What's New in 20R3

Pre-Release Date: November 2, 2020 | Release Date: November 20 & December 4, 2020

---

We are pleased to bring you Vault 20R3. Read about the new features below. You can find information on enabling new features in 20R3 Release Impact Assessment. Information on developer features (API, VQL, etc.) is in the Developer Portal.

Vault Objects

High Volume Object

This feature adds an alternative data store option for Vault objects, optimized for large or frequent transactions. The new High Volume data store option delivers fast write performance, but has a narrower feature set than standard Vault objects and requires technical knowledge to configure optimally. For this reason, we recommend thoroughly reviewing the documentation on High Volume Objects before using this data store option. Learn more about High Volume Objects.

Section Level Help

This feature allows Admins to define help content for each section on the object record details page. Admins can define this custom help content in the Add Section or Edit Section dialogs when configuring object page layouts. Learn more about configuring object page layouts.

Audit Action Security for Objects

This feature allows Admins to hide the Audit Trail action for object records based on object, state, and role. An Admin must enable this feature when configuring Vault objects. Learn more about configuring Vault objects.

Default by Object Type

This feature allows Admins to configure object field default values at the object type level. Object field defaults configured at the object type level can override object field default values defined at the base object level. Admins can define object type default overrides for all field types that support default values.

Working with Documents

Enhanced Large Size Asset Upload via API

As of 20R3, there is a new, more reliable way to import Large Size Asset renditions into Vault. To use this new method, users first upload their files to the file staging server, and then use the Vault REST API’s Add Multiple Document Renditions endpoint to upload renditions to the correct documents. This feature also adds the new largeSizeAsset query parameter to the Add Multiple Document Renditions endpoint, allowing users to add Large Size Asset renditions even if they do not have Document Migration permission.

Note that uploading files directly to the Inbox folder on the file staging server will still automatically upload files to Vault, but we no longer recommend this approach. Instead, we recommend uploading files to a different folder and then using the new Add Multiple Renditions API endpoint. Vault no longer automatically creates dummy.txt files when users supply Large Size Asset renditions without a source file.

Enhancement to Import Document Links

To improve performance and reliability when a user performs the Import Document Links action, Vault now displays the latest version of documents for which the user has View Document permission and which contain at least one Linked Document relationship. Previously, Vault only displayed a document if it was the absolute latest version and had at least one Linked Document relationship.

Changes to Make a Copy for Read-Only Fields

When a user chooses to copy fields while making a copy of a document, any Read Only fields now retain their values. If a user chooses not to copy fields, Vault populates fields with any default values configured by Admins. Learn more about copying documents.

Improved Rendering Feedback

With this release, Vault detects content in documents that cause rendering failures and provides users with error messages to troubleshoot issues.

Show Current Time in Overlays

This feature adds a new token, ${currentTime__v}, to display the current time and time zone on document overlays in order to provide a more compliant way to track documents exported from Vault. Vault displays the token in the user’s time zone. This new token, used along with the existing current date token, allows the overlay to capture the full date and time the rendition was downloaded from Vault. Learn more about managing overlays.

Cross-Document Links in Binders

With cross-document linking, users can now view and navigate to other documents within a binder using embedded relative path links in PDF documents. Link navigation relies on the target document’s location within the binder’s section structure. Vault opens supported links in a mini-browser review window, the contents of which refresh when the user clicks subsequent cross-document links. If the target document does not exist in the defined location within the binder structure, Vault displays a “Document Not Found” message. Learn more about cross-document linking in binders.

Apply Title to Multiple Documents

When uploading or classifying multiple documents at once, users can now choose to apply the same Title to all of the documents in the upload. This field is labeled Description in some Vaults.

Merge Fields Token Character Length Increase

This feature increases the total length of a Merge Field token in Microsoft Word DOCX files to a maximum of 1,000 characters. The increased character limit makes it easier to reference fields in related object records. Learn more about Merge Fields.

Read & Understood Download Button Visibility Update

Users who have a Read & Understood task to complete will now only see the Download button if their security profile includes the Download Rendition permission and they have a role on the document that includes the View Content permission. Learn more about Read & Understood document workflows.

Lifecycle & Workflow

Object & Multi-Document Workflows: Update Task Due Date

Object workflows and multi-document workflows now allow users to update a task’s due date with a user action. While due dates can be extended or reduced with this action, the updated date needs to be on or after the day of the update. Due date updates are always per task assignee. Access to the Update Task Due Date action is controlled by permission sets and Atomic Security based on the lifecycle state and the user’s role. Workflow initiators can update the due date at any time, regardless of permission sets or Atomic Security configurations. Learn more about using object and multi-document workflows.

Object & Multi-Document Workflows: Ad Hoc Task Instruction

Object workflows and multi-document workflows now support ad hoc task instructions provided by the Workflow Initiator in the workflow start dialog. The Workflow Initiator can provide a different set of instructions to each participant group.

Admins can enable optional or required ad hoc task instructions in the workflow configuration. To display ad hoc task instructions in Vault notifications and emails, an Admin must also configure the instructions token in the appropriate templates. Learn more about configuring object and multi-document workflows.

Object & Multi-Document Workflows: Undo Acceptance of Tasks

Object and multi-document workflow task recipients can now undo acceptance of an optional task. When a user clicks Undo acceptance, Vault returns the optional task to the list of Available Tasks. The task is then available to everyone in the recipient list, and a user must accept the task before it can be completed. Learn more about using object and multi-document workflows.

Object & Multi-Document Workflows: Additional Task & Workflow Initiator Tokens

Object message templates now support additional tokens for Workflow Initiators and tasks. This enhancement includes tokens for the Workflow Initiator’s first name, last name, email, and phone number, as well as tokens for task verdicts.

Admins can also select task verdict tokens from previous tasks in a Notification step of a workflow. Learn more about configuring object and multi-document workflows.

Object & Multi-Document Workflows: Update Sharing Settings in Task Step

Admins can now configure object and multi-document workflow task steps to update sharing settings via rules. Admins can configure rules to trigger sharing settings updates upon task completion, cancellation, or assignment. During the workflow, Vault adds users to a role or removes from a role in object or document sharing settings based on the rule configuration. Learn more about configuring object and multi-document workflows.

Object & Multi-Document Workflows: Default Users from Sharing Settings

Admins can now configure object and multi-document workflows to auto-populate users and groups at the workflow start step based on their roles. For example, if the Approver role is allowed to participate in a workflow, Vault auto-populates all Approvers on the record at the start step, and the Workflow Initiator no longer needs to select them manually. Workflow Initiators can always change the defaulted list by manually removing users or groups.

This feature is available for both object workflows and multi-document workflows. In multi-document workflows, users and groups need to be in the role on every document in the workflow. Learn more about configuring object and multi-document workflows.

Object & Multi-Document Workflows: Participant Control Help Labels

Workflow Initiators for object and multi-document workflows now see the Assigned to every user or Available to any user label on the participant control at the start of the workflow.

Vault displays the label depending on whether tasks in the workflow use the Assign to all users in a participant group or Make available to users in the participant group options. Learn more about configuring object and multi-document workflows.

Object Workflows: Task Comment & Object Type Tokens

Object workflows can now have Object Type and Task Comment tokens in object messages. Note that both object and multi-document workflows also support Task Verdict notifications for previous tasks in the Task step itself. Learn more about configuring object workflows.

Atomic Security for Active Workflow Actions in Objects

This feature allows Admins to have more granular control, based on lifecycle state and role, over the following active workflow actions: Cancel Workflow, Cancel Task, Reassign, Add Participants, and Update Task Due Date.

Workflow Initiators will continue to have access to these actions regardless of permission sets and Atomic Security. Learn more about Atomic Security for active workflow actions.

Sibling Record State Check Entry Action

The Check sibling records before updating related record lifecycle entry action is now available in all Vaults.

