Create an Audit Trail Report

The Audit Trail Report includes traceability for item-level inserts/edits, query changes, form status changes, SV status changes, and comment and signature history. This report is only available in CSV format.

The report also includes audit trail information for the following Oracle InForm form and SV statuses:

• Date Form Started
• Date Form Frozen / Unfrozen
• Date Form Locked / Unlocked
• Date Form Signed / Unsigned
• Date Form Deleted / Undeleted
• Date Form is marked SDVReady, SDVPartial, & SDVComplete
• Date SDVReady, SDVPartial, & SDVComplete are deleted

1. On any My Requests page, from the Create Requests drop-down, select Create History Request.
2. On the Study Information page, accept the default Request Name (composed of the study name and the current date-time) or enter a different name.

   Tip:

   The Request Name appears on lists of Processing, Completed, Saved, and Deleted requests. The default name is comprised of the study name and the current date-time string concatenated together. The name can contain blank spaces. For example, Mass General Subject Audit History.
3. Enter a Description (optional).
4. Select Audit Trail Report, and click Next.
5. Enter the Request Settings:
   • Headings Language—The language to use for bookmarks, headers, and labels.
   • Share with Sites—Select Yes to provide sites with the Audit Trail Rreport. This field appears only if you have the Share with Sites right.
   • Site Confirmation Required—If the report is meant for final archiving, or an MHRA site audit, select Yes to require sites to confirm download and review of this report.
   • Select the rights group to control content—Select the rights group with control over the content of the request type. The default is the logged-in user's rights group. See What do rights groups do?
   • Allow Any Site User to Download the Request—Select Yes to allow any site user with Archives access to download request output. Select No to allow only site users assigned to the rights group selected for Select the Rights Group to Control Content to download the request output.
   • Generate TOC—Create a table of contents as a separate file with links to all generated records in the report. The default is Yes.
   • Include or exclude Candidate Queries, preliminary queries issued by a sponsor user and visible only to other sponsor users.
   • Select Date Range—Enter the date range the report should cover in the From and To fields.
   • Selection Criteria—Customize the report by selecting the history to include for each item. Click the right-arrow and move items from the Available List to the Selected List.
6. Click Next.
7. Review your settings. You can view your selection criteria. You can also print the settings or go back and change settings.
8. Click Submit.
9. To create another request, click Yes, Create Another , or to process this request, click No, Go to Processing Page.
10. You can monitor the progress on the My Requests - Processing page.
    • To update the processing statistics shown, click Refresh.
    • To pause processing, select a request checkbox and click Pause. To resume processing, click Resume.
    • To cancel the request, select a request checkbox and click Cancel.

    When the request disappears from the My Requests - Processing page and moves to the My Requests - Completed page, processing is complete.

11. Select the checkbox and click Download.
12. Review the output.

    The file is in CSV format for import into MS Excel. One folder per site with one .CSV file per subject within each site is generated.