The Delegation of Authority (DoA) log provides a record of a principal investigator’s (PI) decisions to allow specific site staff members to perform one or more of the PI’s study responsibilities. Instead of having to manually manage a paper-based, handwritten DoA log, the Digital Delegation feature enables users at your site to delegate, accept, and approve responsibilities directly in SiteVault, and SiteVault creates or updates the DoA log document for you.

For more information about meeting regulatory needs with SiteVault’s Digital Delegation Log, download SiteVault’s Digital Delegation Vision and Design.

Viewing the Delegation of Authority Log

When the PI approves delegations, SiteVault generates a new or updated version of the Delegation of Authority (DoA) document and files it to the PI Oversight section of the study eBinder. You can view the DoA in the Study eBinder or Library.

Viewing the Audit Trail

SiteVault provides a robust audit trail of all actions performed on a document. SiteVault also allows you to export this information in order to facilitate reporting and filtering at a more granular level. The audit trail window displays the following:

• Timestamp: Date and time that the action was performed, adjusted to your own timezone. Timestamps also indicate the time of year an event occurred using daylight savings time. For example, audit trails in SiteVaults using the GMT timezone show GMT times during the fall and winter and BST time during the spring and summer.
• User Name: Login name for the user who performed the action; this sometimes shows “System” to indicate that the action was performed automatically by SiteVault. “System” actions include state changes and field updates performed as part of a workflow, as well as initiating an auto-start workflow.
• Version: Version of the document on which the action occurred
• Event Description: Description of the action that occurred, for example, “‘tlee@veevapharm.com’ was added to the ‘Name’ field”. Note that when data changes, the description shows both the previous value and the new value.

Note: Audit logs support a precision to one second. Events occurring within a single second may appear in an unexpected order.

Accessing Document Audit Trails

1. From the All Actions menu in the Library or Doc Info page, choose Audit Trail.
2. The audit trail information displays in a window. Actions appear in most recent to least recent order.
3. Optional: To change the audit trail filter, choose an option from the drop-down.
4. Optional: To download the audit trail, click the action menu icon and select CSV, Text, or PDF. Note that the exported file has different columns than the audit trail window.
5. When finished, click Close.

Filtering Audit Trails

By default, the audit trail is filtered by Timestamp, all. You can select a different time frame from the second drop-down.

1. Select Timestamp, Event, or User from the drop-down.
2. Optional: If you selected Timestamp, select a date range in the drop-down to the right. If you selected in the range, two additional date fields will appear. Click on each field to select a start and end date for the range.
3. Optional: If you selected Event, the operator In and a second drop-down will appear. Select the desired event(s) from the second drop-down. Click Apply.
4. Optional: If you selected User, the operator In and a second drop-down will appear. Select the desired user(s) from the second drop-down. You can select multiple individual users, but not user groups.
5. Optional: Click on the Add filter button to add any of the remaining filters (Timestamp, Event, or User).
6. Click Apply to update the table.

Exporting Audit Trails

To download the audit trail, click the action menu icon and select CSV, Text, or PDF.

CSV Exports

The exported CSV file shows information in a slightly different format. For example, the CSV file separates the details of each event into individual columns.

PDF Exports

When you export as PDF, SiteVault adds page numbers and a cover page to the PDF. All audit histories and audit trails use the same Audit Export Cover Page template.