Audit reports make up the combination of factors tracked across the study. These include the following which is covered in this document:
On the App and Web
- Subject Record Transaction Audit
- Subject Record Change Audit
- Site/User Audit
On the App
- Study Version Difference Audit
- Role Rights Audit Report
- Blinded Field Audit
- Version Override Audit
On the Web
- Legacy Audit Report
- Export Data Deletion Audit
Users can access most reports covered in this article under Reports – Form Data Audits on the Web, or Reports – Regulatory Audit Reports on iOS. The only exception to this is the Study Events Report, which on the app can be accessed from the Report menu, before selecting Regulatory Audit Reports. Access to this reporting requires the corresponding permission(s), and is normally only made available to Admins or Data Managers.
On the web:
On the app:
The following reports pertaining to audit information, support role blinding:
- Subject Record Transaction Audit - For users without view permissions to specific form(s)
- Subject Record Change Audit - For users blinded to specific fields
On the App
The following reports will be listed to choose from on the app. Results can be filtered on many reports using the magnifying glass icon at the top right of the report results screen (where available). Filters applied to a report by a User are automatically applied to other reports when selected by that User. For example, if a User applies a Filter for a Site at the Subject Record Transaction Audit report, that Site filter will be automatically applied if the Users then selects the Subject Record Change Audit report. Filters should be cleared manually. Various export options are also available at the report results screen for most reports.
Site/User Audit
Displays a history of all changes made to user and site access to the host and studies.
Study Version Different Audit
Displays a table of all changes made in the form builder from one version to another. To populate a list of changes in the Form and Field Difference tables, a row for a Version (other than the initial version) must be selected in the Current Versions table.
Subject Record Transaction Audit
Displays a listing of all form transaction related audit events.
Subject Record Change Audit
Displays a listing of all data changes that have occurred between saving events within form fields, including the Reason for Change where available.
Role Rights Audit Report
Displays a history of all changes made to role rights/permissions.
Blinded Field Audit
Displays each instance of field blinding being applied to, or removed from, a role in the Study.
Version Override Audit
Displays each instance of a form change being applied within a published version.
On the web
Filter options are available at most of the reports, and Users should be mindful of filters applied while reviewing report results. User can also select the column header to sort results on the screen, and use the export option(s) to export results out of the system.
Subject Record Transaction Audit
When the Form Data Audits option is selected, the page opens with the Subject Record 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.
Subject Record Change Audit
Displays a listing of all data changes that have occurred between saving events within form fields, including the Reason for Change where available.
Study Events Report
Displays a listing of all events that have occurred within Subject Records, and an option to perform bulk lock/unlock action for users with the proper access. See Study Events Report for more detail.
Legacy Audit Report
The Legacy Audit Report was replaced with the updated Subject Record Transaction Audit report, but is still available for use until further notice. It allows a user to view and filter all changes made to Subject Records that occur within the Datatrak Direct system.
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.
Subject Record Audits at Form Entry
Form related audit detail is also available for review at the form entry screen at the app and Web.
On the app:
The book icon, when selected, will open the Record Transaction Diary detail for the selected form. The Record Transaction Diary dialog will list all form transaction related audit events.
The page with eye icon, when selected, will open a listing of all data changes that have occurred between saving events within form fields, including the Reason for Change where available.
On the web:
At the bottom of the form entry screen, the Form Audit Table will include listing of all data changes that have occurred between saving events within form fields, including the Reason for Change where available. Entries can be expanded or collapsed by selecting the up/down arrow.
At the bottom of the form entry screen, the Form Transaction Diary will list all form transaction related audit events.
