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An element
| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-731 |
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is a building block for creating study cells, and an
arm is composed of study cells. Or, from another point of view, an arm is composed of elements; that is, the trial design assigns subjects to arms, which comprise a sequence of steps (elements).
The element typically indicates the study product being administered ( e.g., Study Product A) or, if no study product is being administered , the other activities that are the purpose of this period of time (e.g., "Screening", "Follow-up", "Washout"). In some cases, this time period may be quite passive (e.g., "Rest"; "Wait, for protocol defined event").Trial elements represent an interval of time that serves a purpose in the trial and are associated with certain activities affecting the subject. “Week 2 to week 4” is not a valid element. A valid element has a name that describes the purpose of the element and includes a description of the activity or event that marks the subject's transition into the element as well as the conditions for leaving the element.
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| Example |
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| SDTM Example.TE Trial Elements 1 |
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| SDTM Example.TE Trial Elements 1 |
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| Example |
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| SDTM Example.TE Trial Elements 2 |
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| SDTM Example.TE Trial Elements 2 |
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