New in 21R2.4

Release Date: October 15, 2021

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

Working with Documents

Google Drive Integration

With this release, Vault is now integrated directly with Google Drive. Once authenticated, users can check out, edit, and check in files using Google Drive. Users can also undo files checked out to Google Drive. The Check Out process is similar to Standard Check Out, but instead uses your Google Drive as the download location for Checked Out files. If the file checked out is a .DOCX, .XLSX, or .PPTX, Vault automatically opens them for editing in a new browser tab using the appropriate Google Workspace Editor (Google Docs, Sheets, or Slides). Learn more about the Google Drive integration.

Protected PDF Renditions

With this release, Vault allows users to download PDF viewable renditions with safeguards applied that restrict them from being altered. Vault applies a password to the PDF viewable rendition, and Vault Administrators can configure permissions to prevent users from easily being able to edit, copy information, print, comment, or fill forms on the document. Learn more about protected renditions.

Export Binder Notifications: Show Failed Document Exports

With this release, Vault notes the documents that download and that fail to download in the notifications users receive after performing the Export Binders action. Previously, Vault did not include this information in the notification/email.

Vault Objects

Document Reference Field Constraints

Vault can now constrain document reference fields on objects based on document types, subtypes, and classifications, or based on values of other document fields. This can help narrow the documents available for selection to those tailored for the purpose of the document reference field. Learn more about configuring reference constraints.

Lifecycle & Workflow

Workflow Version History

Workflow administrators can now view the previous versions of the workflow in the workflow details page. Workflow versions can quickly provide customers and Veeva services a visual representation of the changes from a previous workflow version. The list of active workflow instances running on an older version is also displayed. Administrators can go back to the latest version. Older version steps are shown in a read-only mode. If there are deleted fields or states in an older version, they are shown as errors. Learn more about workflow configurations.

Reporting & Dashboards

Multi-Down Object Reports Support Summary Calculations

This feature allows users to perform summary calculations, such as counts and averages, across non-primary records in a report that includes multiple objects referencing the primary object directly. Summary calculations can be defined on number, date, and ID fields after adding a grouping to a report.

Increase Contains Operator Limit per Report

With this release, users can define up to three (3) filters on their reports using the contains operator. Prior to this enhancement, users were limited to one (1) per report.

Report Field “Public Key” Renamed to “API Name”

This feature renames the Public Key field in the report list page and the report viewer to API Name.

Usability & UI Updates

Text() Function Accepts Number Without Format

This feature allows users to convert numbers to text using the Text() function without having to define a format. If no format is specified, Vault preserves the current number of decimal places defined for the number.

Administration

Deprecating Vault-wide Document Migration Mode

After the 21R3 release, Vault-wide Document Migration Mode will be deprecated completely. Instead, use the X-VaultAPI-MigrationMode API header with the Vault REST APIs Create Multiple Documents, Create Multiple Document Versions, Update Multiple Documents, and Add Multiple Document Renditions endpoints, or use Vault Loader with the Document Migration Mode checkbox selected. These methods minimize risk and end-user impact by ensuring that only the documents being created and updated in the API request are subject to migration mode limitations, allowing the rest of the Vault to remain fully operational.

Veeva ID Field on Person Object

This feature adds a text field labeled Veeva ID to the Person object. This field can only be populated by Veeva applications for cross-product integrations.

System Managed Connections

With this feature, Veeva-owned standard connections may be marked as System Managed. A new read-only field, System Managed, appears on all connection records. Custom Vault Java SDK code cannot use system managed connections.

Email to Vault: Inbound Email Address Enhancements

This feature enhances the administrative experience for Inbound Email Addresses:

  • The page listing Inbound Email Addresses now provides a help link and the ability to edit columns.
  • When creating or updating an Inbound Email Address, the list of Allowed Senders is filtered by the selected Email Processor.
  • When creating or updating an Inbound Email Address, the Email Processor User is no longer required if the Allowed Senders is always a Vault User.
  • Emails sent with the subject line Email to Vault Test provide administrators with a way to confirm that their first Inbound Email Address is ready for use without actually running the Email Processor. This check is not required for subsequent Inbound Email Addresses.

