Use the Study Audit Log to view a history of actions on Subjects in the current Study. Only certain user Roles can access the log.

To access the Study Audit Log, click the Study Audit Log link in the navigation bar. The View Study Log page opens for the current Study, presenting a table with each Study Subject in its own row.

You can change the number of Subjects shown per page, change the sort order, and filter the table to show only the Subjects you want to see. These features work the same way as in the Subject Matrix: for more information, see Find and Organize Data in the Subject Matrix.

The View Study Log Page, Sorted by Subject ID:

Study Audit Log

1.2.1 Audit Logs Page for a Subject

To view the Audit Logs of Events for a Subject, click the View icon in the Actions column of the View Study Log page. The Audit Logs page opens for the Subject, providing a detailed history for all Events for the Subject.

You can also access the Audit Logs for a Subject from the Subject Matrix. Click the View icon in the Actions column of the Subject Matrix, and then on the View Subject page, expand the Study Subject Record section and select the Audit Logs link (located at the top of the section). The Subject’s Audit Logs page opens.

Excerpt from Audit Logs Page for a Subject (CAM103):

Audit Logs Page, Part 2

Download the Audit Log to Excel

To download the Audit Log to Excel, click the blue download button to the right of the Audit Log header.

Then, to open the Audit Log in Excel, click OK.

The Subject information is displayed on the first worksheet, and the audit information for each Event is displayed on a separate worksheet.

Note: Though the Audit Log may be easier to read in Excel, this cannot be considered a compliant Audit Log since it can be edited. This functionality is solely provided for ease of viewing the audit information. The Audit Log that is viewed in OpenClinica, however, is fully compliant and cannot be edited.

1.2.2 What the Study Audit Log Tracks

The Audit Log tracks the following for Events:

  • Date and time
  • Location
  • Status
  • Date started

This table lists the actions the Audit Log tracks:

CRFInitial data entry complete
CRFInitial data entry completed with password
CRFDouble data entry complete
CRFDouble data entry completed with password
CRFMarked complete
CRFCompleted with password
CRFProperties changed
CRFSource data verification status changed
Item on CRF
Data value updated (see Note, below the table)
Item on CRF
Data status changed
Item on CRF
Data deleted
Item on CRFData inserted for repeating row
EventData entry started 
EventStart date changed
EventEnd date changed
EventLocation changed
Study SubjectCreated
Study SubjectStatus changed
Study SubjectValue changed
SubjectStatus changed
SubjectValue changed
SubjectGlobal value changed
SubjectSite assignment made
SubjectGroup assignment made
SubjectGroup changed

Note: Starting with the OpenClinica 3.1.2 release, initial values for CRF Items provided during data entry are tracked in the Audit Logs, and reported as “Item data value updated.” This is only tracked when a value is provided; empty or non-existent values are not tracked. Prior to the OpenClinica 3.1.2 release, initial values for CRF items were not tracked.

The Audit Log does not track Discrepancy Notes, but you can view or download the full thread for any Discrepancy Notes you want to see. Discrepancy Notes cannot be removed, so they are all always available.