New in 20R2.3: High Volume Object and more

Release Date: September 25, 2020

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

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.

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.

Working with Documents

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 the user chooses not to copy fields, the fields are populated with any default values configured by Admins. Learn more about Make a Copy.

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 for easier use of referencing fields in related object records. Learn more about Merge Fields.

Improved Rendering Feedback

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

Lifecycles & Workflows

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

With this release, Admins can now configure object and multi-document workflows to have users and groups auto-populated at the workflow start step based on their roles. For example, if the Approver role is allowed to participate in a workflow, all approvers on the record are auto-populated at the start step, and the workflow initiator will no longer need to select them manually. Workflow initiators can always change the defaulted list by manually removing items.

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 in every document of the workflow. Learn more about configuring object and multi-document workflows.

Object & Multi-Document Workflows: Participant Control Help Labels

With this release, workflow initiators for object and multi-document workflows now see the label Assigned to every user or Available to any user 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 & 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, the system returns the optional task to the list of Available Tasks. The task is available to everyone in the recipient list, and must be accepted by a user before it can be completed. Learn more about using object and multi-document workflows.

Object Workflows: Task Comment & Object Type Tokens

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

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.

Reporting & Dashboards

Early Timeout Detection for Reports

This feature allows Vault to predict if a single entity report will time out. If Vault determines that a report will time out, the system displays an error message advising the user to add filters or schedule a flash report.

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.

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.

Generate Outbound Package from Vault Compare

This update enhances the Vault Comparison 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 generating Outbound Packages from Vault Compare.

Audit Action Security for Objects

This feature allows admins to hide the Audit Trail action for records based on object, state, and role. This feature must be enabled within object configuration. Learn more about audit trails.

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.

Integration Query Object Rules

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

Application Performance Statistics

This feature has been postponed to a later release.

FTP Staging Permission Name Update

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

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.

Platform Data Model Changes

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

Added components to support Checklist Question Guidance Text:

• Added the Question Help Text (question_help_text__v) field to the following objects:
  • Question Design (question_design__sys)
  • Response (response__sys)
  • Library Question (library_question__sys)

Added components to support Checklist Enhancement: Decimal Response:

• Added the Decimal Places (decimal_places__sys) field to the following objects for the Number Question object type (number_question__sys):
  • Question Design (question_design__sys)
  • Response (response__sys)
  • Library Question (library_question__sys)

Added the following components to support Application Performance Statistics:

A new standard object Performance Stats-Application (app_perfstats__sys) has been added to all Vaults. This object captures additional performance statistics specific to your application. As of 20R2.3, this object exists to support this future functionality and does not yet track any statistics.

Added the following components to support Landing Tabs:

• Added the Tab Group (tab_group__sys) object, which contains records of all tabs that can be selected for a Landing Tab.
• Added a new User Landing Tab (landing_tab__sys) field to the User (user__sys) object.

Added the following components to support Integration Query Object Rules:

• The Integration Rules component is extended with subcomponent Query Object Rules, including fields:
  • Active (active)
  • Label (label)
  • Filter (filter_clause)
  • Object (query_object)
  • Primary Object (Yes/No) (primary_object)
  • Relationship (relationship)

Clinical Operations

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Clinical Operations Data Model Changes

Expand this section to view Clinical Operations Data Model Updates.

Commercial

Configurable Standard Metrics

Based on customer feedback, we have increased the flexibility of Standard Metrics in 20R2.3 by making the Global Content Type, Content Creation Currency, and Content Creation Cost fields not required by default. All 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.

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 all 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.

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 20R2.3 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. 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.

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.

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

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: 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.

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.

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: 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.

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.

Commercial Data Model Changes

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

Expand this section to view Commercial Data Model Updates.

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. A reportable event object supports generating eMDRs for the US FDA, going to FDA CDRH as an XML file. Learn more about Vault Product Surveillance.

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.

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.

Quality Data Model Changes

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

Expand this section to view Quality Data Model Updates.

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.

Date Filters 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 columns for the Content Plan and Content Plan Item objects. 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 and 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.

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

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.

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.

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.

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.

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.

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

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.

Expand this section to view Regulatory Data Model Updates.

In this release, we have also enabled the Required attribute on additional standard objects and fields. This allows organizations to configure these components according to their business requirements without needing to contact Veeva Support or Product Management to make these configuration changes. In order to utilize these newly-enabled attributes, Admins must perform the desired configuration to make them available for users.

QualityOne

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.

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.

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.

Safety

Safety features are targeted for tentative availability on October 1, 2020.

VAERS Combination Products Submission Support

Vault Safety now allows for the capture, tracking, and submission of vaccine combination product reports to the FDA CBER VAERS AS2 Gateway using the FDA VAERS E2B (R3) file format.

As part of this feature, the Vault Safety data model has been extended to support FDA E2B (R3) combination product fields. Field mapping is based on the latest ICH VAERS ICSR Business Rules document at the time.

