New in 22R1.4: Add Documents to Expanded Search and more

Release Date: June 24, 2022

We are pleased to bring you the following new functionality in this week’s release. See details about feature enablement below.

Platform

Usability & UI Updates

Vault Help: Application-Specific Help Pages

With this release, Vault Help is divided into application-specific URLs designed to present the information most relevant to each Application Suite. Learn more links are directed to a specific area where users have access to the corresponding information as well as the applicable Platform features. Search is streamlined to supply results from the specific URL.

Localize Vault to Norwegian

The Vault UI now supports Norwegian localization. Administrators can fully localize Vault to Norwegian by using Bulk Translation or by modifying individual configured labels. Users can then update the language Vault displays for them by changing the language settings on the User Profile page. Vault also supports setting Norwegian translations for labels in user-configurable data such as document types, fields, picklist values, and lifecycle names. Learn more about supported languages and localization settings.

Preserve eSignature Page Signer Info

Signature pages are generated upon the first view of the page and after a new signature is captured. For signatures captured after 22R2, a regenerated page reflects the signer’s title at the time of signature. If a delegate user adds the signature, their name and title also reflect the values from the time of signing.

This feature is Auto-on and was released in 22R1.3 without documentation.

Customers can now add documents to a collection, which enables expanded searches across documents and objects for the first time. When adding documents to a collection, Admins can choose to include all documents or a subset by choosing a specific document type. If documents are participating in a collection, any tabs sharing the same Document type as a scope can include the option for expanding a search to that collection.

Both documents and objects in a collection have a new option to apply VQL criteria to the configuration so that filtering can be applied to each section within an expanded search.

Freeze Column Header & Rows on Object Tabs

When searching records in an object tab, column headers are now frozen so that the names of the columns are always visible, making it easier to navigate the results when scrolling vertically. With this enhancement, the search results have been increased to 50 since the context will never get lost when scrolling deep into the results. Users can now freeze additional columns to make scrolling horizontally easier as well.

Clinical Operations

CTMS

Sync Principal Investigator Field with Study Person

This feature extends our clinical capabilities by introducing a bi-directional update of the Principal Investigator field on the Site and Study Person objects. Vault updates the Principal Investigator field whenever a new Study Person with the role of Principal investigator is created. Additionally, if the Principal Investigator field is updated and a corresponding Study Person does not exist, Vault creates a Study Person record with the role of Principal Investigator.

CTMS Oversight Metrics

This feature extends Vault CTMS by adding support for managing Enrollment Metrics in studies where the subject data are not tracked in Vault. Once enabled for a Study, Vault CTMS tracks changes to Metrics values and roll-ups changes from lower levels.

Clinical CRM Connection

This feature enables Vault Clinical to transfer HCP-related Activities between Vault Clinical and Medical CRM.

Recruitment Planning: Metric Over Time Expansion

This feature revises the logic for creating Metrics Over Time records to allow for the creation of Metrics Over Time records for the largest expected range of the recruitment period. Vault uses the earliest of the Baseline Finish Date, Forecast Finish Date, or Planned Finish Date for the relevant Milestone as the starting date of the Metrics Over Time date ranges. Vault uses the latest date for the end date of the Metrics Over Time date range.

Metrics: Status Snapshot Refinements

With this feature, for CTMS Studies for which Vault tracks metrics as Status Snapshot, or when no value is selected, Vault only creates Enrollment Status Log records when there is a change to Subject data in the Study.

Yuzu CTN: Site Medical Department Not Required

Vault CTMS customers that have enabled Yuzu, the Japan CTN functionality, can now generate CTNs even if the CTN Medical Department field on the Study Site CTN data record is blank.

Recalculate Enrollment Actuals: Notification

Vault CTMS sends a notification to the user who initiates the Recalculate Enrollment action when the action is complete.

eTMF

Clinical Archival Validation Check

This enhancement introduces an error notification when unclassified documents are present for a Study during Archival. Vault cannot archive a Study with unclassified study documents.

Clinical Operations Data Model Changes

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the Clinical Operations data model to support new features:

The following changes were made to support the Clinical CRM Connection feature:

  • Removed Requiredness on the Subject field on the Activity (crm_activity__v) object
  • Added the new standard external connection: CRM/Clinical Operations Connection (crm_clinops_connection__v)
  • Added the new Enter Connected App Details (connection_details__v) action on Connection Authorization object (connection_authorization__sys)

The following items were added to support the CTMS Oversight Metrics feature:

  • New Picklist items Metrics Only (metrics_only__v) and Transferred Metrics (transferred_metrics_v) to the Metric Calculation Picklist (metric_calculation__v)
  • New field Subject Metrics Only Level (subject_metrics_only_level__v) on the Study object

Commercial

PromoMats & MedComms

Auto Publish to CRM for Approved Email Fragments

This feature introduces new document fields and lifecycle entry actions to automate the creation of Email Fragments and their lifecycle state changes. Vault now keeps specific document fields in sync between the related piece/medical content and the email fragment.

