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The SE dataset is particularly useful for studies with multiple treatment periods (e.g., crossover studies). The SE dataset contains the date/times at which a subject moved from one element to another, so when this dataset, the Trial Arms (TA), and the Trial Elements (TE) dataset are included in a submission, reviewers can relate all observations made about a subject to that subject’s progression through the trial.
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- Comparison of the --DTC of a finding observation to the element transition dates (values of SESTDTC and SEENDTC) identifies which element the subject was in at the time of the finding. Similarly, one can determine the element during which an event or intervention started or ended.
- “Day within Element” or “Day within Epoch” can be derived. Such variables relate an observation to the start of an element or epoch in the same way that study day (--DY) variables relate it to the reference start date (RFSTDTC) for the study as a whole.
- Having knowledge of SE start and end dates can be helpful in the determination of baseline values.
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