New in 19R3.5: Manager Groups and more

Release Date: March 6, 2020

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

Users & Groups

Manager Groups

When this functionality is enabled, Vault creates system-managed groups that include each user’s direct manager. Manager Groups is a platform feature, but it also supports the Manager Access to Training Records feature for Vault Training. Learn more in Creating & Managing Groups.

This feature leverages the Manager field on User object records. If this field is blank for someone’s User record, Vault will create the manager group, but it will have no members. When the reporting hierarchy changes and an Admin updates User records, Vault updates the manager group memberships accordingly.

Manager groups show throughout Vault in user and group selectors. Each user’s manager group will appear directly below the user. Manager groups can be used like other user groups, for example, to provide access to a document or object record.

Example Manager Groups

Gladys is a manager. Her direct reports are Carla and Cody. Gladys also has a manager, Theresa. Theresa’s User record does not include a manager.

Manager Groups functionality automatically creates the following groups:

• Carla – Manager:
  • Gladys (direct manager)
• Cody – Manager:
  • Gladys (direct manager)
• Gladys – Manager:
  • Theresa (direct manager)
• Theresa – Manager:
  • No members because the Manager field on Theresa’s User record is not populated

User Object Page Enhancements

This feature introduces enhancements to the updated Admin > Users & Groups > Vault Users page and the User object, including:

• The ability for Admins to filter for users by lifecycle state on the Vault Users list page
• A Study Site Assignments section for users with the Portal-only license type in Clinical Operations Vaults
• An Edit Localized Labels field on the User object to support Vaults with multilingual labels enabled
• A banner at the top of the User record details page to alert the Admin when the user has been locked out of their Vault due to too many failed password attempts
• An update to highlight the Security Profile field in yellow on User records to indicate that the field is required

Learn more about managing users.

System Owned User Field

In this release, the Veeva Clinical Network User is now correctly set as Yes for the System Owned User. Admins can no longer edit any fields for the Veeva Clinical Network User.

Working with Documents

New OCR Limits

This feature improves usability and supportability of the OCR (Optical Character Recognition) rendering feature by clearly defining maximum default limits for documents to be processed for OCR. These new limits include a maximum number of pages for PDF and TIFF files, as well as maximum file sizes for all documents that support OCR. Learn more about viewable renditions.

Collaborative Authoring with Microsoft Office Usability Enhancements

When working with a document in Vault, users have a new option in the Action menu: Edit in Microsoft Office. This option checks out the document and starts a collaborative authoring session. If the document is already checked out for collaborative authoring, this option opens the Microsoft Office editing view. Learn more about Collaborative Authoring.

Vault Objects

Deletion Rule Label Updates

This feature updates the labels of the Deletion Rule drop-down options on both object reference fields and document reference fields to more accurately reflect the functionality.

For example, the rule to block object record deletion is now labeled Prevent deletion of related object record. The rule to allow object record deletion is now Set field to blank when related record is deleted. Learn more about deletion rules for document reference fields and object reference fields.

Lifecycle & Workflow

Multi-Document Workflow: Add Participants, Reassign Tasks & Start Workflow Respect Constraints

In past releases, participant controls did not respect the Roles allowed to participate constraints configured in the workflow start step. With this release, Vault will respect those constraints when adding participants, reassigning tasks, and starting multi-document workflows. If a workflow configuration uses this setting, Vault will only allow selection of a user who belongs to the specified role in all content documents. Learn more about Multi-Document Workflows.

Search

Truncate Long URLs on Internet Explorer

On Internet Explorer™ browsers, Vault now shortens URLs that contain more than 2,000 characters. This can happen when users search for documents or object records using many filters or when the grid view displays a large number of columns.

Constrain Filter Value Lookups by Search Results

With this feature, Vault constrains object reference field values in filter value searches on document tabs. These filters now only return values that are included in a user’s search results. Vault no longer supports using double quotation marks when searching for filter values, but users will not need to use these when searching for multi-term values.

Reporting

Multi-Pass Reporting: Ladder Scenario

This enhancement to the Multi-Pass reporting feature adds further flexibility to the data models it can support, and introduces a Date report type. Admins may now define multi-pass report types that contain entities with multiple inbound references and the entities making those references. For example, a parent with multiple children. The Date report type can be used in multi-pass reports to present activity timelines, such as Regulatory’s Application Chronology Report. Learn more about Multi-Pass reports.

