New in 20R3.4: Link Annotations to Permalinks and more

Release Date: February 5, 2021

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

Working with Documents

Admins can enable an option that allows users to create link annotations that target permalinks rather than creating version-specific links to documents and anchors. Link annotations to permalinks utilize the Permalink object in Vault and always navigate to the latest available version of the target document.

To create a link annotation to a permalink, users must select the Permalink option from the drop-down next to the cursor mode icons. When users select document content, Vault opens a Select targets dialog, in which users can select whole documents, as well as pages, bookmarks, and named destinations within documents. Learn more about creating link annotations to permalinks.

Video Review: Bring Forward Annotations

With this release, users can bring forward annotations on video documents. Users can also enter Move mode to edit the time signature of annotations. Note that annotations between video and non-video renditions, such as a storyboard PDF, cannot be brought forward. Learn more about annotating videos.

Annotate Filters: Enhancements

This enhancement provides updates to annotation filters, including:

  • Moving annotation filters to a sidebar
  • Reorganizing some filter options
  • Adding two new filters: Author and Tag

Document Inbox Enhancements

Document Inbox Drag & Drop

This feature allows users to drag and drop files into the Document Inbox to create new unclassified documents. Users can track the progress of their upload in a new dialog, which they can minimize so they can continue working in Vault while the upload is in progress. In Clinical Operations Vaults, Vault prompts users to enter the Study, Study Country, and Study Site after they drop a file into the Document Inbox. Users can opt in or out of this prompt in the Document Inbox Actions menu. Learn more about Creating Unclassified Documents.

Always Display the Document Inbox

This feature enhances the Document Inbox to always be available in the Library for users with the Create permission on at least one document type. This enhancement supports the Document Inbox Drag & Drop feature. Before this release, the Document Inbox was only available in the Library for users with access to at least one document in the Document Inbox.

Document Inbox Improvements

This feature includes several enhancements to the Document Inbox, including:

  • Updated Tabular View user interface
  • The Classify action is now called Complete
  • A new button to Complete
  • The ability to upload up to 250 documents at a time via drag and drop

Updated UI for Add Renditions

With this release, the Add Rendition modal UI supports uploading Large Size Assets using the Vault File Manager desktop application. As part of this change, users can now select the Large Size Asset rendition type in the UI if the selected document type is configured with this rendition type.

In past releases, the Large Size Asset rendition type was assigned to the Base document type on all Vaults, but was not available for selection in the UI because Large Size Asset renditions could only be added via the FTP Inbox. To ensure it does not appear for all users, we have removed this rendition type from the Base document type for all Vaults other than PromoMats in this release.

To upload Large Size Asset renditions using Vault File Manager, Admins can assign this rendition type to their document types. Note that this is currently the only rendition type supported for 100GB uploads using Vault File Manager.

Template Search Enhancements

When creating documents from templates, the field where users select a template is now a type-ahead field. This allows users to find templates in Vaults where there are a large number of templates available for the selected document type.

Increase to Maximum Source File Size for Videos

With this release, the maximum source file size for video files is 4GB. Files up to this size will also be rendered, allowing users to review and annotate them in Vault.

Vault Objects

This feature allows Admins to configure Criteria VQL filters on Related Document sections in object page layouts to restrict the documents that users can add, similar to dynamic reference constraints on object reference fields. Admins can use fields on the related document and on the current record to construct query conditions and filter the list of documents shown in the related document section.

For example, if the filtered list of documents should belong to the same product as the current object record, an Admin could write a condition that matches the Product field on the document to the Product field in the Criteria VQL of the Related Document section. Learn more about Related Document Section Filters.

Rich Text Fields for Vault Objects

Users can now format the content of field values with Rich Text fields. Vault supports most common formatting options such as font size, font family, text alignment, text decorations, lists, and scientific notation. Admins can configure Rich Text fields in most places that support text fields, including object list pages, object detail pages, reporting, workflows, VQL, Vault Loader, exports, and APIs.

This feature is especially useful for customers with business needs to capture information in a specific format, for example, if certain types of information must conform to standardized formatting for audit and compliance purposes. Learn more about configuring Rich Text fields.

Lifecycle & Workflow

Object Lifecycle & Workflow: Long Text & Rich Text Fields

Admins can now configure Rich Text and Long Text fields on object lifecycle and workflow components. Vault can update Rich Text and Long Text fields via:

  • Entry actions, such as Update Record Field and Update Related Record Field
  • Event actions, such as Update Record Field
  • Workflow steps, such as Update Record Field and Update Related Record Field

Both Rich Text and Long Text fields are available in field prompts for workflow Task steps. Rich Text fields are also available in action conditions. Learn more about configuring object and multi-document workflows.

Object & Multi-Document Workflow: Replace Workflow Owner

Users with the appropriate permissions can now change the owner of an active or in-progress workflow using a new Replace Workflow Owner action. Workflow ownership can be changed through a workflow action in the Vault UI or by using the API. The new owner must have the permission to start the workflow. When a user replaces the workflow owner, Vault automatically assigns all current and future incomplete tasks from the previous to the new owner.

Access to this action is controlled at the user profile level by a new Replace Workflow Owner permission. By default, this permission is available only to Vault Owners, System Admins, and Business Admins.

The Replace Workflow Owner action is also available in Bulk APIs. Learn more about using object and multi-document workflows.

Object & Multi-Document Workflow: Timeline View & Task Bar Enhancements

This feature includes several enhancements to the Timeline View and Task Bar:

  • Users can now see verdict details in the Timeline View of a multi-document workflow, including the verdict, comments, reason, and capacity. In a multi-verdict scenario, the verdict for each document is visible in the multi-document viewer’s Timeline View.
  • Vault now shows Task Instructions provided by the Workflow Initiator in the Task Bar for both object and multi-document workflows.
  • Multi-document workflows now show pending tasks in the Lifecycle Stage Chevron panel.

Learn more about the Timeline View.

Object & Multi-Document Workflow: Capacity Without Requiring eSignature

This feature allows Admins to configure capacity in an object or multi-document workflow verdict without configuring an eSignature. Capacity is now available outside the eSignature section of a verdict in a workflow task.

Existing verdicts continue to require a capacity. However, Admins can make them optional or remove them. There can be only one capacity value for each task completion. Learn more about configuring object and multi-document workflows.

Multi-Document Workflow: Use Role as Participants

Multi-document workflows now support user roles as participant groups. For example, a participant group can consist of users in the Approver role. This automatically adds all users who have the Approver role on every document in the workflow as participants in the workflow. Admins can only select one role per participant group to include. Vault does not currently support exclusion-based roles. Learn more about configuring object and multi-document workflows.

Multi-Document Workflow: Optional eSignature Manifesting on Documents

This feature allows Admins to configure whether eSignatures will be manifested on documents in a multi-document workflow. By default, Vault continues to manifest eSignatures for all applicable verdicts. Learn more about configuring multi-document workflows.

Multi-Document Workflow: Edit Document Fields

This feature allows users with appropriate permissions to edit document fields within the multi-document workflow viewer. Users no longer need to open individual documents to edit fields. The Edit Fields button is available in both Field View and Mixed View.

Some functionalities, like access to workflow timeline, document actions, and task completion, are not available while in the field-editing mode. Learn more about using multi-document workflows.

Object & Multi-Document Workflow: Reassignment Task Event in Update Sharing Settings

Admins can now configure a new Task Event called Task Reassignment From in the Update Sharing Settings section of an object or multi-document workflow Task step. This event allows Admins to add a user to or remove a user from a role on document or object sharing settings when the task is reassigned from that user. Learn more about configuring object and multi-document workflows.

Inactivate Roles Used in Multi-Document Workflows

Admins can now make document lifecycle roles used in multi-document workflow Start, Notification, and Sharing Settings steps inactive.

Admins cannot select inactive roles in new participant groups as a constraining role, in role-based Participants controls, as notification recipients, or as participants when updating sharing settings. Existing workflow steps with inactive roles continue to work as before. Learn more about configuring object and multi-document workflows.

Reporting

Multi-Pass Reports Support Binders & Document Relationships

With this release, Admins can define binder reports and document relationship reports as report views. Admins may now join binder reports and document relationship reports to other report types, including object, document, and workflow reports. Learn more about Multi-Pass reports.

Enhanced Support for Rich Text & Long Text in Reports

This feature allows users to export the full text of Rich Text and Long Text fields from reports. For Rich Text fields, users can choose to export either formatted or unformatted text. Additionally, users can now view the full text within the context of the report.

Formula Fields in Document Reports

This feature allows users to define formula fields directly in their document reports. Users have access to a rich set of functions and operators to analyze and format their document data without making changes to their data model. In addition, users can define formula fields in Expected Document reports and use formula fields in conditional fields.

With this release, report exports to Microsoft Excel support more than 65,000 links.

Additional Functions in Report Date Filters

This feature adds support for the If() function and several logical operators, including = and !=, to report date filters.

Exports of Icon Fields in Reports Return Alternative Text

This feature makes exports of Icon-type Formula fields from reports consistent with exports from object list views. Exports now display alternative text instead of the full formula.

Auditing

Document ID in Document Audit Exports

With this release, document audit exports to CSV contain a Document ID column.

This feature allows Admins to create collections of objects that users can search together. Once an Admin creates a collection of objects, users can expand their search from a single object in a custom tab to all of the objects in the collection. Users can filter and sort the search results for each of the objects independently to build a refined view of records across the collection. Learn more about Expanded Search.