When configured, this entry action validates that all siblings of an object record are in the same state or group of states before changing the state of a related record. This functionality was previously available to Quality Vaults but is now available to all Vault applications. Learn more about configuring the sibling record state check entry action.

Object Workflow Timeline Enhancements

This release enhances the Workflow Timeline section on the object record detail page. This section now shows information about workflow tasks, including verdicts, comments, reasons, and eSignature capacity.

Update Expressions in Workflow & Lifecycle

This feature adds support for populating Picklist and Yes/No fields using lifecycle and workflow formulas. In addition, the UI for defining formulas in document lifecycles and workflows is now consistent with object lifecycles and workflows.

Reporting & Dashboards

Object Formula Fields in Reports

This feature allows users to define formula fields directly in their reports. This feature also expands the ability to define formula fields from System Admins to all users that have the ability to create and edit reports. Learn more about creating reports.

Combine Dashboard Prompts

This feature combines dashboard prompts referencing the same object and using the same operator. For example, the Study > Country in… and Document > Country in… prompts both reference the Country object and use the in operator, so users will only need to select a country once.

Support Is Latest Version in Matched Document & Relationship Reports

This feature adds support for the Is Latest Version field in Matched Document and Document Relationship reports. This field is often used to understand whether a document has been superseded, and is currently available in other document reports.

Join Report Views Using Number Fields

This feature allows Admins to join Report Views together in a Multi-Pass report type using number fields. Admins may join Report Views using number fields when the number is and is not an aggregate, meaning the number is a calculation created by adding a group to a Report View and applying an aggregate function such as max().

Early Timeout Detection for Reports

This feature allows Vault to predict if a report will time out. If Vault determines that a report will time out, users will see an error message advising them to add filters or schedule a flash report. Reports with down objects are not supported.

Decrease Maximum Size for Flash Report Emails

This feature reduces the default maximum email size to 3 MB for flash reports in order to avoid potential email distribution issues. Vault will still send all flash report emails, but the emails will only include 3 MB of content. If a report contains more than 3 MB of content, the email will inform the recipient that not all data is included.

Usability & UI Updates

Filter by All Dates in Object Record Audit Trail

This feature adds the all option back to the Timestamp filter in individual object record audit trails. Users may now more easily view and export complete audit trails for records.

Truncated Search Result Warning

For performance reasons, Vault limits the number of full-text search results to only the first 5,000 most relevant matches. With this release, users who perform full-text searches that hit this limit will now see a banner on the top of the page informing them that some results have been omitted. To see a complete set of results, users must simply apply additional filters before performing another full-text search.

Login Page Enhancement for Mobile Devices

This feature updates the Vault login page to correctly display the User Name and Password fields on mobile devices.

Checklists

Checklist Question Guidance Text

This feature allows Admins to configure question help text in a new Question Help Text field which then displays in the checklist response UI, providing guidance so that the checklist respondent better understands the question and can answer appropriately. Learn more about configuring question guidance text.

Checklist Enhancement: Decimal Response

This feature allows Admins to specify the number of decimal places that users are allowed to enter in a response from the checklist response UI. This option is configurable for number questions only, which previously did not accept decimals in responses. Learn more about configuring checklists.

Asynchronous Cascade Delete for Checklist Design

When configured, this feature allows users with the appropriate permissions to delete a checklist design and all the related cascading records (the corresponding section design, question design, available answer design, and dependency design) asynchronously using the new Delete in Background user action. Learn more about the asynchronous cascade delete action.

Vault File Manager

Auto-Refresh for Check In from Vault File Manager

After users select Check In from Vault File Manager from the document Actions menu, the browser tab now refreshes automatically when the check-in is complete. Vault then displays the latest version of your document.

Vault Loader

Support Upsert with Object Types

This feature updates default behavior for Upsert operations in Vault Loader. By default, Vault Loader now ignores values in Object Type fields and in Parent Object-type fields if the object record already exists and the value has not changed. In previous releases, Upsert operations would fail because these field types become read-only after initial record creation. Learn more on the Developer Portal.

Vault Loader Bulk Remove Users from Document Roles

This feature adds support for bulk removal of users from document roles to the Vault Loader UI, Command Line Tool (CLI), and the Multi-File Load REST API. Learn more in Vault Loader: Update Document Roles.

Administration

Configurable Landing Tabs

This feature allows Admins to configure which tab a user navigates to when they log in to Vault, instead of navigating to the Home tab by default. This feature also adds the new Landing Tab field to the User object to support this configuration. Learn more about using landing tabs.

Flexible Job Scheduling

This feature expands the options for scheduling jobs to allow hourly, daily, weekly, and monthly jobs. Previously, Admins could only schedule daily jobs from the Admin > Operations > Job Definitions page.

Managing Sandbox Allowances

This feature enables Admins to manage sandbox allowances across all their sandboxes. Admins can view and interact with any sandbox descended from the same production Vault.

Generate Outbound Package from Vault Compare

This update enhances the Vault Compare feature to optionally generate outbound packages based on the differences found in the comparison report. Each outbound package in the generated sequence can contain up to 200 components. The Summary and Description fields of each outbound package include information on the contents of the package as well as the Vaults the comparison was based on. Learn more about using Vault Compare.

Vault Configuration Report Enhancements

This feature introduces an updated UI for component and object data selection, as well as enhancements to the Microsoft Excel cover page and table of contents for better readability. Learn more in Generating Vault Configuration Reports.

Configuration Migration Review & Deploy Performance Optimizations

Vault now includes the Description column in the default list layout on the Inbound Packages and Outbound Packages pages in Vaults where the default list layout has not been modified. This supports the Generate Outbound Package from Vault Compare feature. In Vaults with custom list layouts for these pages, we recommend adding the Description column manually. Learn more in Using Configuration Migration Packages.

Exclude Security Overrides Referencing Auto-Managed Groups When Migrating Document Fields

When migrating document fields, Vault does not include security overrides that reference Auto-Managed Groups in configuration migration packages.

Access Control

Domain User UI Enhancement

With this release, the Vault Memberships section on the Domain User record detail page lists only Vaults for which a domain user has an active or inactive Vault membership.

Pages Admin Permission

When a Vault application provides a configurable Page, Admins can use the Pages permission to grant View and Edit permissions that control which user can configure the Page. This permission is available in the Configuration section on the Admin tab of the Permission Sets page.

Page Permission

When a Vault application provides a Page to display certain application features, Admins can grant access to view the page via the View permission. This permission is available on the Pages tab of the Permission Sets page.

FTP Staging Permission Name Update

This release renames the FTP Staging application permission to File Staging.

Authentication & Security

OAuth Profiles: Enable Azure as a Standalone Authorization Server Type

This feature splits the Authorization Server Type configuration or ADFS / Azure AD on OAuth / OpenID Connect Profiles into two separate options:

• ADFS
• Azure AD

By default, all current configurations with Authorization Server Type set to ADFS / Azure AD, will receive a value of ADFS after this release.

Vault Java SDK

Integration Rule Query Object Filters

Integration query object rules allow Admins to define rules that restrict the data or documents sent to a target Vault in HTTP callbacks associated with Spark Messaging integrations.

Like field rules, query object rules are a rule type within Integration Rules. Where the existing field rules SELECT data or documents, the new query object rules can filter the data further with a WHERE filter clause, using Criteria VQL. Learn more about creating query object rules for integration rules.

Spark Messaging Field Rules: Additional Data Type Support for Field Defaults

Spark Messaging field rules for mapping fields now support Number, Yes/No, Date, Datetime, and Picklist (single and multiple) types in the field defaults, supplementing the existing string and array data types. If the format is correctly entered, a field default can be persisted to a target object field of these data types.

SDK Job Administration

This feature enables Admins to manage SDK Jobs through the new SDK Job Metadata UI, available from the Admin > Operations page.

Platform Data Model

Platform Data Model Changes

See 20R3 Data Model Changes: Platform.

