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Auditing in the Clintrial software
In the Clintrial software, auditing tracks changes to clinical data and notes associated with clinical data:
- For data entered with the Enter module, study designers can configure the point at which auditing begins, and auditing tracks changes or deletions made to records and notes after the audit start point: Entry, Verification, Validation, Validity, or Merge.
- For EDC data, when you synchronize metadata for an integrated study designed with the Central Designer software to a Clintrial protocol, CIS creates new panels if they do not already exist in the protocol. When CIS creates Clintrial panels, it automatically sets the audit start point of each panel to Entry.
Note: If you create a panel with the Design module of the Clintrial software to be used for EDC data, you must manually define the panel with an audit start point of Entry. Similarly, do not change the audit start point for panels created by CIS. Creating or changing a panel to an audit start point other than Entry can result in the inability to reinstate data that has been deleted in the InForm software.
Audit data is stored in the AUDIT table for each clinical data panel in a protocol.
The Audit Record Report, available in the Manage module of the Clintrial software, shows changes and deletions made to a selected panel’s records after the audit start point has been reached.
