Digital Trials Platform Current Release


December 01, 2023, General Release

23R3.0

About the Release

Important Dates

The release dates below are important for the Digital Trials Platform. See the About the 23R3 Release page in the Vault Release Notes for Vault release dates.

Event Date Description
Pre-Release October 30 The release is deployed to pre-release Vaults and the MyVeeva for Patients pre-release environments.
Validation Package October 30 - December 1

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, Site Connect, Veeva eConsent, and Veeva ePRO.

  • System Release Memo: October 30
  • Compliance Documents: October 30
  • Executed OQs: October 30
  • Executed PQs: December 1
General Release December 1 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 23R3 Release page in the Vault Release Notes for Vault resources and information.

Resource Publication History Description
Digital Trials Platform 23R3 Release Impact Assessment Updated November 3

The release impact assessment analyzes the regulatory, configuration, and user impacts of the MyVeeva for Patients, SiteVault, Site Connect, Veeva eConsent, and Veeva ePRO features in this release.

What's New Updated December 1

The What's New information provides detailed explanations of the new features for MyVeeva for Patients, SiteVault, Site Connect, Veeva eConsent, and Veeva ePRO.

Fixed Issues Available November 17

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

Known Issues Available November 17

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 23R3 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 and Clinical Operations.
  • SiteVault: The SiteVault What's New documents new SiteVault features from the point of view of site users.

What’s New

MyVeeva for Patients

Registration and Login

  • Email Option for Verification Code Delivery
    This feature adds the option for MyVeeva users to complete multi-factor authentication (MFA) with a secure link sent to their email when they log in to the application. Upon receiving the email verification, the user selects a link that opens the app and logs the user in.
Email Verification


App User Experience

  • Ask Site for Help
    This feature allows MyVeeva users to request contact from site staff by completing a short help request form. Users can access it from the Study tab and eConsent forms. The form asks the MyVeeva for Patients app user to select a topic and preferred contact method. Site staff receive the help request notification in SiteVault.
Ask for Help
  • New To Do Page With Current, Completed, and Future Tasks and Visits and Information Reorganized Between Tabs
    This feature enhances the overall MyVeeva user experience and provides a stable framework in which to add new features in the future. The update combines all actionable items onto one To Do page, which also allows users to see future tasks and visits that will soon become available or occur. This feature also enables users to review all study-related documents on the Study page and allows MyVeeva users to switch studies to view information related to the selected study.
23R3 App Layout


Notifications

  • Plain Text Email Notification and Improved Email Images
    This feature improves images displayed in emails and creates a plain text email notification alternative for users who have connectivity issues or email clients with content restrictions. This update helps ensure that email content is always readable so that notifications function as intended.


Site Experience

  • Update Past Visit Details
    This feature allows a site staff member to reschedule and cancel visits scheduled for a past date or time. Additionally, a banner is displayed for MyVeeva users when they view a visit scheduled for a past date or time through a notification, bookmark, or email.



SiteVault Release Highlights

SiteVault


  • VeevaID in SiteVault
    VeevaID provides single sign-on to Veeva systems. All SiteVault users with an “@sitevault.com” user name have been migrated to use VeevaID with the 23R3 release. VeevaIDs will be issued to all newly added Staff and Monitors/External Users unless an existing Vault account is chosen by the administrator who is adding the Staff or Monitor/External User. Enterprise customers can block the use of VeevaID and cross-domain accounts for new External Users.

    Existing Users
    Your accounts are automatically upgraded to VeevaID as part of the release. Watch for a VeevaID email, advising you of your new login process.

    Logging in with VeevaID
    Following the release, log in to SiteVault using your “@sitevault.com” username and current password. Your account will upgrade automatically and you’ll receive a notification that you’ve been converted to VeevaID. Upon subsequent logins, your username will be your email address. Your password will remain the same.

    Note: If you have multiple VeevaID accounts or share a computer with another VeevaID user, you can select Switch user to enter a different email address.

    Additional User Administration Impacts

    • Email addresses must be unique within a Research Organization.
    • Staff users cannot be added as cross-domain users.

    For more information, see Logging In and Out.


