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Both of the trials in TA Examples 1 and 2 (see Section 7.2.1, Trial Arms) are 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 treatment 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 Trial 3, where an element may appear in 1 of multiple epochs, the wording must be appropriate for all possible epochs (e.g., "OPEN LABEL TREATMENT"). The SDS Team is considering adding a separate variable to the TE dataset that would hold information on the treatment that is associated with an element. This would make it clearer which elements are "treatment elements” and, therefore, which epochs contain treatment elements and thus are "treatment Epochs."
| Example | ||
|---|---|---|
| TE Example Trial 1 | TE Example Trial 1
| Example | ||
|---|---|---|
| TE Example Trial 2 | TE Example Trial 2
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