Clinical Operations

Site Connect: Safety Distribution

This Vault Site Connect feature set allows sponsors and CROs to send safety reports and letters to sites using SiteVault. These dedicated Safety Distribution components give sponsors and CROs the ability to define a set of country-specific distribution rules and to track the delivery and acknowledgment of these distributions across their study sites. Learn more about Safety Distributions.

Study Expenses

This feature allows users to create Payable Item records to track expenses not incorporated within a predefined Fee Schedule. A new fee type, Additional Fees, is available to allow for tracking these expenses. Users can use these fees to track other types of study vendor payments that are not related to an individual site.

Customers can now create Payment Requests for organizations that are not related to a specific study site. Payment Requests also support the inclusion of Payable Items from various locations in the same Payment Request for organizations associated with multiple sites or study countries. Learn more about Study Expenses.

TMF Viewer Doc Type Model Support

The TMF Viewer has previously allowed users to select from the RM 2.0, RM 3.0, and Vault Clinical Docs document structures for displaying documents. This feature adds a fourth option that displays documents according to your configured document type hierarchy, such as a type, subtype, and classification folder structure. Learn more about TMF Viewer view models.

Milestone Completeness Snapshot

This auto-on feature updates the milestone autocomplete job to lock a milestone’s completeness metrics when it is marked done and does not update them after that. It also updates the job that sets the Milestone (milestone__v) document field, so that the job only modifies that field on the current document version and only adds open milestones to it.

Trip Report Question Enhancements

One-Click Trip Report Question Data Entry

This auto-on feature improves the entry of Trip Report question responses and comments by allowing CRAs to one-click select multiple-choice responses and one-click type into text response and comment fields. This feature also includes quick-entry shortcuts to enter data even faster. Learn more about keyboard shortcuts for Trip Reports.

Displaying Required Responses & Comments in Trip Report Questions

This configurable feature allows CRAs to easily see which questions require responses on their Trip Report Questions. For multiple-choice questions, Admins can specify which answers require comments from CRAs. When required, a comment field is displayed to the user when they select that answer option. Learn more about configuring required responses and comments in Trip Report questions.

Note that displaying required responses on Trip Report questions is auto-on when the Response Required field on a Question record is set to Yes.

Displaying Instructions on Trip Report Questions

This configurable feature allows Admins to enter instructions for how a user should answer their Trip Report questions. These instructions are visible to users via a clickable icon on the Trip Report Question. Learn more about instructions on Trip Report questions.

Long-Text Trip Report Question Responses & Comments

This admin-enabled feature allows customers to use a long text field for their Trip Report Question responses and comments instead of the current text field, allowing for a maximum character length of 32,000 instead of the current 1,500. Learn more about configuring long-text fields for Trip Reports.

Note that enabling this feature requires a small migration of the data from the current text field to the new long text field. Contact your services representative for more details.

Auto-Populate Milestones from Subject Data

This feature automates the population of the Actual Finish Date field on first and last subject-related Milestone records at the site level. Last subject Milestones are not populated until the No New Subjects checkbox is set. Learn more about automated enrollment milestones.

Auto-Manage Principal Investigator Field on Study Site

This feature allows customers to auto-manage the Principal Investigator field on Study Site records with the use of the Study Person object. Learn more about creating study sites.

Securing Quality Issues

This feature allows customers to secure Quality Issue records by study with new Study and Content (blinding__v) fields on the Quality Issue object. For single-study documents, the Study field is auto-populated. For documents reused across multiple studies, users can select any of the studies associated with the document. For both single-use and reused documents, the Content field is automatically populated based on the corresponding value on the document. Learn more about securing Quality Issues.

Editable Home Page: Labels & Milestone Types

This auto-on feature updates widget labels on the Startup Specialist Home Page, TMF Home Page, and Study Manager Home Page so that they reflect the configured labels for the Milestone and Quality Issue objects, as well as for the certain milestone object types and picklist values. This feature also introduces a new field, Milestone Category, and the ability to filter based on that value while viewing milestones on those pages.

TMF Index Management: Core Data Model

This configurable feature adds standard objects, lifecycles, and fields to support the definition, management, and versioning of a client’s TMF index, such as document-types and related configuration. Learn more about managing the TMF Index.

TMF Viewer Level Support & Additional Enhancements

This feature allows users to filter the TMF Viewer contents to study- and country-level documents using a new system-managed Filing Level field.

Additional small enhancements to the TMF Viewer include freezing the top row so that users can more easily retain context while scrolling and the option to display Artifact numbers on the left-side Reference Model folder structure.

Data Model Changes to Support Simple TMF Transfer & Vault Site Connect

We have added a collection of objects and document configuration to Clinical Operations Vaults to support our productized integrations. This feature activates the collection of objects and document configuration required to use Simple TMF Transfer and Vault Site Connect.

Smart Profile Document Transfer

With this enhancement, Vault Site Connect can create and classify profile documents transferred to Clinical Operations Vaults from SiteVault based on role-specific information tracked in SiteVault. Learn more about receiving profile documents.

Site Connect: Completed CRFs

With this feature, Vault Site Connect customers can easily send Completed CRFs packages to their SiteVault sites. Learn more about configuring the Completed CRF Artifact.

Site Connect: Payment Letters & Site Invoices

With this feature, Vault Site Connect customers can send Payment Letters and Requests for Site Invoices to SiteVault sites. Learn more about sending Payment Letters via Vault Site Connect.

Additional Subject Milestones

This feature adds new First Subject Out, First Subject Treated, and Last Subject Treated Milestone Types to CTMS Vaults.

Changes to the Fee & Payable Items Objects

This feature adds the Additional Fee object type to the Fee and Payable Item objects, which may be visible to users. This feature also adds to the Payment Level and Item Description fields to the Payable Item object and the Payment Level field to the Fee object.

Study Organization Levels

The Study Organization object now includes the Level field to indicate study-, country-, or site-level. In Vault Payments Vaults, this field is populated based on related fields on the Study Organization record.

TMF Homepage Review Overcount Link

This feature includes improvements to the Review Overcount link on the TMF Homepage to help users attempting to view an Overcount report with more than 200 items. Users are now alerted to adjust their filter settings before navigating to the report to ensure documents display as expected.

Remove Study Field Defaulting During Document Upload

Previously, when users selected a Study in the Study Selector in the Library and later uploaded a document, Vault populated the document’s Study field with the selected Study value. This feature removes the auto-population behavior.

Remove Milestone Inactivation from Archive TMF Job

To improve performance, the Archive TMF job no longer inactivates Milestone records.

Clinical Data Model Changes

See 20R3 Data Model Changes: Clinical Operations.

Commercial

eCTD Compliance Package Generation

This feature helps customers meet FDA guidelines released in June 2019 by automatically generating a new eCTD Compliance Package with Submission Ready Copies of the documents and converting Vault link annotations to relative PDF links. These documents can be exported from PromoMats and submitted to the FDA through a publishing tool. Automatically generating these documents and creating relative PDF links saves time and reduces the risk of errors occurring.

Note that the pre-existing Create Compliance Package bulk action will remain. Users will need to configure the new Compliance Package functionality. Learn more about eCTD Compliance Packages.

Configurable Standard Metrics

Based on customer feedback, we have increased the flexibility of Standard Metrics in 20R3 by making the Global Content Type, Content Creation Currency, and Content Creation Cost fields not required by default. Configuration options available to other standard fields are now available to Standard Metrics fields, including making fields required using field dependencies and hiding Standard Metrics information from all or certain users and roles using field level security.

For more information please visit the Vault PromoMats Standard Metrics resource center.

Standard Metrics Job to Update Global Content Type to Mapped Value

To ensure that PromoMats Standard Metrics collects a rich set of data, this feature introduces a new asynchronous job called Standard Metrics GCT Mapping Document Update. This job will run automatically with the 20R3 release and will update any documents whose Global Content Type is Not Specified to a mapped Global Content Type value. If no mapped Global Content Type value is configured or inherited from the parent document type, Vault will not update the document. Vault logs this update on the Job Status page instead of the document audit trail. This job will not update archived documents.

