A general note about clinical data. If an annotation has both a comment and flags, the flags should be related to the comment.
| Element Name | Annotation |
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| Parent Elements | ReferenceData, ClinicalData, SubjectData, StudyEventData, ItemGroupData, ItemData, Association |
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| Element XPath(s) | - /ODM/ReferenceData/Annotation
- /ODM/ReferenceData/ItemGroupData/Annotation
- /ODM/ReferenceData/ItemGroupData/ItemData/Annotation
- /ODM/ClinicalData/Annotation
- /ODM/ClinicalData/ItemGroupData/Annotation
- /ODM/ClinicalData/ItemGroupData/ItemData/Annotation
- /ODM/ClinicalData/SubjectData/Annotation
- /ODM/ClinicalData/SubjectData/StudyEventData/Annotation
- /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/Annotation
- /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/ItemData/Annotation
- /ODM/Association/Annotation
|
|---|
| Element Textual Value | None |
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| Attributes | SeqNum, TransactionType |
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| Child Elements | (Comment?, Coding*, Flag*) |
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| Usage/Business Rules |
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| Attribute | Schema Datatype or Enumeration | Usage | Definitions | Business Rule(s) |
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| SeqNum | positiveInteger | Required | Uniquely identifies the annotation within its parent entity. |
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| TransactionType | (Insert | Update | Remove | Upsert | Context) | Optional | Indicates the insertion, update, removal of the annotation when it differs from the implied transaction for it's parent entity. | - An empty Annotation (one with no annotation value, no comment and no flags) is not allowed unless the TransactionType is Remove.
- On Update, the entire value of the annotation is replaced.
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