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- The timing of collected observations (e.g., all vital signs measurements will be represented in domain Vital Signs (VS) irrespective of when measurements occurred).
- How collected data are used (e.g., all vital signs measurements will be represented in domain VS and a custom domain "safety" domain will not be created for measurements used to assess safety).
- Data collection methodology (e.g., all vital signs measurements will be represented in domain VS irrespective of whether measurements were recorded using separate CRFs).
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