Vault Loader

Vault Comparison Report: Notification Update with Auto Generate VPK Enabled

Vault Compare report notifications with Auto Generate VPK enabled will now display a link to the outbound packages page instead of a link to each package file when there are more than 40 packages generated with the report.

Vault Loader: Updating Object References with Map Fields Enabled

In previous releases, Vault ignored empty object reference values in the CSV input file when Map Fields were enabled and only removed corresponding object references with Map Fields disabled. With this release, Vault removes the corresponding object references on the object record when loading empty or blank object reference field values in your CSV with Map Fields enabled. Learn more about field mapping.

Vault Java SDK

Spark Message Reverse IP Lookup Change

Outbound Spark messages are now sent from an IP address associated with Veeva Vault. Developers and network engineers can apply network and firewall rules by allowlisting *.veevavault.com. Customers who are currently allow listing by domain will need to update their rules to support *.veevavault.com domains.

Platform Data Model Changes

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, weve added the following components to the Platform data model to support new features: The following component was added to Vault to support the Google Drive Integration feature:

  • Added value Google Drive (google_drive__sys) to the Check Out Types (checkout_types_sys) picklist

The following components were added to Vault to support the Veeva ID Field on Person Object feature:

  • Added the text field Veeva ID (veeva_id__sys) to the Person (person__sys) object

Clinical Operations

Expanded CTMS Subject Metrics

This feature adds additional metrics to be automatically calculated in Vault CTMS. New subject Statuses include Consented, “Started Treatment”, “In Follow Up” and “Lost to Follow Up”. This capability will extend to the following CTMS capabilities: Metric Calculation, Monitored Metric calculation, Vault CDMS/ClinOps Connection, Automatic Subject Milestones, Seeding Metrics Records, Metrics Not in Use, and CTMS Homepage Enrollment Status Graphs.

Trip Report Question Branching

This feature provides a way to control which Trip Report questions a CRA must populate, depending on their answers to previous questions. For multiple-choice questions, Admins can specify which previous question and answer will allow a later question to be editable.

TMF Bot: Auto-on for All Vault eTMF Customers

This feature will automatically create, train and deploy a Document Classification Trained Model in all customer Vaults that do not already have one deployed as long as there are more than 1,500 steady state documents. Training and deployment of this model may take 48 to 72 hours in some cases. Once Vault deploys the model, documents within the customers Document Inbox may be auto-classified by the TMF Bot. Click Here for more information about Trained Models.

Yuzu: CTN PMDA XML Update

This feature allows Vault CTMS customers that have enabled the Enable Japanese CTN Feature to create CTN Documents corresponding to the latest guidance from Japans PDMA. Customers may continue to generate CTN documents and XML using the Initial version or update their CTN data collection to capture additional data elements specified using the updated PDMA format.

Improved Visibility into TMF Transfer

This feature provides greater visibility into TMF Transfer activity on both the sending and receiving Vaults. Users can now see the status of a given transfer, when it started, and when it is finished. Visibility into individual items that may have failed to transfer is provided along with a new ‘Retry Failures’ action to reattempt their transfer..

Clinical Activities for Investigators

This feature adds support for tracking activities related to Investigators in Vault CTMS. With the new Activity object, users can capture details about all actions and interactions performed regarding the selected Investigator.

Site Connect: Send One or More Documents from Expected Document

With this feature, Site Connect customers will be able to send one or more documents to SiteVault from an Expected Document if there are multiple documents matched to that Expected Document.

