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  • The Interventions Observation Class represents investigational, therapeutic, and other treatments and products that are administered to or used by a subject (with some actual or expected physiological effect). This includes treatments and products specified by the study protocol (i.e., "exposure").
  • The Events Observation Class represents planned protocol milestones such as randomization and study completion, and occurrences, conditions, or incidents independent of planned study evaluations occurring during the study (e.g., adverse events) or prior to the study (e.g., medical history).
  • The Findings Observation Class represents observations resulting from planned evaluations to address specific tests or questions such as laboratory tests, electrocardiogram (ECG) testing, and questions listed on questionnaires. The Findings class also includes a subtype, Findings About, which is used to record findings related to observations in the Interventions or Events classes.

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