In this example, subjects ABC1-001, ABC1-021, and ABC1-041 all experienced their planned sequence of elements. The SE dataset documents the start and end dates of each element.
se.xpt
se.xpt
Row
STUDYID
DOMAIN
USUBJID
SESEQ
ETCD
ELEMENT
SESTDTC
SEENDTC
1
ABC1
SE
ABC1-001
1
SCRN
Screen
2008-01-08
2008-01-14
2
ABC1
SE
ABC1-001
2
GP 01
Control
2008-01-15
2008-01-27
3
ABC1
SE
ABC1-021
1
SCRN
Screen
2008-01-08
2008-01-14
4
ABC1
SE
ABC1-021
2
GP 02
100 mg/kg Product A
2008-01-15
2008-01-27
5
ABC1
SE
ABC1-041
1
SCRN
Screen
2008-01-08
2008-01-14
6
ABC1
SE
ABC1-041
2
GP 03
500 mg/kg Product A
2008-01-15
2008-01-27
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The following table is the corresponding Trial Arms (TA) dataset outlining the planned arms and elements for the same study. This is provided to assist with understanding how the actual experienced elements (SE dataset) relate to the planned arms defined here.
ta.xpt
ta.xpt
Row
STUDYID
DOMAIN
ARMCD
ARM
TAETORD
ETCD
ELEMENT
TABRANCH
EPOCH
1
ABC1
TA
01
Control
1
SCRN
Screen
Randomized to Group 01
Screen
2
ABC1
TA
01
Control
2
GP 01
Control
Exposure
3
ABC1
TA
02
100 mg/kg
1
SCRN
Screen
Randomized to Group 02
Screen
4
ABC1
TA
02
100 mg/kg
2
GP 02
100 mg/kg Product A
Exposure
5
ABC1
TA
03
500 mg/kg
1
SCRN
Screen
Randomized to Group 03
Screen
6
ABC1
TA
03
500 mg/kg
2
GP 03
500 mg/kg Product A
Exposure
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Note: This is a simple design where ARMCD relates directly to dose groups. In more complex designs, a separation between arms and groups may be required in naming conventions (e.g., "Randomized to Exposure 1").
Example: High Dose Changed from 900 mg/kg to 700 mg/kg
In this example, the high-dose group originally scheduled to get 900 mg/kg was intentionally changed to 700 mg/kg after 1 week of the study. Prior to this change, a protocol amendment was created that altered the plan; therefore, this element would appear in TA, Trial Elements (TE), and SE.