History report details
As part of a study decommissioning package, some regulatory agencies require
the following history reports.
Table 1-2 History report details
Report name | Description | Included in the .zip file |
---|---|---|
Audit Trail Report |
This report includes traceability details for item-level inserts and edits, query changes, form status changes, SV status changes, and comment and signature history. This report is only available in CSV format. |
|
User Assignment History report | This report includes an audit history of changes made
to each user account.
|
|