Release Notes

CTMS General Enhancements

This release introduces several usability and workflow updates across SiteVault CTMS, making it easier to manage study schedules, view and book participant appointments, and report on site finances:

• Centralized Schedule Management & Direct Builder Launch: The redesigned Schedules tab brings all study schedule versions together in one location, replacing the previous schedule versions page. Users can now launch the Schedule Builder directly by selecting a schedule version from the tab.
• At-a-Glance Calendar Blocks: Calendar appointment blocks now show the participant ID and name directly on the block so you can quickly see who is coming in, while the visit name and time remain visible in the details. Clicking an appointment opens a read-only overview modal, with a direct option to switch into edit mode if you need to update visit details.
• Faster, Smarter Appointment Scheduling: When scheduling a visit, the appointment day automatically defaults to the target study window (if available), and the time defaults to the next half-hour. Users can specify both the start and end time during scheduling to set the exact visit duration upfront, and automatic warnings alert you if an appointment is scheduled outside of its protocol window.
• Bulk Calendar Selection: You can now add multiple study and staff calendars to your calendar view in bulk rather than adding them one by one.
• Payable Items Reporting: Site finance users can track and report on site payments using the new Payable Item report type.
• Updated Permission Settings: Access to payable items, expenses, and expense overrides is now restricted to users with the Financial Management permission, and general site staff will no longer see these items.

Create Expense Plans From Chargemaster

Finance site users can now automatically generate study expense plans using standard hospital charge codes, turning hours of manual cost entry into a single process:

• One-Click Expense Plan Generation: After completing the study's Coverage Analysis and linking an active Chargemaster on the Expense Plan's Overview tab, users can select the Draft from Chargemaster action. The system builds the plan within seconds.
• Automatic Itemized Breakdown: If a study activity has multiple charge codes assigned to it, the tool automatically breaks it down into individual line items and applies the exact price from your Chargemaster for each code.
• Smart Code Matching: The action only applies to activities with billing codes assigned in the Coverage Analysis. Non-billable tasks, research-only visits, stipends, and personnel fees are automatically skipped.
• Overwriting Custom Edits: Running this action will overwrite any existing line items or custom cost adjustments previously saved for activities with charge codes.
• Smart Versioning: When you create a new version of an expense plan, your linked Chargemaster automatically carries over as long as it remains active. If the old Chargemaster has been archived, the field will clear so you can select the most up-to-date price list.

NCI Study Registration Wizard

Registering cancer trials for National Cancer Institute (NCI) and Cancer Center Support Grant (CCSG) reporting requires detailed, specialized study information. The new NCI Study Registration Wizard guides site teams step-by-step through collecting, organizing, and validating this complex data directly within SiteVault. This feature is for NCI-designed Cancer Centers and must be enabled by Veeva. If you are interested in enabling this feature please contact SiteVault Support.

• Dedicated NCI / CCSG Tracking Tab: A new NCI / CCSG Info tab on the Study page centralizes all study registration details. An orange indicator dot lets your team know when information is waiting to be completed.
• Flexible, Guided Walkthrough: Selecting Enter Details opens an interactive wizard that walks you through governance, funding sources, and trial attributes. Different team members can complete sections in any order and save progress across multiple sessions.
• Automatic Pre-Filling: The wizard automatically pulls existing information from your study setup—such as research organization details—so you don't have to enter the same data twice.
• Smart Consistency Checks: Built-in logic catches common data entry mistakes and displays clear warning banners without blocking you from saving unique protocol setups.
• Single-Page Summary and Easy Editing: A final summary screen lets you review all entered registration data and active warnings in one view. Once submitted, information can be reviewed or edited at any time directly from the Study tab.
• New General Study Fields: All study records now include standard fields for Study Phase and NCT ID (ClinicalTrials.gov Identifier).

Participant Visit Tracking Enhancements

This update brings several improvements to how participant visits are tracked:

• Multiple Records for a Single Patient: A patient can now be linked to more than one participant record within the same study. Each record is tracked on its own and automatically syncs with Veeva EDC.
• Track How Visits Happen: A new Visit Method field lets you record how each appointment took place (such as in person, over the phone, or by video call).
• Clearer Status for Missed Visits: The status previously labeled Cancelled is now called Did Not Occur. When you select this option, you will also choose a specific reason explaining why the visit did not happen.

