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Each row in the TE dataset may be thought of as representing a "unique element" in the same sense of "unique" as a CRF template page for a collecting certain type of data is referred to as "unique page." For instance, a CRF might be described as containing 87 pages, but only 23 unique pages. By analogy, the trial design matrix in TA Example Trial 1 (See Trial Arms (TA) has 12 study cells, each of which contains 1 element, but the same trial design matrix contains only 6 unique elements, so the TE dataset for that trial has only 6 records.

An element

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is a building block for creating study cells, and an arm is composed of study cells. Or, from another point of view, an arm is composed of elements; that is, the trial design assigns subjects to arms, which comprise a sequence of steps (elements). The element typically indicates the study product being administered (e.g., Study Product A) or, if no study product is being administered, the other activities that are the purpose of this period of time (e.g., "Screening", "Follow-up", "Washout"). In some cases, this time period may be quite passive (e.g., "Rest"; "Wait, for protocol defined event").

Trial elements represent an interval of time that serves a purpose in the trial and are associated with certain activities affecting the subject. “Week 2 to week 4” is not a valid element. A valid element has a name that describes the purpose of the element and includes a description of the activity or event that marks the subject's transition into the element as well as the conditions for leaving the element.

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Example
Include Page SDTM Example.TE Trial Elements 1 SDTM Example.TE Trial Elements 1

Example
Include Page SDTM Example.TE Trial Elements 2 SDTM Example.TE Trial Elements 2

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