Checklists

Checklists: Updated Confirmation Banner & Send Confirmation Notification After Starting a Checklist

This enhancement updates the confirmation banner that alerts users when a checklist starts to include more detailed text. Additionally, Vault now sends a notification to confirm when a checklist is being created.

Auto Claims Linking

Auto Claims Linking: Display Match Text Variation in Info Card

With this release, Vault displays the Match Text Variation record ID next to the Claim ID in the footer of Suggested, Approved, and Auto Link annotation info cards when a Match Text Variation is used to match a Claim record to a document. Users can hover over the ID to view a hover card, or click the ID to open the record detail page in a mini-browser window.

Auto Claims Linking: Configurable Columns in Select Claims Dialog

With this release, any Claim object field configured to appear in the Claim hover card now also appears as a column in the Select Claim dialog when users are selecting records to manually create Claim Links on documents. Learn more about Auto Claims Linking.

Vault File Manager

Upload Large Size Asset Renditions Using Vault File Manager

With this release, users with the Check Out to File Manager and File Staging: Access permissions will see a link when adding renditions to documents and selecting the Large Size Asset rendition type. This link allows users to select and upload their Large Size Asset rendition via the Vault File Manager desktop application. We recommend using Vault File Manager to upload files larger than 1GB.

To support this feature, we have also updated the UI for the Add Rendition modal in Vault and made it possible to select the Large Size Asset rendition type if it is included on the document type. Before this release, users could only upload Large Size Asset renditions via the FTP Inbox. Learn more about Large Size Asset renditions.

Track User, Machine & Vault File Manager Version

With this release, Admins can track which users are using Vault File Manager and which version of the application they are using. When users log in to the Vault File Manager desktop application or switch Vaults within the application, the events are recorded in a new object in the Vault to which the user connected. Note that Vault File Manager is only available on Windows. Learn more about Vault File Manager.

Administration

Enhancements to Document Name Inheritance

Admins can configure a document type’s Document Name Format and select whether the document name regenerates whenever the document is saved. With this release, it is easier for users to determine in the Edit Document Type dialog if the Document Name Format or Document Name Regeneration settings are inherited from a parent document type.

Templates: Hide Inactive Document Types

With this release, templates for inactive document types are no longer displayed by default on the Document & Binder Templates page in Business Admin. To display inactive document type templates, Admins can click the Show Inactive button.

Web Tab URL Tokens

Web tabs allow external applications to display inside a tab in Vault. With this release, Admins can use a token in the web tab URL definition to specify passing a query string parameter or the entire query string from a web tab request to the embedded external application.

Enhancements to API Limits

As of 20R3.4, the Vault API no longer enforces daily limits and no longer returns the Daily Limit HTTP Headers in responses for calls made using v21.1 of the API and higher. Previous versions of the API will return static values for these headers:

  • X-VaultAPI-DailyLimitRemaining: 999,999
  • X-VaultAPI-DailyLimit: 999,999

Additionally, the burst limit has been enhanced to automatically delay all API calls for 500ms after a user reaches the burst limit and no longer returns an error.

Learn more about API Limits.

Access Control

Enhanced User Profile Page

With this release, the User Profile page has been updated with a new layout and has added customizability. The new User Profile page is based on the User object. Admins can now configure the User Profile page to show or hide User fields.

For example, by adding the Tasks field, Admins can allow their users to set notification preferences for workflow tasks by choosing whether to receive a notification every time a workflow task is assigned to them or to get a daily summary notification. Previously, these preferences could only be set by Admins.

As part of this feature, Vault now has a new application permission for users: View User Profile. By default, all users have this permission to maintain existing behavior. Admins now have the ability to remove this permission and hide the User Profile page, if needed. Learn more about the User Profile page.

Flexible DAC Field Mapping

In previous releases, Admins had to use similar field names when matching a document or object field with a User Role Setup field in a Dynamic Access Control (DAC) matching rule. This feature provides more flexibility in DAC rule configurations as needed while maintaining the previous default behavior of matching fields with similar names.

When creating a DAC matching rule, Admins can now match an Object– or Picklist-type field to a User Role Setup field as long as both fields reference the same object or picklist. This applies to DAC matching rules securing documents and objects.

Vault Loader

File Staging for Vault Loader CLI

In addition to viewing and creating directories on Vault’s file staging server, users can now move and rename files and folders in addition to uploading and downloading to and from the remote file staging server.

Learn more about file staging for Vault Loader CLI.

Vault Loader Where Clause Validation

This feature adds a new Validate button to the Vault Loader Extract page, which allows users to check the syntax of the Where Clause prior to submitting the Vault Loader export job. Learn more about extracting data with Vault Loader.

Vault Java SDK

Inactivate Standard Integration Rules & Edit Field Defaults on Standard Field Rules

Standard integration rules can now be delivered as inactive, enabling Admins to turn them on or off as needed. Additionally, Admins can now edit field defaults for standard field rules.

Separate Job Queue & Spark Queue Permissions

SDK job queues and Spark queues serve different purposes and are often managed by different administrative users. These queues are now managed independently from each other and are controlled with separate permissions.

Instead of one Queues permission, the queues are now controlled by the Spark Queues and SDK Job Queues permissions. Users who previously had the Queues permission and access to both queue types will automatically have both the Spark Queues and SDK Job Queues permissions.

Any MDL or VPKs generated prior to this change which include permission sets must be regenerated to accurately reflect permissions.

Query Object Rules Filter Clause Enhancements

In this release, we’ve modified the Criteria VQL available for a query object’s Filter Clause. Filter clauses now only support the WHERE clause. The following clauses are no longer supported:

  • ORDER BY
  • PAGESIZE
  • PAGEOFFSET

Additionally, users no longer need to enter the keyword WHERE in their filter clauses. For example, in previous releases users would enter a filter clause as WHERE status__v = 'active__v', but now users only need to enter status__v = 'active__v'.

Any existing filter clauses which still have WHERE, ORDER BY, PAGESIZE, or PAGEOFFSET in them after this release must have these keywords removed for the integration to continue to work. We encourage users to make the appropriate changes as soon as 21R1 is released.

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 the following components to support the Link Annotations to Permalinks feature:

  • Added the Bookmark Title (bookmark_title_v) field to the Permalink (permalink_sys) object.

Added the following components to support the Track User, Machine & Vault File Manager Version feature:

  • Added the Vault File Manager User (vfm_user__sys) object.

Added the following component to support future functionality:

  • Added the Model Training VMC Action Complete(vmc_model_training_complete__sys) notification

Clinical Operations

RBSM: Automated Risk Mitigation Actions

This extension of our Risk Based Study Management (RBSM) capabilities includes the ability to define standard Risk Mitigations for potential Risks. Generating a Risk Assessment will automatically pull these mitigations into a Study Risk Assessment. This feature also provides the ability to automatically generate mitigation tasks for users in selected roles to perform for each Study, Study Country, or Study Site. These actions are tracked with Vault’s enhanced issue management capabilities. Learn more about Automated Risk Mitigation Actions.

Issue Management Enhancements

This CTMS feature extends our current Protocol Deviations object to include full Issue Management capabilities. To fully utilize this feature, we recommend that all organizations relabel their Protocol Deviations object to “Issues.” To track preliminary observations and findings in Vault, we have introduced an Observations issue type that users can utilize in conjunction with the Change Issue Type action. Additionally, Admins now have greater flexibility when configuring the requiredness of fields on the Issues (formerly Protocol Deviations) object, such as Category, Sub-Category, and Severity. Learn more about Issue Management.

Change Issue Type Action

The Change Issue Type action allows Admins on CTMS Vaults to configure user actions that change the object type of an Issue (formerly Protocol Deviation) record. This allows users to promote and demote Issue records to other Issue types. For example, users can promote an Observation to a Protocol Deviation.

Seeding Issues on Monitoring Events

This feature allows users to seed open Issues (formerly Protocol Deviations) and Issues closed since the last Monitoring Event within the current Monitoring Event. Additionally, Admins can specify which Issue types seed into Monitoring Events. This action works similarly to the Seed Follow Up Items action.

CRA Homepage Study/Country/Site Quality Widget Enhancements

This feature enhances the CRA Homepage to display all active Issues (formerly Protocol Deviations) object types in the Protocol Deviations and Other Issues graph. This feature also updates widget labels to reflect configured names and introduces the ability to filter based on Issue status.

Safety Distribution Email Support

This enhancement to Veeva Site Connect’s Safety Distribution feature allows users to email Safety Distribution documents to Study Sites not using SiteVault. Safety Documents are bundled into a deduplicated daily digest email and sent to designated Safety Distribution study team members. Vault also provides tracking for email delivery and whether or not recipients have viewed documents. Learn more about Safety Distribution Email Support.

USN Picker

With this feature, users on Clinical Operations Vaults can search for a site’s Universal Site Number (USN) from within their Vault and assign it to an Organization record in their Global Directory. Additionally, users can now easily identify “connected” Organizations and Study Sites via a new visible icon on the object records.

Optional State Change for the Send Document via Clinical Network Action

This feature allows Admins to configure an optional state change on Veeva Site Connect’s Send Document via Clinical Network action. For example, a document can be moved from an In Progress lifecycle state to an At Site lifecycle state automatically once Vault successfully delivers it to a Study Site.

