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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 RulesAt least one SubjectData element must be provided.
Attributes

SubjectKey, TransactionType

Child Elements(
AuditRecord
InvestigatorRef?, 
Signature
SiteRef?, StudyEventData*,
 InvestigatorRef
AuditRecord?, 
SiteRef
Signature?, Annotation*, 
StudyEventData*,
Query*)
SubjectKeysubjectKeyTransactionType(Insert | Update | Remove | Upsert | Context)(optional)The TransactionType attribute need not be present in a Snapshot document
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.