Minor Enhancements

Localize Vault to Dutch

Veeva Vault UI now supports Dutch for customers that request it through Veeva Support. Users can update the language Vault displays for them by changing the language settings on the User Profile page. Vault also supports setting Dutch translations for labels in user-configurable data such as document types, fields, picklist values, and lifecycle names. Learn more about supported languages and localization settings.

Commercial

Auto Claims Linking: Where Used Component

The Where Used component is visible in PromoMats Vaults where Auto Claims Linking is enabled. From the Claim Detail page, it displays a list of documents where suggested links have been generated from the Claim. Each row includes the linked document and version, as well as sortable columns containing counts for total Suggested Links plus totals for each suggestion’s status: Pending, Accepted and Rejected. Learn more about the Where Used Component.

Enablement Change: Standard Metrics (Non-Mandatory)

The PromoMats Standard Metrics feature allows brand and MLR teams to unlock key metrics about their content and MLR process. Released in 19R3 as an optional feature, Standard Metrics will be auto-on for all customers in 20R1. Note that we will not make these fields mandatory as part of the 20R1 release.

Standard metrics introduces the following document fields:

• Global Content Type
• Content Creation Currency
• Content Creation Cost

For existing documents, Vault automatically sets any blank values for these fields to Not Specified.

Permission Sets

By default, the following permission sets include Read access to the Content Creation Currency and Content Creation Costs objects:

• Custom permission sets included in the PromoMats template: PromoMats User Action and External PromoMats User Action
• Standard permission sets: Business Administrator Actions, External User Actions, Full User Actions, Read Only User Actions, System Administrator Actions, and Vault Owner Actions

Any new permission sets created after 20R1, Admins will need to update permission sets to allow Read access to these objects so that those users can add the standard metrics records for cost and currency. Users need to have this access in order to populate the newly required fields.

Enhanced Medical Inquiry Email Capabilities

Medical Inquiry allows users to respond to medical inquiries via email directly from MedComms. This feature enhances these email capabilities by:

• Tracking sent emails and, notifying the user if and why an email was not successfully delivered
• Logging sent emails by writing the status of the email in the audit trail and storing a record what was sent
• Including a “Reply to” email address in the response sent, so that the recipient can easily reply to the user who emailed the response by clicking reply in their email client

Learn more about Medical Inquiry and Configuring Email Tracking.

New Shared Field for CLM iOS Native Resolution

For 20R1, Veeva CRM for iOS is implementing native resolution for CLM content. Currently, all CLM content, regardless of iPad size and resolution, is fixed at 1024 x 768 px. With the introduction of native resolution, CLM content renders in the actual resolution for 10.5”, 11”, and 12.9” iPads.

This CRM change has the potential to cause content that is hardcoded to 1024 x 768 px to display incorrectly. To better support existing content, users can populate the new shared document field iOS Resolution (ios_resolution__v). This field will control how CRM adjusts and renders content:

• Default for Device displays in the device’s native resolution
• Scale to 1024×768 fixes the resolution and displays the content centered and letterboxed
• Scale to Fit stretches the content to full screen

If the field is not populated, Vault will default it to Scale to 1024×768.

Clinical Operations

Vault EDC/CTMS Connection with Spark

In previous releases, customers could use the EDC to CTMS Connection feature to facilitate the exchange of data from an EDC Vault to a CTMS Vault using an FTP server.

This new feature introduces an improved method of connecting EDC and CTMS Vaults using Spark Messaging. This connection adds the capability for customers who own both the Vault EDC and Vault CTMS applications to transfer the following record data:

Vault CTMS to Vault EDC:

• Studies
• Study Countries
• Sites

Vault EDC to Vault CTMS:

• Subjects
• Subject Visits (Events in Vault EDC)
• Visit Definitions (Event Definitions in Vault EDC)

Learn more about the EDC/CTMS Spark connection.

eTMF to Submissions Connection

This feature leverages the Spark Messaging framework to connect Clinical Operations eTMF Vaults to RIM Submissions Vaults and automate the creation of CrossLink documents between the two Vaults. Using Spark Messaging, Vault can:

• Transfer Clinical Studies and Sites from the eTMF Vault to the Submissions Vault when a user creates or updates a record
• Transfer Product Family records from the Submissions Vault to the eTMF Vault when a user creates or updates a record
• Automatically create a CrossLink document in one Vault after the document is approved in the other

The eTMF to Submissions connection uses Spark Messaging Integration Rules to define which documents, records, and fields to transfer, as well as Reference Lookups to translate field values across Vaults. Learn more about configuring the eTMF & Submissions Spark Connection and how the eTMF & Submissions connection works.

