What is an Audit Trail?
An audit trail is a chronological record of:- Who did what
- When they did it
- What changed
- The before and after values
What Gets Audited
Data Changes
User Actions
Status Changes
Accessing Audit Trails
Record-Level Audit
View changes to a specific record:1
Open Record
Navigate to the participant record or questionnaire response.
2
View History
Click “History” or “Audit Trail”.
3
Review Events
See all changes to this record.
Study-Level Audit
View all study activities:1
Navigate to Study
Open the study.
2
Open Audit Log
Go to Settings > Audit Log.
3
Filter and Review
Filter by date, user, or event type.
Organization Audit
View organization-wide activities:- Settings changes
- Member management
- Study creation
Audit Event Details
Each audit event includes:Exporting the audit log includes the full user ID (alongside the display name), the old value, the new value, and the change field — so compliance exports carry the same fidelity as the viewer on screen.
Filtering Audit Logs
Filter to find specific events:Exporting Audit Logs
Export for compliance or review:1
Set Filters
Configure desired scope.
2
Export
Click export button.
3
Download
Download the audit log file.
- CSV for spreadsheet analysis
- JSON for system integration
Regulatory Requirements
Audit trails support:21 CFR Part 11
ICH GCP
Using Audit Trails
Compliance Audits
During regulatory audits:- Export relevant audit logs
- Demonstrate change control
- Show user accountability
Investigations
When investigating issues:- Identify when something changed
- Determine who made changes
- Understand the sequence of events
Quality Reviews
For quality purposes:- Review patterns of changes
- Identify potential issues
- Monitor data quality
Best Practices
Regular Review
Regular Review
Periodically review audit logs for anomalies.
Export for Retention
Export for Retention
Export logs to meet retention requirements.
Understand Coverage
Understand Coverage
Know what is and isn’t captured in the audit trail.
Use for Training
Use for Training
Identify issues to address in training.
Related
Regulatory
Compliance requirements.
Organization Audit
Organization-level audit.