Viewing Audit Trails

Vault CDMS automatically collects and records information about any data entry, change, or action taken on any data, including system-generated data. You can view the details of the updates to any electronic record. Each audit entry includes the timestamp, user name, affected object, and a description of the event.

Administrators can view record-specific audit trails from certain locations in Vault CDMS. Complete, detailed audit logs for the entire vault are available in Admin > Logs.

Timezones: Vault shows the user’s timezone in audit trails. Learn more about timezones here.

Viewing the Audit Trail

You can view the audit trail of an individual object record.

To view the audit trail from the Data Entry tab:

From the Data Entry tab, use the breadcrumb menu to navigate down to a form record.
Select the audit trail action for the type of record you want to view:
- For Casebooks, select Casebook Audit Trail from the casebook schedule’s Actions menu.
- For Events, select Event Audit Trail from the event’s More Actions menu.
- For Forms, select Form Audit Trail from form’s Actions menu.
- For Items, select Item Audit Trail from the item’s More Actions menu.
The Audit Trail dialog opens. Click X to return to the object record page.

Audit Events in End User Audit Trails

The following are the various actions, both system and manual, for which Vault will create an audit trail entry that is visible in the Data Entry and Review tabs. Vault audits all data changes in the audit logs, available from Admin > Logs.

Query-Level

Query Opened
Query Answered
Query Closed

Item-Level

Item Creation
Item Level Autosave
Form Submission
Item Value Change
SDV Applied
SDV Broken
DMR Applied
DMR Broken
eSignature Applied
eSignature Invalidated
Data Locked
Data Unlocked
Data Frozen
Data Unfrozen
Item Status
Exam Uploaded
Exam Deleted

Form-Level

Form Creation
Form Submission
Form Status

Event-Level

Event Creation
Event Inactivation
Event Date Changed
Event Status

Event Date-Level

Event Date Changed
SDV Applied
SDV Broken
DMR Applied
DMR Broken
eSignature Applied
eSignature Invalidated
eSignature Removed
Event Date Locked
Event Date Unlocked
Event Date Frozen
Event Date Unfrozen

Casebook-Level

Casebook Creation

Subject-Level

Subject Creation
Subject Status Updated

Assessments

Assessment Creation
Assessment Updated
Assessment Deleted

Protocol Deviations

Protocol Deviation Creation
Protocol Deviation Updated
Protocol Deviation Deleted

EDC Tools: Audit Trail Export

Lead data managers and users with permission to run jobs in Vault CDMS can export all audit trails for an entire Study from EDC Tools > Jobs, using the Audit Trail Export job. That export includes audit trails for deleted records, which are not exposed in any of the areas detailed above.

Learn more about the Audit Trail Export job.