  • Ask for Help Request from MyVeeva for Patients
    With this feature, SiteVault system and email notifications will include patient requests for assistance submitted through the MyVeeva for Patients application. Notification details include the requestor, the question topic, and the preferred method of contact. The requestor detail includes a direct link to the requestor’s contact information. When the request for help is initiated in MyVeeva for Patients, the requestor is advised “The response will not be immediate, but a team member will contact you as soon as they can.”
Ask for Help




SiteVault eReg


Managing Documents

  • Site eBinder
    This feature introduces a central location to manage site operational documents not associated with a study. Using the familiar structure and navigation of the Study eBinder, users can upload, access, approve, and initiate workflows on site documents. The site eBinder also offers the ability to bulk upload staff and organization profile documents. Non-study-specific documents filed in the Study eBinder, such as those in the Staff and Partner Organizations folders, are accessible from either eBinder.

    Site Documents appear in the following eBinder folder structure:

    • SOPs & Policies
      • Policy Memo
      • Standard Operating Procedure
      • Work Instruction
    • Staff
      • Curriculum Vitae (CV)
      • Medical License
      • Signature and Initials
      • Training Evidence (non-study-specific)
    • Partner Organizations
      • IRbs/IECs
      • IRB/IEC Compliance
      • IRB/IEC Composition
    • Labs
      • Lab Certification
      • Lab Director Qualifications
      • Lab Normal Ranges

      For more information, see Site eBinder.

Site eBinder


  • Upload and Start Workflow
    This feature expands the current upload functionality to include the ability to initiate a workflow when uploading to the Study eBinder or Site eBinder. Users can initiate eSignature, Read and Understand, and Review workflows without opening each document after upload.

    For more information, see Upload Documents

Study eBinder - Start Workflow
  • Additional Study eBinder Document Actions
    With this feature, actions that were previously only available from the document info page are now available from the action menu in Study eBinder. For sites, newly available actions include Send for Review, Send for eSignature, Send for Read and Understand, and others. For monitors, newly available actions include Passed Review with No Issues and Review Issues Found.

    For more information, see Study eBinder.

  • Document Sharing for Caregivers
    This feature allows sites to share non-eConsent documents with caregivers before, during, or after a study.



Managing Users

  • Study Team Assignments: Copy and Bulk Create
    This feature enables Site Administrators to create study team assignments in bulk or to copy assignments from an existing study. The +Assign button prompts a dialogue to select one or multiple users to assign in a single process. The dialogue also includes the option to copy assignments from an existing study. This action populates the dialogue with the assignments of the existing study and then remains active for any needed adjustments. Additional enhancements to the Study > Study Team Assignments section include the ability to filter by Role or Assignment Status and to edit statuses directly in the Assignment Status column.

    For more information, see Study Team Assignments.

    Bulk add study to Staff from Administration > Staff > Study Assignments:

Add Studies to Staff

      Bulk add Staff to study and copy study from Study > Study Team Assignments:

Study Team Assignments
  • Edit Study Assignments on Staff Detail Page
    This feature enables Site Administrators to edit the status of study assignments directly from the Staff Details Page in SiteVault eReg. This section of the Staff Details Page has also been updated with more filtering and navigation controls.

    For more information, see Study Team Assignments.



eConsent - eReg

  • Caregiver Support
    With this eConsent/ePRO feature, patient caregivers are able to complete assigned surveys and sign consent forms.

    • ePRO: When enabling a participant for ePRO, site users can select an existing guardian, proxy, or caregiver for a patient or create a new one if none exist.
    • eConsent (eReg & Study Connect): The Caregiver role is an option for Role selection fields when creating a signatory, sending an eConsent, or using the eConsent Editor. When consenting, caregivers can only sign signature blocks assigned to the Caregiver role; they cannot sign or answer questions in place of other signatories.

    For more information, see Managing Patients.

  • eConsent Custom Header and Footer Options
    This eConsent Editor feature offers sites the ability to define their own custom header and footer text for print copies of their eConsents.

eConsent Editor Header and Footer




SiteVault Study Connect


eConsent - Study Connect

  • In-Person eConsent Enhancements in Study Connect
    This feature provides the following navigational and usability enhancements to the in-person eConsent workflow in SiteVault Study Connect:

    • The name of the Signed Consent Forms section on a participant’s page is updated to Consent Forms.
    • The View In-Person Code icon on the participant’s page is replaced by a Start Consent In Person button in the Consent Forms section.
    • When you initiate the session, a new Start Consent In Person modal is available that enables you to start an in-person consent session using your current device or start a session on another device by scanning a QR code.

    For more information, see Initiating an In-Person Consent.

eConsent View In-Person Code


  • Site-Specific Informed Consent Forms in Study Connect
    With this feature, site-specific informed consent forms are accessible and can be sent to participants from Study Connect.


ePRO

  • ePRO Caregiver Support
    With this eConsent/ePRO feature, patient caregivers are able to complete assigned surveys and sign consent forms.