Vault Owners can run and re-run this job using Vault REST API version 20.1 or higher. Learn more in the Vault Developer Portal release notes.

Auto Claims Linking: Create Claims from Link Annotations

This enhancement streamlines the process for creation and approval of the Claims Library by leveraging existing approved references in promotional materials. Users can create Claim (annotation_keywords__sys) records in bulk from existing document references (link annotations) using a new bulk action and Vault Loader. The resulting Claims can adopt the selected text, references to both documents and anchors, metadata attributes such as Country and Product, and can set the resulting Claim record’s status to Approved when all requirements are met. Learn more about creating Claims from Link Annotations.

Auto Claims Linking: Excluded Characters

With this feature, Vault defines a set of special characters (© ® ™ ℠) which are ignored when comparing Match Text and Match Text Variation values to document content. As a result, a string of text will match regardless of the presence or absence of those characters in either location. For example, Vault considers Trust Cholecap and Trust Cholecap© identical when matching Claim records to documents. Admins can also edit the default set of excluded characters. Learn more about configuring Excluded Characters.

Auto Claims Linking: Where Used Enhancements

This enhancement adds two columns to the Claim’s Where Used component: Document Number and Document Status. Users can also choose which columns to display. These enhancements provide additional details when viewing the Where Used table on a Claim record. Learn more about the Where Used component.

Auto Claims Linking: Hide Suggest Links Button When No Matching Claims Exist

Vault no longer displays the Suggest Links button or Document/Claim Link Annotation selector on documents when no matching approved Claims exist. This avoids a frustrating user experience where clicking the button does not produce results.

Auto Claims Linking: References in Audit Trail

With this feature, users can see changes to related objects, including Link Targets and Match Text Variations, in the Claim record’s audit trail. This provides comprehensive visibility to important changes to a Claim, including when references are added or removed, and when Match Text Variations are added, edited or removed.

Auto Claims Linking: Simple Version Binding on References

With this update, Vault no longer removes references from a Claim record when the targeted document is up-versioned. Once a user adds a reference to a specific version, it remains unmodified regardless of the creation of a new version of the document. This allows users to link to approved documents, and to keep those references to the Approved version intact when a subsequent Draft version is created and in review.

Note that Vault still removes references from Claim records when:

• A user deletes the targeted document version or anchor annotation.
• The target document enters a lifecycle’s Obsolete State.
• A target document’s document type configuration is changed to be ineligible as a target for suggested links.
• A target document’s document type is changed to a different document type that is ineligible as a target for suggested links.

Learn more about Using Auto Claims Linking.

Auto Claims Linking: Add Annotation (Approved Links) Field

With this feature, Vault is able to differentiate manually created link annotations (annotations_links__v) from Approved Link annotations (annotations_approved__v). The latter is created by approving a Suggested Link annotation. Previously, both link types were combined in the single annotations_links__v field. Counts for this new link annotation type become visible in Library Tabular view as well as in Reporting and Lifecycle configuration.

Persist Relationships from Approved and Auto Links on Make a Copy

When enabled, all Linked Document relationships from Approved Links and Auto Links are persisted on new documents created by the Make a Copy action. Note that the corresponding Approved Link and Auto Link annotations are not persisted; only the relationships are copied.

When not enabled, only manual link annotations and Claim Links are persisted by Make a Copy, along with the corresponding Linked Document relationships.

Regardless of the enablement status, Suggested Links in Pending status are never persisted by Make a Copy.

Enhancements to Medical Inquiry Case Response Email Capabilities

With this feature, the following enhancements have been made to MedComms Medical Inquiry Case Response Email functionality:

• The ability to add CC and BCC recipients
• The option to remove the Vault header and footer from all emails
• The ability to define one or more email addresses that can be set as the Reply To field

Medical Inquiry: Cover Letter Generation Enhancements

This feature introduces the new Medical Inquiry Case Response Cover Letter document type. Users can choose to generate a cover letter using this document type to populate three document fields: Related Case, Related Case Request and Related Case Response. Fields on the particular Case Response record and related Case Request record are referenced as tokens in the document template.

Previously, the Generate Cover Letter function used the Medical Inquiry Cover Letter document type. For this document type, the Related Case document field is populated when the user action is run, which means that tokens in the template referencing Case Request and Case Response records retrieve every child Case Request and Case Response record under the parent Case Record and use Merge Fields to combine the token values.

Using the new document type prevents duplicated fields retrieved from multiple Case Request and Case Response records under a Case record by referring directly to the field on the Case Request or Case Response object. Learn more about Configuring Medical Inquiry.

Case Response Email Body Rendering

With this feature, Vault renders Case Response Emails as the Case Contact receives them, rather than in HTML. This feature must be enabled via using the Vault API. Contact your CSM for further details.

Related Portals

This feature allows Portal Admins to associate multiple Portals. With this feature, users can filter and search results from the current and any related Portals. Learn more about Portals.

Commercial Data Model Changes

See 20R3 Data Model Changes: Commercial.

Mobile

Maintain Document State

Station Manager now remembers the position at which a user last viewed a document or video and returns them to that position when they navigate away and return. This enables manufacturing operators to quickly switch back and forth between a related set of documents and videos without losing their place. This feature is available on both platforms:

Maintain Document State on iOS

Maintain Document State on Android

Custom URL & QR Code Support for Categories

With this release, customers can generate custom URLs to view specific categories of documents in Station Manager. When a manufacturing operator opens these custom URLs on their tablet device by, for example, scanning a QR code, the Station Manager mobile app can open the list of documents pre-filtered to the categories specified in the custom URL. This enables customers to create shortcuts for operators to quickly navigate to the appropriate set of documents for their current task. This feature is available on both platforms:

Custom URL & QR Code Support for Categories on iOS

Custom URL & QR Code Support for Categories on Android

Video Support on Android

Customers can now view videos in Station Manager for Android.

Sync Interval Update

The interval at which Station Manager periodically syncs with Vault has been updated from every 15 minutes to every 15-20 minutes. This variability improves the scalability and performance of the application when distributed across a large number of devices.

Video Auto-Play Update on iOS

With this release, videos in Station Manager for iOS do not start to play until the user taps the play button. This provides a consistent experience no matter how the user navigates to the video.

Login with Keyboard on Android

Users logging into Station Manager for Android can now use the keyboard to login after entering credentials. This improves the user experience for IT administrators setting up tablet devices for use on the shop floor.

Settings Page Updates on Android

The settings page within Station Manager for Android now displays two additional items:

• The name of the Station Device record in Vault associated with the tablet device
• The version of the application running on the tablet device

Application Icon Update on Android

With this release, we have updated the Station Manager for Android application icon to match current Android application icon guidelines.

Azure Support for Veeva Snap

Veeva Snap currently supports ADFS, Ping, Okta, and Exostar authorization servers. This feature allows Veeva Snap to support Azure Active Directory (Azure AD), Microsoft’s cloud-based identity access management service.

Quality

Vault Product Surveillance

Vault Product Surveillance is a new application add-on for QMS to support our Medtech / Medical Device and Diagnostics customers in reporting adverse event information to health authorities. This initial release adds support to triage Medtech Complaints as reportable events by utilizing configurable country-specific reporting rules to help determine if an incident should be reported, where to report it to, and when the initial report would be due based on the severity of the incident and the date of awareness.

The Reportable Event object supports generating eMDRs for the US FDA, going to FDA CDRH as an XML file. Vault Product Surveillance supports electronic transmission of generated eMDR XML files to the FDA’s CDRH agency via the FDA gateway. This connection also processes response and acknowledgments coming back from the FDA to the Vault for visibility on the transmission’s status. Learn more about Vault Product Surveillance.

Learner Homepage

This Vault Training release introduces the Learner Homepage, an intuitive, easy to use dashboard that provides the Learner with an overview of the Learner’s open assignments. Assignment cards display key information such as the related Curriculum, estimated completion time, the training document’s Effective Date, due date, categories, and more. In addition, the Learner can access their completed Training Assignments. These sets of information and the quick-access nature of the interface help Learners make the most of their training time.

