Exporting Study Document Audit Trails

eTMF Vaults allow you to generate audit trails for documents associated with Study records.

Configuration Overview

  • Configure the Export Full Study Audit Trail system action on the Study object.
  • Optional: Enable the Available in All Lifecycle States flag. If this is enabled, Admins do not need to configure the Export Full Study Audit Trail user action on the Study Lifecycle.
  • Configure the Export Full Study Audit Trail user action on the applicable Study Lifecycle lifecycle states. 
  • Optional: Configure atomic security atomic security for the Export Full Study Document Audit Trail user action to manage user’s access to the action.

Exporting Study Document Audit Trails

When configured, the Export Full Study Document Audit Trail user action generates a downloadable audit trail for all documents associated with a Study record. This action is available for both active and archived Study records. Selecting the Export Full Study Audit Trail user action on a Study record opens a dialog box where you can select a Start and End Date for the document audit trail.

Vault generates the Study document audit trail for the dates between the Start and End Date values. Vault defaults the Start Date to 30 days before the current date. A blank End Date field generates a file up to the current date. Selecting a Start or End Date is optional. When the Start and End Date are blank, Vault generates a document audit trail for the entire history of the Study record.

When you select Confirm in the dialog box, the system generates the audit trail. Once complete, Vault sends you a notification with a link to download the document audit trail CSV file. The Study Document Audit Trail file captures the Document Name, Document ID, and Classification for each document in addition to the audit trail.

Users can complete all steps in this article with the standard Business Admin, System Admin, or Vault Owner security profile. If your Vault uses custom security profiles, your profile must grant the following permissions:

Permission Type Permission Controls
Security Profile Application: All Object Records: All Object Record Actions Give you the permission to configure and execute the Export Full Study Document Audit Trail action.