Clinical Data Model Changes

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

Added the following objects to support the Improved Visibility into TMF Transfer feature:

  • Agreement Transfer (agreement_transfer__v) with the following system-managed fields:
    • Agreement (agreement__v)
    • Start Time (start_time__v)
    • Finish Time (finish_time__v)
  • Transfer Failure (transfer_failure__v) high-volume object with the following system-managed fields:
    • Agreement (agreement__v)
    • Component (component__v)
    • Item Global ID
    • Transfer Scope (transfer_scope__v)
    • Error Message (error_message__v)

Added the following components to support the Trip Report Question Branching feature:

  • New Fields on Trip Report Question Template
    • Controlling Question (controlling_question__v)
    • Controlling Answer (controlling_answer__v)
  • New Fields on Trip Report Question Response
    • Controlling Question (controlling_question__v)
    • Controlling Answer (controlling_answer__v)
    • Dependent Question Behavior (dependent_question_behavior__v)
  • New Picklist Dependent Question Behavior (dependent_question_behavior__v) with values:
    • Editable
    • Not Editable

Added the following components to support the Clinical Activities for Investigators feature:

  • Activity (crm_activity__v) object with the following fields:
    • Activity ID (name__v)
    • Channel (channel__v)
    • Complete (complete__v)
    • Date (date__v)
    • From (from__v)
    • Notes (notes__v)
    • Organization (organization__v)
    • Person (person__v)
    • Study (study__v)
    • Study Country (study_country__v)
    • Study Person (study_person__v)
    • Study Site (site__v)
    • Subject (subject__v)
  • Veeva Link (veeva_link__v) field on the Person object

Updated the following picklists to support the Expanded CTMS Subject Metrics feature:

  • Metric Type (metric_type__ctms) with the following items:
    • Total Consented (consented__v)
    • Total Started Treatment (started_treatment__v)
    • Total In Active Enrollment (in_active_enrollment__v)
    • Total In Treatment (in_treatment__v)
    • Total In Post-Treatment (in_post_treatment__v)
    • Total Started Follow Up (started_follow_up__v)
    • Total In Follow Up (in_follow_up__v)
    • Total Lost to Follow Up (lost_to_follow_up__v)
    • Lost to Follow Up Rate (%) (lost_to_follow_up_rate__v)
  • Subject Status (subject_status__clin) with the following items:
    • Started Treatment (started_treatment__v)
    • Started Follow Up (started_follow_up__v)
    • Lost to Follow Up (lost_to_follow_up__v)
    • Consented (consented__v)
  • Milestone Type (milestone_type__v) with the following items:
    • First Subject Consented (first_subject_consented__v)
    • Last Subject Consented (last_subject_consented__v)
    • First Subject Started Treatment (first_subject_started_treatment__v)
    • Last Subject Started Treatment (last_subject_started_treatment__v)
    • First Subject Started Follow Up (first_subject_started_follow_up__v)
    • Last Subject Started Follow Up (last_subject_started_follow_up__v)

Added the following components to support the Yuzu: CTN PMDA XML Update:

  • CTN Combination Product (ctn_combination_product__v) object with the following fields:
    • Order (order__v)
    • Product Category (product_category__v)
    • CP ID (combination_id__v)
    • CP ID Type (type_combination_id__v)
    • Other Detail (other_detail__v)
    • CP Class (other_detail__v)
    • Other Category (other_combination_category__v)
    • Application Status (application_status__v)
    • 30 days inv category (30day_investigation_category__v)
    • Ingredient and Dosage (ingredient_and_dosage__v)
    • Manufacturing Method (manufacturing_method__v)
    • Indications and Effects (indications_and_effects__v)
    • Indication Code (indication_code__v)
    • Dosage and Administration (dosage_and_administration__v)
    • Targeted Disease (target_disease__v)
    • Protocol Dosage Administration (protocol_dosage_administration__v)
    • Drug Cartagena (drug_cartagena__v)
    • Drug Cartagena Details (cartagena_detail__v)
    • Biological Product Type(biological_prod__v)
    • Companion Diagnostics(researchforcodx__v)
    • Combination Products (combination_prod__v)
    • Other Comments (other_comments__v)
    • Remarks (remarks__v)
    • ADR Report (adr_report__v)
    • CTN (ctn__v)
    • Include in CTN (include_in_ctn__v)
  • CTN CP Organizations (ctn_cp_organizations__v) object with the following fields:
    • Order (order__v)
    • Organization (organization__v)
    • Combination Product (combination_product__v)
    • CP Organization Role (cp_organization_role__v)
    • Include in CTN (include_in_ctn__v)
    • CTN Reference CTN(ctn_reference_ctn__v) object with the following fields:
    • Order (order__v)
    • Product Category (product_category__v)
    • Test Substance ID (test_substance_id__v)
    • Serial Notification Number (submission_count__v)
    • Reference Type (type_reference__v)
    • Reference Details (content__v)
    • CTN (ctn__v)
    • Include in CTN (include_in_ctn__v)
  • CTN Combination Equipment(ctn_combination_equip__v) object with the following fields:
    • Content (content__v)
    • CTN (ctn__v)
    • Name (name__v)
    • Order (order__v)
    • Include in CTN (include_in_ctn__v)
  • Clinical Registry Vocabulary Mapping (ctn_crv_mapping__v) object with the following fields:
    • Clinical Registry Vocabulary (clinical_registry_vocabulary__v)
    • CTN (ctn__v)
    • Field Type (field_type__v)
    • Order (order__v)
    • CTN Combination Product (ctn_combination_product__v)
    • Registry Vocabulary Type (registry_vocabulary_type__v)
    • Include in CTN (include_in_ctn__v)

