Digital Trials Platform Upcoming Release

Digital Trials Platform releases include updates for MyVeeva for Patients, SiteVault, Site Connect, Veeva eConsent, and Veeva ePRO. See the release notes below for information about our upcoming features.


April 19, 2024, General Release

24R1.0

Feature information for MyVeeva for Patients, Veeva eConsent, and Veeva ePRO can be found in the Vault Release Notes.

About the Release

Important Dates

The release dates below are important for the Digital Trials Platform. See the About the 24R1 Release page in the Vault Release Notes for Vault release dates.

Event Date Description
Pre-Release March 25 The release is deployed to pre-release Vaults and the MyVeeva for Patients pre-release environments.
Validation Package March 25 - April 19

The Digital Trials Platform validation package is available in VeevaDocs on the dates below. The Digital Trials Platform validation package includes validation documents for MyVeeva for Patients, SiteVault, Veeva eConsent, and Veeva ePRO.

  • System Release Memo: March 25
  • Compliance Documents: March 25
  • Executed OQs: March 25
  • Executed PQs: April 19
General Release April 19 The release is deployed to all general release Vault PODs and MyVeeva for Patients general release environments.

Release Information and Impacts

The release resources and information below are planned to be available on the dates in the Publication Date/History column. See the About the 24R1 Release page in the Vault Release Notes for Vault resources and information.

Resource Publication History Description
Release Impact Assessment Available February 26

The release impact assessment analyzes the regulatory, configuration, and user impacts of the MyVeeva for Patients, SiteVault, Veeva eConsent, and Veeva ePRO features in this release. The 24R1 Digital Trials Release Impact Assessment is located on the eConsent, ePRO, and Sites tab in the Vault Release Impact Assessment.

What's New Available March 18

The What's New information provides detailed explanations of the new features for SiteVault. Feature information for MyVeeva for Patients, Veeva eConsent, and Veeva ePRO can be found in the Vault Release Notes.

Fixed Issues Available April 12

The SiteVault Fixed Issues at the bottom of this page list issues that affected previous versions or the pre-release and are fixed in this general release. MyVeeva for Patients Fixed Issues can be found in Vault Help.

Known Issues

SiteVault Pre-Release: Available March 25

General Release: Available April 12

See the following pages for known issues that affect this general release or previous ones and aren't fixed yet:

Maintenance Releases Both available with the first maintenance release

See the following pages for fixed issues that affected the general release:

Digital Trials Platform Release Notes See links

See the following release notes for more information about new features across the Digital Trials Platform:

  • Clinical Operations: The About the 24R1 Release page in Vault Help provides the Vault release dates, release impact assessment, What’s New, and other Vault release information. This includes What’s New information for Site Connect, MyVeeva for Patients, Veeva eConsent, Veeva ePRO, and Clinical Operations.
  • SiteVault: The SiteVault What's New documents new SiteVault features from the point of view of site users.

What’s New in 24R1

SiteVault


Create and Manage Staff without a User Account
With this feature, administrators can create a Staff without also giving them SiteVault access. The creation process follows the regular Staff creation steps, but when prompted to complete the Create As field, select Staff (No SiteVault Access). Administrators can also add a User Account to a Staff should they later require access.


Create and Manage Staff Access and Permissions
Administrators will enjoy a streamlined process for creating and managing access and permissions for both Staff and Monitors/External Users. These enhancements include:

  • Visible confirmation of meeting email address requirements
  • Required duplicate entry of email address upon user creation
  • A simplified process for managing site-specific access and permissions


Additional Languages with Locales
This feature adds the following language locales to the list of available languages for document and patient records in SiteVault:

  • Arabic (Israel)
  • Catalan (Spain)
  • English (Australia)
  • German (Belgium)
  • Hebrew (Israel)
  • Hungarian (Hungary)


Study Team Assignments: Notes
This feature introduces a Notes section to the Study Assignment record. This section will include the Notes field, a space to share additional details regarding the user or assignment information.


Study Team Assignments: Bulk Actions
When in the Study Team Assignments section of a study, administrators can simultaneously apply an action to one or more assignments. Using checkboxes and the bulk action menu, the following actions can be applied:

  • Activate assignments
  • Populate the Start and End Date-Time fields
  • Initiate the Delegation Acceptance workflow
Study Team Assignments Bulk Actions


SiteVault User Administration APIs
This feature introduces new APIs for user administration functionality, including creating new Staff and Monitors/External Users and editing their system permissions. These APIs are available to SiteVault Enterprise customers for use in system integrations.