Agreement Wizard

Agreement Wizard is a new interface that streamlines and improves the process of accepting a Clinical Network Agreement by making the associated changes clearer and more readable. Users assigned the task of accepting an incoming agreement will see this new interface. This presents a short description of the changes the agreement will make in their Vault. Next, they have the option of linking the agreement to an existing study in their Vault, or allowing the agreement to create a new study.

Study Team Role Field Enhancements

This feature allows users to edit the following fields on a Study Team Role record when the Study Team Role record is referenced by a User Role Setup record:

• Name (name__v)
• Description (description__v)
• Monitoring Visit Participant (monitoring_visit_participant__v)
• Link (link__sys)

Clinical Operations Data Model Changes

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

Added the following components to the support the Submissions to eTMF Connection feature:

• Added the Site Country (site_country__v) field on the Site (clinical_site__v) object
• Added the Inbound Transfer Document State Type to document lifecycles
• Added the Clinical to RIM Connection Document Type Group

Added the following components to the support the Vault EDC/CTMS Connection with Spark feature:

• Added Connect to Vault CDMS (connect_to_vault_cdms__v) field on Study/Study Country/Site objects
• Added Site Timezone (site_timezone__v) field on Site object
• Added Site Name (site_name__v) lookup field on Site object
• Added Integration Lifecycle (integration_lifecycle__v) with Active (active_state__v) and Inactive (inactive_state__v) lifecycle states
• Added “Inactivate” User Action on Active Integration lifecycle state
• Added “Activate” User Action on Inactive Integration lifecycle state
• Added Refresh Inbound Data workflow (refresh_inbound_data__v) on Integration lifecycle
• Added “Refresh Inbound Data” User Action on Active Integration lifecycle state
• Added “Reprocess Request” Action available to be added to User Exception Message object

Added the following components to support Yuzu: Japanese Clinical Trial Notification Generation:

• New objects:
  • Clinical Trial Notification / 治験届 (ctn__v)
  • CTN Attached Document / 届出書添付資料 (ctn_attached_document__v)
  • CTN Remarks / 備考 (ctn_remarks__v)
  • Clinical Registry Vocabulary (clinical_registry_vocabulary__v)
  • CTN Site IP / 治験施設治験薬情報 (ctn_site_ip__v)
  • CTN Data / 治験届関連情報 (ctn_data__v)
  • CTN Data Change Log (ctn_data_change_log__v)
  • CTN / CTN Data Change Log (ctn_ctn_data_change_log__v)
• New fields on Person object:
  • CTN Name / 治験届出用氏名 (ctn_name__v)
  • CTN Person for Japan (ctn_flag__v)
  • CTN Related Information / 治験届関連情報 (ctn_data__v)
  • Currently Used in CTN (ctn_used__v)
• New fields on Organization object:
  • CTN Organization for Japan (ctn_flag__v)
  • CTN Org Name / 治験届出用組織名称 (ctn_org_name__v)
  • CTN Related Information / 治験届関連情報 (ctn_data__v)
  • Currently Used in CTN (ctn_used__v)
• New fields on Product object:
  • CTN Product for Japan (ctn_flag__v)
  • CTN Related Information / 治験届関連情報 (ctn_data__v)
• New fields on Study Site (site__v) object
  • CTN Related Information / 治験届関連情報 (ctn_data__v)
• New fields on Study Person (study_person__clin) object:
  • CTN Related Information / 治験届関連情報 (ctn_data__v)
• New fields on Study Organization (study_organization__v) object:
  • CTN Related Information / 治験届関連情報 (ctn_data__v)

Made the following object field changes to support Multi-Status Fees:

• Fields on Fee (fee__v) and Fee Template (fee_template__v) objects converted to multi-value picklist fields:
  • Site Fee Status (site_fee_status__v)
  • Procedure Status (procedure_status__v)
  • Visit Status (event_status__v)

Added the following components to support Agreement Wizard:

Added the Description (description__v) field on the Rule Set object.