Added the following new fields to the Clinical Trial Notification(ctn__v) object:

  • Version Info (ctn_version__v)
  • CTN Category (ctn_category__v)
  • Drug Cartagena (drug_cartagena__v)
  • Drug Cartagena Details (cartagena_detail__v)
  • Biological Product Type(biological_prod__v)
  • Companion Diagnostics(researchforcodx__v)
  • Combination Products (combination_prod__v)
  • Other Comments (other_comments__v)
  • Expanded Access Program (expanded_access__v)
  • Global Trial (global_trial__v)
  • Global Trial Details (global_trial_detail__v)
  • Genome Testing (include_genetest__v)
  • Microdose Trial (include_microdose__v)
  • Combination Equipment (comb_equipment__v)

New picklists:

  • CTN Version (ctn_version__v)
    • Effective Date Aug 2020 (2020__v)
    • Initial Version (initial__v)
  • CTN Category(ctn_category__v)
    • 1 (1__v)
    • 2 (2__v)
    • 3 (3__v)
  • Drug Cartagena (drug_cartagena__v)
    • (na__v)
    • (class1__v)
    • (class2__v)
    • (class1and2__v)
  • Biological Product Type(biological_product_type__v)
    • (na__v)
    • (bio_tobe__v)
    • (bio_specified__v)
    • (special_bio_tobe__v)
    • (special_bio_specified__v)
  • Expanded Access Program (expanded_access_program__v)
    • (na__v)
    • (expanded__v)
    • (main_trial__v)
  • CP Product Category(cp_product_category__v)
    • (drug__v)
    • (md__v)
    • (ext_diag__v)
    • (regenerative__v)
  • CP ID Type (cp_id_type__v)
    • (ingredient_code__v)
    • (trial_code__v)
    • (generic_name__v)
    • (other__v)
  • CP Class(cp_class__v)
    • (test_drug__v)
    • (control_drug__v)
    • (combination_drug__v)
    • (rescue_drug__v)
    • (other__v)
  • Application Status(application_status__v)
    • (unapproved__v)
    • (na__v)
    • (approved__v)
  • CP Organization Role (cp_organization_role__v)
    • (foraing_manufacturer__v)
    • (manufacturere_importer__v)
  • Product Category(ref_ctn_product_category__v)
    • (drug__v)
    • (md__v)
    • (regenerative__v)
  • Reference Type (ref_ctn_reference_type__v)
    • 1 (1__v)
    • 2 (2__v)
  • CRV Field Type (crv_field_type__v)
    • Dosage Form Code (dosage_form_code__v)
    • Administration Code (administration_code__v)
    • Protocol Administration Code (protocol_administration_code__v)
  • Registry Vocabulary Type (registry_vocabulary_type__v)
    • Dosage Form Codes (dosage_form_code__v)
    • Route of Administration Codes (administration_code__v)
    • Medical School Codes (medical_school_code__v)
    • Indication Codes (indication_code__v)

Commercial

Automated Email Intake for Medical Inquiries

When a medical inquiry is received via email to a dedicated address, it can be ingested by MedComms which will automatically create a case. Not only does this drive efficiency for users, automating the process allows the medical information team to operate entirely within MedComms which drives accuracy and consistency across the function. Learn more about configuring automated email intake.

