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

Follow the steps below to generate the Audit Trail Report

1. On the My Requests page, select Create History Request from the Create Requests drop-down.
2. On the Study Information page, accept the default Request Name (comprised of the study name plus the current date and time) or enter a different name.
3. Enter an optional Description.
4. Select Audit Trail Report, and click Next.
5. Enter the Request Settings, then click Next.

   Table 3-1 Audit Trail Report - Request Settings

   Setting	Description
   Headings Language	Specify the language to use for labeling headers. English is the default language.
   Include Study Name in the Subject CSV File name	Select Yes (default) to include the study name in the output file. Select No if the study name is not needed.
   Share with Sites	Select Yes if you want to make the report made available for download by site users. Select No (default) if site users do not need to download this report.
   Site Confirmation Required Note: Appears only if Share with Sites is Yes.	Select Yes if you want site users to confirm downloading the report shared with them. Note: For more information about the site confirmation process, see Confirm archives and reports Select No (default) if you do not require confirmation from site users.
   Select the rights group to control content	The rights group selected determines what content gets included in the PDF output. The default is the logged-in user's rights group.
   Allow any Site User to download this request Note: Appears only if Share with Sites is Yes.	Select Yes to allow any site user with Archives access to download this request. Select No (default) to allow only site users assigned to the rights group selected for Select the Rights Group to Control Content to download the request.
   Notify CRFS Site Users Note: Appears only if Share with Sites is Yes.	Select Yes to send site users the, PDF or History Request is available for download (Site user, when share with sites) notification when a request is available for download. Note: The notification is only sent if it has been enabled. For more information, see About email notifications. The setting displays even if the notification is not enabled. Select No (default) if the notification should not be sent.
   Generate TOC	Select Yes (default) to include a table of contents (TOC). Select No to not include the TOC.
   Candidate Queries	Select Yes (default) to include Candidate Queries. Select No to exclude them.
   Select Date Range	The date range entered determines the audit trail data included in the report.
   Selection Criteria	Use the following filters to generate an Audit Trail Report for an entire trial or site or for a specific subject or form. Sites Subjects Visits Forms Modification Type Rights Group Usernames

6. Review the request settings on the Review and Submit page for accuracy.
   • Click Print to print a copy of the request settings. The zip file also includes a copy of the request settings.
   • Click Submit to generate the report.
7. The PDF Request Submitted window opens and presents the following options.
   • Click Yes, Create Another to return to the Create History Request page.
   • Click No, Go to Processing Page to be taken to the My Requests - Processing page.
8. On the My Requests - Processing page, click Refresh until the % Complete column displays 100.

   Note:

   Completed requests are moved to the My Requests - Completed page.
9. You can now Download a history report.

   Table 3-2 Audit Trail Report (ATR) Output Details

   Output Column	Output Column Description
   Study Name	InForm study name
   Site ID	InForm site number
   Site Name	InForm site name
   SubjectID	InForm subject number
   Abbreviated Visit Name	InForm visit refname
   Abbreviated Form Name	InForm form refname
   Form Index	This number uniquely identifies the instance of the repeating form within a subject visit, starting from 1.
   Itemset Index	This number uniquely identifies the instance of a repeating section (i.e. itemset) within a subject form.
   Item Question	InForm question text
   Modification Type	Indicates the type of modification made to the Item Question. Modification Types: Initial Entry, Association Added, Association Removed, Form Comment, Form Deleted, Form Frozen, Form SDV Complete, Form SDV Partial, Form SDV Ready, Form Started, Form Undeleted, Form Unfrozen, Item Comment, Modification, Query, BOOK Signature, and CRF Signature
   Entered Reason	Reason entered in InForm for the modification made to the Item Question. This could be an option from a drop down, i.e., Transcription Error or the text entered by the InForm user.
   Current Value	Value currently visible in the Item Question in the InForm study UI
   Current Value Date/Time	Date/Time the value was updated to the Current Value
   Current Value Date/Time (UTC)	Date/Time in Coordinated Universal Time (UTC) the value was updated to the Current Value
   Query Text	The query text associated with the Current Value
   Previous Value	The value present in the Item Question prior to the change
   Previous Value Date/Time	Date/Time the Previous Value was entered
   Previous Value Date/Time (UTC)	Date/Time in Coordinated Universal Time (UTC) the Previous Value entered
   Rights Group	InForm Rights Group of the user that made the change
   Username	InForm Username of the user that made the change
   User Type	InForm user type of the user that made the change