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Clinical data for a single subject.
Element Name | SubjectData |
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Parent Elements | ClinicalData |
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Element XPath(s) | /ODM/ClinicalData/SubjectData |
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Element Textual Value | None |
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Attributes | SubjectKey, TransactionType |
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Child Elements | (InvestigatorRef?, SiteRef?, StudyEventData*, AuditRecord?, Signature?, Annotation*, Query*) |
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Usage/Business Rules | - Other Information:
- The SubjectKey attribute is used to identify a specific subject. It uniquely identifies a subject within the study specified by the parent ClinicalData element. If the same SubjectKey is used in multiple ClinicalData elements in a single study, this is interpreted as being the same subject.
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Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rule(s) |
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SubjectKey | subjectKey | Required | Unique identifier for the Subject. | - For CDISC SDTM regulatory submission, the SubjectKey value should be the SDTM SUBJID variable value.
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TransactionType | (Insert | Update | Remove | Upsert | Context) | Conditional - Required when contained within an ODM Transactional file and the SubjectData element has no child element content.
| Identifies the transaction type when /ODM/@FileType is Transactional and there is no child element. | - When importing data from an ODM Snapshot file, the TransactionType attribute must not affect the processing of the SubjectData element.
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