Reviewing a Form Audit Trail

Viewing a Form Audit Trail in StudyWorks

When reviewing the audit trail, you will see two tables. The top table shows all field-level changes, while the bottom table displays form-level changes.

Launch forms from your subject’s clinical data page. Press + in the Actions column and then press View Audit Trail.
Press Print to print the audit trail.
Press hyperlinked text (e.g., “Initial Entry”) to view more details related to that field’s comment.
Close the Form Audit Trail by pressing the X.

The Form Audit Trail is particularly useful for tracking data changes related to your subjects. If a Data Change Request (DCR) was used, the DCR reference number will be listed in the Comment field. Be on the lookout for these two key items:
The DCR reference number will be marked as HD or SW followed by numbers.
A New Value appears where a DCR was performed, while the original data point appears as an Old Value.

Information Scope

Solution: eCOA

Platform: StudyWorks

Taking a closer look at StudyWorks Form Audit Trails

The Form Audit Trail records changes to system variables or reference data on form fields, showing the field name, visit name, and form where the change occurred. Our audit trails capture:

New data submitted for the first time.

Edits to any data previously submitted.

Record of the person who edited the data.

Data are sorted by the server’s UTC timestamp in descending order (most recent first) and then alphabetically by field value.

We also provide both Server Timestamps and Local Timestamps (i.e., the user’s time) to detect device clock changes and track the original submission time.

The header at a glance

Subject ID/Initials — Displays the subject’s reference number.
Visit — Displays the visit’s name.
Form — Display’s the form’s name.
When visits and forms are designed to repeat, a sequential number appears next to the visit/form name (e.g., “LogPad (0)”).

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 Party — Displays the initials or username of the person performing the action. If these are hidden fields, it may show as “---”.
Domain — Shows the user’s domain if the study uses domains and the user is assigned to one.
Performed By — Records the username of the person performing the action.
User Role — Shows the user’s role in StudyWorks.
Signature Type — Identifies the signature type (i.e., ink signature, electronic signature).

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 “---”.
Change Type — Shows “Comment” for added data and “Edit” for modified data.
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]”.
Comment — Records extra details about the entry or change. “System Generated” appears for data submitted by software or devices, while “Edit by” information is shown for modified data.