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changes.mady.by.user Lorraine Sobson

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changes.mady.by.user Lex Jansen

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AttributeSchema Datatype or EnumerationUsageDefinitionBusiness
Rules
Rule(s)
SubjectKeysubjectKeyRequiredUnique identifier for the Subject.
When the collected data will be transformed to SDTM for
  • 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 contained within an ODM Transactional file and the SubjectData element has no child element content the TransactionType must be specified
.
  • When importing data from an ODM Snapshot file, the TransactionType attribute must not affect the processing of the SubjectData element.