Subject Elements (SE)

Example: Parallel Design

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

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

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: Parallel Design

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Example: Mis-dosing of an animal

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Example: High Dose Changed from 900 mg/kg to 700 mg/kg

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Subject Elements (SE)