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:

  1. From the Data Entry tab, use the breadcrumb menu to navigate down to a form record.
  2. 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.
  3. 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.