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changes.mady.by.user Geoff Low

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changes.mady.by.user Marcelina Hungria

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Comment: Per ODM-13, adjusting wording on the Usage/Business Rules

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Element NameAuditRecord
Parent ElementsReferenceData, ClinicalData, SubjectData, StudyEventData, ItemGroupData, ItemData, Query
Element XPath(s)
  • /ODM/AdminData/Location/Query/AuditRecord
  • /ODM/ReferenceData/AuditRecord
  • /ODM/ClinicalData/AuditRecord
  • /ODM/ClinicalData/Query/AuditRecord
  • /ODM/ClinicalData/SubjectData/AuditRecord
  • /ODM/ClinicalData/SubjectData/Query/AuditRecord
  • /ODM/ClinicalData/SubjectData/StudyEventData/AuditRecord
  • /ODM/ClinicalData/SubjectData/StudyEventData/Query/AuditRecord
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/AuditRecord
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/Query/AuditRecord
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/ItemData/AuditRecord
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/ItemData/Query/AuditRecord
Element Textual ValueNone
Usage/Business Rules
  • Business Rule(s):
    • For the Archive use case, all AuditRecord information in the data collection system must be provided within the ODM ClinicalData.
    • When the ODM FileType attribute is set to Transactional, every ClinicalData that has a TransactionType must also have an AuditRecord.
  • Other Information:
    • An AuditRecord applies
to 
    • to any
descendent
    • descendant data element that allows a TransactionType and does not have an AuditRecord.  Query elements must have their own AuditRecord(s).
    • AuditRecord information describes a change to clinical data, but is not itself clinical data. The value of some clinical data can always be changed by a subsequent transaction, but history cannot be changed -- only added to.

For the Archive use case, all AuditRecord information in the data collection system must be provided within the ODM ClinicalData.

When the ODM FileType attribute is set to Transactional, every ClinicalData that has a TransactionType must also have an AuditRecord.

AttributesEditPoint, UsedMethod.
Child Elements(UserRef, LocationRef, DateTimeStamp, ReasonForChange?, SourceID?, StateTransition?)