Admins can define approved Master Email Fragment Templates for combinations of Targeted Document Type, Country, and Product to help automate template selection.

AIR PSD Image Enhancements

This feature introduces the option to improve the image quality of .PSD images which may have imperfections in .PNG Automated Image Renditions.

MedComms

Data Agnostic MedComms to CRM Connection for Medical Inquiry

This feature introduces a new connection to Veeva CRM to pull Medical Inquiries. This only pulls information entered onto the Medical Inquiry in CRM, and does not require Accounts to be synced. When the Inquiry is pulled into MedComms, Vault either assigns it to an existing Case Contact if present or creates a new Case Contact.

Network (OpenData) Connection to Look Up HCP Reference Data for Medical Inquiry

This feature introduces a new connection to Veeva Network. For eligible customers, this connection allows MedComms users capturing Medical Inquiries to search OpenData for reliable, accurate HCP reference data when creating a Case Contact.

Commercial Data Model Changes

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the Commercial data model to support new features:

The following changes were made to PromoMats and MedComms Vaults to support the Auto Publish to CRM for Approved Email Fragments feature:

  • Added the following shared document fields:
    • Publish for Veeva CRM (Email) (email_content__v)
    • Targeted Document Type (targeted_doc_type__v)
  • Added the Deleted (deleted__v) state to the Approved Email lifecycle
  • Added the Language (language__v) field to the Country (country__v) object

The following changes were made to MedComms Vaults to support the Data Agnostic MedComms to CRM Connection for Medical Inquiry and Network (OpenData) Connection to Look Up HCP Reference Data for Medical Inquiry features:

  • Added the following fields to the Case (case__v) object:
    • Last Modified in CRM Date (crm_last_modified_date__v)
    • Response Contact (response_contact__v)
  • Added the Response Contact (response_contact__v) field to the Case Response (case_response__v) object
  • Added the Connection (connect__v) field to the CRM Org (crm_org__v) object
  • Added the OpenData Healthcare Provider ID (opendata_healthcare_provider_id__v) field to the Person (person__v) object
  • Added the Veeva OpenData (veeva_opendata__v) value to the Source (source__v) picklist

Quality

Vault LIMS

With this release, Vault LIMS continues to add features to support static data management and test execution, including the evaluation of lab results. Vault LIMS is available in 22R2 for Early Adopters.

Regulatory

RIM Registrations

EU UDI Submission Viewer

A new Registrations wizard will be provided to review the data quality of UDI submissions that have been generated for EUDAMED.

RIM Publishing & RIM Submissions

Publishing Completeness Check on State Change

With this release, the Content Plan Hierarchy State Change User Action can be configured to prevent entry into a state when there are still pending publishing jobs.

RIM Publishing

Merge & Publish Submission Content Plan

With this release, users are able to create a single PDF file of all PDF files matched within a Submission Content Plan.

Health Canada Validation Criteria v5.1 Support

With this release, Vault Submissions Publishing supports validating Canadian submissions against Health Canada’s v5.1 Validation Criteria specification.

22R2 RIM Data Model Changes

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the Regulatory data model:

  • Added the following components to support the Publish & Merge Submission Content Plan feature:
    • Added the Merged PDF Document Number (merged_pdf_document_number__v) field to the Submission (submission__v) object.
    • Added the Merge in Progress (merge_in_progress__v) value to the Dossier Status (dossier_status__v) picklist.
  • Added the following components to support the EU UDI Submission Viewer feature:
    • Added the following object actions for the UDI Submission (udi_submission__v) object:
      • Review UDI Submission (review_udi_submission__c)
      • UDI Submission Accepted by HA (udi_submission_accepted_by_ha__c)
      • UDI Submission Rejected by HA (udi_submission_reject_by_ha__c)
    • Added the UDI Submission (udi_submission__v) document lifecycle.
    • Added the following object state types:
      • UDI Submission Data Failed to Generate (udi_submission_data_failed_to_generate__v)
      • UDI Submission Ready to Review (udi_submission_ready_to_review__v)
      • UDI Submission Canceled (udi_submission_canceled__v)
      • UDI Submission Ready to Submit (udi_submission_ready_to_submit__v)
      • UDI Submission Rejected by HA (udi_submission_rejected_by_ha__v)
    • Added the Additional UDI-DI Registration (additional_udi_submission__v) object type to the UDI Submission (udi_submission__v) object.
    • Added the Version (version__v) field to the Registered Device Identifier (registered_device_identifier__v) object.
    • Added the Medical Device Type (medical_device_type__v) field to the UDI Submission (udi_submission__v) object.