In addition, the System manages field value (read-only) setting is now editable in the Name (name__v) field for the following objects:

• Visit Definition (visit_def__v)
• Site Fee Definition (site_fee_def__v)
• Fee Template (fee_template__v)
• Fee (fee__v)

Quality

Manager Access to Training Records

In many organizations, managers are responsible for the training completion status of the employees that report to them. With this release, Vault Training introduces the ability for a Learner’s direct manager to have visibility into Learners’ Training Assignment records, as well as other training-related records.

When Vault Training issues a Training Assignment to a Learner, it also automatically adds the Learner’s manager group to Sharing Settings for that Training Assignment record. This Sharing Settings access allows the Learner’s manager to monitor the Learner’s training progress.

The Manager Groups feature must be enabled before configuring this feature in Vault Training. Learn more about Manager Access.

Training Requirement ZIP File Limitation

To ensure Vault Training requirements function as intended, ZIP files cannot be added to the Related Training Materials page section for Training Requirements, regardless of object type. Learn more about creating Training Requirements.

QualityOne

Create Action Items Directly from Quality Event Checklists

In QualityOne Vaults, this feature allows Admins to configure questions to allow users to create one or more action items directly from the checklist response UI for the Quality Event Checklist Type. When configured, suggested actions can appear when users hover over the help icon to provide recommended actions to help users decide what action item records to create. These action items are common as part of the change control process when deciding what actions to complete as a result of the change control impact assessment. Learn more about the configuration for action items in checklists.

Regulatory

Content Plan Hierarchy Viewer: Tree Grid

The new Content Plan Grid Viewer displays Content Plan records, Content Plan Item records, and matched documents together in a hierarchical structure within the grid. The new grid offers more robust search and filter functionality. Users can also view and perform actions on matched documents within the grid so they don’t need to navigate to a new screen or lose their location in the content plan. Learn more about working in the new Content Plan Hierarchy Viewer.

Drag & Drop Documents into Content Plan Structure

This feature improves and simplifies the process of matching documents to a content plan. Users no longer need to navigate away from the grid viewer to match new documents. Instead, users can now open a document in the Library, Cart, a report, or elsewhere in one browser window, drag the document link into the grid viewer in a separate window, and drop the link directly onto a Content Plan Item record to match the document. When configured, users can also drop a document link onto an Inactive Content Plan Item record to move to the Content Plan Item record and its parent records to an Active state before matching the document. Learn more about dragging and dropping to match documents in the Content Plan Hierarchy Viewer.

XEVMPD Bulk Updates

Organizations generate and submit XEVMPD data at a very granular level: per strength, per country, per package, per language. However, some updates impact all medicinal products, such as changing the company’s Qualified Person for Pharmacovigilance (QPPV), while others impact a large subset of medicinal products, such as updating labeling documents for 20 strengths in 30 countries.

With this feature, Vault users can select impacted medicinal products, recreate the product report structures, and submit the updated XML to the EMA in bulk. Learn more about updating and submitting XEVMPD data in bulk.

Manage Registered Details Updates

This feature delivers a new user interface for the Manage Registered Details wizard. In the wizard, users can now update registration data as well as the Registered Detail records. The new UI also removes the aggregate data updates. Users can now perform targeted data updates, either individually or in bulk, so changes impact only the intended registrations. This additional level of granularity supports regulatory approval in multi-market regions, such as the European Union. Learn more about managing registered details.

Submissions to eTMF Connection

This feature leverages the Spark Messaging framework to connect RIM Submissions Vaults to Clinical Operations eTMF Vaults and automate the creation of CrossLink documents between the two Vaults. Using Spark Messaging, Vault can:

• Transfer Product Family records from the Submissions Vault to the eTMF Vault when a user creates or updates a record
• Transfer Clinical Studies and Sites from the eTMF Vault to the Submissions Vault when a user creates or updates a record
• Automatically create a CrossLink document in one Vault after the document is approved in the other

The Submissions to eTMF connection uses Spark Messaging Integration Rules to define which documents, records, and fields to transfer, as well as Reference Lookups to translate field values across Vaults. Learn more about configuring the eTMF & Submissions Spark Connection and how the eTMF & Submissions connection works.

