Auditing in the InForm software

In the InForm software, auditing tracks all additions, changes, and deletions made to clinical data from the point of original entry.

Users of the InForm software can track audit data on the Audit screen for each data item of an electronic CRF. For each addition, change, or deletion, the Audit Trail screen shows the server, date and time of change, user, change data, and change reason.

The source machine of each transaction appears in the Server column of the Audit Trail screen. For an EDC transaction, the source machine is the one on which the InForm software is installed. For a query transaction originating in the Clintrial software and synchronized to the InForm software through CIS, the audit trail shows the Oracle TNS name used by the CIS machine to connect to the database, along with the name of the protocol, in the format TNSName.ProtocolName.