Safety

Safety features are targeted for tentative availability on June 30, 2022.

Safety

Field Limit Updates for E2B (Enablement Change and Data Migration) Auto-on

Vault Safety now supports the maximum E2B-compliant field limits for Dose Text, Transmission Reason, and Test Result Value. This feature was originally introduced in 22R1 through Support-enablement. In 22R2, this feature is automatically supported in all environments.

The Case Product Dosage > Dose Text field and Case Test Result > Test Result Value fields will be automatically replaced on page layouts and available for data entry. However, the Localized Case Product Dosage > Dose Text and Transmission > Transmission Reason fields must be replaced on page layouts, if required for data entry. Existing field data and security configuration will be copied from the pre-existing Dose Text, Transmission Reason, and Test Result Value fields to the new fields.

Learn More

Domestic Case Processing for Agency Jurisdictions Configuration

This release brings multiple enhancements to domestic case processing. Administrators can now manage a Country State/Province library with configurable support for state/province codes. You can select the Country State/Province from a picklist during intake and case processing. The system will map the domestic state codes upon E2B(R3) import and export. This enhancement is for domestic cases originating in a country, such as Spain or Italy, where the state code is required in submissions to a specific agency, such as the EMA.

Administrators can also now manage the type and scope of localization for domestic case processing. The localization scope can be for all fields or specific to Narratives and/or Company Comments. If configured, the localized values for Company Comments and Narratives will also be exported in E2B formats.

Additionally, this feature introduces two new Vault Settings for system administrators. One setting is to configure Inbox Item localization to default based on Reporter Country and Language. Another setting is introduced to prevent auto-submissions when a Case contains unapproved Localized Cases.

Learn More

Combination Product FDA E2B(R2) Export and Case Processing Enhancements Auto-on

In this release, Vault Safety provides multiple enhancements for FDA E2B(R2) generation related to drug/biologic-led combination products having device constituents. Combination Products are now exported as a single <drug> block, with the device constituent referenced within the block. In addition, device product codes and brand names are exported to FDA E2B(R2). Vault Safety will also support adding combination products during data entry after Case promotion. Finally, Vault Safety will no longer automatically generate Case Assessments or Expectedness records for device constituents, which can be error-prone and lead to unnecessary work during case processing.

Learn More

Narrative Templates for Report Types and Studies Configuration

This release enhances the administration of narrative templates. You can now configure and maintain narrative templates by Organization, Report Type, Study Type, Study, and Localization. During Case promotion, the system matches the Case to an appropriate template based on the specified fields. Also, you can now re-render a Case narrative document to refresh merge field tokens without versioning the document.

Learn More

Pagination in Dose Section Control Auto-on

With this release, the Dosage section control supports paging and the manual creation of more than 10 dosages per product on a Case.

Learn More

Copy Patient Information from Existing Case Admin Checkbox

This feature was released in 22R1.3 and contains additional capabilities in 22R1.4. In this release, where auto-calculation is enabled for a field, that setting is copied to the new Case so that the new Case will continue auto-calculating the value of the respective field.

See New in 22R1.3 for more detail on what was previously released.

Learn More

Support for Unconstrained UCUM for Test Result Units Auto-on

Vault Safety will now support test result units from the unconstrained (infinite) UCUM dictionary to align with E2B(R3) specifications. This support will extend to migrations, E2B imports, E2B/CIOMS/3500A generation, and Case processing.

Learn More

Optimized BFC E2B(R2) Export Auto-on

Vault Safety now supports the generation of E2B(R2) formats with optimized backward-forwards compatibility logic. This export logic enhances support for global health authorities including Health Canada.

Learn More

Admin users will now be able to switch the import of E2B through the Receive E2B API and Safety Link to the Inbox Item using the Transmission Profile “Import to Inbox Item”. The field is now available on all Transmission Profile types, including the Partner Exchange Transmission Profile type.

Learn More

SiteVault

Digital Delegation: Usability Optimizations

This feature introduces various enhancements to the Digital Delegation functionality:

  • Easy Enablement and Disablement: Additional automated triggers are in place to simplify the enablement process.
  • Data Validation: Enhanced logic is applied to eliminate unnecessary workflows and tasks.
  • Bulk Edit Staff Delegations: Users will now have the ability to add/remove multiple delegations from a staff member at once, simultaneously add/remove multiple staff delegations, and edit delegations without leaving the study person details page.