Study Schedule Branching and Optional Paths

This update gives site teams more flexibility when creating study protocols in Schedule Builder, making it easier to map out optional visits and complex participant journeys:

• Optional Branches and Empty Paths: Schedule Builder now supports optional branches, allowing you to model clinical studies where some participants complete certain visits while others skip them. Newly created branches now start as optional by default, containing one visit group and one empty bypass path. You can also add an empty path to any existing branch to turn it into an optional route. Empty paths can be assigned to study arms just like standard visit groups.
• Automatic Path Selection for Participants: In the Add Visits from Schedule window, selecting the visit groups before and after an optional section automatically selects the empty bypass path in between, making participant assignment quick and accurate.
• Complex Branching with Custom Destinations: For intricate study designs where different paths do not meet back at the same visit group, you can redirect individual paths using the Change Destination tool. Hovering over a visit group displays a handle icon that lets you repoint its exit path directly to a different downstream visit group.

This feature is not available in pre-release environments.

eConsent General Enhancements

Listed below are several enhancements designed to improve the overall eConsent experience:

• SiteVault confirms a Signatories’ preferred language prior to the viewing of the Terms of Service and Privacy Policy, ensuring the information is presented in the appropriate language.
• After completing an in-person consent, site users are now prompted to return to SiteVault to continue their work.
• When editing PDF consent forms, you can now drag configuration boxes away from form fields, making it easier to see your document clearly while making updates.
• Notifications sent when sharing a consent form now include a direct link to the eConsent list for quicker navigation and follow-up.

Copy Delegations Between Study Persons

SiteVault now allows study staff to copy a complete set of assigned delegations from one study team member to one or multiple other study team members in a single action. This feature eliminates repetitive manual entry during study startup and ongoing maintenance, ensuring role-based delegation consistency across study teams.

• Full Overwrite: Copying delegations completely replaces all existing assigned delegations for the recipient study team member in the Delegations Editor.
• Excluded Attributes: Specific start and end dates, inactive responsibilities, notes, and delegation dates from the source team member are not copied.

Digital Delegation Log Enhancements

This release includes several functional updates to the Digital Delegation Log (DDL) to improve workflow efficiency, user interface navigation, and data validation.

• Support for Personnel Without SiteVault Access: Sites can maintain a complete, centralized record of all study personnel on the Digital Delegation Log, including individuals without access to SiteVault. Non-SiteVault-using staff are automatically included on the generated Delegation of Authority (DoA) document and excluded from the user acceptance workflows. If an individual is later provisioned with SiteVault access, their existing delegation records and assignments are fully retained.
• Document Generation Safeguards: To maintain version integrity and prevent conflicting drafts, generating a new Delegation of Authority is now temporarily disabled while the delegation log is actively checked out or is in an active workflow. On-screen guidance directs users on how to proceed, such as checking in the log or completing/cancelling the pending workflow before generating the document.
• Centralized Responsibility Management: To streamline administrative workflows and provide a more unified editing experience, responsibility management is now housed directly within the Delegations Editor. With this consolidation, the standalone Responsibilities tab has been retired from the Study page, reducing navigation steps and establishing a single workspace for configuring both responsibilities and delegations.
• Date Sequence Validation for Staff Assignments: Built-in validation rules now ensure chronological accuracy by preventing study staff assignments from being saved with an end date that precedes the start date. If an invalid date range is selected, an on-screen alert clearly outlines the requirement so the timeline can be adjusted before saving.
• Date Sequence Validation for Staff Delegations: In alignment with assignment safeguards, delegation entries now enforce end-date validation to ensure delegation periods remain chronologically sound. Users attempting to record an end date that occurs before the start date will receive an informative error notification explaining the date rule.

Digital FDA Form 1572

We are excited to introduce a feature designed to streamline the creation of your FDA Form 1572 directly within SiteVault. From the Study eBinder, you can generate a standardized, digital FDA Form 1572 using the information you are already tracking in your SiteVault study.