Users access the Learner homepage via the My Learning tab, which can be associated with a permission set. Learn more about the Learner homepage.

Audit Finding External Response Collaboration

This QMS feature introduces components and configurations designed to streamline temporary, short-term access to customer’s Vault for suppliers, partners, contractors, or other external parties who need to respond to audit findings. Customers can now give auditors the ability to request responses from recognized external contacts, collaborate with those individuals in Vault, and close out findings with minimal or no need to manage user account provisioning.

When Auditors or other authorized Vault users request collaboration in this way, Vault can now automate the provisioning of External User accounts for those contacts, invite them to collaborate with specialized email messages, and can close out their user accounts when the collaboration is complete. Customers have full control over how much information is available to these collaborators through configuration.

This feature has several core elements: Contact lists, User account provisioning automation, specialized emails, and a streamlined Vault experience for external users. The new functionality and its configurations are unique to the QMS application, and will require configuration to take advantage of. This feature is not intended to replace long-term or regular day-to-day interaction with external parties within your Vault. We strongly recommend engagement with your CSM or Professional/Managed Services contacts if you are interested in implementing functionality within your business processes or learning more. Read more about working with external collaborators.

Audit Program Planning

This feature allows QMS customers to leverage a standard data model and feature set to initiate, plan, and approve audit programs to be executed by a company for a given time period. Once the audit program is in execution, Vault automatically creates audits from proposed audits. As audits are executed, related proposed audits can be updated to track execution to plan. Learn more about Audit Program Planning.

Mobile Training Task Completion

With this release, Vault Training allows Learners to view and complete Vault Document Training Assignments from mobile device browsers.

When a Learner accesses a Vault Document Training Assignment from a phone or a tablet browser, Vault displays the assignment in a mobile-friendly way that’s appropriate based on the device size. In the mobile interface, the Learner can view the document or documents, scroll through the document pages, view key document metadata, and complete the workflow task with e-signature from their mobile device. Learn more about completing assignments in Vault Training.

Issue Escalation & Notification

This feature enables QMS customers to traceably record severe issues that are surfaced through Quality events and relate those issues back to the originating event. Issues can then be escalated to management for awareness and triaged to closure. All notifications that are sent to management through this feature will be audited, and a receipt of who was contacted will be available through the system. Learn more about Issue Escalations.

Quality Teams: Replace Invalid Team Assignments

This feature allows QMS customers leveraging Quality Teams to better control invalid user replacement when managing Quality Teams. For a given Quality Team, if any assignment in that team is invalid, QMS users can now, on an assignment-by-assignment basis, choose whether to simply remove the invalid user from the team or to replace them with an alternative, valid assignment.

Replacing invalid users with this feature will automatically handle task reassignment for any currently open tasks assigned to the replaced user. This feature does not require configuration, and will be immediately available to all users managing invalid Quality Team assignments. Learn more about working with Quality Teams.

Hide Training Report from Document Actions Menu

This feature hides the Training Report from the document Actions menu for customers who do not utilize Read & Understood functionality in Quality Vaults. This feature is enabled in Admin > Settings > Application Settings, and the Training Report can be made available again through the document Actions menu if a customer later chooses to utilize Vault Read & Understood capabilities. Learn more about the Training Report.

Update MDCC Document Picker Dialog

With this release, we have updated the UI shown when adding or removing documents in Multi-Document Change Control records.

Quality Data Model Changes

See 20R3 Data Model Changes: Quality.

Regulatory

Save Views in Content Plan Hierarchy Viewer

Users can now save custom views to bookmark their filter and column settings within the Content Plan Hierarchy Viewer and return to these views with a single click. Users can also update or delete saved views, as well as share views with other users and groups in their Vault. The views that users save are specific to submission content plans or report level content plans, depending on the content plan in which they create the view. Learn more about saving custom views in the Content Plan Hierarchy Viewer.

Additional Filtering in Content Plan Hierarchy Viewer

This feature extends filtering functionality in the Content Plan Hierarchy Viewer to support additional field types. Users can now apply filters to Date, Picklist, Lifecycle State, and Object Reference columns. Learn more about applying filters in the Content Plan Hierarchy Viewer.

Import Submissions with Unreferenced Files Using Vault File Manager

With this release, users can select multiple folders when uploading an eCTD submission dossier with Vault File Manager. When selecting the folders for upload, users can choose the eCTD submission folder as well as a working documents folder and other folders containing unreferenced files. Vault processes the selected folders as a single import and displays the working documents folder alongside the eCTD submission content in the Submissions Archive Viewer. Learn more about importing submissions with unreferenced files using Vault File Manager.

Enhancements to Submission Import with Vault File Manager

This release includes several updates to the Submission Import with Vault File Manager feature:

• When submission uploads fail due to a dropped connection or files that are currently in use, users can now retry the upload directly from the Upload Failed status in Vault File Manager instead of needing to restart the import.
• If uploads fail for other reasons, the upload status in Vault File Manager is now set to Upload Corrupted.
• In Vault File Manager, users now have a Skip Upload action for uploads in the Pending Upload status. Skipped uploads move to the end of the upload queue and are initiated after all other uploads have completed.

Auto-Create Application Country & Submission Country Joins

This release introduces new settings on the Settings > Application Settings page that enable Vault to create join object records automatically when users create or update certain records. When enabled, Vault can:

• Create Submission Country records automatically when users create Submission records
• Create Application Country records automatically when users create or update Application records

Learn more about automatic record creation in RIM Vaults.

Update Hyperlinking Creation Logic

This feature improves the logic used to create hyperlinks in Submissions Publishing Vaults. These updates allow for more accurate link creation, including cross-submission and cross-application linking. Learn more about link publishing.

Linking to Submissions Archive Content

In RIM Publishing Vaults, users can now publish link annotations and permalinks that target content in RIM Submissions Archive Vaults. Users can also create hyperlinks to previous submission content.

Configurable Impact Assessment Reports

This feature provides enhancements to regulatory impact assessment reports, allowing for more comprehensive impact assessments through targeted cross-object reporting. For example, by leveraging multi-pass reporting functionality, organizations can now determine the impact of a manufacturing change across all possible uses of the manufacturing site. This feature also adds support for medical device details and includes the ability to configure business-specific filters on the reports to reduce additional work for end users. Learn more about setting up configurable Impact Assessment Reports and using impact assessment reports.

Additional Registration Scopes in Create Registrations

With this release, the Create Registrations wizard now supports bulk creation of:

• Active Substance registrations
• Manufacturing Site (Establishment) registrations
• Product and Product Group registrations for medical devices
• Product registrations for site-based markets

Learn more about bulk creating product registrations, investigational registrations, active substance registrations, and manufacturing site registrations.

Additional Registration Scopes in Manage Registered Details

With this release, the Manage Registered Details wizard now supports bulk management of:

• Active Substance registrations
• Manufacturing Site (Establishment) registrations
• Product and Product Group registrations for medical devices
• Product registrations for site-based markets

Create Registrations Enhancements

This feature updates the Create Registrations wizard to provide more control over which details to include in registrations. The new grids in the wizard show details that more closely reflect the data that was included on the selected Submission record. In addition, users can choose whether to create separate registrations for complex products and their component products or to create registrations for the complex products only. Finally, users can now include multiple products on Investigational Study and Site registrations, which is common for medical devices.