Learn More:

• Enter Case Data
• E2B Generation Data Mapping

Masked Distribution for VAERS E2B R3 File Format Admin Checkbox

With this release, Vault Safety extends 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 Safety Reports

CIOMS Enhancements Auto-on

The CIOMS form now includes the following information when it is available on the Case:

• The top priority Seriousness value for each Case Adverse Event
• The Outcome for each Case Adverse Event
• Patient drug history
• Assessment results

Also, the system now populates section 8-12 using the Seriousness values of the entire Case and not just the primary Case Adverse Event.

Learn More: CIOMS I Generation Data Mapping

ICH E2B R2 Export Auto-on

Vault Safety now supports exporting Cases to the ICH E2B (R2) format.

Learn More: E2B Generation Data Mapping

Extended Data Model for Vaccines Support

Vault Safety’s data model has been extended to better capture and track Vaccine-specific information.

Learn More:

• Prepare Vaccine Submissions
• Enter Case Data

Replace Configured MedDRA VQL Constraints with System Constraints Auto-on

This release features improvements to system performance. MedDRA system constraints have replaced configured VQL constraints to increase the performance of page Saves, Promote to Case, and Create Follow-up.

Promote to Case from Inbox Item Configuration

Safety.AI now checks case validity for Inbox Items directly, eliminating the need to promote to AER. After verifying the data of an Inbox Item, users can check for duplicates and directly promote the Inbox Item to a Case.

Structured Case Data Intake and New Inbox Item Fields Auto-on

The Safety.AI Intake API can now ingest and validate fields that are not editable on the Inbox Item object, including Case, Case Contact, Case Adverse Event, Case Product, Case Product Dosage, and Case Product Indication fields. The system snapshots these fields to the Case on case promotion.

Safety.AI now also supports the Patient Route of Administration (RoA) and Adverse Event Outcome fields for structured data API intake and for verification of the Inbox Item.

Veeva Claims

Note that Veeva Claims features are targeted for tentative availability on October 6th.

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.

SiteVault

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.

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.

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.

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.

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 person-level information such as first name, last name, date of birth, contact information, etc.

20R3 SiteVault Data Model Updates

Expand this section to view SiteVault Data Model Updates.

