This example shows data for 2 subjects for a crossover trial 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 treated incorrectly. 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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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 treated accordingly.
Row 2:
Subject 790 was assigned to the Prod Y- Prod X, but their actual treatment was Product X then Product Y .