Manage Registered Details Enhancements

This feature introduces enhancements to the Manage Registered Details wizard, including:

• Better enforcement of relationships between products and substances, ingredients and packaging to prevent bad data
• The ability to add additional details for multiple products to the same Investigational Study or Investigational Site registration
• The ability to add and update medical device details in Vaults that use Submission object data as the source for the Manage Registered Details wizard

Filter Grids & Select All in Manage Registered Details Wizard

This feature introduces the following enhancements to the Manage Registered Details wizard UI:

• Column filters on all grid pages; users can filter on Picklist, Yes/No, Lifecycle State, and Date fields, as well as Object fields that don’t reference complex join objects
• A Select All button that allows users to select all records in the grid
• On the Add New Details page, the Select Details button is relabeled to Add New Details

Create Activities per Application

This feature adds an additional level of granularity when users create activities from an Event record using the Create Related Records wizard. Users can now create one activity per application, even if the application spans multiple products.

In previous releases, selecting the Application option activity scope level created one Activity record for each unique combination of Application and Product. The Application and Product activity scope level preserves this behavior.

IDMP Phase 2: Data Model

This feature updates the RIM Registrations data model to further support the IDMP dataset. The full IDMP feature set will be delivered across multiple releases. New data model components appear in RIM Registrations Vaults automatically, but Admins must update object page layouts in order for users to work with them.

IDMP Phase 2: Algorithms

This feature updates the aggregation algorithm that will recurse through RIM Registrations data to compile submission data in new IDMP objects. The full IDMP feature set will be delivered across multiple releases. Learn more about generating IDMP data.

Submissions Archive: Jordan 1.1

With this release, RIM Submissions Archive Vaults support importing and viewing eCTD submissions based on the Jordan v1.1 DTD.

FTP Folder Selection Update

This update allows users to maintain more contextual object record names in Vault while more accurately locating submissions on FTP. When users import submissions via FTP, Vault now leverages the selected dossier format parameters to match the folders on FTP. If the dossier format has not been defined, Vault will use the Application Folder Name or Sequence ID, when populated, before relying on the Application and Submission record names. Learn more about preparing submissions for import.

Submissions Archive Ordering Update

With this release, Vault will now display newly-imported submission eCTD files above the eCTD section. Vault will also order non-eCTD submissions based on the date in the Actual Submission Date field. If the Actual Submission Date field is blank, Vault will order these submissions based on the date and time of the import instead. Vault will then order submission content alpha-numerically.

Submissions Archive Viewer Display Update

Within the Submissions Archive Viewer, sections and document names can now display up to 250 characters. Note that the actual number of characters displayed may vary based on window size and resolution.

Submissions Archive Viewer Document Download

When users open documents from the Submissions Archive Viewer, they will now see the option to download the document or the rendition.

Add Submission Import Information to Notification Token

This feature adds additional import details to the token used in the Submissions Archive import notifications. Users now see the application folder name, the submission folder name, and the number of files when they receive these notifications.

Pause RIM Registrations Vault Java SDK Triggers

Customers performing large migrations that do not wish to have the RIM Registrations Vault Java SDK triggers running can now pause these from the Application Settings page to prevent automatic record creation and updates. This allows for a smoother migration of data with Vault Loader or Vault API. When the Registrations Vault Java SDK Record Triggers are paused, Vault will not automatically create or update the following records:

• Country Decision Details: Vault will not automatically create Country Decision Detail records or update the Country Decision Detail Count field on the Regulatory Objective records.
• Administered Product: Vault will not automatically create Administered Product Active Substance or Administered Product Inactive Ingredient records for Administered Product records of object type Administered as Manufactured.

Learn more about pausing the Registrations Vault Java SDK triggers.

Jordan eCTD DTD 1.1 Publishing & Validation

With this release, RIM Submissions Publishing Vaults support the Jordan (JO) JFDA v1.1 (DTD 1.1) specification. Users can now create content plans and generate submissions that are compliant with JO JFDA 1.1 specifications. Vault validates these submissions based on the corresponding JO JFDA 1.1 Validation Criteria. Learn more about working with Jordan regulatory submissions.

Japan eCTD XSD 1.0 Publishing & Validation

With this release, RIM Publishing Vaults support the Japan XSD 1.0 specification. Users can now create content plans and generate submissions that are compliant with Japan 1.0 specifications. Vault validates these submissions based on the corresponding Japan Validation Criteria. Learn more about working with Japanese regulatory submissions.

Support for Default Values in Field Rules

With this release, the eTMF & Submissions Spark Connection supports the inclusion of default values within the integration’s field rules. This allows for Admins to define explicit default values when there is no value defined for a field in the source Vault. Learn more about configuring the eTMF & Submissions Spark Connection.

US FDA eCTD Specification v2.4 Support

This release updates RIM Submissions Publishing Vaults to support the new REMS Supplement Submission Type, announced in the US FDA eCTD Specification v2.4. There is no associated DTD update. To support this, an Admin or other user must create a new Controlled Vocabulary record for the REMS Supplement Submission Type.

Support Health Canada Validation Profile v5.0

With this release, RIM Submissions Publishing supports validating Health Canada eCTD submissions using the Health Canada eCTD v5.0 validation rules. Contact your Managed Services representative for information about configuring your Vault to use the Health Canada Validation Criteria Profile v5.0.

Publishing Improvements for Split Content Plan Items

When continuous publishing is enabled on Vaults with Submissions Publishing, Vault now runs an on-demand publishing job on the parent content plan once the Split Content Plan Item user action completes. Learn more about splitting content plan items.

Enablement Change: IDMP

Previously, customers would need to contact Veeva Support to enable IDMP functionality. Now, customers who wish to configure the IDMP functionality can do so without contacting Veeva Support to request the feature. This does not automatically enable the feature, but makes the configuration options available to Admins. Learn more about configuring your Vault to generate IDMP data.

Enablement Change: Submission Import with Vault File Manager

In past releases, an organization needed to contact Veeva Support to enable submission import with Vault File Manager. Now, Admins can enable this feature by selecting a checkbox on the Settings > Application Settings page and performing additional configurations. Learn more about enabling submission import with Vault File Manager.

20R3 Regulatory Data Model Updates

See 20R3 Data Model Changes: Regulatory.

Safety

Safety features are targeted for tentative availability on November 25, 2020 & December 11, 2020.

Automatic Email of Case Questionnaire & Scheduled Reminders

Vault Safety can now automatically send questionnaires to a reporter by email depending on the product, country, language, and watchlist. Vault Safety will also send reminders to the reporter a specified number of times at specified intervals. In addition, the system can track whether these emails are delivered and opened.

Learn More:

• Set Up Scheduled Follow-Up Questionnaire Emails
• Send a Follow-Up Email Questionnaire to a Case Reporter

System Managed Lock Object Protection (Approved, Closed, Superseded, Locked)

The Vault Safety system now has mandatory edit protections on all standard Case-related objects in the Approved, Closed, and Superseded states. As before, with system-configured locking, Vault Owners are still able to edit Case-related objects in these protected states.

Atomic Security Support on App Controls

Vault Safety’s app controls have been enhanced to fully support atomic security on a field by field basis. Fields that are logically grouped together will all respect the most stringent security of any of the underlying fields.

Multilingual MedDRA

Central MedDRA now supports the following MedDRA Languages: Chinese, Czech, Dutch, French, German, Hungarian, Italian, Korean, Portuguese, Brazilian Portuguese, Russian, and Spanish. This support is a back-end change to serve as a foundation for future enhancements to the MedDRA Browser, Local Case Translation, and Local Case Intake.

Learn More:

• Set Up MedDRA Centralization
• Supported Languages

PBRER Unmasked Cumulative SAE from Clinical Trials and Line Listings

The unmasked Cumulative SAE from Clinical Trials and Line Listing reports are now available for PBRER periodic reports. Additionally, the logic to generate masked Cumulative SAE from Clinical Trials is updated to generate blind-protected unmasked versions of tabulations in addition to the masked version.

Learn More:

• Create PBRER Aggregate Reports
• Generated Masked Aggregate Tabulations (PBRER and DSUR)

CIOMS Enhancements

The CIOMS form will now include the following information (if available in a Case): the top priority seriousness value with each Adverse Event, Drug History, Adverse Event outcome, and the Assessment Result. Section 8-12 will now also represent the seriousness values of the whole Case and not just the primary Adverse Event.

