New in 21R3.5: Learn More Links: Vault Help Update, and more

Release Date: March 4, 2022

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

Usability & UI Updates

With this release, “Learn More” links within Vault now target a new Vault Help site.

Administration

Jobs: Disable Session ID Token in External URL Call Configuration

Session ID tokens in the external URL call job configuration are no longer supported and will not work in this release. Please update your job definitions to use the Post Session Credentials via Form Data with Key “Session.id” option.

System Vault Tokens

Vault now includes the following system-provided Vault tokens that developers can use to reference Vault information:

  • ${Vault.vault_dns__sys}
  • ${Vault.vault_id__sys}
  • ${Vault.vault_name__sys}

Clinical Operations

RBSM: Critical Data & Processes

This feature adds support for tracking Critical Data and Processes for a Study. As part of a Study Risk Assessment, users can define which data points and processes are critical to study execution and link the records to Study Risks.

TMF Bot : Bulk Upload Pipeline

This feature optimizes the TMF Bot to prioritize documents uploaded via the UI over those uploaded in bulk via the API, allowing end user uploaded documents to be auto-classified first.

Clinical Email Ingestion: Relevant Communications

This feature leverages platform email ingestion functionality to support inbound email addresses that create a TMF document from an inbound message and relate it to a Study Communication Log record. 

ClinOps/CDMS Connection: Single Study Refresh

Single Study Refresh enables refreshing Clinops/CDMS connected data only for a single study. Single Study Refresh replaces the current full refresh mode which refreshes the connected data across all the connected studies.   

Summary Notification of Returned Documents

With this feature, Vault now notifies the specific Site Connect users who have sent document requests to sites over Site Connect when documents return in a summary email notification specific to a given Study Site.

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:

Added the following components to support the Clinical Email Ingestion: Relevant Communications feature:

  • Study Communication Log (study_communication_log__v) document field
  • Created via Correspondence Email (created_via_correspondence_email__v) tag
  • Study Communication Log (study_communication_log__ctms) items:
  • Ingested Email (ingested_email__v) object type
  • Relevant Document (relevant_document__v) field
  • Email Message ID (email_message_id__v) field
  • Study Item:
  • Email Subaddress (email_subaddress__v) field

Added a new message template to support the Summary Notification of Returned Documents feature:

  • Received from SiteVault (received_from_sitevault__v)

Added the following components to support the RBSM: Critical Data & Processes feature:

  • New Objects:

    • Critical Process (critical_process__v)
    • Study Critical Data (study_critical_data__v)
    • Study Critical Process (study_critical_process__v)
    • Study Risk Critical Data (study_risk_critical_data__v)
    • Study Risk Critical Process (study_risk_critical_process__v)

  • New Lifecycles:

    • Study Critical Data Lifecycle (study_critical_data_lifecycle__v)
    • Study Critical Process Lifecycle (study_critical_process_lifecycle__v)

  • New Picklist:

    • Critical Data Category (critical_data_category__v)

In addition to the above changes to support new features, we also added the following:

  • New Study Cohort (study_cohort__v) object
  • New Study Cohort Lifecycle (study_cohort_lifecycle__v)
  • New field on Subject (subject__clin):
    • Cohort (cohort__v)
  • Maximum value setting is now editable for the following field:
    • Person (person__sys) > Suffix (suffix__v)

Commercial

Customisable “From” Email Address for Case Response Emails

This feature allows customers to configure the “From” email address on Medical Inquiry case response emails. When the contact receives the email, they see the sender as the address configured in the customer Vault rather than a generic Vault email address.

CRM Document Field Label Updates

This feature updates the labels for some CRM related document fields to align with Veeva’s best practices and documentation. The updated labels provide clarity on the intended use of the fields and their impact on the CRM integration.

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 components were added to MedComms and PromoMats Vaults to support the Customisable “From” Email Address for Case Response Emails feature:

  • Added the object type From Email Address (from_email_address__v) on the Person (person__sys) object 
  • Added the field From (from__v) on the Case Response (case_response__v) object, enabled for the Email (email__v) object type 

The following components were added to MedComms and PromoMats Vaults to support the CRM Document Field Label Updates feature:

  • Updated the labels on document fields as follows:
  • Publish for Veeva CRM (CLM) (clm_content__v)
  • Publish for Veeva CRM (CoBrowse) (cobrowse_content__v)
  • CRM Directory (crm_directory__v)
  • Hide from CLM Library (crm_hidden__v)
  • CRM Searchable Keywords (crm_keyword__v)
  • Publish for Veeva CRM (Portals) (engage_content__v)
  • Publish for Veeva CRM (URL) (shareable_as_an_approved_link__v)
  • Publish for Veeva CRM (WeChat) (wechat_content_wec__v)

Quality

Send Email to Non-Vault Users: Improved Error Messages & Removal of Reply to Field

With this release, user-friendly error messages will be displayed if an invalid Quality External Notification configuration is attempted or when the Send External Notification action encounters an error upon execution. In addition, the Reply To field has also been removed from the Quality Event object and deferred to a future release.