Commercial Data Model Changes

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, weve added the following components to the Commercial data model to support new features: The following components were added to MedComms Vaults to support the Automated Email Intake for Medical Inquiries feature:

  • Added the following new fields on the Case Request (case_request__v) object:
    • Recipient Email Address (email_recipient_address__v)
    • Recipient Email Username (email_recipient_username__v)
    • From (email_from__v)
    • To (email_to__v)
    • CC (email_cc__v)
    • Subject (email_subject__v)
    • Attachments (email_attachments__v)
    • Body (email_body__v)
    • Body Text (email_body_text__v)
    • Sent (email_sent__v)
    • Received (email_received__v)
    • Message ID (email_message_id__v)
    • Email Forwarding Address (email_forwarding_address__v)
  • Added value Email (email__v) to the Source (source__v) picklist
  • Added object type Email Forwarding Email Address (email_forwarding_address__v) to the Person (person__sys) object

Quality

QMS Entry Action: Create Related Record

With this release, Quality customers can pursue a greater degree of automation via configuration of their Vault. The Create Related Record entry action allows customers to automate the creation of a full record or a placeholder record based on the lifecycle progress of another record. For example, suppose that a Deviation has an initial triage step in its lifecycle where a user indicates, as part of their task, that investigation is required. With Create Related Record functionality, a customer can configure Vault to automatically create an Investigation record, such that the workflow for that investigation can be assigned via Quality Teams, and assigned users can immediately start work following the completion of triage tasks. This initial release introduces the Create Related Record framework, allowing the initial required metadata to be derived from the triggering record or records related to it, if not otherwise set by default field value configurations. Continuing the example from above, if the Investigation record requires an owning department field value, an Admin could configure that the Owning Department of the investigation is set to the Owning Department value of the triggering Deviation. While we anticipate further investment in this area, in this initial release there are several limitations for which types of fields may be set, and for which objects one may configure automated creation with this feature. Learn more about configuring related record automation.

Facilitated Training Section Button Permissions

Record actions performed within the Facilitated Training section, such as Add or Delete, now respect the users security permissions and other security configuration.

Remove Document from Document Change Control Usability Improvements

With this release, when a user removes a document from the Documents to be Made Effective section of a Document Change Control, all versions of the document that referenced that change control are removed. In previous releases, only the latest version of the document was removed from the document change control and required the end user to remove each version of the document to completely detach it from the change control. This enhancement improves the prior experience and allows the user to remove all versions of a document from a change control with a single remove gesture.

MDCC: Prevent State Changes on Non-Latest Document Versions

This feature allows Vault QualityDocs to further enforce best practices and now prevents a Document Change Control from performing a state change on a non-latest version of a document. If a user attempts to perform a state change on the non-latest version of a document through a Document Change Control, the action is blocked and Vault displays an error to the user.

Regulatory

IDMP Message Generation

This feature creates discrete messages in accordance with the FHIR (Fast Healthcare Interoperability Resources) standard by transposing product data in the IDMP Medicinal Product Element and its child objects into an XML structure. Depending on Submission Mode, messages will either contain the XML file in a ZIP file along with any applicable attachment files for submission directly to the EMAs PMS (Product Management Service) database, or messages will be stored as XML files in the Vault Library for submission with the eCTD dossier through the EMAs gateway. Message generation can be completed individually for IDMP Product Data Submission or in bulk from the Regulatory Objective for all related Registrations. Export of generated messages can also be completed from either location.

