Release Notes

Digital Delegation General Enhancements

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

• Study Closure Action: A new study closure action from Study > View Study Details ends all active delegations, generates a new DOA document version, and routes it for PI Approval. The workflow stops short of full DDL disablement to ensure site staff can make any necessary final manual adjustments.
• Fast Fill Tool Available on Start/End Dates: While working in the Delegations Editor, SiteVault’s Fast Fill tool is available to apply the same date to all staff listed in the Start Date or End Date columns.
• Manage Study Responsibilities: Users can now create and edit Study Responsibility names directly inside the Delegations Editor.
• Assignment Status Management: The Assignment Status can now be updated directly via Administration > Staff > Select Staff > Study Assignments for studies enabled with Digital Delegation.
• Automated Document Date: The date the Principal Investigator (PI) applies their electronic signature for approval is automatically populated as the Document Date on the Delegation of Authority (DOA) document.
• Staff Details Drawer: Selecting a name in the Delegations Editor's Study Team column opens a drawer showing assigned responsibilities, start/end dates, and delegation details. These fields are editable for authorized users.
• Date Validation Logic: For ease of use, the following validation rules have been implemented:
• Prevent delegation start and end dates from extending before or after the staff's overall Study Team Assignment Dates.
• Start dates are no longer required when assigning the Study Team on studies enabled with DDL.
• Inactive Responsibilities Filtering: Inactive responsibilities are hidden from the main view of the Delegations Editor. If an inactive responsibility was historically delegated, it remains visible within the individual staff member's detail drawer to preserve historical records.

Dynamic Delegation Acceptance Participants

The Digital Delegation Log (DDL) Send for Acceptance workflow now automatically populates the participant list with study team members who have delegation updates since the last approved version of the DDL. This eliminates the need for workflow initiators to manually select individual reviewers.

Please Note:

• Staff members who are hidden from the delegation log or removed from the study are excluded from the workflow and will not block acceptance.
• For the initial version (V1) of a log, the full study team will still default into the workflow because an approved baseline does not yet exist.

Read & Understand History Report Refresh

The R&U History report has been upgraded to provide deeper visibility into training tracking and improved audit compliance.

• Enhanced Version Tracking: The report now displays version-specific document names and descriptions, making it effortless for monitors to track training history across multiple document iterations.
• Flexible Export Options: Easily download data in Excel, CSV, or PDF formats.
• Audit Trail Support: A new history log tracks exactly who generated the report and when it was run.

PI Approval Workflow Available in eBinder Upload

The Send for PI Approval workflow utilized in SiteVault's Digital Delegation feature is available for Delegation of Authority (DoA) documents that are uploaded in the Study eBinder. Previously, this action was only available from the document Action menu after upload.

Study Archival Automated Reattempts

This feature introduces an automated daily process that re-evaluates and attempts to progress stalled study archivals. SiteVault will run a daily check of studies in the Archival in Progress state and automatically move them to the Archived state once all outstanding requirements are met.

For archivals completed by this daily process, the audit trail will indicate that the System (not a user) updated the study status to Archived. The Note to File will continue to display the name of the initial user who originally requested the archival.

Reason for Rejection Fields on eSignature Workflows

To improve communication and visibility within document history, a mandatory Reason for Rejection field has been added to specific eSignature workflows. When a reviewer selects a Reject verdict, they must provide a reason, capturing the rationale directly within the document record and eliminating the need for offline follow-up.

The required rejection reason field is enforced on the following workflows:

• Financial Disclosure Form: Send for eSignature Approval
• CV: Send for eSignature Approval
• ICF Signed: Send eConsent for Signature

Study-Level Site Connect Document Auto File Override (navigation change only)

With this feature, Site Connect users can opt out of Site Connect Auto-File at the SiteVault study-level in a study's View Details drawer. This is not new functionality; previously, this action was completed from the Studies list.

eConsent Preview Role Selector

While previewing an eConsent form, site users can choose to view a form from the perspective of any assigned signatory. A dropdown field listing all of an eConsent forms’ signatory roles is provided in the Preview Mode banner. This enhancement allows site users to become familiar with each signatory’s experience as well as confirm accuracy during the editing process.

CTMS Central Activity Library

This feature introduces a centralized repository to seamlessly create, define, and manage a master list of standard study activities. These library tools streamline the workflow for adding activities to a study schedule, while allowing users to link clinical activities directly to financial data, such as Charge Codes.

CTMS PDF Invoice Generation

This update introduces automated PDF invoice generation within SiteVault. Instead of manually exporting billable items to external spreadsheets, the system now automatically generates and files finalized invoice documents directly into the study eBinder.

• Automated PDF Compilation: Moving an invoice out of Draft generates a standardized PDF invoice containing relevant study information and itemized fee tables.
• Ready to Send State: A new lifecycle state, Ready to Send, is available immediately following the Draft state. Moving an invoice to Ready to Send finalizes the data, automatically generates the PDF, and locks the invoice record from further changes.
• On-Demand Previews: Site staff can generate a layout preview at any time while the invoice is in the Draft state. Previews are saved in the study eBinder as Draft Invoice documents.
• Version Stacking: To prevent duplicate files in the eBinder, all generated previews and finalized versions for a single invoice are automatically stacked as versions under a single document record.
• Template Fields: All sites utilize a single standardized layout. Options for site customization include:
• Site Logo: An optional image upload to display on the invoice header.
• Free-Text Comments: An optional field for adding invoice-specific notes.

