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changes.mady.by.user Lorraine Sobson

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changes.mady.by.user Marcelina Hungria

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Comment: Per ODM-13, moved text from Business Rules to Usage with wording adjustment
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.