SDTM TE, TA, and SE Domains: Demystifying the Development of SE
Kristin Kelly, Fred B. Wood · 2015
There is a necessary relatedness among the SDTM Trial Design domains, TA (Trial Arms) and TE (Trial Elements), and the special-purpose domain, SE (Subject Elements), that serves to convey both the planned (TE/TA) and actual (SE) treatment paths for a subject within a study. The SE domain is derived from the subject-level general observation class domains based on 1) the Start and End rules in TE, and 2) the Transition and Branching rules (TATRANS and TABRANCH) in the TA domain. The SDTMIG principles state that there are no gaps between Elements, meaning that the start date/time of an Element (SESTDTC) is the same as the end date/time of the previous Element (SEENDTC). The SE domain can be cumbersome to create if the code attempts to account for both the Start Rule and End Rule for each Element. This paper will discuss a streamlined process for deriving SESTDTC and SEENDTC by accounting for only the Start Rule (SESTDTC) for each Element, while including the End Rule (SEENDTC) in the code only if the subject does not fulfill the planned Start Rule of their next Element (e.g., due to study discontinuation, some other unplanned occurrence), or if it is the last Element.