Key Benefits & Features:

• Automated Data Population: SiteVault automatically pulls in your Principal Investigator, Subinvestigators, partner organizations (Labs and IRBs), and protocol details to populate the document.
• Guided Wizard Experience: A simple, step-by-step wizard allows you to quickly review, verify, and complete all eight sections of the 1572 form before generation.
• Seamless eSignature Routing: Once verified, completing the wizard automatically compiles a PDF copy of the form, files it directly into your study's eBinder, and sends it to your PI for electronic signature.
• Address Management: Site Administrators can conveniently manage and create new addresses for PIs and partner organizations directly within the wizard.
• Compliance: SiteVault’s Digital Form 1572 feature will remain aligned with FDA updates to the Form 1572 versioning.
• Monitor Sharing: Generated 1572s remain fully accessible to monitors and can be seamlessly shared with sponsors via Site Connect.

eISF General Enhancements

• Start and Track Financial Disclosure Forms: Once initiated, the Financial Disclosure Form requestor can track the progress of their open requests at any time under the Active Workflows section on the Home tab.
• Enhanced Wizard Guidance & Document Clarity: Both the interactive Financial Disclosure Form wizard and the final generated PDF document feature minimum required disclosure thresholds and other specified disclosure requirements to align with FDA guidance.
• Comprehensive Sorting for Read and Understand Reports: The Read and Understand History report now offers full column-sorting capabilities across all displayed fields. Also, sorting selections are preserved upon export and are accompanied by several display refinements such as the 'Version Description' relabeling to 'Document Description,' and the removal of the Document Description from the report header.

Internal Study Materials Document Type

Sites can now store and manage study-adjacent resources directly in SiteVault using a dedicated document type for internal study materials. This provides your team with a centralized space for day-to-day operational items—such as team briefings, contact and vendor lists, safety event summaries, and enrollment checklists—while maintaining complete control over visibility.

Key highlights include:

• Full document lifecycle support: Manage internal materials using SiteVault’s standard review and approval workflows, with the flexibility to exchange files with your Clinical Vault via Site Connect when appropriate.
• Monitor privacy: These documents remain internal to your site team and are not visible to or reviewable by monitors.
• Smart duplicate detection: To help keep your study documents organized, SiteVault automatically flags files with identical content uploaded within the same study (Duplicate File Check).

SiteVault eSource (Early Adopters)

This release introduces SiteVault eSource, a brand-new application designed to make collecting data electronically much easier. You can use this tool completely on its own, or you can connect it directly to Veeva EDC (Electronic Data Capture) to streamline your work even more.

Whether you are using the app by itself or with Veeva EDC, you now have some great new ways to manage participant visits:

• Create Custom Forms: You can design your own electronic Case Report Forms (CRFs) to gather information whenever participants come in for their visits.
• Built-in Help and Rules: To ensure everyone fills out the forms correctly, you can set up data rules and even embed helpful instructions right inside the electronic forms.
• Real-Time Data Entry: Instead of waiting until later, you can type trial data directly into SiteVault while the participant is there.
• Easy Sign-Offs: Once a form is completely filled out, you can easily send a request to the investigator to review and electronically sign it.

If your study happens to be hooked up to Veeva EDC, you get a few extra perks to help things run smoothly:

• Manage Subjects Easily: You can create a brand-new subject record in Veeva EDC right from SiteVault, or simply link a subject to a participant who is already in your system.
• Pull in EDC Forms: You can bring in electronic forms from Veeva EDC and customize them so they are ready to be filled out in SiteVault.
• Automatic Syncing: Any participant data you type into these forms will automatically sync up with the matching subject records in Veeva EDC.

This feature is not available in pre-release environments.

Allow Removal of Name Column by Default

When creating or editing reports, users can now remove the standard Name column from any report. In some cases, the Name value may not be the most meaningful identifier for users, so this enhancement provides flexibility to exclude it if needed.

Create Incomplete Documents via Drag & Drop into Library

Users can now create Unclassified documents in the Incomplete state by dragging and dropping documents from their desktop into the Library tab or other custom document tab. This creates the documents in the Incomplete state and adds them to the Document Inbox. This allows users to upload more content more quickly and easily. Prior to 26R3, this drag-and-drop option was only available directly within the Document Inbox.

Current User Field Filters

When adding field filters in a report, if the field has a corresponding field on User, users now have additional Current User options available. This can significantly reduce the number of reports that need to be maintained by providing more dynamic options based on the viewing user’s information. For instance, filtering on a field that points to Organization shows an option for Current User Organization because Organization is also a field on User.

Document Action to Reclassify Document

The action to reclassify documents is now available in the All Actions menu for consistency with other document actions.

