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changes.mady.by.user Sally Cassells

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changes.mady.by.user Sam Hume

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Comment: removed ref to auditrecords changed UsedMethod

Body:

(UserRef, LocationRef, DateTimeStamp, ReasonForChange?, SourceID?)


Attributes:

EditPoint(Monitoring | DataManagement | DBAudit)(optional)
UsedImputationMethod

UsedMethod(Yes | No)(optional)
IDID(optional)
If an AuditRecord is contained within an AuditRecords element, the ID attribute must be provided.


Contained in:

FormData (Deprecated), 
ItemData, ItemGroupData, StudyEventData, SubjectData
, AuditRecords (deprecated)


An AuditRecord carries information pertaining to the creation, deletion, or modification of clinical data. This information includes who performed that action, and where, when, and why that action was performed.

The EditPoint attribute identifies the phase of data processing in which action occurred, and the UsedImputationMethod UsedMethod attribute indicates whether the action involved the use of a Method. (Note: In ODM 1.3, the new element MethodDef was introduced and the ImputationMethod element was deprecated). 

Note: The monitoring phase includes any data collection and correction involving the clinician, study-site personnel, or study monitor. The data management phase includes any changes made for internal data processing reasons (for example, coding or updating derived data) and before database lock. The DB audit phase occurs after database lock.

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