Clinical data for a study event (visit). The model supports repeating study events (e.g., when the same set of information is collected for a series of patient visits).

Element NameStudyEventData
Parent ElementsSubjectData
Element XPath(s)

/ODM/ClinicalData/SubjectData/StudyEventData

Element Textual ValueNone
Attributes

StudyEventOID, StudyEventRepeatKey, TransactionType

Child Elements(ItemGroupData*, AuditRecord?, Signature?, Annotation*, Query* )
Usage/Business Rules

AttributeSchema Type or EnumerationUsageDefinitionBusiness Rule(s)
StudyEventOIDoidref

Required

Reference to the StudyEventDef.

The StudyEventOID and StudyEventRepeatKey are used together to identify a particular study event. This pair of values uniquely identifies a StudyEvent within the containing subject. The StudyEventRepeatKey is present if and only if the StudyEventDef is repeating.

  • Must match a StudyEventGroupDef/@OID or StudyEventDef/@OID for the MetaDataVersion /@OID value that matches the ClinicalData/@MetaDataVersionOID attribute.
StudyEventRepeatKeyrepeatKeyConditionalA key used to distinguish between repeats of the same type of study event for a single subject.
  • If the StudyEventDef/@Repeating attribute has the value "Yes" and there is more than one ClinicalData/SubjectData/StudyEventData/@OID element, the StudyEventRepeatKey attribute must be provided.
  • Must be unique among the set of ClinicalData/SubjectData/StudyEventData/@OID elements.
  • The StudyEventRepeatKey must be present only when the StudyEventDef/@Repeating attribute has the value "Yes".
TransactionType(Insert | Update | Remove | Upsert | Context)

Conditional

  • Required when contained within an ODM Transactional file and the StudyEventData element has no child element content the TransactionType must be specified.
Identifies the transaction type when /ODM/@FileType is Transactional and there is no child element.
  • When importing data from an ODM Snapshot file, the TransactionType attribute must not affect the processing of any of the StudyEvent child elements.

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