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.
| 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.
| 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"). |