CTMS Schedule Builder

This feature is initially available only to Enterprise Early Adopter CTMS customers.

The new Schedule Builder introduces Veeva AI capabilities to CTMS to significantly reduce study startup time. Instead of manually transcribing and building study schedules from scratch, users can now leverage Veeva AI to automatically generate an initial draft directly from a protocol document.

• Automated Draft Generation: Analyzes an uploaded protocol document's Schedule of Events to automatically extract and map key protocol data.
• Rapid Background Processing: Generates a comprehensive draft schedule behind the scenes within minutes.
• Core Element Mapping: Automatically populates visit groups, branching logic, visits (including timing and windows), activities, and links activities to the Activity Library.
• Conservative Data Extraction: The system will leave a required field blank if it cannot determine the correct information with high confidence, rather than guessing.

• Draft Status Only: The builder is designed to provide a head start, not a final product. All AI-generated schedules are created as drafts and are not ready for immediate production use.
• Mandatory Review Workflow: Human validation is required. Users must review, refine, and manually promote from Draft to Current. Common areas requiring manual adjustment include off-by-one activity assignments and complex visit windows.
• Functional Limitations: The system does not track or populate study arms, default cycle numbers, custom ad hoc visits, or whether an activity is optional or repeated.
• Document Formatting Impact: Accuracy may decrease if the protocol table is oriented incorrectly (e.g., rotated landscape pages) or if the grid is highly dense and compressed.

CTMS Address Book for Invoicing

SiteVault now includes a centralized Address Book for invoice management. This feature allows sites to record, store, and manage payee and payer addresses directly within the system rather than tracking them externally.

With this feature, invoices now include optional From and Bill To address fields.

• Select or Create On-the-Fly: Users can choose an existing address from a side panel drawer or create a new address during the invoicing workflow.
• Automatic Saving: Any new address created while editing an invoice is automatically saved to the Address Book for future use.
• Smart Defaulting: To minimize repetitive data entry, new invoices will automatically default to the last used From and Bill To addresses for that specific study.
• Workflow Reminders: While both address fields remain optional, the system will display a prompt reminding users to fill them out if they are left blank when advancing the invoice state.

Key Considerations

• Address Associations: Addresses are associated with sites and organizations and can be used across studies/invoices:
• From addresses must be associated with the study site.
• Bill To addresses must be associated with either the study sponsor or an organization.
• Site-Level Maintenance: Address books are separated by site. Users who manage multiple sites will have a distinct address book for each individual site to maintain data integrity.
• Duplication Prevention: To avoid duplicate entries, the system utilizes strict string matching for key address components. Exact matches will automatically map to the existing address record.

CTMS Visit Calendar General Enhancements

This update introduces several key improvements to the Visit Calendar:

• Chronological Sorting: Visits in the Scheduler are now displayed in sequential order for better visibility.
• Streamlined Editing: Modifying appointment times and durations is now quicker and more intuitive.
• Time Zone Localization: The calendar display now automatically adjusts based on the user’s profile time zone.

CTMS Chargemasters and Charge Codes

You can now manage institutional procedure codes and pricing directly in SiteVault CTMS. This update reduces manual, offline tracking by seamlessly integrating Chargemaster data with your coverage analysis and study budgets.

• Updated Finance Navigation: The Finance tab is now a drop-down menu containing three dedicated sections: Budgets & Billing, Chargemasters, and Charge Codes.
• Chargemaster & Bulk Import Support: Provides the ability to centralize your institution's menu of services and upload thousands of codes simultaneously via CSV. The import utilizes all-or-nothing validation to prevent partial or corrupted data uploads.
• Enhanced Coverage Analysis: The CPT Codes column has been replaced with a Charge Codes selector, allowing users to assign multiple codes to a single study activity.
• Central Activity Library Integration: Allows you to map charge codes directly to Activity Templates so that pricing and codes automatically inherit whenever the template is added to a study schedule.
• Pricing Integrity: Once a Chargemaster import is complete, the record automatically shifts to a read-only (Current) state to protect billing compliance. Outdated records can be set to Archived to clear the way for new pricing versions.

CTMS General Enhancements

This release includes the following general enhancements to CTMS:

• Increased Decimal Precision: The Overhead and Withholding fields can now accommodate up to two decimal places.
• Smart Tab Navigation: When a study schedule is present, opening a Participant record will now automatically focus on the Visits tab.
• Automated Budget Recalculation: Finalizing a budget now prompts SiteVault to automatically recalculate billable items for visits completed after the budget's effective date. Note: Visits containing items that are already invoiced or paid will be skipped.
• Automated Expense Recalculation: Finalizing an expense plan triggers SiteVault to automatically recalculate payable items for visits completed after the plan's effective date. Note: Visits containing items that are already paid or voided will be skipped.
• Billable Items can be added directly to a payment.

Study Lifecycle Action: Change to Active

Site users can now change a study’s status from Active - Not Recruiting to Active directly within SiteVault. Previously, this change required a request to Site Support.