CDMS & Clinical Operations Vault Connection: Procedures

With this release, a new integration is available in the CDMS & Clinical Operations Vault Connection. This feature allows users using both Vault EDC and Vault CTMS to transfer Procedures. An Admin must enable the new standard Procedure Status picklist values and activate the Procedures integration to utilize this feature. Learn more about the CDMS & Clinical Operations Vault Connection.

Note that organizations should not activate this integration on their CDMS and Clinical Operations Vaults until the 21R1 General Release.

TMF Transfer Archived Documents

This feature expands TMF Transfer so it can transfer archived documents from a source Vault. When users select a study to transfer that contains archived documents, Vault creates those documents as archived documents in the target Vault. Additionally, users can now transfer archived Study Sites and Study Countries. Learn more about TMF Transfer.

TMF Viewer for TMF Transfer

This feature allows users who have received documents via TMF Transfer to view those documents in a meaningful hierarchical manner using the TMF Viewer. When users select the RM 2.0, RM 3.0, or Vault Clinical Docs display model of the TMF Viewer, Vault displays documents classified as TMF Document document type based on the Artifact record in its Source Hierarchy field. Learn more about the TMF Viewer.

Clinical Operations & RIM Vault Connection Document Versioning

This feature improves the Clinical Operations & RIM Vault Connection by introducing new versioning behavior for CrossLink documents to keep multiple versions of the same document. When a document reaches Steady state in the source Vault, the target Vault will create a new CrossLink if one does not already exist or version the existing CrossLink if a prior version CrossLink exists. Learn more about the Clinical Operations & RIM Vault Connection.

Clinical Operations & RIM Vault Connection CrossLink Metadata Sync

This feature improves the Clinical Operations & RIM Vault Connection by introducing metadata syncing capabilities across CrossLinked documents. When the fields on a source document for a CrossLink are modified, that document’s fields are updated in the target Vault to reflect the updates. Learn more about the Clinical Operations & RIM Vault Connection.

Create Document from Template Up-Versioning

This feature enhances the existing Create Related Document from Template action to up-version the document instead of replacing the current version, allowing users to track previous versions created using this action.

This action is primarily utilized in CTMS Vaults for monitoring follow up letters and confirmation letters and in Vaults that have Vault Payments enabled to generate payment letters. It is also possible to use this action for a protocol deviation log and study communication log. Learn more about the Create Related Document from Template system action.

Rule Set-Level Field Defaults

This feature allows Admins to create field defaults at the Rule Set- level for Veeva Site Connect and Simple TMF Transfer. Field Defaults no longer need to be created for every Connection.

User Profile Accessible for Existing Site Users

With Platform’s Enhanced User Profile Page feature, Site Users can now access their User Profiles in Clinical Operations Vaults. If necessary, Admins can disable access via the new View User Profile permission flag in the appropriate permission sets.

Yuzu: CTN Enhancements

With this release, we’ve made various enhancements to Yuzu Clinical Trial Notifications, including:

  • Auto-populate the Study Site field on Study Organization and Study Person types of CTN Data records
  • Populate the Site field for Study Organization and Study Person CTN Data
  • CTN generation error dialog now includes a link to the record with error
  • Various Change Log enhancements
  • Trial Applicant / 治験届出者 and Applicant Representative / 治験届出担当者 handling enhancements
  • Validation check for CRO/SMO service area

Clinical Operations Data Model Changes

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

Added the following components to support the CDMS & Clinical Operations Vault Connection: Procedures feature:

  • Added the Procedures (procedures__v) integration to the CDMS/Clinical Operations Connection (cdms_clinops_connection__v) with the Procedures Transfer (procedure_transfer__v) integration point and the Procedure Integration Rule (procedure_integration_rule__v)
  • Added the following standard values to the Procedures Status (procedure_status__v) picklist:
    • Planned (planned__v)
    • Blank (blank__v)
    • In Progress (in_progress__v)
    • Submitted (submitted__v)
    • Did Not Occur (did_not_occur__v)

    • Added the following components to support the RBSM: Automated Risk Mitigation Actions feature:

  • New objects:
    • Risk Mitigation (risk_mitigation__v)
    • Assigned Risk Mitigation (assigned_risk_mitigation__v)
    • Study Risk Mitigation (study_risk_mitigation__v)
  • New Picklists:
    • Mitigation Type (mitigation_type__v)
    • Mitigation Source (mitigation_source__v)
  • Added the Study Risk Mitigation Lifecycle (study_risk_mitigation_lifecycle__v) lifecycle
  • Added the following fields to the Issue (pdv__ctms) object:
    • Study Risk Assessment (study_risk_assessment__v)
    • Study Risk (study_risk__v)
    • Study Risk Mitigation (study_risk_mitigation__v)
  • Added the Country Selected Date (country_selected_date__v) field to the Study Country (study_country__v) object
  • Added the Risk Mitigation Action (risk_mitigation_action__v) object type to the Issue (pdv__ctms) object
  • Added the Risk Mitigation Action Detail Page Layout (risk_mitigation_action__v) page layout to the Issue (pdv__ctms) object
  • Added the Mitigation Action Task (mitigation_action_task__c) Object Message
  • Added the Complete Risk Mitigation (complete_risk_mitigation__v) workflow to the Issues (issues_lifecycle__ctms) lifecycle
  • Added the Assign Risk Action (assign_risk_mitigation__v) workflow user action to the Open state of the Issue (issue_lifecycle__ctms) lifecycle
  • Added the Risk Mitigation Library (risk_mitigation_library__v) tab

    • Added the following components to support the Rule Set-level Field Defaults feature:

  • Added the following object types to the Field Default (cdx_field_default__v) object:
    • Document Field Default (Rule Set) (doc_field_default_rule_set__v)
    • Object Field Default (Rule Set) (obj_field_default_rule_set__v)
  • Added the Rule Set (rule_set__v) field to the Field Default (cdx_field_default__v) object

    • Added the following components to support the Issue Management Enhancements feature:

  • Added the Observation (observation__v) object type to the Issue (pdv__ctms) object
  • Added the standard Monitored Issue (monitored_issue__v) object
  • Added the Resolved Date (resolved_date__v) field to all Issue (pdv__ctms) object types
  • Added custom entry action on the resolved state of the Issues lifecycle that sets Resolved Date (resolved_date__v) to today()

    • Added the following components to support the Safety Distribution Email Support feature (these changes are active only in Vaults with Veeva Site Connect enabled):

  • Added the Safety Distribution Recipient (safety_dist_recipient__v) field to the Team Role (team_role__v) object
  • Added the following fields to the Distribution Task (distribution_task__v) object:
    • Email (email_id__v)
    • Email Recipient (email_recipient__v)
    • Email Status (email_status__v)
    • Email Recipient Type (email_recip_type__v)
    • Email Detail (email_detail_-v)
    • Person (__v)
  • Added the Email (email__v) value to the Delivery Method (delivery_method__v) picklist on the Distribution Task (distribution_task__v) object
  • Added the Safety Distribution Recipient (safety_distribution_recipient__v) picklist field to the Study Team Role (team_role__v) object
  • The Recipient (recipient__v) field on the Distribution Task Recipient (distribution_task_recipient__v) object is no longer required
  • Added the Viewed (viewed__v) value to the Email Status (email_status__v) picklist
  • Added the Email (email__v) value to the Email Status (email_status__v) on the Distribution Task (distribution_task__v) object
  • Added the Safety Distribution Email Notification (safety_distribution_email__v) Object Message

    • Made the following changes to support the USN Picker feature:

  • The USN (usn__v) field on the Organization (organization__v) object is now a Vault-controlled field and limited to valid values in the Global Directory
  • The Organization (name__v) field on the Organization (organization__v) object is now automatically populated based on the value in the USN (usn__v) field

    • Added the following components to support future functionality:

  • Added the following fields to the Distribution Task (distribution_task__v) object:
    • Comments (comments__v)
    • Return Comments (return_comments__v)
  • Added the Default Comments (default_comments__v) field to the Site Package Document (site_package_document__v) object

    • Added the following components to support the Yuzu: CTN Enhancements feature (these components are only active in Vaults with Yuzu enabled):

  • Added the CTN IP Name / 治験薬名称 (ctn_ip_name__v) object
  • Converted the IP Name / 治験薬名称 (ip_name__v) field from Text to Object
  • Added the Original CTN (original_ctn__v) field to the Clinical Trial Notification / 治験届 (ctn__v) object
  • Added the following fields to the CTN Data / 治験届関連情報 (ctn_data__v) object:
    • External ID (External ID)
    • Study Organization Name (study_organization_name__v)
    • Study Organization Site (study_organization_site__v)
    • Study Person Name (study_person_name__v)
    • Study Person Role (study_person_role__v)
    • Study Person Site (study_person_site__v)
  • Added the following lifecycles:
    • CTN Data Lifecycle (ctn_data_lifecycle__v)
    • CTN Data Change Log Lifecycle (ctn_data_change_log_lifecycle__v)
    • CTN Site IP Lifecycle (ctn_site_ip_lifecycle__v)
    • Added the Clinical Trial Notification / 治験届 (ctn__v) shared document field

    Commercial

    Modular Content: Create & Approve Modules

    With this release, users can create and approve content modules that can be reused in multiple material pieces. This feature allows users to relate Claims Library items, image documents, and data assets from within Vault and add text elements and business rulesets, including rules for placement, inclusion, and exclusions. Learn more about Content Modules.

    Capture Adverse Events

    Medical Inquiries are a frequent source of Adverse Events. With this release, a standard object in MedComms Vaults allows users to capture additional data related to Adverse Events as part of Medical Inquiries. This additional data can then be shared to Pharmacovigilance.