Learn More: CIOMS I Generation Data Mapping

Generate ICH E2B R2

Vault Safety now supports exporting ICH E2B R2 submission documents. This feature includes the ability to generate E2B files with ICH-specific data elements and a new user-facing option for generating an ICH E2B R2 file.

Learn More: E2B Generation Data Mapping

ICH E2B (R3) Case Validation

Vault Safety now provides Case-level validation based on ICH E2B (R3) specifications. The validation includes over 150 ICH E2B (R3) validation rules and applies to EMA E2B R3, FDA VAERS E2B R3, and ICH E2B R3 file formats.

Learn More: Case and Submission Validation

ICH E2B (R3) Submission Validation

Vault Safety now provides Submission-level validation based on ICH E2B (R3) specifications. The validation includes over 150 ICH E2B (R3) validation rules and applies to EMA E2B R3, FDA VAERS E2B R3, and ICH E2B R3 file formats.

This feature includes a change to remove the “Generate Transmission Document(s)” Entry Action from the Pending state in the Transmission lifecycle.

Learn More: Case and Submission Validation

VAERS Submission

Vault Safety now supports the capture, tracking, and submissions of ICSRs with suspect or interacting Vaccine-type products to the Food and Drug Administration (FDA). Submissions are supported through the FDA CBER VAERS Gateway, using a new FDA VAERS E2B (R2) file format.

As part of this feature, Vault Safety’s data model was extended to new fields to capture the data required for VAERS submissions.

Additional enhancements include translation of Vaccine specific object types, conditional auto-calculation of Age at Vaccination, the prevention of creating multiple Patient Contacts or Best Doctors, and the mapping of VAERS specific acknowledgments to Vault Transmission lifecycle states.

Learn More:

• Prepare Vaccine Submissions
• Create a Submission
• E2B Generation Data Mapping
• Configure FDA Gateway

EMA/UK Vaccines Submission

Vault Safety now allows for the capture, tracking, and submissions of Vaccines to EMA.

VAERS Combination Products Submission

Vault Safety will now support Combination Product submissions to VAERS to ensure compliance with upcoming January 2021 FDA regulations.

This includes Case Processing with vaccine-led combination products and E2B (R3) submission to VAERS with vaccine-led combination products.

Learn More:

• Prepare Vaccine Submissions
• Create a Submission

Extended Data Model for Vaccines

Vault Safety data model was extended to better capture and track vaccine-specific information.

Data model extensions include adding the Health Care Professional object type to Case Contact, adding a new text field for Reason Received Late on Case, adding a new External System UID for integrations on Case, as well as adding the Hospital Admission Date for Patient (PHI), the Hospital Discharge Date for Patient (PHI), the Conception Date for Patient (PHI), and the Pregnancy Due Date for Patient (PHI).

A new Suppress Submission Case field has also been added but does not control any functionality in this release.

Masked Distribution for VAERS E2B (R3) File Format

With this release, Vault Safety has extended sensitive data protection for distributions. Sensitive FDA VAERS-specific fields are now masked in addition to the pre-existing masked fields for Distributions with Patient Content Protection (PII) Masking and/or E2B Masking turned on.

This enhancement applies to the FDA VAERS E2B (R3) file format.

Learn More: Generate Masked Distributions

Email Distributions & Submission

Vault Safety now supports a new type of Transmission Profile for sending ICSR submissions and distributions via email. A cover letter template can be configured to send as part of an email transmission, and multiple recipient email addresses can be specified for each email transmission profile. Email transmissions are tracked for delivery, opening, and error for each recipient.

Learn More:

• Configure Email Transmissions
• Send an Email Transmission

MHRA Submission Setup (BREXIT)

Administrators can now configure Vault Safety to allow submissions to the Medicines and Healthcare products Regulatory Agency (MHRA) AS2 gateway. Submissions to the MHRA follow EMA E2B (R3) guidance and are in the EMA E2B (R3) file format.

Learn More: Configure MHRA Gateway

Auto-Submissions

Vault Safety can now submit multiple ICSR files to the gateway and email destination directly from the Case. Once the reporting obligations are evaluated for a Case, you can submit at the Case level without having to navigate to each Submission/Distribution.

Admins can configure which agencies and distribution partners qualify for auto-submission at the Transmission Profile-level.

Learn More: Auto-Submissions

Local Region Submissions and Language Translation Support

Vault Safety now supports the ability to translate and distribute Cases to local regions. This includes the ability to add translations for text fields from a global English Case. Submissions for many languages are available by default and additional ones can be added. This feature enables global submissions to agencies, partners, ethics committees, and other organizations.

When a Case is approved, Vault Safety prepares the Case for translation with respect to reporting obligations. Localized E2B(R2) and E2B(R3) are generated including all translated text.

Learn More: Prepare Local Transmissions

E2B+ SDK Extension for Custom Distribution Formats

Vault Safety now allows custom developers to extend existing E2B XML formats or create their own new text data transfer formats.

Add Regulatory Agencies as Standard Organizations

Vault Safety is now pre-loaded with many worldwide health authorities. In addition, Vault Safety now supports gateway submissions to Health Canada.

This feature includes a change to new gateways where the Gateway User is now required and all Vault gateway URLs will show /inboundv2/, regardless of the gateway type. These changes do not impact communication between existing gateways.

Learn More:

• Standard Organizations
• Configure Health Canada Gateway

Vaccine Aggregates - High Volume

Vault Safety has optimized system performance for generating Periodic Reports with high volumes of cases, including vaccine cases.

High Volume Case Processing

Vault Safety now has performance tuning for a high volume of cases.

Replace Configured Unit of Measurement VQL Constraints with System Constraints

In this release, Vault Safety will further improve system performance when users create and save Case-related data. To achieve these gains, VQL criteria will be removed from Unit of Measurement fields such as Age, Height, and Duration.

These constraints will be replaced by system-managed validation that will warn users when an incorrect Unit of Measurement is selected.

Inbox Item Security and Audit Trail

Safety.AI now enforces Vault security around Inbox Items including Permission Sets, Lifecycle State, and Atomic security, to ensure only authorized users can access Inbox Items. Users must be assigned the API Vault Action permission to be able to create Inbox Item records for any sponsor organizations by calling the Intake API.

In addition, Safety.AI automatically compiles an audit trail that logs actions on Inbox Item records and sections as well as Create AER actions.

Inbox Item Date Validations

Safety.AI now prevents users from saving invalid dates and from promoting an Inbox Item to case with invalid dates. The validation rules include that dates cannot be in the future, before 01-01-1800, or later than the date of death, and that the start date cannot be before the end date for events and Dose Administration.

Learn More: Inbox Item Data Validation

Manual Inbox Item Intake

Users can manually create Inbox Items as an alternative to automated intake through the API.

Learn More: Create an Inbox Item Manually

Inbox Item Document Linking

Safety.AI automatically links the Source Document from the Intake API to the Inbox Item using the new Source Document field. Users can also manually link multiple documents to an Inbox Item using the new Document field on the Inbox Item. Documents will be automatically linked to the case when promoting an Inbox Item.

Case Level Seriousness Detection For Inbox Priority

Safety.AI will now predict and suggest priority for new Inbox Items based on the Case-level seriousness from text if seriousness is not provided in structured data.

Vaccine Administration Facility and Cause of Death Intake

Safety.AI Intake API will now validate and ingest Vaccine Administration Facility and Cause of Death information. Case Contact and Cause of Death records will be generated upon promoting to Case.

Structured Case Data Intake and New Inbox Item Fields

Safety.AI Intake API can now validate and ingest case information that is not editable on the Inbox Item form, including Case Contact, Adverse Event, Case Products, Product Dosage, and Product Indication fields. These fields will be snapshot to the Case upon promoting to Case.

Safety.AI will support two new fields, Product Patient Route of Administration (RoA) and Adverse Event Outcome for structured data API intake and for verification on the Inbox Item form.

