How to read the System Audit Trail export

Modified on Thu, 5 Feb at 3:11 PM

Learn how to export and interpret your complete System Audit Trail for comprehensive compliance documentation and inspection readiness.

TABLE OF CONTENTS

1. What is the System Audit Trail Export?
2. How to export the System Audit Trail
3. Understanding the System Audit Trail
4. Reading and interpreting the data
5. Best Practices for analysis

1. What is the System Audit Trail Export?

The System Audit Trail Export is a comprehensive Excel file that documents every configuration change made to your study or survey settings. This includes all modifications made during study setup (Steps 1-6), as well as changes to project-specific dashboards, smart filters, views, reports, documents and files.

The System Audit Trail captures all configuration changes from the very beginning of your study setup, including updates made before your study status was set to "Active."

⭐️ Good to know: The System Audit Trail does NOT include subject-related data such as field data updates, performed signatures, or triggered notifications. For subject-level audit information, use the subject audit trail available in the sidebar or export individual subject audit trails in PDF format. Please refer to How to read the Subject Audit Trail.

There is currently no user interface for viewing the System Audit Trail within the application - it is only available as an Excel export.

2. How to export the System Audit Trail

To export the system audit trail, navigate to the Data Export module in your study or survey and scroll to the "Type of Data" section, where you will find System audit trail listed. Select System audit trail as your export type, adjust any additional export settings as needed, and submit your request. The export file will be delivered to you via email rather than directly through the application. Refer to the data export articles for studies and surveys.

⚠️ Important: Only users with respective management rights can download the System Audit Trail.

This access allows you to view all study setting data, including all sites and collaborators of the study. Therefore, this permission should only be granted to super administrators.

3. Understanding the System Audit Trail

Your System Audit Trail export contains the following columns:

Audit_Trail_Log_ID: Unique technical identifier for each audit log entry
Primary_Information: Main category of the change (e.g., General, Access, Workflows)
Secondary_Information: Sub-category providing more specific context
Tertiary_Information: Additional detailed information when applicable
Primary_Identifier: Specific identifier (e.g., email of collaborator, name of a specific item)
Collection: The datbase collection or project where the change occurred
Collaborator: Email address of the user who made the change
Timestamp: Date and time when the change was made
Field_Path: Technical path indicating exactly what was modified
Operation: Type of operation performed (created, updated, deleted, exported)
Old_Value: Previous value before the change
New_Value: New value after the change

4. Reading and interpreting the data

4.1. Information Hierarchy

The Primary, Secondary, and Tertiary Information columns follow a hierarchical structure that corresponds to your study configuration:

Primary Information: Relates to main study steps (Steps 1–6) and major functional areas
Secondary Information: Corresponds to sub‑tabs within the setting steps
Tertiary Information: Provides additional useful context when applicable

4.2. Common System Audit Trail categories

Use the pre-set filters in Excel to focus on specific areas:

Primary information	What it tracks	Example Secondary Information
General	Core study‑level settings include generic configuration such as universal study information or QR code creation for self-registration.	Self‑Registration
Access	Everything related to who can access the study and what they can do. This includes users, collaborators, roles, site information, and lab setups.	Collaborators, Roles, Sites, Labs
Forms	All aspects of form management: creating forms, configuring form settings, handling SDV and locking/signature options, template behavior, and deletion. Applies to all form types.	Scheduled Event Forms, Unscheduled Event Forms, (S)AE Forms, eConsent Forms
Input Fields	Individual form fields. Covers field creation, configuration, updates, and deletions.	Export Label
Workflows	Defined processes and module configuration in the study, including event schedules, signatures, bulk locking, randomization configuration, participant consent, (S)AE workflows, and other step‑based flows.	Scheduled Events, Randomization, (S)AEs, Participant Consent, Forwarding Email, Subject‑Facing Analytics
Trigger Events	Automated reactions to study activity. These include validation checks, automated queries, notifications, mirrored fields/table rows, i.e. any logic that triggers when certain conditions are met.	Validations / Automated Messages, Notifications, Mirrored Fields, Mirrored Table Rows
Translations	Languages and their status used in the study. Supports uploading, replacing, and managing translations and their files for multilingual setups.	Language
Export	All export‑related functionality such as annotated PDF exports, settings, blank PDFs, and export of access settings.	-
Dashboards	Study‑specific dashboards, including admin rights, access settings, widgets, and the structure/visibility of dashboards.	Settings, Widgets
Smart Filters	Logic-based filters used in subject overview, queries, or (S)AE views. Includes filter definitions, and sharing settings.	Subject Overview, (S)AE Overview, Query Overview
Views	Customizable data views within the system. Tracks view definitions, visibility, and exact data points included.	Subject Overview, (S)AE Overview
Reports	Creation and management of study reports, including report types, update history, and deletion.	-
Documents and Files	File management operations, such as uploading documents, renaming files, creating folders, and deleting materials.	-

4.3. Common use cases

1. To find when your study went live

If your study status was set to "Active" in Step 1 rather than using the Activation button in the study card, and you want to focus on post-go-live changes:

Filter for Primary Information = "General"
Look for Field Path = "status"
Find the entry where New Value = "Active"
Sort by Timestamp for chronological order to view all changes since the study went live

2. To track role changes

Filter for Primary Information = "Access"
Filter for Secondary Information = "Roles"
Use Primary Identifier to see which collaborator was affected

3. Access for collaborators

Filter for Primary Information = "Access"
Filter for Secondary Information = "Collaborators"
Filter for Tertiary Information = "Site Access"
Use Primary Identifier to see which collaborator was affected

4. To track form updates and field changes:

If you want to track a form update and want to understand exactly what changed in specific fields:

Step 1: Find the form updates

Filter for Primary Information = "Forms"
Filter for Secondary Information as needed (e.g. Scheduled events)
Locate your field of interest in the Field_Path column, which shows the format "formSkeleton/x/y" (where "x" represents the field's position in the form)
In the New_Value column, copy the Field ID found in the "formSkeleton/x/draggable" entry
⚠️ Important: During most form updates, fields are recreated rather than simply modified. This means you may see "deleted" operations in your view - this is normal behavior and indicates the field was rebuilt with new settings.
In the New_Value column, copy the Field ID found in the "formSkeleton/x/draggable" entry

Step 2: Get detailed field change information

Filter for Primary Information = "Input Fields"
Search for the Field ID you copied from Step 1 in the New_Value column
Look for the Audit_Trail_Log_ID, which groups all updates for that field under the same identifier
Review the detailed changes, such as:
- Label updates
- Validation rule modifications
- Option list changes
- Field configuration adjustments

⚠️ Important: The audit trail structure may vary depending on your specific search criteria and the type of changes made to your study. Always check the available columns and filter options relevant to your particular investigation.

5. Best Practices for analysis

Sort by Timestamp: Always sort entries by the Timestamp column to get a chronological overview of changes.
Use Excel Filters: Take advantage of the pre-set filters to focus on specific areas of interest rather than reviewing the entire file at once.
Focus on Primary Identifier: This field helps you understand exactly what the log entry refers to, making it easier to trace specific changes.
Track Related Changes: Some modifications may trigger multiple log entries. Group related timestamps to understand the full scope of a change.

✉️ Need Support? If you need support interpreting your System Audit Trail export or have questions about specific entries, please contact your Customer Success Manager for assistance or email us at support@climedo.de.