You are viewing an old version of this page. View the current version.

Compare with Current View Page History

Version 1 Next »

Element NameAnnotation
Parent Element(s) SubjectData,StudyEventDataItemGroupData,ItemDataAssociation
Element XPath(s)
  • /ODM/ReferenceData/ItemGroupData/Annotation
  • /ODM/ClinicalData/SubjectData/Annotation
  • /ODM/ClinicalData/SubjectData/StudyEventData/Annotation
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/Annotation
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/ItemData/Annotation
Element Textual ValueNone
UsageOptional
AttributesSeqNum, TransactionType
Child Elements(Comment?,  Flag*)


Attributes:

AttributeSchema Datatype or EnumerationUsageDefinitionsBusiness Rules
SeqNumintegerRequiredUniquely identifies the annotation within its parent entity.
TransactionType(Insert | Update | Remove | Upsert | Context)OptionalIndicates the insertion, update, removal of the annotation when it differs from the implied transaction for it's parent entity.An empty Annotation (one with no annotation value, no comment and no flags) is not allowed unless the TransactionType is Remove. On Update, the entire value of the annotation is replaced.


Contained in:


A general note about clinical data. If an annotation has both a comment and flags, the flags should be related to the comment.


The SeqNum attribute (a small positive integer) uniquely identifies the annotation within its parent entity.

An empty Annotation (one with no annotation value, no comment and no flags) is not allowed unless the TransactionType is Remove. On Update, the entire value of the annotation is replaced.

  • No labels