Regulatory Audit Reports (Form Data Audits)

Audit reports make up the combination of factors tracked across the study. These include the following which are covered in this document:

Accessing All reports covered in this article is done via the “Regulatory Audit Reports” option under the Reports Menu.

On the web:

Open

On the app:

Open

On the App

The following reports will be listed to choose from on the app:

Record Transaction Audit

Displays a listing of all save or record transaction events.

Data Change Audit

Displays a listing of all data changes that have occurred between saving events

Role Rights Audit

Displays a history of all changes made to role rights/permissions

Site/User Audit

Displays a history of all changes made to user and site access to the host and studies

Version Differences

Displays a table of all changes made in the form builder from one version to another

On the web

The page opens with the transaction audit report which displays each event across all records. Other reports with further details can be accessed via the links on the right side.

Legacy Audit Report

The Subject Audit Report on the web allows a user to view and filter all changes made to Subject Records that occur within the TrialKit system. This report requires the corresponding permission, normally only available to Admins or Data Managers. The Report can be found under the Reports menu on the website.

See the descriptions for each part of the report below the image:

1. Choose Variables To Filter Report form.  The Choose Variables To Filter Report section allows a user to define the information that will be displayed in the Audit Log data table. To filter the data table display, select the desired filter drop-downs, and select the desired filter. AS each filter is selected the Audit Log quickly changes the displayed information. Individual filters or multiple filters can be selected to narrow the information the Audit Log data table displays.

2. The Audit Log Table. All audited times are based on the database setting. For studies stored in the US, this is GMT-5/-6. For studies stored in the EU, this is GMT.

3. Select number in Transactions column highlighted to open up that forms transaction history as shown below:  Notice the text highlighted in Record detail table that shows which subject's information you are reviewing.

4. The Audit Log data table contains a Rows Pagination drop-down like all the tables in TrialKit.  The changes column has a link called Field Value Changes if the data has been changed.  Click on that link to open up the table for details.  Across the top of the table are descriptive header columns as shown in the figure below.  Each column is sort-able, in ascending and descending order, by clicking the header. To reverse the sort order, click the header again. Sort-able columns are defined by hovering your mouse over the header column.  If the mouse pointer changes to a hand with the finger pointing up the column is sort-able.

5. The Field Value Changes link opens up the Field Changes table where you can see Old Value vs New Value and Reason for data change.

6. Field Changes table displays old and new values along with Reason for Change from the field audit that is answered when data is changed in eCRFs by data entry personnel.

To the right of the page (not shown) is a link to export the data. This will export a table of all data changes for the data currently displayed in the Audit Log table. Note, the export will only contain data changes, not all events on the records. 

There are filters available to define the Audit Log data table display.  Below is a description of each filter.

• Site – The Site drop-down list is populated with the sites that have been entered for the current sponsor. The filter allows the user to select either All Sites or an individual Site for the active Sponsor and Study that will be displayed in the Audit Log data table.

• Subject – The Subject drop-down list is populated with all Subjects that have been registered in the current study. The filter allows the user to select either All Subjects or filter by a specific Subject ID for the active Sponsor, Study and Site.

• Form - The Form drop-down list is populated by all the forms associated with the Study. The filter allows the user to display either All Forms or an Individual Form for the Active Sponsor, Study, and Site(s).

• Low Date – The Low Date field allows the user to define a specified low date for the Audit Log data table display. In other words, any date that precedes the date entered in the Low Date field would not be displayed in the Audit Log data table. The "Go" button must be clicked to enforce the filter. To clear the Low Date filter field, click in the field and click the delete button; tab through each section of the field and click the delete button until all fields are empty. Then select the "Go" button again to reset the filter.

• High Date - The High Date field allows the user to define a specified high date for the Audit Log data table display. In other words, any date that falls after the date entered in the High Date field would not be displayed in the Audit Log data table. The "Go" button must be clicked to enforce the filter. To clear the High Date filter field, click in the field and click the delete button; tab through each section of the field and click the delete button until all fields are empty. Then select the "Go" button again to reset the filter.

Setting the Low and High Date Filters together allows the user to define a range of dates to display in the Audit Log data table.

The Subject Audit Report is an extremely useful and valuable report and is required by FDA regulation 21 CFR Part 11.

Data Deletion Audit

This is an exportable-only report accessible from the transaction audit screen. This will isolate all deleted records and underlying details.

Associated deleted records are accessible from the Deleted Records list on the web.

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