Enhanced Report & Dashboard Prompt Experience

When adding prompts to reports, users can now set default values, making it easier for report viewers to run reports while still giving them the flexibility to adjust prompts, if needed. Additionally, when running a report or dashboard with prompts, users can now choose to explicitly filter on blanks. Prior to 26R3, if a user left an optional prompt field blank, the system treated that as Is Blank in the returned results. This enhancement reduces confusion and gives users a clear option to filter on blanks when needed. This also allows users to filter on blanks for required prompts.

Improved Spreadsheet Rendering

SiteVault now renders spreadsheets (XLSX, CSV, XLS, XLSB, and XLSM) with a much larger page width and height, and often eliminates page breaks. This updated viewing experience ensures that wide columns and long rows remain connected, making large datasets easier to read in the document viewer.

Last Initiated By for Object Records

SiteVault introduces a new Last Initiated By system field across all objects to capture the user who “initiated” the record update. This feature makes it clear at a glance who initiated the transaction that led to the modification of the record. Additionally, this feature enhances the Created By, Last Modified By, and Last Initiated By fields so they will now display the value as a link and display a hovercard on hover in Detail View.

Object Permissions Refactor

To prepare SiteVault for future improvements to system security and flexibility, we have updated how permissions (viewing, editing, and deleting records) are handled behind the scenes; your day-to-day work in SiteVault will remain largely unchanged.

Updated Objects: Research Organization, Site, Study, User Access Event, User Access Assignment

NOTE: Closing a Study Delegation Log: You can no longer select the Start Delegation Log Closure action while working in the broader Research Organization context. To start closing out a delegation log, you must first switch to the specific Site context for that study.

Picklists: Increase Limit for Active Values

A single picklist can now include up to 3,000 active picklist values available. This is an increase from the prior limit of 2,000.

Report Action to Export Documents

When viewing a report in SiteVault, users can now export up to 1,000 unique document versions directly from the All Actions menu using the new Export Documents action. This new action streamlines the workflow by exporting exact report results in their exact display order and with duplicate versions automatically removed, so that users can quickly retrieve historical records and audit sets. The action appears only on reports that return at least one document version and remains hidden for object-only reports.

When using the Export Documents action, users can choose to export renditions, source documents, document fields, attachments, or audit trails. The document versions shown in the report will be exported. Users must have the appropriate download permissions (such as Download Source or Download Rendition) for the specific artifacts to export.

Once the export finishes processing in the background, SiteVault sends a notification and an email containing a downloadable ZIP file. This ZIP file includes the requested files alongside a CSV manifest that details the successful and failed exports.

Sort Document Type Filter Alphabetically

When using the Document Type filter in the Library, the available document types, subtypes, and classifications will be sorted alphabetically, providing a more intuitive experience for users. Prior to 26R3, this list was sorted based on the number of documents in each document type.

Standard Reports & Dashboards for Veeva AI

SiteVaults with Veeva AI enabled now include a new standard Dashboard and related reports. This functionality allows simple monitoring of agent usage to understand how users are leveraging Veeva AI, and how much token consumption is occurring.

Standardization for Middle, Prefix, and Suffix Fields

To align with VeevaID and Vault standard user profiles, SiteVault is transitioning Prefix, Middle Name, and Suffix from custom fields to standardized system fields.

• Existing Staff and Monitor/External User records will automatically migrate during the general release on December 4, 2026. No user action is required.
• In alignment with current security settings for First and Last Name, standard Prefix, Middle Name, and Suffix fields will not be editable for Staff and Monitor/External Users using VeevaID or Vault cross-domain users. Updates to these fields can be made in the VeevaID Portal under My Account or a user's profile in their home Vault domain.
• NOTE: Users should update any applicable custom reports, saved views, and column preferences to include the new fields.

This feature is not available in pre-release environments.

Standardizing VeevaID & Vault User Profiles

Prefix, Middle Name, and Suffix standard fields now exist within the VeevaID portal and Vault User object. This enhancement standardizes the identity data model across the Veeva ecosystem.

Previously, users often embedded titles, middle initials, or suffixes directly into the First Name or Last Name fields, which caused operational inefficiencies, disrupted integrations, and complicated electronic signature compliance. By establishing the VeevaID portal as the global source of truth for VeevaID users, this feature ensures that SiteVault user schemas perfectly mirror the VeevaID schema so that your environments maintain unified, compliant, and synchronized identity profiles.