Regulatory

Manage & Edit Table of Contents (TOC)

With this release, Submissions Publishing and Report Level Content Plan users can edit a generated Table of Contents (TOC) from within Vault RIM.

IDMP Viewer

This feature provides a data visualization UI that consolidates cross-medicinal product submission data for a unified view. The viewer also highlights differences among like records within the submission set to facilitate data review.

Labeling Process Improvements

This feature extends the existing Vault RIM data model to better support tracking of labeling concepts and local label deviations by adding the ability to support multi-document changes, bolstering the relationship between deviations and health authority communications, and supporting the deviation approval process.

22R1 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 to support new features:

  • Added the IDMP Grouping (idmp_grouping__v) object to support the IDMP Viewer feature.
  • Added the TOC Edited by User (toc_edited_by_user__v) field to the Content Plan Item (edl_item__v) object to support the Manage & Edit Table of Contents (TOC) feature
  • Added the following components to support the Label Process Improvements feature:
  • Added the following fields to the Labeling Concept (labeling_concept__v) object:
  • Document to be Updated (document_to_be_updated__v)
  • Updated Document (updated_document__v)
  • Contains Core Safety Information (contains_core_safety_information__v)
  • Added the following fields to the Labeling Deviation (labeling_deviation__v) object:
  • Resulting Local Label (resuling_local_label__v)
  • Deviation Review Disposition (deviation_review_disposition__v)
  • Added the Labeling Deviation (labeling_deviation__v) shared document field.
  • Added the following fields to the Activity (activity__rim) object:
  • Impacts Artwork (impacts_artwork__v)
  • Safety Category (safety_category__v)
  • Lead Reference Market Due Date (lead_reference_market_due_date__v)
  • Due Date (due_date__v)
  • Added the Lead Dependency (lead_dependency__v) field to the Activity Dependency (activity_dependency__v) object.
  • Added the following join objects and components, available in RIM Registrations Vaults only:
  • HAQ-Labeling Deviation (haqlabeling_deviation__v)
  • Activity-Labeling Concept (activity_labeling_concept__v) with an associated object lifecycle, Activity Labeling Concept (activity_labeling_concept_lifecycle__v)
  • Added the Local Concept Disposition (local_concept_disposition__v) picklist.
  • Added the Multiple Lead Dependencies Identified (multiple_lead_dependencies_identified__v) object message.

Safety

Safety features are targeted for tentative availability on March 10, 2022.

Inbox Item Global Actions for Manual Intake Auto-on

Vault Safety now supports global actions to create, edit, and save all Inbox Item records in a single click during manual Inbox Item intake. The system warns users when navigating away from an Inbox Item with unsaved data.

Learn More

Deep Duplicate Search Support

Vault Safety will now search for potential matches using all Case Adverse Events and Company or Study Products, including non-primary records. Additionally, users will be able to confirm new case creation when no potential match is found.

Learn More

Attach Custom Child Objects to Case on Follow-Up From Inbox Item Auto-on

When promoting an Inbox Item to a Follow-Up Case, custom child object records will now be added to the new Case version.

Learn More

Rank Suggestion and Validation for E2B-Imported Blinded Products Auto-on

Vault Safety will now suggest Rank 1 for Investigational Blinded Products (G.k.2.5 = Yes) on E2B R3 import to Inbox Item. These Case Products won’t need a Study Product or Company Product to be a primary suspect (rank 1).

Strict Case Locking Admin Checkbox

Administrators can now enable a system setting to enforce strict case locking, which prevents users from making changes to a Case unless that user had locked the Case themselves.

Learn More

Provision Standard Verbatim Fields for Case Drug History and Case Diagnosis Configuration

In this release, Vault will allow for standard fields to support migration of verbatim values for Case Drug History and Case Diagnosis records.

Learn More

  • Enablement: (Optional) To expose the new verbatim fields to users, an administrator can add the new fields to the following page layouts, if required. Note: These fields are primarily added for data migration and are not currently supported for E2B import or export or any type of report generation. These fields do not need to be added to page layouts for migration:
    • Case Drug History:
      • “Indication (Reported)” (indication_reported__v)
      • “Reaction (Reported)” (reaction_reported__v)
    • Case Diagnosis:
      • “Name (Reported)” (name_reported__v)
  • User Help: Enter Case Data

Generate Assessment Results With Clinical and Post Market Source Defaults Auto-on

This release enhances EMA E2B(R3) file generation by ensuring that the Source Type on system-generated Case Assessment Results is accurately set for postmarket submissions to the EMA EVHUMAN module. Table constraints for the DSUR Interval Line Listings of Serious Adverse Reactions have also been updated with further protections to ensure only related adverse events are listed. Additionally, administrators can now edit the name of system-provided Controlled Vocabulary records, if required.

