Reviewing the DCI History

You can review audit trail information for Received DCIs, Received DCMs, and Responses, since Oracle Clinical captures all changes to patient data and their associated CRF header records. The Audit Trail function can be useful for reviewing the history of changes to data in a study, as well as for documenting the correct behavior of the Oracle Clinical software during a user-acceptance validation. The Audit Trail window is query-only; you cannot make changes to data here.

Note:

The audit trail only contains changes to study data, so the addition of new records to a study is not auditable.

To review audit trail information for Received DCIs, Received DCMs, or Responses:

1. Invoke the Received DCI or the Received DCM from any data entry task.
2. Select the Show Audit function while in the RDCI or the RDCM window.

   If the cursor is in the RDCI window when the function is invoked, the Audit Trail window shows all Received DCMs and all changed response data for the currently displayed Received DCI. If the cursor is in the Received DCM window, the Audit Trail window shows just that Received DCM, along with all changed response data and its parent Received DCI. (The Audit Trail window is not currently available from within the data entry window.)

3. When you Exit from this window, you return to the window that called the Audit Trail window, and you can continue normal processing.

See the following topics for additional information:

• Audit Trail Window
  
• How the System Stores the Audit Trail