Create Registrations Enhancements

With this release, name-based object type mapping will provide Create Registrations the ability to add registered details with a mix of object types to the same registration, needed for Unique Device Identification (UDI) as well as combination products. This requires the internal names of the object types on the source and target objects to match. Create Registrations is now also able to add the following details to product registrations to support UDI: Registered Clinical Studies, Registered Organizations, Registered Authorizations, and Registered Regulatory Text. Finally, support is added for copying additional standard fields that were added to the preexisting registered details in 21R2 for UDI.

EUDAMED UDI XML Generation for Regulation & Legacy Devices

With this initial release of UDI, Vault Registrations users will be able to generate UDI data submissions from EU Marketed Device Product Registrations. The resulting XML files can be uploaded to EUDAMED to register EU Regulation devices as well as legacy Directive devices.

IDMP Data Model Configuration Errors

New configuration error messages are introduced to the IDMP data generation process in which users are notified of data requirements and data dependencies within the IDMP data set. This feature supports updates made to align the Registrations data model with the EMAs latest guidance on IDMP, IG V2.1 and is a continuation of the configuration errors first introduced in 20R2.

21R3 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 and updated the following components to the Regulatory data model. To support the EUDAMED UDI XML Generation for Regulation & Legacy Devices feature:

  • Added the Submission Authorization (submission_authorization__v) object
  • Added the Device Premarket Submission (device_premarket_submission__v) object type to the Registered Authorization (registered_authorization__v) object
  • Added the following fields to the Classification (classification__v) object:
    • Parent (parent__v)
    • Category (category__v)
    • Lowest Level (lowest_level__v)
  • Within the Organization (organization__rim) object:
    • Added the EUDAMED Sender ID (eudamed_sender_id__v) field
    • Increased the GUDID Code (gudid_code__v) field length to 128
    • Added the Use for UDI (use_for_udi__v) field to the following objects:
      • Submission Shelf Life or Condition (submission_shelf_life_storage__v)
      • Regulatory Objective ShelfLife Condition (regulatory_objective_shelf_life_storage__v)
  • Added the Applicable Device Legislation (applicable_device_legislation__v) value to the Controlled Vocabulary Type (controlled_vocabulary_type__rim) picklist
  • Updated the Characteristic Value (characteristic_value__v) field to be optional within the Regulatory Objective Packaging Characteristic (reg_objective_packaging_characteristic__v) object

Safety

Safety features are targeted for tentative availability on October 21, 2021.

Email to Vault Safety Inbox Item Configuration

This feature enables customers to send emails to a Vault-owned email address and automatically create Inbox Items with the email and attachments. Vault Intake users will receive a notification when new Inbox Items are created from emails so they can start case intake.

Customers can continue to use an existing email address by setting up an auto-redirecting rule to a Vault-owned email or Vault users can send emails directly to a Vault-owned email address. Admins can define up to 50 Vault-owned email addresses and configurations associated with each email address.

Learn More: Manual Inbox Item Intake

Inbox Item Follow-Up: Pre-calculations Admin Checkbox

Vault Safety now pre-calculates and displays automatic field calculations, Combination Product Constituents, and Study Products when merging an Inbox Item to a follow-up Case version. This behavior ensures that automatically calculated fields are always up-to-date on the new follow-up Case version. This feature also introduces the Case Promotion Settings Page, where administrators can enable and configure settings for Inbox Item Follow-up.

Learn More: Inbox Item Follow-Up: Auto-Calculations

Inbox Item Intake Enhancements Auto-on

Manual intake and verification on Inbox Items is made easier with several new enhancements. Firstly, the New Info Date will now be available in the Inbox grid to sort new Inbox Items by date and easily identify late Cases. Secondly, the display for imported long text fields (such as Case Narratives) is now wider to facilitate the verification using the Source Pane. Thirdly, the Inbox Item sections will now show a Save button instead of Verify for manual entry to differentiate that from verification of imported or extracted data. Fourthly, all the required fields will be highlighted in yellow and will not have a blank option.