Learn More

Ignore Validation Rule Auto-on

Validation Results on a Case or Transmission can now be changed to the Ignored state. This allows users to proceed with case processing and submissions while ignoring certain validation failures. Subsequent validation evaluations will not execute on ignored results.

Learn More

SiteVault

Digital Delegation: Email Notifications

This feature provides the following general usability enhancements to the Digital Delegation feature:

  • Users receive email notifications for pending and completed digital delegation tasks, for example, when delegations are ready for principal investigator (PI) approval and when the PI approves.
  • Users can reinitiate study staff acceptance of delegations before PI approval. This enables users to update a study team member’s delegations after they’ve accepted but before the PI has approved, if needed.

The Digital Delegation feature can only be configured in vaults with the Extensible SiteVault Permissions feature enabled.

Standard Participant Workflows

This feature adds new standard workflows for the Participant object. Configuration is required to begin using the new workflows.

Veeva eConsent: In-person eConsent

This feature enables SiteVault users to quickly connect a mobile device to MyVeeva for Patients so that patients can read and complete an eConsent form in person.

Users can select the View In-person Code action on the study participant’s record to generate a unique QR code to access the eConsent form in MyVeeva for Patients. Patients can use their own mobile devices or a site’s device when available.

SiteVault 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 SiteVault data model to support new features:

  • To support the Digital Delegation: Email Notifications feature, updated all of the Digital Delegation feature-related custom (__c) components to standard (__v) components
  • To support the Standard Participant Workflow feature, updated all of the custom  (__c) state change Participant Lifecycle (subject_lifecycle__v) workflows to standard (__v) workflows. In addition, added the Change State to First Visit Scheduled (change_state_to_first_visit_scheduled__v) workflow.
  • To support the Veeva eConsent: In-person eConsent feature, added the MyVeeva ID (myveeva_id__v) field to the Subject (subject__v) object.

In addition to the changes supporting new features, we added or updated the following components:

  • Added Criteria VQL on the following fields:
  • Organization (organization__v) field on the Study Organization (study_organization__v) object_
  • Patient (patient__v) field on the Participant (subject__v) object
  • Product (product__v) field on the Study Product (study_product__v) object
  • Updated the User (person__sys) object to User Profile (person__sys)
  • Updated the User (sys) (user__sys) object to User Account (user__sys)
  • Updated the Users (sys) (users__c) subtab to User Accounts (user_sys__v)

QualityOne

FSMA Supplier Verification (FSVP/SCAC)

This feature offers the ability to verify the supplier’s capability of controlling the known or foreseeable hazards associated with the supplied material, in accordance with the FSMA (Food Safety Modernization Act) requirements, using a Material Verification Checklist. This checklist allows users to configure the FSMA requirements for both Supply Chain Applied Controls (SCAC) as well as Foreign Supplier Verification Programs (FSVP).

Veeva Claims

Veeva Claims features are targeted for tentative availability on March 15.

Project Hierarchy Viewer Enhancement

This enhancement enables users to filter the project hierarchy only on the Product and Country values which are joined with the Project.

Enablement Details

Feature Enablement Application
Usability & UI Updates    
Learn More Links: Vault Help Update Auto-on Platform
Administration    
Jobs: Disable Session ID Token in External URL Call Configuration Auto-on Platform
System Vault Tokens N/A Platform
Clinical Operations    
RBSM: Critical Data & Processes Auto-on CTMS
TMF Bot: Bulk Upload Pipeline Auto-on eTMF
Clinical Email Ingestion: Relevant Communications Configuration eTMF
ClinOps/CDMS Connection: Single Study Refresh Auto-on CTMS<>CDMS
Clinical Operations Data Model Changes Auto-on CTMS, Site Connect, Study Startup, Vault Payments, eTMF
Commercial    
Customisable "From" Email Address for Case Response Emails Configuration MedComms
CRM Document Field Label Updates Auto-on MedComms, Multichannel, PromoMats
Commercial Data Model Changes Auto-on MedComms, PromoMats
Quality    
Send Email to Non-Vault Users: Improved Error Messages and Removal of Reply to Field Auto-on QMS
Regulatory    
Manage & Edit Table of Contents (TOC) Configuration RIM Publishing, RIM Submissions
IDMP Viewer Configuration RIM Registrations
22R1 RIM Data Model Changes Auto-on RIM Publishing, RIM Registrations, RIM Submissions, RIM Submissions Archive
SiteVault    
Summary Notification of Returned Documents Auto-on Site Connect
Digital Delegation: Email Notifications Support SiteVault Enterprise, SiteVault Free
Standard Participant Workflows Auto-on SiteVault Enterprise, SiteVault Free
Veeva eConsent: In-person eConsent Auto-on SiteVault Enterprise, SiteVault Free
SiteVault Data Model Changes Auto-on SiteVault Enterprise, SiteVault Free
QualityOne    
FSMA Supplier Verification (FSVP/SCAC) Configuration QualityOne
Veeva Claims    
Project Hierarchy Viewer Enhancement Auto-on Veeva Claims

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.