Clinical data for a single subject.

Element NameSubjectData
Parent ElementsClinicalData
Element XPath(s)

/ODM/ClinicalData/SubjectData

Element Textual ValueNone
Attributes

SubjectKey, TransactionType

Child Elements(InvestigatorRef?, SiteRef?, StudyEventData*, AuditRecord?, Signature?, Annotation*, Query*)
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.

AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)
SubjectKeysubjectKeyRequiredUnique identifier for the Subject.
  • For CDISC SDTM regulatory submission, the SubjectKey value should be the SDTM SUBJID variable value.
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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