Reviewing a DCR Audit Trail

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Viewing a DCR Audit Trail in StudyWorks

The DCR automatically displays the creator, create date/time, closed by, and closed date time. You can press Audit Trail from within the DCR page to view a record of changes made to the DCR.  

Information Scope

Solution: eCOA

Platform: StudyWorks

Taking a closer look at StudyWorks DCR Audit Trails

The header at a glance

  • Study — Displays the protocol reference.

  • Sponsor — Displays the Sponsor’s name.

  • Site — Display’s the Site number.

  • Subject — Displays the subject number.

Time of Occurrence & Responsible Party

  • Server Time — Shows the activity or form submission date and time based on the server settings, including the UTC offset.

  • User Time — Displays the activity or form submission date and time based on the PC or device settings, including the UTC offset.

  • Responsible ID — Displays the initials or username of the person performing the action. If these are hidden fields, it may show as “---”.

  • Responsible User Name: Records the user name of the person performing the action.

  • Responsible User Role: Shows the user’s role in StudyWorks.

  • Domain — Shows the user’s domain is shown if the study uses domains and the user is assigned to one.

Understanding each column

  • Field — Displays the name of the field where action was taken. A field may be hidden when a user lacks viewing privileges; the old and new values will show as “---”.

  • Old Value — For a new value in the field, this column displays: “Added [new-value]”.

  • New Value — For a modified value, this column displays: “Changed [old-value]”.

  • Reason — Records extra details about the entry or change.

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