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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 sub ject's transition into the element as well as the conditions for leaving the element.

The trial in TA Example 1 (See Trial Arms (TA) is is assumed to have fixed-duration elements. The wording in TESTRL is intended to separate the description of the event that starts the element into the part that would be visible to a blinded participant in the trial (e.g., "First dose of a product epoch") from the part that is revealed when the study is unblinded (e.g., "where dose is 5 mg"). Care must be taken in choosing these descriptions to be sure that they are arm- and epoch-neutral. For instance, in a crossover trial such as TA Example 2 (See Trial Arms (TA), where an element may appear in 1 of multiple epochs, the wording must be appropriate for all possible epochs (e.g., "OPEN LABEL PRODUCT"). The SDS Team is considering adding a separate variable to the TE dataset that would hold information on the product that is associated with an element. This would make it clearer which elements are "product elements” and, therefore, which epochs contain product elements and thus are "product Epochs."

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