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| Element Name | Class |
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| Parent Elements | ItemGroupDef |
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| Element XPath(s) | /ODM/Study/MetaDataVersion/ItemGroupDef/Class |
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| Element Textual Value | None |
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| Attributes | Name |
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| Child Elements | (SubClass*) |
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| Usage/Business Rules | - Business Rule(s):
- One Class element is allowed for each ItemGroupDef element for a dataset that follows the CDISC SDTMIG, SENDIG, or ADaMIG.
- For analysis datasets, if the ItemGroupDef IsNonStandard attribute is used, the Class should not be provided.
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| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rule(s) |
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| Name | text | Conditional - Required when ODM/@Context="Submission"
| Name of the Class | - Text must follow CDISC Controlled Terminology for General Observation Class.
- For analysis datasets, if the ItemGroupDef IsNonStandard attribute is used, the Class should not be provided.
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