Learn More:

Domestic Case Processing Configuration

Vault Safety now supports domestic case processing in a unified interface including region-specific fields. You can also view cases in your preferred language. For example, for Japanese domestic cases, the PMDA-specific fields are available for data entry in addition to the global fields on the Case screen. You can complete case processing in your chosen language, from intake through the medical review stage.

Learn More: Domestic Case Processing

MedDRA Synonyms Configuration

Vault Safety can now capture company-specific MedDRA coding preferences and speed up coding with a MedDRA Synonym list. You can manually create and edit synonyms in Vault Safety, or bulk import synonyms from an external source.

When auto-coding a MedDRA field from a reported term, Vault Safety will first search for an exact match to an active MedDRA Synonym. If no exact match is found, the system will search the MedDRA dictionary for a matching term.

Learn More: Manage MedDRA Synonyms

Japan PMDA Gateway Submission Configuration

Vault Safety now supports AS2 gateway submission settings for Japan Pharmaceuticals and Medical Devices Agency (PMDA) ICSR submissions in the PMDA E2B (R3) file format.

Learn More:

Japan PMDA Submission Rules Configuration

A new standard reporting rule set is now available for PMDA ICSR Submissions. If the system identifies a Japanese Product or Study Registration in a Case as reportable to PMDA, a submission record for the PMDA will be scheduled based on the reporting rules.

Learn More: Reporting Rule Sets

PMDA E2B(R3) Submission Validation Auto-on

This feature introduces full PMDA E2B(R3) conformance rules and extends the ICH E2B(R3) validation capabilities delivered in 20R3. Validation is automatic when an ICSR submission in PMDA E2B(R3) file format is generated or regenerated for a reporting destination. PMDA E2B(R3) regional validation can be triggered at the Case level using the Evaluate Regulatory Conformance user action. Validation Result records are created based on each evaluated Validation Criteria and can have an outcome of Pass, Fail, or Warning.

Learn More: Case and Submission Validation

Japan PMDA E2B(R3) Export Auto-on

Vault Safety now supports PMDA E2B(R3) export files for individual cases.

Learn More: PMDA E2B(R3) Mapping

Expectedness in Periodic Reports (RSI) Configuration

Vault Safety now supports evaluating adverse event expectedness within a specific time period, to accurately identify SUSARs in periodic reports. In a Product Datasheet, you can specify the approval date range for each term. When generating a DSUR, PBRER, or PSUR, you can select the relevant Product Datasheet version to evaluate term expectedness in periodic reports.

Learn More:

AER Extraction from Email Attachments to Inbox Item Configuration

Vault Safety.AI will now automatically extract case information from EML and MSG email files. Intake users can start the extraction process from an email file and attachments with Viewable PDF Renditions. Upon successful completion, the system creates a single Inbox Item linked to the email and attachments.

Intake API Using JSON Object

The Intake JSON endpoint now accepts JSON passed through as text in the request body.

To support this capability, two new body requests can be used in addition to the existing one:

  • multipart/form-data: To pass JSON text in the intake_json parameter when passing another document in the intake_form parameter
  • application/json: To only pass JSON text as raw content

Learn More: Vault Developer Portal: Intake JSON

SiteVault

Protected PDFs for 1572s

The Protected PDF Renditions feature available in this release can be used to prevent Vault-signed 1572s from being edited once downloaded from SiteVault..

User Administration Enhancements

For Vaults using the Extensible Permissions security model, a single action is now available to fully inactivate a user. Also, user administrators working in the context of a research organization can update a user’s permissions across all sites at once.

Starting Multi-Document Workflows from Regulatory Document Request

With this feature, users can start multi-document workflows from the Regulatory Document Request page. For example, users can send multiple documents for Principal Investigator signature or bundle many training material documents into a single Read & Understood workflow.

QualityOne

Enhanced Configurability for the Formulation Object

In this release, we have added the ability for Admins to configure the attribute Values must be unique for the Formulation ID (name__v) field on the Formulation (formulation__v) object.

RegulatoryOne

RegulatoryOne features are targeted for tentative availability on October 26.