Learn More: Developer Docs

Human Verification Enhancements For Predictions

Dropdown fields will now be searchable to make selection easier, especially from long lists (e.g. country). In addition, Safety.AI will now automatically populate medium confidence level predictions in addition to high-level ones.

Case Contact Intake and Classification

Vault Safety.AI API will now ingest structured contact information for reporters, patients, and other contacts. While entering and verifying data, Safety.AI allows users to classify Case Contact types, including differentiating between reporters and the patient.

Intake and Verification for New Product and Reporter Fields

Safety.AI will now support Product Indication and Lot Number intake. The Intake API will accept these fields in the JSON structured data that will be presented in Product sections of the Inbox Item user interface. Users will be able to edit and save these fields.

Product And Medical Event Classification

Safety.AI attempts to classify products (Case Product or Drug History) and medical events (Adverse Event or Medical History) to help intake users triage and verify product and event information. Users can verify and edit the product and event type when they verify the Inbox Item.

When the Inbox Item is promoted, the system creates the appropriate Case Product or Drug History records and Adverse Event or Medical History records based on the Case Product type and Event type respectively.

Promote to Case from Inbox Item

Case Validity will now be checked on the Inbox Item form. After verifying the data of an inbox item, users will be able to check duplicates and promote to Case directly. Users will then automatically be redirected to the Case.

Learn More: Promote to Case

SiteVault Enterprise

Safety Distribution: SiteVault

SiteVault users will now receive a daily digest notification when safety distribution documents have been received from a given sponsor or CRO using Vault Site Connect.

Source Upload: Preview Files

When uploading source documents via the Source Upload tab, users can view the first page of a document using the preview icon next to the filename.

Source Upload Enhancements

When enabled, this feature adds a Document Type column to the Source Upload grid, allowing SiteVault users to upload other types of source documents, such as deviation logs, AE logs, and signed ICFs. Additionally, SiteVault now warns users if it detects an existing source document of the chosen type for the same participant.

SiteVault – MyVeeva: Integration User

This feature provisions a secure Admin user account that is used exclusively by MyVeeva to support a productized integration between MyVeeva and SiteVault.

Document Type Additions

With this release, we have added a new document type for invoices, which can be directly received in SiteVault from Sponsors and CROs who use Veeva Site Connect. We have also added document types for Completed CRFs, Adverse Event Logs, Study Site Contact Info, and Equipment Logs.

Patient & Participant Data Model

This release introduces several new objects and fields that allow SiteVault users to track and manage study participants with greater detail. The Participant Lifecycle has new lifecycle states that reflect a participant’s status throughout the study, from recruitment through closeout. Users can also create Participant Visit records to plan and track visits for each participant. Lastly, a new object, Patient, supports tracking of non-study-specific information such as first name, last name, date of birth, contact information, etc.

Research Organization Object

The Research Organization object provides a way to group the research sites in an Enterprise SiteVault. This functionality will be expanded upon in future releases.

SiteVault Data Model Changes

See 20R3 Data Model Changes: SiteVault Enterprise.

QualityOne

QualityOne Mobile for iPadOS

QualityOne Mobile for iPadOS allows respondents to perform an Audit via a checklist on an iPad device for an audit checklist configured in Vault. QualityOne Mobile for iPadOS is designed to work in environments where consistent cellular or WiFi connectivity cannot be presumed or is not permitted. Respondents can download a checklist while connected and then while offline they can respond to questions, attach evidence, and indicate if a response leads to an audit finding.

QualityOne Training Management Phase 2

With the 20R2.3 release, we’ve improved QualityOne Training Management in the following ways:

• Instructor-Led Training: This improvement introduces a new Training Requirement type, Classroom Training Requirement, and allows Admins to configure class rosters, schedules, session quizzes, and training materials. Learn more about Instructor-Led Training.
• Multi-Document Training Requirements: Enhancements to the QualityOne Training application’s Vault Document Training Requirement type support multiple documents as part of a single training assignment and facilitate the informed assessment of the impact of any changes to documents within that document group. Learn more about Multi-Document Training Requirements.
• Learner Task Page for Document Training Assignments: This feature updates QualityOne Training’s Learner task page to support more than one document per Training Requirement and to provide additional information to the Learner. Learn more about updates to the learner experience.
• Issue Training Assignments Based on Training Eligibility: Allows the QualityOne Training application to use a field, Training Eligibility, to determine whether a Person should receive Training Assignment tasks. Learn more about training eligibility.
• Training Requirement Recurrence Enhancement: A new Absolute recurrence option for documents and classroom Training Requirements allows Vault to issue training tasks to Learners on a fixed date. Learn more about the absolute recurrence option.
• Change Related Training Requirements to Retired Entry Action: Adds the Change Related Training Requirement to Retired document lifecycle entry action, which automatically changes the state of Training Requirement records to the Retired state, ensuring that the Training Requirement record is not used for future Training Assignments. Learn more about this entry action.
• Validation & Learner Enhancements: Enhancements to add validation to prevent misconfiguration between the Person and User records and automatically add the Learner to the Learner Role for the Assignment Details and TA Response objects. Prevents a User record from being referenced in multiple Person records. Learn more about person records.
• Issue Training Assignments Based on Document State: Allows Admins to tag, for each lifecycle, the trainable states for documents referenced by Training Requirements. Learn more about issuing training assignments based on document states.
• Issue Training Assignments Entry Action Enhancement: Adds an Issue Training Assignment document lifecycle entry action checkbox called Keep Open Training Assignments. When Admins select this checkbox, the application will not cancel open Training Assignments. With this enhancement, Vault will use the Steady state and Ready for Training state types to determine whether Training Assignment tasks should be issued. Learn more about this entry action option.
• Copy Custom Fields: QualityOne Training can copy data from a field on a Training Requirement record to the identical, matching field on a Training Assignment record. Admins can set up custom sharing or matching rules on the Training Assignment record based on the copied data to determine record access. Learn more about copying custom fields.
• Training Assignment Record Migration Improvements: QualityOne Training will use Assigned Date instead of Created Date for migrated Training Assignment records when determining the most recent record. This will prevent the application from erroneously issuing new Training Assignment records due to the Created Date being the same for most migrated records. Learn more about migration improvements.
• Cancel Open Training Assignments Entry Action: The Cancel Open Training Assignments entry action, configured on the Superseded document lifecycle state, cancels any open Training Assignments that reference the superseded document. Learn more about this entry action.
• Job Logging: This improvement enhances the log file for the Update Training Assignments job to provide additional detail about what the job did during its run. Learn more about job logging.

QualityOne Mobile for iOS Enhancements

With the 20R3 release, we have enhanced QualityOne Mobile for iOS by improving the overall user experience and adding support for iOS 14.

QualityOne Data Model Improvements

This feature provisions new objects (CAR, Complaint, Change Control, CII, CAR-NAR) in QualityOne to transition from Quality Event object types. Organizations can now use this improved standard data model to simplify implementation and better represent quality processes.

Incident Management Standard Object Model

This feature provisions a standard Incident Management object model as the first step towards allowing organizations to report, track, and manage a safety or environmental or vehicle or property damage incident so that organizations can develop a safety-first culture and become more data-centric in their approach towards safety.

Data Model Changes

See 20R3 Data Model Changes: QualityOne.

RegulatoryOne

Data Model Changes

See 20R3 Data Model Changes: RegulatoryOne.

Veeva Claims

Note that Veeva Claims features are targeted for tentative availability on December 15th.

Pack Copy Hierarchy Viewer & Navigator

This feature allows users to easily view and navigate a packaging copy hierarchy. Users can view all packaging levels and panels on one page and navigate between different panels quickly. During configuration, Admins can optionally provide help content to guide users. Learn more about configuring the hierarchy viewer.

Substantiation Object

With this release, Veeva Claims is introducing a new standard Substantiation object that can be leveraged to store substantiation records which can then be linked to Claims.

Data Model Changes

See 20R3 Data Model Changes: Veeva Claims.