    Export Adverse Events to E2B(R3) Compatible Case Safety Report

    This feature is used in conjunction with the standard data model for capturing Adverse Event data as part of a Medical Inquiry and allows users to export the standard Adverse Event data in an XML format using the E2B(R3) standard. The exported data can subsequently be transferred to a Pharmacovigilance/Safety system. Learn more about configuring Medical Inquiry.

    eCTD Compliance Package: Generate Correspondence Letter

    This feature adds the ability to automatically create a Correspondence Letter when generating a Pre-Clearance Compliance Package in Vaults with eCTD Compliance Package Generation enabled. The Correspondence Letter contains information that must be submitted to the FDA, preventing users from manually creating the letter. Learn more about eCTD Compliance Packages.

    Commercial Data Model Changes

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

    The following components have been added to MedComms Vaults:

  • Added the following new objects:
    • Event (event__v) with the object types Base Event (base__v) and Adverse Event (adverse_event__v)
    • Event Report Type (event_report_type__v)
    • Event Reporter Qualification (event_reporter_qualification__v)
    • Event Gender (event_gender__v)
    • Event Outcome (event_outcome__v)
  • Added new document lifecycle Event Generated Document (event_generated_document__c)
  • Added new object lifecycle Event (event_lifecycle__v)
  • Added new document type Individual Case Safety Reports (ICSR) (individual_case_safety_reports__v) with document subtype E2B(R3) (e2br3_v)
  • Added new shared document field Related Event (related_event__v)
  • Added new user action Generate E2B Report
  • Added new notification Generate E2B Report

    • The following components have been added to PromoMats Vaults:

  • Added the following new objects:
    • Content Module (content_module__v)
    • Content Module Asset (content_module_asset__v) with object types Claim (claim__v), Data (data__v), Image (image__v), Text (text__v), and Rule (rule__v)
    • Content Module Ruleset (content_module_ruleset__v)
    • Promotional Material Information (promotional_material_information__v)
    • Ruleset Rule (ruleset_rule__v)
  • Added new document field Promotional Material Information (promotional_material_information__v)
  • Added the following new document types:
    • Content Module (content_module__v) with subtype Approval Document (approval_document__v)
    • Correspondence Letter (correspondence_letter__v)
  • Added new multi-document workflow Content Module Approval Document (content_module_approval_document__v)
  • Added new document lifecycle Content Module Approval Document (content_module_approval_document__v)
  • Added the following new object lifecycles:
    • Content Module Asset Lifecycle (content_module_asset_lifecycle__v)
    • Content Module Lifecycle (content_module_lifecycle__v)
  • Added the following new picklists:
    • Rule Type (rule_type__v)
    • Text Element Type (text_element_type__v)
  • Added the following new notifications:
    • Content Module Workflow Approval Task (content_module_workflow_approval_task_v)
    • Content Module Task Assigned (content_module_task_assigned_v)
    • Content Module State Change Notification (content_module_state_change_notification_v)

    • Quality

    Process Navigator

    The goal of the Process Navigator is to provide a way for customers to define process hierarchies and their supporting documents directly in Vault QualityDocs using a standard data model.

    Documents that support a process can be associated with one or many processes and can be viewed as a user browses their process hierarchy relevant to their role. A purpose-built user interface allows casual end-users an experience that allows them to view process information along with their supporting documents in an intuitive, visually guided way. Learn more about setting up a Process Navigator page.

    Prerequisite Training

    This Vault Training feature allows a customer to require that certain training, which is a prerequisite, is completed first before the next set of training, which has a prerequisite, can be completed by a Learner.

    In this release, a Training Admin can configure a single prerequisite Training Requirement for another Training Requirement. On the Learner Homepage or the Learner Task Page, the system indicates whether the Training Assignment has an incomplete prerequisite and will not allow the Learner to complete training until the prerequisite Training Assignment is completed first. Learn more about setting up prerequisite training requirements.

    Use Document Date Field as Due Date

    With this feature, Vault Training can use document Date fields, such as Proposed Effective Date, as a Training Assignment’s due date when it is assigned due to document revisions. The Training Admin can choose which document Date field to use as the Training Assignment’s due date. The system automatically uses the configured document due date as the Training Assignment’s due date when creating the Training Assignment. Learn more about document revision impact.

    Learner Homepage: Resources Section

    Training Admins can now add and configure a Resources section for the Learner Homepage. The Resources section allows the Learner to view key information about Training, and can contain configurable FAQ information, descriptions, and links to internal or external sites. Learn more about the Learner homepage.

    Learner Homepage: Mobile Web Support

    This feature allows a Learner to view the Learner Homepage from a mobile browser. The Homepage is optimized for mobile devices and allows the Learner to quickly see open Training Assignments, grouped by due date. The Learner can then view and complete Training Assignments from the mobile browser. Learn more about the Learner homepage.

    E-Learning Content Mobile Web Support

    This feature allows a Learner to view and complete e-learning courses, such as SCORM or AICC, from a mobile browser. E-Learning Training Assignment is mobile-optimized and allows the Learner to launch, play, and complete training on the e-learning course. Learn more about completing Vault Training assignments.

    External Training Type Mobile Web Support

    This feature allows a Learner to view and complete External Training Assignments from a mobile browser. The External Training Assignment is mobile-optimized and allows the Learner to view information about the Training, upload attachments, and complete training. Learn more about completing Vault Training assignments.

    Classroom Training Type Mobile Web Support

    This feature allows a Learner to view Classroom Training Assignments from a mobile browser. The Classroom Training Assignment is mobile-optimized and allows the Learner to view key classroom training information, such as when and where class is, as well as view class materials. Learn more about completing Vault Training assignments.

    Quality Teams: Team Role Restrictions & Enhancements

    With this feature, Quality Teams can now be made to enforce business logic rules such as: For a given Deviation, the same person cannot be both Owner and Approver. Quality teams now support the declaration of team roles as exclusive, meaning a given user, if they’re a member of an exclusive team role, cannot also be a member of any other role for that record.

    For customers with existing team-enabled Vault configurations, this feature can be enabled individually on a team-by-team, team role-by-team role basis. Once the feature is enabled, Vault flags affected records as requiring new Team assignments from that point forward. Vault allows reassignment of such invalid assignments, allowing users to select new assignees from the pool of potential assignees for each role impacted by an exclusive assignment, and allowing for the preservation of any assignments to non-exclusive roles.

    In addition to making these Quality Team Role assignment changes, Quality Teams can now be employed on a wider variety of processes and objects, like the QRM Risk Event. Quality Teams now supports objects which are modeled as Child Objects in the Vault, with some exceptions based on the depth of such relationships. Learn more about working with Quality Teams.

    QMS: Product & Supplier Data Model

    With this release, new data model changes are included to improve both our Product hierarchy and our Supplier Quality Management components. For the Product Hierarchy, we introduced additional related objects to optionally support three levels starting at the Product Family level.

    For Supplier Quality Management, we are introducing several data model changes. This includes new Organization object types to distinguish between site locations, a new SCAR object to support Supplier Corrective Action Requests, and a Qualification object that can manage what a given supplier or site is approved and qualified to provide.

    US FDA eMDR: PDF Generation

    With this release, VPS users are able to generate a formatted PDF output of the eMDR 3500A Medwatch form. This PDF form allows users to view the data included in the Adverse Event Report in a more readable format, suitable for sharing within their organization.

    EU MIR: XML Generation

    This feature enables support for generation of EU MIR XML payloads. Users can manually submit the XML payload to the health authorities via email. The generated XML payload adheres to validation criteria provided by EU health authorities.

    EU MIR: PDF Generation

    This feature adds the ability to generate formatted PDF output of the EU MIR form. Customers can use this feature to submit the PDF file manually to the appropriate health authorities within the EU, or to share the information within their organization.

    US FDA eMDR Enhancements

    This feature was postponed to a future release.

    eMDR: Attachment Support for XML Payload

    Customers can now submit any additional information to the FDA in the form of attachments on the XML payload.

    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 and updated the following components to the Quality data model.

