Body:
Attributes:
| EditPoint | (Monitoring | DataManagement | DBAudit) | (optional) | |
| UsedMethod | (Yes | No) | (optional) | |
| ID | ID | (optional) |
Contained in:
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 UsedMethod attribute indicates whether the action involved the use of a Method.
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.
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.
Whenever an element has a TransactionType (either explicit or inherited), an AuditRecord must be provided. However, an AuditRecord has no meaning in a Snapshot transfer.
As with the TransactionType attribute, an AuditRecord is inherited by any subelement that is allowed to have an AuditRecord and does not already have one attached.
Note: Contrast with Signature.