Australia eCTD XSD 3.1 Publishing & Validation

With this release, RIM Submissions Publishing Vaults support the AU TGA v3.1 (XSD 3.1) specification. Users can now create content plans and generate submissions that are compliant with AU TGA v3.1 specifications. Vault validates these submissions based on the corresponding AU TGA v3.1 Validation Criteria. Learn more about Learn more about working with Australian regulatory submissions.

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 the following components to the Regulatory data model to support new features:

Added the following components to support the Content Plan Hierarchy Viewer: Tree Grid feature:

• Added the Hierarchy Path (hierarchy_path__v) field to the following objects:
  • Content Plan (edl__v)
  • Content Plan Item (edl_item__v)
  • Content Plan Template (edl_template__v)
  • Content Plan Item Template (edl_item_template__v)
• Added the Notes (notes__v) field to the following objects:
  • Content Plan (edl__v)
  • Content Plan Item (edl_item__v)
• Added the Hierarchy Level (hierarchy_level__v) field to the following objects:
  • Content Plan (edl__v)
  • Content Plan Item (edl_item__v)

Added the following components to support the XEVMPD Bulk Updates feature:

• Added the Bulk Action ID (bulk_action_id__v) field to the following objects:
  • Product Data Submission (product_data_submission__v)
  • Product Data Message (product_data_message__v)
• Added the following fields to the Product Data Submission object:
  • Change Summary (change_summary__v)
  • Most Recent Submitted (most_recent_submitted__v)
• Added the XEVMPD Submitted (xevmpd_submitted__v) Lifecycle State Type

Added the following components to support the Australia eCTD XSD 3.1 Publishing & Validation feature:

• Added the following field to the Organization (organization__rim) object:
  • eBS Client ID (ebs_client_id__v)

Added the following components to the support the Submissions to eTMF Connection feature:

• Added the Site Country (site_country__v) field on the Site (clinical_site__v) object
• Added the Inbound Document State Type to document lifecycles
• Added the RIM to Clinical Connection Document Type Group

Safety

Safety features are targeted for tentative availability on March 16, 2020.

Case-Level Relatedness Configuration

Users can view the Relatedness for the primary assessment at the Case-level.

Learn More: Enter Case Data

SUSAR and SAE Detection Auto-on

New and revised Case Assessments and Cases that meet the appropriate seriousness criteria are automatically tagged as a SUSAR or SAE.

Learn More: Enter a Case Assessment

Reporter Assessment Result Configuration

Users can enter the Reporter Assessment Result during Adverse Event Report intake.

MedDRA Auto-Coding Configuration

Vault Safety now supports automatic coding of medical terms from the MedDRA Dictionary.

After entering a reported medical event description, you can use the auto-code button to automatically match the reported term with the MedDRA term.

Learn More: Code MedDRA Terms

xEVMPD Dosage Forms and Non-Standard Dose Units Configuration

In order to offer users a more comprehensive list of dosage information options, Vault Safety now supports a selection of dosage forms from the Extended Eudravigilance Medicinal Product Dictionary (xEVMPD). Users now also have the ability to enter custom, E2B compliant dose units outside of the standard Units of Measurement (UoM) dictionary.

Additionally, a new combo box field allows users to enter Routes of Administration (RoA), Dosage Forms, and dose units more easily.

Learn More:

• About the Case Page
• Enter Case Data

Case Product Dose and Indication Sections Configuration

This enhancement enables users to enter product dosages and indications directly on the Case Product page, ensuring faster data entry and more intuitive usability.

Learn More: Enter Case Data

CIOMS I Form Update and Comprehensive Overflows Auto-on

This release features a revised CIOMS I form with a new format in line with ICH guidelines and additional pages to enable the overflow of information from fields. All suspect products, doses, and indications related to adverse events will now be displayed on the form, as well as ISO country code and name.

