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changes.mady.by.user Lex Jansen

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

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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.

Element NameAuditRecord
Parent ElementsItemData, ReferenceData, ClinicalData, SubjectData, StudyEventData, ItemGroupData,  StudyEventData ItemData, SubjectData,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/SubjecDataSubjectData/Query/AuditRecord
  • /ODM/ClinicalData/SubjectData/StudyEventStudyEventData/AuditRecord
  • /ODM/ClinicalData/SubjecDataSubjectData/StudyEventStudyEventData/Query/AuditRecord
  • /ODM/ClinicalData/SubjectData/StudyEventStudyEventData/ItemGroupData/AuditRecord
  • /ODM/ClinicalData/SubjecDataSubjectData/StudyEventStudyEventData/ItemGroupData/Query/AuditRecord
  • /ODM/ClinicalData/SubjectData/StudyEventStudyEventData/ItemGroupData/ItemData/AuditRecord
  • /ODM/ClinicalData/SubjecDataSubjectData/StudyEventStudyEventData/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?)