Split Registration Items

This feature allows users to create related Registration Items based on Admin-configured Split Rules. Admins link Split Rules to relational tokens and object field mappings, which determine how Vault creates the related Registration Item records as the relational token resolves. For example, if an item in the EU needs to be registered in member states as well, users can split the Registration Item for EU to generate related Registration Item records for each member state. Learn more about Splitting Registration Items.

Enhanced Configurability for the Formulation Object

In this release, we have added the ability for Admins to configure the attribute Values must be unique for the Formulation ID (name__v) field on the Formulation (formulation__v) object.

Enablement Details

     
Feature Enablement Application
Working with Documents    
Google Drive Integration Admin Checkbox Platform
Protected PDF Renditions Admin Checkbox Platform
Export Binder Notifications: Show Failed Document Exports Auto-on Platform
Vault Objects    
Document Reference Field Constraints Configuration Platform
Lifecycle & Workflow    
Workflow Version History Auto-on Platform
Reporting & Dashboards    
Multi-Down Object Reports Support Summary Calculations Auto-on Platform
Increase Contains Operator Limit per Report Auto-on Platform
Report Field “Public Key” Renamed to “API Name” Auto-on Platform
Usability & UI Updates    
Text() Function Accepts Number Without Format Auto-on Platform
Administration    
Deprecating Vault-Wide Document Migration Mode N/A Platform
Veeva ID Field on Person Object Auto-on Platform
System Managed Connections Auto-on Platform
Email to Vault: Inbound Email Address Enhancements Auto-on Platform
Vault Loader    
Vault Comparison Report: Notification Update with Auto Generate VPK Enabled Auto-on Platform
Vault Loader: Updating Object References with Map Fields Enabled Auto-on Platform
Vault Java SDK    
Spark Message Reverse IP Lookup Change Auto-on Platform
Platform Data Model Changes Auto-on Platform
Clinical Operations    
Expanded CTMS Subject Metrics Configuration CTMS
Trip Report Question Branching Configuration CTMS
TMF Bot: Auto-on for All Vault eTMF Customers Auto-on eTMF
Yuzu: CTN PMDA XML Update Auto-on CTMS
Improved Visibility into TMF Transfer Auto-on eTMF
Clinical Activities for Investigators Auto-on CTMS
Send One or More Documents from Expected Document Auto-on Site Connect
Clinical Operations Data Model Changes Auto-on CTMS, eTMF
Commercial    
Automated Email Intake for Medical Inquiries Configuration MedComms
Commercial Data Model Changes Auto-on MedComms
Quality    
QMS Entry Action: Create Related Record Configuration QMS
Facilitated Training Section Button Permissions Auto-on Training
Remove Document from Document Change Control Usability Improvements Auto-on QualityDocs
MDCC: Prevent State Changes on Non-Latest Document Versions Auto-on QualityDocs
Regulatory    
IDMP Message Generation Configuration RIM Registrations
Create Registrations Enhancements Auto-on RIM Registrations
EUDAMED UDI XML Generation for Regulation & Legacy Devices Configuration RIM Registrations
IDMP Data Model Configuration Errors Auto-on RIM Registrations
21R3 RIM Data Model Changes Auto-on RIM Registrations
SiteVault    
Protected PDFs for 1572s Configuration SiteVault Enterprise, SiteVault Free
User Administration Enhancements Auto-on SiteVault Enterprise, SiteVault Free
Starting Multi-Document Workflows from Regulatory Document Request Auto-on Site Connect, SiteVault Enterprise, SiteVault Free
QualityOne    
Enhanced Configurability for the Formulation Object Auto-on QualityOne
RegulatoryOne    
Split Registration Items Configuration RegulatoryOne Registration & Dossier Management
Enhanced Configurability for the Formulation Object Auto-on RegulatoryOne Compliance Management, RegulatoryOne Registration & Dossier Management, RegulatoryOne Regulatory Documents
Veeva Claims    
Enhanced Configurability for the Formulation Object 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.