Enablement Details

Name	Enablement	Application
Vault Objects
High Volume Object	Configuration	Platform
Support Upsert with Object Types	Auto-on	Platform
Working with Documents
Changes to Make a Copy for Read-Only Fields	Auto-on	Platform
Merge Fields Token Character Length Increase	Auto-on	Platform
Improved Rendering Feedback	Auto-on	Platform
Lifecycle & Workflow
Object & Multi-Document Workflows: Default Users from Sharing Settings	Configuration	Platform
Object & Multi-Document Workflows: Participant Control Help Labels	Auto-on	Platform
Object & Multi-Document Workflows: Undo Acceptance of Tasks	Auto-on	Platform
Object Workflows: Task Comment & Object Type Tokens	Configuration	Platform
Object Workflow Timeline Enhancements	Auto-on	Platform
Reporting & Dashboards
Early Timeout Detection for Reports	Auto-on	Platform
Object Formula Fields in Reports	Auto-on	Platform
Administration
Configurable Landing Tabs	Configuration	Platform
Generate Outbound Package from Vault Compare	Auto-on	Platform
Audit Action Security for Objects	Configuration	Platform
Exclude Security Overrides Referencing Auto-Managed Groups When Migrating Document Fields	Auto-on	Platform
Integration Query Object Rules	Configuration	Platform
Application Performance Statistics	Auto-on	Platform
FTP Staging Permission Name Update	Auto-on	Platform
Checklists
Checklist Question Guidance Text	Configuration	Platform
Checklist Enhancement: Decimal Response	Configuration	Platform
Asynchronous Cascade Delete for Checklist Design	Configuration	Platform
Vault File Manager
Auto-Refresh for Check In from Vault File Manager	Auto-on	Platform
Platform Data Model Changes
Platform Data Model Changes	Auto-on	Platform
Clinical Operations
TMF Index Management: Core Data Model	Configuration	eTMF
One-Click Trip Report Question Data Entry	Auto-on	CTMS
Displaying Required Responses & Comments in Trip Report Questions	Configuration	CTMS
Displaying Instructions on Trip Report Questions	Configuration	CTMS
Long-Text Trip Report Question Responses & Comments	Admin Checkbox	CTMS
Site Connect: Safety Distribution	Configuration	SiteConnect
Site Connect: Payment Letters & Site Invoices	Auto-on	CTMS, SiteConnect, Vault Payments
Site Connect: Completed CRFs	Configuration	SiteConnect
Smart Profile Document Transfer	Auto-on	SiteConnect
TMF Viewer Level Support & Additional Enhancements	Auto-on	eTMF
Study Expenses	Auto-on	Vault Payments
Securing Quality Issues	Admin Checkbox	Study Startup, eTMF
Editable Startup Home Page: Labels & Milestone Types	Auto-on	Study Startup
Milestone Completeness Snapshot	Auto-on	CTMS, SiteConnect, Study Startup, Vault Payments, eTMF
TMF Viewer Doc Type Model Support	Configuration	eTMF
TMF Homepage Review Overcount Link	Auto-on	eTMF
Data Model Changes to Support Simple TMF Transfer & Vault Site Connect	Auto-on	CTMS, SiteConnect, Study Startup, eTMF
Clinical Operations Data Model Changes	Auto-on	CTMS, SiteConnect, Study Startup, Vault Payments, eTMF
Commercial
Configurable Standard Metrics	Auto-on	PromoMats
eCTD Compliance Package Generation	Configuration	PromoMats
Standard Metrics Job to Update Global Content Type to Mapped Value	Auto-on	PromoMats
Related Portals	Configuration	MedComms, PromoMats
Enhancements to Medical Inquiry Case Response Email Capabilities	Configuration	MedComms
Auto Claims Linking: Hide Suggest Links Button When No Matching Claims Exist	Auto-on1	Platform
Auto Claims Linking: References in Audit Trail	Auto-on1	Platform
Auto Claims Linking: Excluded Characters	Auto-on1	Platform
Add Annotation (Approved Links) Field	Auto-on1	Platform
Auto Claims Linking: Create Claims from Link Annotations	Auto-on1	Platform
Auto Claims Linking: Where Used Enhancements	Auto-on1	Platform
Case Response Email Body Rendering	Configuration	MedComms
Commercial Data Model Changes	Auto-on	MedComms, PromoMats
Quality
Vault Product Surveillance	Support	Surveillance
Audit Finding External Response Collaboration	Configuration	QMS
Audit Program Planning	Configuration	QMS
Issue Escalation & Notification	Configuration	QMS
Quality Teams: Replace Invalid Team Assignments	Auto-on	QMS
Quality Data Model Changes	Auto-on	QMS, QualityDocs, Station Manager, Surveillance, Training
Regulatory
Save Views in Content Plan Hierarchy Viewer	Auto-on2	RIM Submissions
Date Filters in Content Plan Hierarchy Viewer	Auto-on2	RIM Submissions
Import Submissions with Unreferenced Files Using Vault File Manager	Auto-on3	RIM Submissions Archive
Enhancements to Submission Import with Vault File Manager	Auto-on3	RIM Submissions Archive
Auto-Create Application Country & Submission Country Joins	Admin Checkbox	RIM Publishing, RIM Registrations, RIM Submissions, RIM Submissions Archive
Update Hyperlinking Creation Logic	Auto-on	RIM Publishing
Configurable Impact Assessment Reports	Configuration	RIM Registrations
Additional Registration Scopes in Create Registrations	Configuration	RIM Registrations
Additional Registration Scopes in Manage Registered Details	Configuration	RIM Registrations
Create Registrations Enhancements	Auto-on	RIM Registrations
Manage Registered Details Enhancements	Auto-on	RIM Registrations
IDMP Phase 2: Data Model	Auto-on	RIM Registrations
Submissions Archive Viewer Document Download	Auto-on	RIM Submissions Archive
Submissions Archive Viewer Display Update	Auto-on	RIM Submissions Archive
Add Submission Import Information to Notification Token	Auto-on	RIM Submissions Archive
US FDA eCTD Specification v2.4 Support	Configuration	RIM Publishing
Enablement Change: Submission Import with Vault File Manager	Configuration	RIM Submissions Archive
20R3 Regulatory Data Model Updates	Auto-on	RIM Publishing, RIM Registrations, RIM Submissions, RIM Submissions Archive
QualityOne
QualityOne Data Model Improvements	Auto-on	QualityOne
Training Management Phase 2	Configuration	QualityOne
Incident Management Standard Object Model	Auto-on	QualityOne
Veeva Claims
Pack Copy Hierarchy Viewer & Navigator	Configuration	Veeva Claims
Substantiation Object	Configuration	Veeva Claims
SiteVault
Safety Distribution: SiteVault	Auto-on	SiteConnect, SiteVault Enterprise, SiteVault Free
Document Type Additions	Auto-on	SiteVault Enterprise, SiteVault Free
Source Upload: Preview Files	Auto-on	SiteVault Enterprise, SiteVault Free
SiteVault – MyVeeva: Integration User	Support	SiteVault Enterprise, SiteVault Free
Patient & Participant Data Model	Auto-on	SiteVault Enterprise, SiteVault Free

1. Auto-on in PromoMats Vaults. This feature is currently unavailable in other Vaults and must be enabled by Veeva Support.
2. Auto-on in Vaults with the Content Plan Hierarchy Viewer enabled.
3. Auto-on in Vaults with Submission Import with Vault File Manager enabled.

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.