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- The Subject Elements domain allows the submission of data on the individual experience: the actual timing and sequence of elements a subject experienced. See Section 7.2, Trial Elements, and Section 7.3, Trial Arms; the TE and TA datasets define a study's planned elements and describe the planned sequences of elements for the arms of the study. There are, by definition, no time gaps between elements; therefore, the value of SEENDTC for one element will always be immediately before or the same as the value of SESTDTC for the next element. Each element continues until the time at which the next element begins, and a subject must be in only 1 element at a time.
- For any particular subject, the dates in the SE table are the dates when the transition events identified in the TE table occurred.
- If the start date/time of an element was not collected directly, the method used to infer the element start date/time should be explained in the Comments column of the data definition file.
- If the sponsor decides that the subject's experience for a particular period of time cannot be represented with one of the planned elements, then that period of time should be represented as an unplanned element.
- For unplanned elements, ETCD should be populated with "UNPLAN", ELEMENT should be left blank, and SEUPDES should be populated with a description of the unplanned element.
- With the exception of unplanned elements, the values of ETCD used in this domain should match values for the same element in the TE dataset.
- The values of SESTDTC provide the chronological order of the actual subject elements. SESEQ should be assigned to be consistent with the chronological order. Note that the requirement that SESEQ be consistent with chronological order is more stringent than in most other domains, where --SEQ values need only be unique within subject.
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