    The following changes were made for the QMS: Product & Supplier Data Model to support expanded usage of Supplier Quality Management:

    • Added the following object types to Organization (qms_organization__qdm)
      • Supplier Site (supplier_site__v)
      • Internal Organization (internal_organization__v)
      • Internal Site (internal_site__v)
    • Added the following field to the Organization (qms_organization__qdm) object:
      • Parent Organization (parent_organization__v)
    • Added the SCAR (scar__v) object with the following additional fields:
      • Supplier (supplier__v)
      • Quality Event (quality_event__v)
      • Description (description__v)
      • Title (title__v)
      • Due Date (due_date__v)
    • Added the Qualification (qms_org_qualification__v) object with the following additional fields:
    • Material (material__v)
    • Product (product__v)
      • Part / Component (part__v)
    • Supplier (supplier__v)
    • Qualification Date (qualification_date__v)
    • Expiration Date (expiration_date__v)

    The following changes were made to support expanded usage of a Product hierarchy:

    • Added the Product Family (product_family__v) object with the following additional fields:
      • Therapeutic Area (therapeutic_area__v)
      • Generic Name (generic_name__v)
      • Abbreviation (abbreviation__v)
    • Added the Product Form (product_form__v) object with the following additional fields:
      • Product Family (product_family__v)
    • Added the following field to the Product (product__v) object:
      • Product Family (product_family__v)
      • Product Form (product_form__v)

    The following changes were made to support the Process Navigator feature:

  • Added the Visual Hierarchy (visual_hierarchy__v) object with the following additional fields:
    • Icon (icon__v)
    • Parent (parent__v)
    • Position within Parent (position_within_parent__v)
  • Added the Hierarchy Document (hierarchy_document__v) object with the following additional fields:
    • Hierarchy Record (hierarchy_record__v)
    • Document (document__v)

    • The following changes were made to support the Prerequisite Training feature:

    • Added the following object types to Training Rule Set (training_rule_set__v)
      • Prerequisite Training Rule Set (prerequisite_training_rule_set__v)
    • Added the following fields to Training Rule Set (training_rule_set__v)
      • Training Rule Set Expression (TR ID) (training_rule_set_expression_tr_ids__v)
      • Training Rule Set Expression (Ext ID) (training_rule_set_expression_ext_ids__v)
      • Training Rule Set Expression (Display) (training_rule_set_expression_display__v)
      • Training Requirement Curriculum (training_requirement_curriculum__v)
      • External ID (external_id__v)
    • Added the following object types to Training Rule (training_rule __v)
    • Prerequisite Training Rule (prerequisite_training_rule __v)
    • Added the following fields to Training Rule (training_rule__v)
    • Training Requirement Curriculum (training_requirement_curriculum__v)
      • External ID (external_id__v)
    • Added the following fields to Training Assignment (training_assignment__v)
    • Prerequisite Status (prerequisite_status__v)
    • Training Rule Set Expression (TR IDs) (training_rule_set_expression_tr_ids__v)
    • Training Rule Set Expression (Display) (training_rule_set_expression_display__v)
    • Added the following fields to Related Training Assignment (related_training_assignment__v)
    • Relationship Type (relationship_type__v)
      • Training Assignment Fulfillment Status (training_assignment_fulfillment_status__v)
      • Learner (learner__v)

    The following changes were made to support the Learner Homepage: Resources Section feature:

  • Added the following Layouts to the Vault Training Learner Homepage: My Learning Page (training_my_learning_page__v)
    • My Learning Page Layout (training_my_learning_page_layout__v)

    • The following changes were made to support the Use Document Date Field as Due Date feature:

  • Added the following fields to Training Requirement (training_requirement__v) object:
    • Document Revision Training Due Date (document_revision_training_due_date__v)
  • Added the following fields to Training Requirement Impact Assessment (training_requirement_impact_assessment__v) object:
    • Document Revision Training Due Date (document_revision_training_due_date__v)

    • The following changes were made for the US FDA eMDR Enhancements feature, to support future functionality:

  • Added a new document classification: Attachment (classification_attachment__v)
    • VPS Reportable Event Document > eMDR > Attachment

    • Regulatory

    Create Records in Content Plan Hierarchy Viewer

    Admins can now configure two new record actions for the Content Plan and Content Plan Item objects: Create Sibling and Create Child. These actions allow users to create Content Plan or Content Plan Item records as children or siblings of a record in the Content Plan Hierarchy Viewer. When users select either of these actions from a Content Plan or Content Plan Item record, Vault automatically populates some fields in the record creation dialog based on the source record to streamline record creation. Learn more about creating sibling and child records.

    Asynchronous Content Plan State Change

    This feature allows Admins to configure a new Content Plan Hierarchy State Change system action on a Content Plan object lifecycle or in a workflow. Once configured, initiating this action changes the state of the Content Plan record and all of its descendant Content Plan and Content Plan Item records to the configured next lifecycle state. Rather than needing to remain on the page until the state change completes, Vault now queues and processes the state change asynchronously. The user who initiated the action receives a notification and a downloadable results log once the state change is complete. Learn more about configuring and using asynchronous content plan state changes.

    Auto-Create Product Family & Submission Language Joins

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

    • Create appropriate join records when users populate the Primary Product Family field while creating or updating Application, Clinical Study, Active Substance, Nonclinical Study, and Product object records
    • Create Submission Language join records when users create new Submission Country records, based on the languages associated with that country

    Learn more about automatic record creation in RIM Vaults.

    Sequence ID Automation

    With this release, Admins can choose to allow Vault to automatically set the XML Sequence ID to the next available number within the application. Learn more about Sequence ID automation.

    Retain Expansion Levels & Scroll Position in Content Plan Hierarchy Viewer

    Prior to this release, every time a user opened the Content Plan Hierarchy Viewer, Vault collapsed the Content Plan and Content Plan Item rows and reset the scroll position to the top of the page. Now, Vault remembers which Content Plan and Content Plan Item rows are expanded and keeps them expanded after users complete actions within the viewer, refresh the page, or navigate to another page and back to the same content plan in the viewer within the current browser tab. Additionally, Vault attempts to scroll back to your previous location in the content plan if the page reloads in the same browser tab. Note that Vault does not retain expanded matched document rows in the viewer.

    Split Content Plan Item Order Update

    This release enhances the Split Content Plan Item action. Vault now places newly-created Content Plan Item records directly after the Content Plan Item record that was split, rather than below all of the other records in the same level of the hierarchy. This prevents users from needing to manually reorder split Content Plan Item records to move them to the correct location. Learn more about splitting content plan items.

    Content Plan Hierarchy Viewer Enablement & Permissions Update

    With this release, the legacy Hierarchy Viewer for content plans has been deprecated. We will only introduce new functionality and fix defects for the Content Plan Hierarchy Viewer, which is the newest iteration. In addition, the Enable tree grid checkbox on the Application Settings page is now one-way, meaning that an Admin cannot revert to the legacy Hierarchy Viewer once they enable the updated Content Plan Hierarchy Viewer. We recommend that all customers who are actively using content planning enable the Content Plan Hierarchy Viewer if they have not done so already.

    To make it easier for customers to enable the Content Plan Hierarchy Viewer, this release also automatically grants Read permission for the Hierarchy Path and Hierarchy Level fields on the Content Plan and Content Plan Item objects for permission sets that include Read access to these objects. Admins no longer need to configure permissions for these fields when enabling the viewer.

    Cross-Application & Cross-Reference Leaf Creation

    Users can now create a cross-reference leaf to a leaf that resides in another application or submission. During publishing, Vault will create the leaf correctly within the resulting XML. Learn more about how to create a reference leaf.

    Continuous Non-eCTD Structure & TOC Publishing

    With this release, RIM Submissions Publishing Vaults can continuously publish non-eCTD structures, as well as continuously generate and publish a Table of Contents (TOC) as part of a submission. Learn more about configuring and using TOC publishing.

    Continuous Publishing Prioritization

    With this release, Vault automatically prioritizes continuous publishing jobs based on the value in the Planned Submission Date (planned_submission_date__rim) field on the Submission record. Continuous publishing jobs where the Planned Submission Date is in the next two (2) days will receive the highest priority.

    Update CrossLink Document Fields & Version CrossLinks

    This feature enhances the Clinical Operations & RIM Vault Connection to version CrossLink documents and update document fields. When a source document reaches its Steady state in the Clinical Operations Vault, the RIM Vault checks to see if a CrossLink document already exists for a prior version of the source document. If the connection already created a CrossLink document for a prior version, Vault will version the existing CrossLink document instead of creating a new one.

    In addition, when users update document fields in the Clinical Operations Vault, the RIM Vault updates the connection’s related document fields as well. For example, if a user adds a study to an Investigator’s CV in the Clinical Operations Vault, Vault updates the CrossLink document’s Clinical Study field in the RIM Vault to include the additional study. Learn more about the Clinical Operations & RIM Vault Connection.

    Submissions Archive: South Korea 1.0

    With this release, RIM Submissions Archive Vaults support importing and viewing eCTD submissions based on the South Korea v1.0 DTD.

    Japan eCTD Section Label Update

    This feature updates the Japan eCTD Module 1 to include section numbers as part of the section name.

    API Job ID in Audit Trail

    When a user initiates a submission import via the Vault API, Vault now includes the Job ID assigned to the import in the Submission record’s audit trail.

    New settings on the Application Settings page allow Admins to configure the default naming patterns for Regulatory Objective and Submission records that Vault creates through the Create Related Records wizard. Admins can reference any field on the Event object to define the naming pattern.

    Another setting on the Application Settings page allows Admins to set a default Activity Scope Level in the wizard according to their organization’s business processes. In past releases, Vault automatically selected the first value in the list. Learn more about configuring the Create Related Records wizard.

    Configure Affiliate Home Page Components

    This feature allows Admins to choose which actions and chart panes appear on the Affiliate Home tab. These customization options let customers hide the actions or charts that may not be relevant to their affiliate users. Vault automatically adjusts the Affiliate Home tab based on the Admin’s selections. Learn more about configuring the Affiliate Home tab.

    Configurable Impact Assessment Report Updates

    In past releases, users needed to have a security profile that included the Object: Report: Create permission in order to use configurable impact assessment reports. This feature removes that requirement, making it easier for users to access these reports. With this feature, Vault also saves any values that users enter in the Impact Report Options dialog as report filters when running the report to store a true snapshot of the data input. Learn more about using configurable impact assessment reports.

    Update Country Decision Detail Count Upon Record Deletion

    This feature updates the behavior of the Country Decision Detail Count field on Regulatory Objective object records. When a user deletes a Country Decision Detail record, Vault now updates the Country Decision Detail Count field accordingly to reflect the actual number of related Country Decision Detail records.

