Reviewing a DCR Audit Trail
- 27 Sep 2024
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Reviewing a DCR Audit Trail
- Updated on 27 Sep 2024
- 1 Minute to read
- Print
- DarkLight
- PDF
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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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