    • ePRO: When enabling a participant for ePRO, site users can select an existing guardian, proxy, or caregiver for a patient or create a new one if none exist.
    • eConsent: The Caregiver role is an option for Role selection fields when creating a signatory, sending an eConsent, or using the eConsent Editor. When consenting, caregivers can only sign signature blocks assigned to the Caregiver role; they cannot sign or answer questions in place of other signatories.

    For more information, see Creating Representatives for Participants and Managing ePRO.

Create Caregiver


  • Surveys Sent Based on Assigned Groups
    This feature allows sponsors to define a list of groups for a study and assign those groups to specific schedules and events, and allows sites to define which group a participant belongs to. Related events and schedules are only created or triggered for a participant when they match the participant’s assigned groups.

    For more information, see Enabling ePRO for a Participant.

Participant Groups
  • Automatically Populate Actual Datetime with Protocol Expected Date
    This feature allows sponsors to specify an anchor event and offset days when they create an event. When defined, this information automatically populates the datetime for related events. The site staff are responsible for updating the value with the actual datetime when it’s known so that the correct dates are calculated for the other events connected to the anchor event.

    For more information, see Managing Participant Event Dates and Times.

  • Controlled Edit of Survey Responses (Data Changes)
    This feature allows site staff greater control over their source data, which enables them to process data changes without involving sponsors or vendors. The user is required to provide a reason for all their changes after the data is changed, and the reason is stored in the audit trail. To ensure compliance with regulations, the user can navigate back through the survey’s history to view all the changes. The sponsor now has access to a report that details all the changes that have occurred on their study.

    For more information, see Editing Survey Responses.

ePRO Edit Responses


Document Exchange

  • New Exchangeable Document Types on Connected Studies
    This feature adds the following document types to the list of document types that can be transferred to a Clinical Vault on a Connected Study:
    • Acceptance of Marketed Product Material
    • Clinical Study Report
    • Equipment Log
    • IP & Supply Shipping
    • Regulatory Authority Response
    • Regulatory Submission.


Additional New Features or Enhancements

  • Approve Person Profile Documents Received via Site Connect
    This feature extends the Change Status to Current user action to documents on the Person Profile lifecycle, in the Received from Sponsor/CRO state. The action is present for Administrators and Site Staff with the Site Profiles permission.

Veeva eConsent

  • Editable eConsent Form Header and Footer
    This feature allows eConsent authors to define the header and footer content for the print versions of eConsent forms. Authors can import, export, and define headers and footers in the eConsent editor as information is discovered throughout the drafting process to ensure the final version includes up-to-date information.

    For more information, see Using the Veeva eConsent Editor in Clinical Vault Help.

eConsent Header and Footer
  • Lockable Consent Forms
    This feature allows sponsor staff to lock eConsent forms, specific sections, or content blocks to prevent site staff from editing them. The entire form is locked by default, which makes it easier for sponsors to manage limited site access at whatever level is appropriate.

    For more information, see Using the Veeva eConsent Editor in Clinical Vault Help.

eConsent Lockable Content
  • Consent Forms for Caregivers
    This feature introduces the Caregiver role to the suite of eConsent signatories. Caregiver is a unique role alongside Guardian and Proxy, and it helps sites better choose the appropriate title for the person signing alongside the participant.
eConsent Caregiver Signatory



Veeva ePRO

MyVeeva Studio Updates

  • Surveys for Caregivers
    This feature allows sponsors to choose whether an ePRO survey is available to either participant or caregiver respondents. When a survey requires a caregiver’s response, site staff will add the caregiver and the caregiver will receive an invitation to create their own MyVeeva for Patients account. After they register and log in, they can answer surveys that have been made available to them.

    For more information, see Configuring Surveys in Clinical Vault Help.

Survey Caregiver Responder
  • Return UAT Approved Collection to Draft Status
    This feature allows sponsor users to move a collection that passed UAT back to the draft status to resume editing. The summary of changes entered before is retained, and the sponsor has to start and complete the UAT to move back to the UAT Passed status.

    For more information, see Performing UAT on a Collection in Clinical Vault Help.

Return UAT to Draft


Survey Updates

  • New Component: Horizontal Visual Analog Scale
    This feature allows sponsors to configure a survey to use a visual analog scale with a horizontal orientation.

    For more information, see Configuring Surveys in Clinical Vault Help.

Horizontal VAS
  • Gradient Removed From the Visual Analog Scale Bar
    This feature removes the gradient coloration from the visual analog scale bar to help ensure that participants and caregivers aren’t influenced to answer the question a certain way based on positive or negative color association.



