The Subject Elements dataset consolidates information about the timing of each subject’s progress through the epochs and elements of the trial. For elements that involve study product exposure, the identification of which element the subject passed through (e.g., Tobacco Product X vs. placebo) is likely to derive from data in the Exposure domain or another Interventions domain. The dates of a subject’s transition from one element to the next will be taken from the Interventions domain(s) and from other relevant domains, according to the definitions (TESTRL values) in the Trial Elements (TE) dataset (see Trial Design Description.
The SE dataset is particularly useful for studies with multiple treatment periods, such as 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.
- 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. See Section 4.4.4, Use of the "Study Day" Variables.
- Having knowledge of SE start and end dates can be helpful in the determination of baseline values.
Overview
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