    Worksharing Improvements

    This feature updates the bundling and splitting wizards to better support cross-application regulatory objective handling. Vault now correctly updates Country Decision Detail records for cross-application regulatory objectives based on related applications. In addition, this feature includes several UI improvements based on customer feedback.

    Worksharing Improvements: Data Model Update

    This feature adds the Application Regulatory Objective object to the RIM data model. The Application Regulatory Objective object provides a many-to-many relationship between the Regulatory Objective and Application objects to better support complex worksharing and cross-application grouping scenarios.

    As part of the 20R3.4 release, we will automatically populate this object with data for all RIM Vaults. See Data Mapping for IDMP Accelerators & Worksharing Improvements in 21R1 for details.

    The Create Related Records wizard can now populate new objects and fields introduced in 20R3 to support IDMP compliance. This update includes mapping data from Event Shelf Life and Storage and Event Site Role records to the corresponding relationships on Regulatory Objective and Submission records. Learn more about creating related records.

    Include New IDMP Relationships in Create Registrations Wizard

    The Create Registrations wizard can now populate new objects and fields introduced in 20R3 to support IDMP compliance, including the Registered Shelf Life and Storage and Registered Site Role objects as well as new fields on the Registered Indication object. An Admin must make the Submission Shelf Life and Storage object available to users in order for the wizard to populate Registered Shelf Life and Storage data. Learn more about bulk creating product registrations, investigational registrations, and active substance registrations.

    Include New IDMP Relationships in Pull Objective Data Action

    This feature enhances the Pull Objective Data action to support pulling data from the Regulatory Objective record relationships to the Submission record relationships for the Submission Shelf Life and Storage object. An Admin must make the Submission Shelf Life and Storage object available to users in order for Vault to populate data. Learn more about pulling Regulatory Objective data to Submissions.

    IDMP Accelerators: Registered Detail Mapping

    As part of the 20R3.4 release, Vault will map existing values from registered details into new object records to support IDMP functionality. Vault will map data as follows:

  • Vault creates one (1) new Registered Shelf Life and Storage record for each unique combination of Packaging and Shelf Life on existing Registered Packaging records.
  • Vault creates one (1) new Registered Site Role record for each unique combination of Finished Product Manufacturer and Manufacturing Site Role on existing Registered Packaging, Registered Product, Registered Active Substance, and Registered Inactive Ingredient records.

    • Vault will use these new records as a source for IDMP record generation. See Data Mapping for IDMP Accelerators & Worksharing Improvements in 21R1 for details.

    XEVMPD Denominator

    This feature updates validation to include the Unit of Presentation controlled vocabulary in XEVMPD denominator units, in alignment with Article 57 guidance. This update allows users to select both Unit of Measure and Unit of Presentation controlled vocabularies for denominator units in XEVMPD data.

    21R1 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.

    Added the following components to support the Create Records in Content Plan Hierarchy Viewer feature:

    • Added the following object actions to the Content Plan (edl__v) object:
      • Create Sibling
      • Create Child
    • Added the following object actions to the Content Plan Item (edl_item__v) object:
      • Create Sibling

    Added the following components to support the Continuous Non-eCTD & Publishing Elements feature:

    • Added the Publishing Element (publishing_element__v) object.
    • Added the Publishing Element (publishing_element__v) field to the following objects:
      • Content Plan Item (edl_item__v)
      • Content Plan Item Template (edl_item_template__v)
    • Added the Page Numbering (page_numbering__v) picklist.

    Added the following components to support future functionality:

    • Added the following fields to the Medicinal Product (medicinal_product__rim) object:
      • Country (country__v)
      • Product (product__v)
      • Product Variant (product_variant__v)

    Added the following components to support the Worksharing Improvements and Worksharing Improvements: Data Model Update features:

    • Added the following fields to the Regulatory Objective (regulatory_objective__rim) object:
    • Reviewing Country (reviewing_country__v)
      • Worksharing Tracking Number (worksharing_tracking_number__v)
  • Added the Worksharing (worksharing__v) object type to the Regulatory Objective (regulatory_objective__rim) object.
  • Added the Application Regulatory Objective (application_regulatory_objective__v) object.

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

    • Added the Product Classification (product_classification__v) object.
    • Added the Applicable Product Type (applicable_product_type__v) field to the Regulatory Objective (regulatory_objective__rim) object.
    • Updated the Vault RIM UUID (vault_rim_uuid__v) field on the Country Language (country_language__v) object to require unique values.
    • Added the Published by Vault (published_by_vault__v) field to the following objects:
      • Dossier Detail (dossier_detail__v )
      • Content Plan Item (edl_item__v)
  • Removed the following lookup fields from the Content Plan Item (edl_item__v) object:
    • Report Level Plan Clinical Study (report_level_plan_clinical_study__v)
    • Report Level Plan Nonclinical Study (report_level_plan_nonclinical_study__v)
    • Report Level Plan Product Family (report_level_plan_product_family__v)
    • Submission Active Substance (submission_active_substance__rim)
    • Submission Country (submission_country__rim)
    • Submission Inactive Ingredient (submission_inactive_ingredient__rim)
    • Submission Indication (submission_indication__rim)
    • Submission Language (submission_language__rim)
    • Submission Pharmaceutical Form (submission_pharmaceutical_form__v)
    • Submission Product (submission_pharmaceutical_product__rim)
  • Updated the cloning rules for the Risk Class (risk_class__v) and Country Language (country_language__v) objects so that cloning a sandbox Vault to a production Vault copies object records from these objects.

    • 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.

    Safety

    Safety features are targeted for tentative availability on February 10, 2021.

    Duplicate Detection Using External System UID Auto-on

    Vault Safety now uses the External System UID for duplication detection. The system returns potential matches for Cases that match only this field on an Inbox Item or AER.

    Learn More: Promote to Case: Overview of Duplicate Detection

    Support Reason Omitted “Other” Auto-on

    You can now select “Other” as a Reason Omitted value for the Race (FDA.D.11) and Vaccination Facility (FDA.G.k.4.r.14.8) fields. The nullflavor value “OTH” is mapped to reason omitted “Other” as part of the FDA VAERS E2B R3 export operations.

    Learn More:

    Pregnancy Cases and Additional Pregnancy & Child Fields to Support Vaccine Configuration

    You can now create and track Pregnancy Cases in Vault Safety via the Parental Information Case.

    Pregnancy outcome without an adverse event in the neonate is captured through the Child Information object, in which case Test Results are automatically generated for the APGAR scores (1, 5, and 10 minute), Birth Outcome, and Head Circumference. In the event that the pregnancy outcome results in an adverse event in the neonate, the information can be captured as a regular Case with a reference to the Parental (Pregnancy) Information Case.

    Learn More: Add a Pregnancy Case

    Case Approval Date Filter for PBRER, PSUR, and DSUR Configuration

    Vault Safety now provides the option to filter PBRER, PSUR, and DSUR reports using either the Case Approval Date or the Case Receipt Date / New Info Date. Users can configure the date filtering option using the Filter Case By field on the Aggregate Report record. The system will continue to use the Case Receipt Date / New Info Date by default.

    Learn More:

    PADER Transmission Date Filter Auto-on

    Vault Safety now filters PADER reports based on Transmission Date by default, which allows a firm cutoff date for including cases in the report. Cases with multiple versions for initial, follow-up or amendment reasons within the same reporting period are counted as initial in the PADER. In the 15 Day Summary Reports, the system considers additional criteria to identify fatal cases.

    Learn More:

    PADER Subtotal/Grand Total and New Appendices Configuration

    PADER now includes two new appendices: Non-Primary Suspect Product Report, and List of Death Cases. Additionally, Subtotals and Grand totals are now displayed in the Summary Tabulation of ADRs.

    Learn More: Create PADER Aggregate Reports

    PSUR: Time to Onset and Group by PT Auto-on

    PSUR line listings have been enhanced to add a Time of Onset column. In addition, the PSUR Summary Tabulations report has been updated to remove reported (verbatim) event names, and ensure that events with the same PT are displayed in the same row.

    Learn More:

    Submissions: Local Expedited, Downgrade, Postmarket Study Configuration

    In this release, Vault Safety is upgrading its agency submission capabilities to more precisely handle a number of submission scenarios and requirements. This includes local expedited criteria that are rules-driven, downgrades (also known as the one-last-time rule), and non-interventional postmarket studies. When ready, customers can transition to the new FDA and EMA submission rule sets that exercise the new capabilities.

    Learn More:

    CIOMS: Assessment Section Updates Auto-on

    The Assessment Results section listed on the CIOMS I overflow pages has been updated to ensure values display properly, including blinded (placeholder) product names.

    Learn More: CIOMS I Generation Data Mapping: Additional (Overflow) Pages

    CIOMS/Medwatch: Display of PT/LLT for AEs Support

    Vault Safety now supports the ability to display adverse events using the MedDRA Preferred Term (PT) on CIOMS I and MedWatch 3500A forms. This feature is available by request only. Contact Veeva Support to request this feature.

    Learn More:

    Submission Validation: VAERS E2B (R3) Validation Auto-on

    This feature extends the ICH validation existing objects - Validation Criteria and Validation Result objects - through the addition of Agency-specific rules and the ability for a rule to supersede another rule. The feature also extends the validation criteria with preloaded VAERS E2B R3 conformance rules.

    A Submission file in the VAERS E2B R3 format is automatically validated once it is generated/regenerated.

    Validation Result records are created based on each evaluated Validation Criteria and can have an outcome of Pass, Fail, or Warning.

