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changes.mady.by.user Lex Jansen

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changes.mady.by.user Marcelina Hungria

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Comment: Per ODM-13, moving notes to the element and attributes tables; moved example to parent page
Element NameSubjectData
Parent ElementsClinicalData
Element XPath(s)

/ODM/ClinicalData/SubjectData

Element Textual ValueNone
Usage/Business RulesAttributes

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.