Enhancements to Vault Clinical

With the latest release, Veeva continues to enhance Vault Clinical to make it easier to manage and maintain Trial Master File (TMF) and clinical trial compliance.

These enhancements aim to accelerate study start-up, simplify oversight, and improve TMF quality.

Study Start-up – Milestone Workspace

What’s new?

A new section on the Milestone page layout called Document Planning and Management summarizes the status of a milestone’s related documents, and expected documents. It also includes a link to a workspace page with tables for the milestone’s Expected Documents and Matched Documents. These tables support searching, column filtering, reviewing, and updating records, and allow you to send documents and/or expected documents on workflows from a single page. A second page lets you view and work with Clinical User Tasks.

How will this help Vault users?

This feature provides Study Team members with a better overview of the milestone activities and allows for a more efficient way to organize, plan, and execute document actions and expected document reviews.

Currently, they may rely on reports, saved views, search collections, and Excel trackers to manage a large number of expected documents, navigating across a range of different object records.

By displaying a unified user-friendly view and allowing users to launch multi-document workflows and bulk object record workflows for Expected Documents all from one place, this process will be significantly simplified.

Study Person Role Constraints

What’s new?

Clinical Operations Vaults now support the restriction of Study Team Role assignment based on Person Type or Security Profile. Validation checks on record save prevent users from creating Study Person records with disallowed combinations. Additionally, a new application-controlled field is available that filters for permitted Study Team Roles during record creation.

How will this help Vault users?

When enabled, this feature reduces the risk of providing incorrect Study-specific access. Since providing an incorrect Study Team Role is a compliance risk and could result in inappropriate or insufficient access to Study records, this enhancement significantly reduces these risks.

Redacted Documents

What’s new?

To better support Sponsor transparency processes, Vault Clinical Operations now provides a redacted document field (yes/no). It helps the clinical study teams to clearly track and identify document copies where the personal data and commercial confidential information (CCI) have been redacted.

How will this help Vault users?

Balancing transparency with data protection can present a challenge in clinical trials. This new feature enables sharing a “for publication” document version with authorities where personal data & CCI are expunged, and a “not for publication” version restricted to authorities is more streamlined and more efficient.

It will also be possible to filter and create reports using this field.

What next?

If you’d like any more information about how these features, or any of the 23R2 enhancements, affect your Vault users, please get in touch.

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