SiteVault Data Model Changes

With every release, we update the SiteVault data model to better support evolving needs and new feature functionality. In this release, we’ve added the following components to the SiteVault data model:

  • Added new document type Source Data Agreement (source_agreement__v).
  • Added new role Other Non-investigator to the Study Team Role object (study_person_role__v). With this feature, users creating or editing Study Team Assignments will have the new role available for use.
  • Added new standard training workflows which can be configured for use.

QualityOne

QMS

SVO to HVO Migration: Purchase Order Line Item Object

This feature migrates the Purchase Order Line Item standard Vault object (SVO) and its data fields to a High Volume object (HVO) to deliver increased performance and scalability.

HVO Migration Preparation: Inspection Sample Test Result Object

This feature prepares the migration of the Inspection Sample Test Result standard Vault object (SVO) to a High Volume object (HVO) planned for 22R3. To prepare for HVO migration, the following changes have been made to the Inspection Sample Test Result object:

  • Standard lookup fields have been replaced with field types compatible with HVO, such as object reference fields and formula fields.
  • Dynamic Access Control (DAC) has been replaced with Application Security.
  • Functionalities related to DAC, such as Sharing Settings, have been replaced by Application Security’s Object Sharing Rule and Record Matching Rule.
  • Role-based participant assignment is no longer supported.
  • Field types that support field-level encryption are no longer supported.
  • Only two (2) multi-value picklist fields can be configured on the object.

In place of DAC, a layer of Application Security will be added to the Inspection Sample Test Result object to allow role setup for individual Users and User Groups. Learn more about Inspections to prepare for the HVO migration.

Enablement Details

See the following explanations for enablement options:

Enablement Description
Auto-On Automatically activated and no configuration is required before using the feature; note that in some cases, a new feature is dependent on another feature that must be enabled or configured.
Admin Checkbox Admins must turn on the feature with an Admin checkbox. Note that some “Auto-On” features have a checkbox setting that hides the feature; these will show “Auto-On.”
Configuration Admins must configure the feature (separately from an Admin checkbox) before it is available to use or is active; for example, an Admin must add document templates before users can create documents from templates.
Support On/off option controlled by Support.
Feature Enablement Application
Usability & UI Updates
Vault Help: Application-Specific Help Pages Auto-on Platform
Localize Vault to Norwegian Auto-on Platform
Search
Add Documents to Expanded Search Configuration Platform
Freeze Columns & Headers on Object Tabs Auto-on Platform
Clinical Operations
Sync Principal Investigator Field with Study Person Admin Checkbox CTMS, Study Startup, Vault Payments, eTMF
CTMS Oversight Metrics Auto-on CTMS
Clinical CRM Connection Configuration CTMS
Recruitment Planning: Metric Over Time Expansion Auto-on CTMS
Metrics: Status Snapshot Refinements Auto-on CTMS
Yuzu CTN: Site Medical Department Not Required Auto-on CTMS
Recalculate Enrollment Actuals: Notification Auto-on CTMS
Clinical Archival Validation Check Auto-on eTMF
Clinical Operations Data Model Changes Auto-on CTMS, Site Connect, Study Startup, Vault Payments, eTMF
Commercial
Auto Publish to CRM for Approved Email Fragments Configuration MedComms, PromoMats
AIR PSD Image Enhancements Support MedComms, PromoMats
Data Agnostic MedComms to CRM Connection for Medical Inquiry Support MedComms
Network (OpenData) Connection to Look Up HCP Reference Data for Medical Inquiry Support MedComms
Commercial Data Model Changes Auto-on MedComms, PromoMats
Quality
Vault LIMS Configuration LIMS
Regulatory
EU UDI Submission Viewer Configuration RIM Registrations
Publishing Completeness Check on State Change Configuration RIM Publishing, RIM Submissions
Merge & Publish Submission Content Plan Configuration RIM Publishing
Health Canada Validation Criteria v5.1 Support Configuration RIM Publishing
SiteVault
Digital Delegation: Usability Optimizations N/A SiteVault Enterprise, SiteVault Free
SiteVault Data Model Changes Auto-on SiteVault Enterprise, SiteVault Free
QualityOne
SVO to HVO Migration: Purchase Order Line Item Object Auto-on QualityOne
HVO Migration Preparation: Inspection Sample Test Result Object Auto-on QualityOne