be represented according to 1 of the 3 SDTM general observation classes: Interventions, Events, or Findings. The lists of variables allowed to be used in each of these can be found in the SDTM.

• The Interventions class captures investigational, therapeutic, and other treatments that are administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., exposure to study drug), coincident with the study assessment period (e.g., concomitant medications), or self‑administered by the subject (e.g., use of alcohol, tobacco, or caffeine).
• The Events class captures planned protocol milestones such as randomization and study completion, and occurrences, conditions, or incidents independent of planned study evaluations occurring during the trial (e.g., adverse events) or prior to the trial (e.g., medical history).
• The Findings class captures the observations resulting from planned evaluations to address specific tests or questions (e.g., laboratory tests, ECG testing, questions listed on questionnaires).

In most cases, the choice of observation class appropriate to a specific collection of data can be easily determined according to these descriptions. The majority of data, which typically consists of measurements or responses to questions, usually at specific visits or time points, will fit the Findings general observation class. Additional guidance on choosing the appropriate general observation class is provided in Section 8.6.1, Guidelines for Determining the General Observation Class.

General assumptions for use with all domain models and custom domains based on the general observation classes are described in Section 4, Assumptions for Domain Models; specific assumptions for individual domains are included with the domain models.

Datasets and Domains - SENDIG v3.1.1 - Wiki (cdisc.org) 

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