Free Tools Menu
This feature introduces the Free Tools menu with links to ClinicalTrials.Veeva (CTV) and Veeva Launch Pad. CTV is a free clinical study search, and Veeva Launch Pad is a free password management tool designed to help you access sponsor systems more easily.

Free Tools Menu

SiteVault eConsent

eConsent: New Fields for Verifying Consent
To assist users during consent verification activities, this feature adds the following fields to the eConsent Form Responses table:

  • Document Description
  • Signature Date



SiteVault eISF

Study eBinder: Subtabs and Bulk Approval
This feature introduces the ability to bulk approve documents from the Study eBinder. Users can select tabs offering two additional views: Approval Needed and Approved. When the Approval Needed tab is selected, users with the appropriate permissions can select one or multiple documents to approve. Once the action to approve is selected, users are prompted to complete any required fields. A green notification bar advises when the process is complete.

Study eBinder Bulk Approval


Site eBinder: Last Site Selected
When a user navigates away from the Site eBinder, this feature ensures the site selected at that time remains selected upon return.


Documents: New Doc Types, Updated Doc Details
This feature introduces four new document types and updates two existing document types.

  • New Document Types:
    • IP Relabeling: IP Re-labeling, IP Relabelling – Evidence of an IP relabeling event that took place at the site.
    • Participant Decoding Event: Emergency Decoding Authorization, IP Treatment Decoding – To record the action of breaking the blind for an individual participant, urgently if needed, or when interim or final unblinding occurs.
    • Recruitment Plan: To describe the planned participant enrollment/recruitment goals for the study, and the methods by which those goals will be tracked and achieved.
    • System User Access: IRT User Account Management, IxRS Account Log –Identifies which site staff have received accounts for a third-party system (such as randomization or ePRO) used for the study. May also identify revocation of access.
  • Document Types - Updated Descriptions:
    • Conflict of Interest: COI Form – for NIH studies, covers the institution’s requirement to manage conflicts of interest in research. For some industry studies, may be required by Sponsor or CRO (in addition to/not a substitute for Financial Disclosure Forms).
    • Feasibility Questionnaire: Feasibility Survey, Site Feasibility Form, Site Suitability Form – Evaluation of site feasibility for a potential study. Completed by site at the request of the Sponsor or CRO, or according to local regulation.



SiteVault Study Connect

Safety Distribution: Select All
This feature enhances existing Safety Distribution functionality in Study Connect. In addition to the Select All checkbox, users can also use the Select All button. The Mark as Read button now includes a document count, advising users of the amount of documents currently selected.

Safety Distribution Select All


Device Registration Code Relabeled to Activation Code
With this change, the code to provide participants who wish to register for MyVeeva for Patients without providing an email address or phone number is the Activation Code. Previously, this was labeled as the Device Registration Code (DRC).

Activation Code



SiteVault Prerelease Known Issues

These issues remain open in the prerelease SiteVault. See the SiteVault Known Issues page for additional issues that users may encounter.

Components Description Workaround Planned Fix Issue
General When a VeevaID user logs out of SiteVault from Study Connect, their next login opens SiteVault in eISF, rather than Study Connect. To be determined SITE-7271
Study eBinder When bulk approving documents in the Study eBinder, users cannot deselect a document after checking the Select All checkbox. Users can check the Select All box, then remove unwanted items on the next screen. To be determined SITE-7540
User Administration When a Staff without SiteVault access converts to a user account, changing the email address to an existing VeevaID does not update the email, first name, or last name fields to match those associated with the existing VeevaID. To be determined SITE-7512
User Administration When assigning or editing access & permissions for a Staff or Monitor/External User, the audit trail for the Staff or Monitor/External User record does not log those assignments or edits. To be determined SITE-7619
User Administration When an inactive Monitor/External User is reactivated and added to a study, the save process does not complete and the user is not added. To be determined SITE-7637
User Administration When a Staff without SiteVault access in a multi-site Research Organization is converted to have a VeevaID user account and is granted permissions to some but not all sites, the Staff is unable to successfully access the Vault. To be determined SITE-7680
User Administration When a Staff without SiteVault access converts to a user account, changes made to the first and last name fields during conversion are not retained. Name changes can be made after saving by the Staff themselves (and in some cases, the Administrator) 24R1.1 SITE-7440
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