| Element Name | SubjectData |
|---|---|
| Parent Elements | ClinicalData |
| Element XPath(s) | /ODM/ClinicalData/SubjectData |
| Element Textual Value | None |
| Usage/Business Rules | At least one SubjectData element must be provided. |
| Attributes | SubjectKey, TransactionType |
| Child Elements | (AuditRecord?, Signature?, InvestigatorRef?, SiteRef?, Annotation*, StudyEventData*, Query*) |
| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rules |
|---|---|---|---|---|
| SubjectKey | subjectKey | Required | Unique identifier for the Subject. | When the collected data will be transformed to SDTM for regulatory submission, the SubjectKey value should be the SDTM SUBJID variable value. |
| TransactionType | (Insert | Update | Remove | Upsert | Context) | Conditional | 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. |