    Learn More: Case and Submission Validation

    Submission Validation: EMA E2B R3 Validation Auto-on

    This feature utilizes the same data model as the ICH and VAERS validation - Validation Criteria and Validation Result objects - and extends the validation criteria with preloaded EMA E2B R3 conformance rules.

    A Submission file in the EMA E2B R3 format (including MHRA submission) is automatically validated once the file is generated or regenerated.

    Validation Result records are created based on each evaluated Validation Criteria and can have an outcome of Pass, Fail, or Warning.

    Learn More: Case and Submission Validation

    Automatic PDF Form Intake Configuration

    Safety.AI will automate intake from PDF forms using Artificial Intelligence and Machine Learning. A new User Action on Vault library documents will allow users to start the extraction process from the document text. Upon successful completion, an Inbox Item will be created with the extracted case information for the Reporter, Patient, Adverse Events and Products and prioritized (P1 to 3) based on the detected seriousness.

    MedDRA Auto-Coding For Intake API and PDF Forms Auto-on

    When an Inbox Item is created from data received through the Intake API or extracted from a PDF form, Safety.AI initiates MedDRA auto-coding. MedDRA auto-coding extends to all MedDRA fields on an Inbox Item with corresponding verbatim (“as reported”) fields. Auto-coding is based on an exact match (case insensitive) search across all MedDRA PTs/LLTs.

    Learn More: Inbox Item Field Reference

    Dosage Extraction From Text Auto-on

    Safety.AI will automatically extract the dose and administration dates from unstructured text and PDF forms, and link them to their case products. The dosage information will be populated with a confidence icon and the source text will show in the Source Data pane to facilitate human verification.

    Multiple Candidates for Dates and Reporter Country Auto-on

    Safety.AI will now show up to four candidates for Date and Country fields supported for extraction from text. Safety.AI will show the confidence level icon for each value and populate the one with the highest confidence score.

    QualityOne

    Comments on Objects with User Mentions

    Once configured on an object, this feature allows an internal user to collaborate with other internal users or external users (suppliers, etc.) on various QualityOne processes. Admins can configure the Comments object for both custom and standard objects. Users creating the Comment record can mention other users using the @/+ signs. Mentioned users are notified via an email and an in-app notification each time they are mentioned in a comment. Learn more about configuring and using comments for QualityOne objects.

    Support for Multiple Findings on Audit Checklist Responses

    This feature allows users to create one or more audit finding records from a checklist respondent UI when the checklist target object is Audit. Previously, users were able to flag a question with only one Finding? each, creating a single Finding record when the checklist is completed. Learn more about Audit Findings.

    QualityOne: Root Cause Analysis support on NCR and HSE Event

    This feature offers users the ability to perform 5Whys Analysis from the NCR and HSE Event object. For every parent of the Root Cause Analysis object, the system automatically creates the related 5Whys Root Cause record for each corresponding Why record identified as a root cause. Learn more about Root Cause Analysis.

    Inspection Sampling & Evaluation

    This feature allows users to define sample and success criteria using a fixed number or percentage of the total method for incoming, in-process, and outgoing inspection types. Users run an action to generate the sample records with inspection test results based on the sample size and method. The success criteria analyzes the status of every sample and provides an immediate inspection result, saving time and improving efficiency. Learn more about using Inspections Sampling and Evaluations.

    Incident Management Standard Object Enhancements

    This feature provisions additional fields for the incident management object model. The improved object model allows organizations to better report, track, and manage safety, environmental, vehicle, and property damage incidents. The improvement simplifies implementation and represents health and safety processes best.

    RegulatoryOne

    Obsolete Raw Material Token feature

    Note that this feature applies to customers who adopted RegulatoryOne up to, and including, 20R3.

    The Submission Content Plan token ${submission_raw_material__v} is no longer supported. Admins can no longer reference the Submission Raw Materials token in cosmetic Content Plan Templates and will not generate Content Plan sections for each Submission Raw Material Variant record.

    Obsolete RegulatoryOne Data Model

    Note that this feature applies to customers who adopted RegulatoryOne up to, and including, 20R3.

    The following standard objects will no longer be available:

    • Substance Restriction
    • Submission Substance Restriction
    • Ingredient List
    • Ingredient List Product Variant
    • Ingredient List Active Substance
    • Submission Ingredient List
    • Raw Material
    • Raw Material Variant
    • Product Variant Raw Material
    • Raw Material Variant Active Substance
    • Submission Raw Material
    • Formula Ingredient Function

    Users can view existing records in these objects but cannot create or edit existing records. Users cannot select a reference to an existing record in these objects from a related object but can view existing references to existing records in these objects from related objects.

    Registration & Dossier Management Data Model

    Note that this feature applies to customers who adopt RegulatoryOne for 21R1. Note that this feature is targeted for tentative availability on February 16th.

    This feature provisions a standard object model for Registration & Dossier Management as a first step towards allowing organizations to create events that require regulatory work to be completed, as well as related requests, registrations, and requirements.

    Product Hierarchy Data Model

    Note that this feature applies to customers who adopt RegulatoryOne for 21R1. Note that this feature is targeted for tentative availability on February 16th.

    Consumer and chemical products and their associated formulations can form multilevel hierarchical relationships. With this release, we are introducing a shared standard product hierarchy data model that can be leveraged to store complex hierarchical products to reduce reliance on customization.

    These data model changes are automatically included in RegulatoryOne, but Admins must make configuration changes to make them available.

    Note that this feature is also available for Veeva Claims.

    Veeva Claims

    Note that Veeva Claims features are targeted for tentative availability on February 16th.

    Auto-Populate Local Pack Copy

    Pack Copy is a specification document that brand marketers create in order to deliver the packaging specifications of a product to artwork and creative teams. In order to service multilingual and global markets, Marketers need to localize Global Pack copy specifications to specify and translate locale-specific Pack Copy elements.

    The auto-populate pack copy capability enables users to create a new local pack copy with already-translated or to-be translated localized elements. This feature allows translators to add the missing translations for a single country in multiple languages in a single view. Learn more about configuring auto-populate local pack copy.

    Pack Copy Hierarchy Viewer Enhancement

    This enhancement ensures consistent performance for the Pack Copy Hierarchy Viewer. If a hierarchy contains more than 10 Pack Levels or more than 500 Panels, the section displays a message to users instead of all records. Learn more about the Pack Copy Hierarchy Viewer.

    Self-Referencing Statement Records

    This feature allows users to store statement translations in the statement library. The translated statement records are tied to the global statement record. Learn more about self-referencing statements.

    Product Hierarchy Data Model

    See: feature description.

    SiteVault

    SiteVault & MyVeeva for Patients: eConsent

    This feature allows site users to consent study participants electronically using Veeva eConsent and MyVeeva for Patients:

    • Site users can create new study eConsent documents either from a template or by copying an existing study eConsent document. The user can then edit the document in their browser using the Edit eConsent action and the Veeva eConsent editor.
    • Site users can select and send one or more steady-state eConsent documents to the participant. The participant receives the forms in MyVeeva for Patients, where they can review and sign electronically. When the participant signs the forms, the forms are automatically uploaded to SiteVault and routed to the site user for countersignature.
    • Site users can cancel eConsent documents that have already been sent to a participant. This enables site users to correct sent eConsent documents and resend for approval.
    • When a participant signs a new version of an eConsent document, the newly signed document becomes the steady-state version and the previous steady-state version, if present, is superseded.

    Veeva eConsent is currently available to early adopters in SiteVault Free, and it will be available in SiteVault Enterprise with Veeva 21R1 in April 2021. If you are interested in becoming an early adopter, contact your Veeva representative to learn more.

    Research Organization Defaulting on Record Updates

    When an existing document or object is updated, the Research Organization field is defaulted in the same manner as it was defaulted on record creation. This behavior is part of a series of updates introducing the Research Organization object.

    Document Deletion Data Model Updates

    This release includes the following components to support the upcoming Deleting Documents feature:

    • Added the following objects:
      • Deleted Document Details (deleted_document_details__v)
      • Deleted Document Form (delete_document_form__v)
      • Deleted Document Record (deleted_document_record__v)
    • Added Deletion Reason (deletion_reason__v) picklist that is used in deleted_document_details__v and delete_document_form__v objects.
    • Added the Deleted Document Records (study_deleted_document_records__v) sub-tab to the Reporting (reporting__c) tab.
    • Added the Deleted Document Records View (deleted_document_records_view__v) permission set.

