- User Guide for Sponsors
- Create a history report
- Audit Trail Report
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
- On the My Requests page, select Create History Request from the Create Requests drop-down.
- 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.
- Enter an optional Description.
- Select Audit Trail Report, and click Next.
- 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
- 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.
- 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.
- 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. - 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
Parent topic: Create a history report