Fixed Issues

MyVeeva for Patients Fixed Issues

The issues below are now fixed. See the MyVeeva for Patients Known Issues page for additional issues that staff and MyVeeva users may encounter.

Component Users Description Issue
eConsent - SiteVault Integration Site Staff A site staff user is able to view a global preview that has several images or videos. MYVC-17501
ePRO - Patient Surveys Site Staff, Sponsor Staff, MyVeeva Users Optional answers are displayed as expected when a site or sponsor staff member adds a paragraph tag when using the JSON editor in MyVeeva Studio. Previously, text in paragraph tags was indented when it was displayed in a web browser. MYVC-16238
ePRO - Reporting Site Staff A study participant's ID is displayed as expected in the Item Data column of the site's audit trail data export for several audit actions. Previously, a participant's unique MyVeeva ID was displayed instead. MYVC-15943
ePRO - Reporting Site Staff The Vault ID is now included in the audit trail data export for patient survey question responses. MYVC-15942
ePRO - Site Surveys Site Staff Site staff can now view the list of surveys for an event as expected when that event only includes an as needed survey that is scheduled in the future. Previously, the status was changed to Pending and the user was unable load the list of surveys for an event in Study Connect. MYVC-17181
General UI MyVeeva Users If a MyVeeva user (User A) is logged in on an open tab in a browser session, and a different MyVeeva user (User B) opens an email notification link in the same browser session, User B has to log in to be able to view the notification. Previously, User B was able to open the tab that User A was viewing and access User A's account page until the page was refreshed. MYVC-17263
General UI MyVeeva Users The timed break between login attempts is functioning as expected on Samsung Galaxy S21 devices. Previously, when a MyVeeva user entered an incorrect personal identification number (PIN) five times, they were unable to attempt to log in again after waiting for ten minutes. MYVC-16069
Platform - Authentication MyVeeva Users When a MyVeeva user (User A) is set up to use biometrics on an Android device, and then another user (User B) uses a PIN to log in on the same device, User A has to set up the biometrics again the next time they log in. Previously, the app re-registered the biometric use for User A. MYVC-15512

SiteVault Fixed Issues

Issues that affected previous versions or the pre-release and are now fixed in this general release.

The issues below are now fixed. See the SiteVault Known Issues page for additional issues that users may encounter.

Component Users Description Issue
eReg - Documents Site Internal Users To ensure the consistent tracking of all deleted documents, the deletion tracking record is now saved prior to deleting a document. Additional logging efforts have also been implemented. SITE-6082
eReg - Documents Site Internal Users A Study Team user is able to move source documents to the Superseded status. SITE-5650
eReg - General Site Internal Users When a document is sent from SiteVault to a Clinical Vault, then edited in the Clinical Vault and returned to the SiteVault, the document status is Received from Sponsor/CRO. DEV-641413
eReg - General Site Admin When an External user is inactivated, any Study Assignment Scheduled Access Date fields are cleared. SITE-1521
eReg - General Site Admin When creating Staff or External users, the option to override selecting an existing account is limited to only the appropriate scenarios. SITE-5759
eReg - General Site Internal Users Sharing settings are correctly applied to documents during reclassification. DEV-612487
eReg - General Site Internal Users Users can successfully finalize a document that was recently reclassified. DEV-619409
eReg - General Site Internal Users When creating an eConsent signatory in eReg, only one email and one phone number field is present for completion. SITE-5363
eReg - Study eBinder All Site Users When more than one document is uploaded to an eBinder folder, all required fields are populated with the expected default values. SITE-4399
eReg - Study eBinder All Site Users When filtering in the Study eBinder, filter selections are retained after editing the selections and closing the filter. SITE-5741
SiteVault - User Administration Site Admin When creating Staff or External users, their email (VeevaID username) must be entered in lowercase letters. SITE-5857
SiteVault - User Administration Site Admin When creating Staff or External users, the system check for existing accounts matching the entered email (VeevaID username) will search for both upper and lower -cased entries. SITE-5855
Study Connect - General Site Admin When accessing the Staff tab in Study Connect as an admin, the Staff tab is visible, without error. SITE-5424
Study Connect - General Site Admin An error displays when a Site Admin working in Study Connect, attempts to change a study's Principal Investigator to another Principal Investigator who is not assigned to the site. This is expected behavior. SITE-4896
Study Connect - General Site Internal Users When a Study Team member Study Assignment is activated in Study Connect, the study is associated with the Staff's profile documents. SITE-2416
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