Feature Details

• Standardized System Fields: New system fields added for Prefix (prefix__sys), Middle Name (middle_name__sys), and Suffix (suffix__sys) across the identity layers.
• Enhanced Person and Prior Person Objects: The Person and Prior Person objects now capture the new standard system fields. Standardizing the Person object ensures that business-level records, such as Clinical Study Teams, use the exact same name components as authentication records. These new fields are also updated during the User-Person sync.
• Expanded Character Limits: The Mobile field character limit on the User, Person, and Prior Person objects has increased from 20 to 40, and the Email field character limit has increased from 120 to 128.
• Seamless Authentication Sync: During login, the active session security token now carries the new standard system field attributes, automatically updating the local SiteVault record to match the global identity.
• Preserved Integrations: System fields will handle the automated platform synchronization. Existing application fields are preserved so that downstream applications and integrations do not break.
• Admin Consideration: We recommend using the VeevaID Portal as the exclusive interface for managing user identity changes to prevent automated synchronization issues and mismatched identity states.

Task List on SiteVault Home

The default Home tab in SiteVault is enhanced with a filterable list of your tasks and workflows. This upgraded tool makes it easier to organize, find, and complete your daily activities by presenting your work directly within the context of your current site and studies.

Feature Highlights

• Automatic Site and Organization Context: Tasks and workflows now automatically filter to match your currently selected organization or site context.
• Filter by Study and Task Details: You can quickly narrow down your list using top filter dropdowns, including Site, Study, Participant, Visit, and Category.
• Dedicated Task Views: The left navigation panel organizes your work into clear categories:
  • All Tasks: Shows every item requiring attention.
  • My Tasks: Shows tasks assigned specifically to you.
  • Available Tasks: Displays shared tasks (such as monitor feedback) that you or another qualified team member can claim and complete.
  • My Workflows: Displays only the workflows that you personally started, making it easier to track documents you sent out.
• Quick Navigation: Selecting either the document name or the Continue button takes you directly to the document viewer to review instructions and complete your task.
• My Active Document Workflows Report: This new report provides a complete, itemized summary of all active workflows you have initiated, showing the full list of participants, due dates, and completion statuses across every assigned task.

Additional Updates

To provide a cleaner and faster experience, several elements from the previous Home page have been updated:

• Unified Page Layout: The option to switch between "Detail" and "Grid" views has been replaced with a single, clean table layout.
• Task Counters: The count numbers in the left menu show your total task counts and stay constant even when you apply table filters.
• Viewing Workflow Progress: Landing page elements like the "Show more / Show less" expandable lists and direct workflow action menus have been removed. To view participant progress or perform actions (such as adding participants or canceling a workflow), click directly into the document and open its workflow details panel.

NOTE: For enterprise organizations using custom document workflows, an additional task configuration step (adding a custom action) is recommended for each workflow task step to ensure full compatibility with the new Tasks functionality.

VeevaID: Upgraded Anti-bot Protection

VeevaID now features Friendly Captcha, an upgraded privacy-first anti-bot protection layer, alongside an improved user experience and updated cookie consent management.

Previously, VeevaID account registrations and password resets relied on traditional verification systems, which often created form friction and data privacy concerns. VeevaID now replaces legacy CAPTCHA tools with a background cryptographic mechanism. Verification runs silently in the browser so that users experience a seamless and secure authentication process without compromising security.

Both users and Admins will see benefits of this update across many key areas of the VeevaID portal:

• Invisible Anti-Bot Protection: Friendly Captcha automatically secures account registrations and password resets in the background without requiring user input.
• Enhanced Privacy Compliance: The verification process operates without tracking cookies and maintains European Union data residency to align with General Data Protection Regulation (GDPR) standards.
• Standardized Registration Fields: The account creation form now features dedicated fields and dropdowns for Prefix, First Name, Middle Name, Last Name, and Suffix to ensure consistent name data across systems.
• Terms of Service Acknowledgment: The VeevaID registration screen includes an explicit agreement checkbox for updated Terms of Service and Privacy Policies, capturing an audit record upon account creation.

View Rendition Types in Document Viewer

Users can now use Split View mode with custom renditions, allowing users to see the viewable rendition that Vault generates side-by-side with a custom PDF rendition.