Additional enhancements include the ability for customers to add case comments in section 7 + 13, additional seriousness criteria, and numbering for suspect products, doses, and indications. Some formats have also been changed, for example, Lab Test Results will now be sorted alphabetically and all dates will be written as (dd-mmm-yyyy).

Learn More: CIOMS I Generation Data Mapping

FDA 3500A Comprehensive Overflows Auto-on

This release features updates to the FDA 3500A form template, such as additional pages to enable the overflow of information from fields. All suspect products, doses, and indications related to adverse events will now be displayed on the form, as well as ISO country code and name.

Additional enhancements include the ability for customers to add case comments in section B5, and the alphabetical sorting of Lab Test Results.

Learn More: FDA 3500A Generation Data Mapping

Precise Naming for Assessment Matrix, Case Product, and Adverse Event Auto-on

For clarity and improved user experience, new and revised Case Products, Adverse Events, and Assessments will now use precise naming instead of the earlier convention (i.e. VV-##### and AE-#####).

Learn More: Naming Conventions for Case Child Records

Enablement Details

Name	Enablement	Application
Users & Groups
Manager Groups	Admin Checkbox	Platform
User Object Page Enhancements	Auto-On	Platform
System Owned User Field	Auto-On	Platform
Working with Documents
New OCR Limits	Auto-On	Platform
Collaborative Authoring with Microsoft Office Usability Enhancements 1	Auto-On *	Platform
Vault Objects
Deletion Rule Label Updates	Auto-On	Platform
Lifecycle & Workflow
Multi-Document Workflow: Add Participants, Reassign Tasks & Start Workflow Respect Constraints	Auto-On	Platform
Search
Truncate Long URLs on Internet Explorer	Auto-On	Platform
Constrain Filter Value Lookups by Search Results	Auto-On	Platform
Reporting
Multi-Pass Reporting: Ladder Scenario	Configuration	Platform
Minor Enhancements
Localize Vault to Dutch	Support	Platform
Commercial & Medical
Auto Claims Linking: Where Used Component	Auto-On	PromoMats
Standard Metrics (Make Mandatory)	Auto-On	PromoMats
Enhanced Medical Inquiry Email Capabilities	Admin Checkbox	MedComms
New Shared Field for CLM iOS Native Resolution	Configuration	PromoMats, MedComms
Clinical Operations
Vault EDC/CTMS Connection with Spark	Configuration	CTMS
eTMF to Submissions Connection	Configuration	eTMF
Agreement Wizard	Auto-On	eTMF
Study Team Role Field Enhancements	Auto-On	CTMS, eTMF, Study Startup, Vault Payments
Clinical Operations Data Model Changes	Auto-On	Clinical Operations
Quality
Manager Access to Training Records	Configuration	Vault Training
Training Requirement ZIP File Limitation	Auto-On	Vault Training
QualityOne
Create Action Items Directly from Quality Event Checklists	Configuration	QualityOne
Regulatory
Content Plan Hierarchy Viewer: Tree Grid	Support	RIM Submissions
Drag & Drop Documents into Content Plan Structure	Support	RIM Submissions
XEVMPD Bulk Updates	Configuration	RIM Registrations
Manage Registered Details Updates	Auto-On	RIM Registrations
Submissions to eTMF Connection	Configuration	RIM Submissions
Australia eCTD XSD 3.1 Publishing & Validation	Configuration	RIM Publishing
Regulatory Data Model Updates	Auto-On	Regulatory

¹ In Vaults with Collaborative Authoring enabled

See the following explanations for enablement options:

Enablement	Description
Auto-On	Automatically activated and no configuration is required before using the feature; note that in some cases, a new feature is dependent on another feature that must be enabled or configured.
Admin Checkbox	Admins must turn on the feature with an Admin checkbox. Note that some “Auto-On” features have a checkbox setting that hides the feature; these will show “Auto-On.”
Configuration	Admins must configure the feature (separately from an Admin checkbox) before it is available to use or is active; for example, an Admin must add document templates before users can create documents from templates.
Support	On/off option controlled by Support.

Known Issues

Manage Registered Details (DEV-303885)

In the Manage Registered Details wizard grid panes, users can’t clear fields in bulk using the Update Fields dialog. Users need to clear each field individually.