    Enablement Details

    Name Enablement Application
    Working with Documents
    Link Annotations to Permalinks Admin Checkbox Platform
    Video Review: Bring Forward Annotations Auto-on Platform
    Annotate Filters: Enhancements Auto-on Platform
    Document Inbox Drag & Drop Auto-on Platform
    Always Display the Document Inbox Auto-on Platform
    Document Inbox Improvements Auto-on Platform
    Updated UI for Add Renditions Auto-on Platform
    Template Search Enhancements Auto-on Platform
    Increase to Maximum Source File Size for Videos Auto-on Platform
    Vault Objects
    Related Document Section Filters Configuration Platform
    Rich Text Fields for Vault Objects Configuration Platform
    Lifecycle & Workflow
    Object Lifecycle & Workflow: Long Text & Rich Text Fields Configuration Platform
    Object & Multi-Document Workflow: Replace Workflow Owner Auto-on Platform
    Object & Multi-Document Workflow: Timeline View & Task Bar Enhancements Auto-on Platform
    Object & Multi-Document Workflow: Capacity Without Requiring eSignature Configuration Platform
    Multi-Document Workflow: Use Role as Participants Auto-on Platform
    Multi-Document Workflow: Optional eSignature Manifesting on Documents Configuration Platform
    Multi-Document Workflow: Edit Document Fields Auto-on Platform
    Object & Multi-Document Workflow: Reassignment Task Event in Update Sharing Settings Configuration Platform
    Inactivate Roles Used in Multi-Document Workflows Auto-on Platform
    Reporting
    Multi-Pass Reports Support Binders & Document Relationships Configuration Platform
    Enhanced Support for Rich Text & Long Text in Reports Auto-on Platform
    Formula Fields in Document Reports Auto-on Platform
    Improved Handling of Hyperlinks in Excel Exports Auto-on Platform
    Additional Functions in Report Date Filters Auto-on Platform
    Exports of Icon Fields in Reports Return Alternative Text Auto-on Platform
    Auditing
    Document ID in Document Audit Exports Auto-on Platform
    Search
    Expanded Search Configuration Platform
    Checklists
    Checklists: Updated Confirmation Banner & Send Confirmation Notification After Starting a Checklist Auto-on Platform
    Auto Claims Linking
    Auto Claims Linking: Display Match Text Variation in Info Card Auto-on Platform
    Auto Claims Linking: Configurable Columns in Select Claims Dialog Auto-on Platform
    Vault File Manager
    Upload Large Size Asset Renditions Using Vault File Manager Auto-on Platform
    Track User, Machine & Vault File Manager Version Auto-on Platform
    Administration
    Enhancements to Document Name Inheritance Auto-on Platform
    Templates: Hide Inactive Document Types Auto-on Platform
    Web Tab URL Tokens Configuration Platform
    Enhancements to API Limits Auto-on Platform
    Access Control
    Enhanced User Profile Page Auto-on Platform
    Flexible DAC Field Mapping Configuration Platform
    Vault Loader
    File Staging for Vault Loader CLI Auto-on Platform
    Vault Loader Where Clause Validation Auto-on Platform
    Vault Java SDK
    Inactivate Standard Integration Rules & Edit Field Defaults on Standard Field Rules Auto-on Platform
    Separate Job Queue & Spark Queue Permissions Auto-on Platform
    Query Object Rules Filter Clause Enhancements Auto-on Platform
    Platform Data Model Changes
    Platform Data Model Changes Auto-on Platform
    Clinical Operations
    RBSM: Automated Risk Mitigation Actions Configuration CTMS
    Issue Management Enhancements Configuration CTMS
    Change Issue Type Action Configuration CTMS
    Seeding Issues on Monitoring Events Configuration CTMS
    CRA Homepage Study/Country/Site Quality Widget Enhancements Auto-on CTMS
    Safety Distribution Email Support Configuration CTMS, SiteConnect, Study Startup, eTMF
    USN Picker Configuration CTMS, SiteConnect, Study Startup, eTMF
    Optional State Change for the Send Document via Clinical Network Action Configuration SiteConnect
    CDMS & Clinical Operations Vault Connection: Procedures Configuration CTMS
    TMF Transfer Archived Documents Auto-on Veeva Clinical Network
    TMF Viewer for TMF Transfer Auto-on CTMS, Study Startup, eTMF, Vault Payments
    Clinical Operations & RIM Vault Connection Document Versioning Auto-on1 eTMF
    Clinical Operations & RIM Vault Connection CrossLink Metadata Sync Auto-on1 eTMF
    Create Document from Template Up-Versioning Auto-on CTMS, Study Startup, Vault Payments, eTMF
    Rule Set-Level Field Defaults Configuration CTMS, SiteConnect, Study Startup, eTMF
    User Profile Accessible for Existing Site Users Auto-on CTMS, SiteConnect, Study Startup, eTMF
    Yuzu: CTN Enhancements Auto-on CTMS
    Clinical Operations Data Model Changes Auto-on CTMS, SiteConnect, Study Startup, Vault Payments, eTMF
    Commercial
    Modular Content: Create & Approve Modules Configuration PromoMats
    Capture Adverse Events Configuration MedComms
    Export Adverse Events to E2B(R3) Compatible Case Safety Report Configuration MedComms
    eCTD Compliance Package: Generate Correspondence Letter Configuration PromoMats
    Commercial Data Model Changes Auto-on MedComms, PromoMats
    Quality
    Process Navigator Configuration QualityDocs
    Prerequisite Training Configuration Training
    Use Document Date Field as Due Date Configuration Training
    Learner Homepage: Resources Section Configuration Training
    Learner Homepage: Mobile Web Support Configuration Training
    E-Learning Content Mobile Web Support Configuration Training
    External Training Type Mobile Web Support Configuration Training
    Classroom Training Type Mobile Web Support Configuration Training
    Quality Teams: Team Role Restrictions & Enhancements Configuration QMS
    QMS: Product & Supplier Data Model Auto-on QMS
    US FDA eMDR: PDF Generation Auto-on Surveillance
    EU MIR: XML Generation Auto-on Surveillance
    EU MIR: PDF Generation Auto-on Surveillance
    US FDA eMDR Enhancements Auto-on Surveillance
    eMDR: Attachment Support for XML Payload Auto-on Surveillance
    Quality Data Model Changes Auto-on QMS, QualityDocs, Station Manager, Surveillance, Training
    Regulatory
    Create Records in Content Plan Hierarchy Viewer Configuration RIM Submissions
    Asynchronous Content Plan State Change Configuration RIM Submissions
    Auto-Create Product Family & Submission Language Joins Admin Checkbox RIM Publishing, RIM Registrations, RIM Submissions, RIM Submissions Archive
    Sequence ID Automation Admin Checkbox RIM Publishing
    Retain Expansion Levels & Scroll Position in Content Plan Hierarchy Viewer Auto-on RIM Submissions
    Split Content Plan Item Order Update Auto-on RIM Submissions
    Content Plan Hierarchy Viewer Enablement & Permissions Update Auto-on RIM Submissions
    Cross-Application & Cross-Reference Leaf Creation Auto-on RIM Publishing
    Continuous Non-eCTD Structure & TOC Publishing Configuration RIM Publishing
    Continuous Publishing Prioritization Auto-on RIM Publishing
    Update CrossLink Document Fields & Version CrossLinks Auto-on1 RIM Submissions
    Submissions Archive: South Korea 1.0 Auto-on RIM Submissions Archive
    Japan eCTD Section Label Update Auto-on RIM Submissions Archive
    API Job ID in Audit Trail Auto-on RIM Submissions Archive
    Configuration Options for Create Related Records Wizard Configuration RIM Registrations
    Configure Affiliate Home Page Components Admin Checkbox RIM Registrations
    Configurable Impact Assessment Report Updates Auto-on RIM Registrations
    Update Country Decision Detail Count Upon Record Deletion Auto-on RIM Registrations
    Worksharing Improvements Auto-on RIM Registrations
    Worksharing Improvements: Data Model Update Configuration RIM Registrations
    Include New IDMP Relationships in Create Related Records Wizard Auto-on2 RIM Registrations
    Include New IDMP Relationships in Create Registrations Wizard Configuration RIM Registrations
    Include New IDMP Relationships in Pull Objective Data Action Configuration RIM Registrations
    IDMP Accelerators: Registered Detail Mapping Auto-on RIM Registrations
    XEVMPD Denominator Auto-on RIM Registrations
    21R1 Regulatory Data Model Updates Auto-on RIM Publishing, RIM Registrations, RIM Submissions, RIM Submissions Archive
    QualityOne
    Comments on Objects with User Mentions Support QualityOne
    Support for Multiple Findings on Audit Checklist Responses Auto-on QualityOne
    QualityOne: Root Cause Analysis support on NCR and HSE Event Auto-on QualityOne
    Inspection Sampling & Evaluation Configuration QualityOne
    Incident Management Standard Object Enhancements Auto-on QualityOne
    RegulatoryOne
    Obsolete Raw Material Token feature Auto-on RegulatoryOne
    Obsolete RegulatoryOne Data Model Auto-on RegulatoryOne
    Registration & Dossier Management Data Model Configuration RegulatoryOne Registration & Dossier Management
    Product Hierarchy Data Model Configuration RegulatoryOne Compliance Management, RegulatoryOne Registration & Dossier Management, RegulatoryOne Regulatory Documents
    Veeva Claims
    Auto-Populate Local Pack Copy Configuration Veeva Claims
    Pack Copy Hierarchy Viewer Enhancement Auto-on Veeva Claims
    Self-Referencing Statement Records Configuration Veeva Claims
    Product Hierarchy Data Model Configuration Veeva Claims
    SiteVault
    SiteVault & MyVeeva for Patients: eConsent Auto-on SiteVault Enterprise, SiteVault Free
    Research Organization Defaulting on Record Updates Auto-on SiteVault Enterprise, SiteVault Free
    Document Deletion Data Model Updates Auto-on SiteVault Enterprise, SiteVault Free
    1. Auto-on in Vaults with the Clinical Operations & RIM Vault Connection enabled.
    2. Auto-on in Vaults with objects and fields introduced in 20R3 configured.

    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.

    Known Issues

    Clinical Operations (DEV-379562)

    In Vaults that contain TMF Documents with Source Artifacts that are not mapped to Type Defaults, non-TMF Documents may appear in the incorrect classifications in the Vault Clinical Docs view model of the TMF Viewer.