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 Section 3.3.1, Trial Design). TOBA-284
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Getting issue details...STATUS
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. TOBA-734
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Getting issue details...STATUS
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.
This example shows data for 2 subjects for a crossover study with 4 epochs.
Row 1:
The record for the SCREEN element for subject 789. Note that only the date of the start of the SCREEN element was collected, whereas for the end of the element (which corresponds to the start of PRODUCT X ) both date and time were collected.
Row 2:
The record for the FIRST PRODUCT EXPOSURE element for subject 789. The FIRST PRODUCT EXPOSURE element started with the start of PRODUCT X dosing and ended with the start of PRODUCT Y dosing, and full date/times were collected for both.
Row 3:
The record for the SECOND PRODUCT EXPOSURE element for subject 789. Only the date, and not the time, of the start of follow-up was collected.
Row 4:
The FOLLOWUP element for subject 789 started and ended on the same day. Presumably, the element had a positive duration, but no times were collected.
Rows 5-8:
Subject 790 was exposed to products in the wrong order. This subject entered the PRODUCT X element before the PRODUCT Y element, although the planned order of elements for this subject was PRODUCT Y, then PRODUCT X. The applicant has assigned EPOCH values for this subject according to the actual order of elements, rather than the planned order. Per Assumption 6, TAETORD is missing for the elements that were out of order. The correct order of elements is the subject's ARMCD, shown in the DM dataset.
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se.xpt
Row
STUDYID
USUBJID
SESEQ
ETCD
SESTDTC
SEENDTC
SEUPDES
TAETORD
EPOCH
1
SEABC
789
1
SCREEN
2006-06-01
2006-06-03T10:32
1
SCREENING
2
SEABC
789
2
PRODUCT X EXPOSURE
2006-06-03T10:32
2006-06-10T09:47
2
PRODUCT EXPOSURE 1
3
SEABC
789
3
PRODUCT Y EXPOSURE
2006-06-10T09:47
2006-06-17
3
PRODUCT EXPOSURE 2
4
SEABC
789
4
FOLLOWUP
2006-06-17
2006-06-17
4
FOLLOW-UP
5
SEABC
790
1
SCREEN
2006-06-01
2006-06-03T10:14
1
SCREENING
6
SEABC
790
2
PRODUCT X EXPOSURE
2006-06-03T10:14
2006-06-10T10:32
PRODUCT EXPOSURE 1
7
SEABC
790
3
PRODUCT Y EXPOSURE
2006-06-10T10:32
2006-06-17
PRODUCT EXPOSURE 1
8
SEABC
790
4
FOLLOWUP
2006-06-17
2006-06-17
4
FOLLOW-UP
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Dataset Wrapper Debug Message
Please add a row column to your dataset.
Row 1:
Subject 789 was assigned to the Prod X-Prod Y arm and was exposed accordingly.
Row 2:
Subject 790 was assigned to the Prod Y-Prod X arm, but their actual product exposure order was Product X then Product Y .