New in 21R2.2: Distinct Count in Reports and more

Release Date: August 20, 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

Overlay Override Page Size Tolerance

With this feature, Vault can match the page size of a PDF Viewable Rendition to the Overlay Override closest in size. A 0.5” page size tolerance has been introduced for Overlay Override templates for document pages that differ from the actual Overlay Override page size. Previously, if a document size did not exactly match the size of an Overlay Override, Vault applied the basic overlay template.

Lifecycle & Workflow

Remove Create for Legacy Workflow

Vault longer supports the creation or copying of legacy workflows in all Vaults. We have communicated this over the past two general releases. New workflows on documents in all Vaults should be created using Admin > Configuration > Workflows. 

Existing legacy workflows remain supported and can be updated to new versions. We will also continue to fix defects in legacy workflows. The Legacy Workflow tab inside Document Lifecycle remains visible if there is at least one existing legacy workflow. 

Performing a Vault Refresh with existing legacy workflows continues to function as expected. Updates to a legacy workflow using VPKs continue to work as long as the target workflow already exists in the destination Vault. 

Email Participants Action

Both object and document workflows now support the Email Participants action to send emails to participants of an active workflow.

Emails can be sent to incomplete or completed task owners as a group, or to individual participants.

The Email Participants action uses the same profile-level permission as legacy workflows. This action also supports Atomic Security.

Single Verdict: Any Lifecycle Workflow

Any Lifecycle document workflow now supports Single Verdict. Users can give a single verdict  to all documents on the workflow.

The verdict will not be applied to excluded documents. 

Support Reference Constraints in Workflows

The task completion dialog in workflows on documents now supports reference constraints. 

As a best practice, both the controlling and controlled fields should be part of the field prompts in the verdict or task completion dialog. Having only a controlled field can cause Vault to display errors if invalid values are selected.

Support for Today(“user”) Function 

The Today(“user”) function now provides the date value in the originating user’s time zone when used in a formula field expression in a lifecycle or workflow.

Previously, Vault did not support the Today(“user”) function in expressions inside lifecycle and workflows and would always provide the date value for the System user. 

Set Reference Field to Blank

Workflow administrators can now set reference fields to blank using formula expressions in lifecycles and workflows. This feature is available for entry actions, event actions and workflow update field steps.

To set a field to blank, use a “NULL” value for the expression in the update field step or action configuration.

You cannot set parent fields to blank in object lifecycles or workflows.

Read & Understood Workflows: Restrict Task Completion by Delegate Users

With this release, delegated users cannot complete Read & Understood workflow tasks in the new Read & Understood workflows released in 21R2 General Release. This matches the behavior of our legacy Read & Understood workflows.

Asynchronous Related Object Change State Entry Action

Object lifecycles now support a new entry action to change the state of related records asynchronously. This should be only used for objects with a large number of related records. Using this action, there is no limit on the number of related records whose state can be changed.

Existing entry actions will continue to work synchronously and can change the state of up to 1000 related records. Learn more about configuring object lifecycle state entry actions.

Reporting & Dashboards

Distinct Count in Reports

This feature allows users to view the total count of distinct records in a grouped report. When building or editing a report, users can add a distinct count aggregate formula on an ID field to count the distinct records. Both multi-pass and standard report types are supported.

Remove Links in Report Exports

This feature allows users to remove links in exported reports. Often, exported reports are given to people who are not Vault users, and links can cause confusion. Users may remove links from exported reports within the Advanced Options section of the report builder.

Checklists

Checklists: Specify Version for Attached Documents

The checklist respondent UI now allows end-users to specify the document version when attaching Vault documents to question responses. This enables end-users to select non-latest document versions, which they were previously unable to do. The default selection remains the most recent version that the user has access to.

Vault File Manager

Vault File Manager: New Icon

With this release, we have updated the desktop and system tray icon for Vault File Manager. As we extend the document file upload and download capabilities in Vault over the next few releases, this icon will also be displayed within Vault for certain actions, helping users make the connection between the desktop application and the actions in Vault.

Vault Loader

Vault Loader Command Line Tool Zip File Improvements

The VaultDataLoader.zip file for the Vault Loader command line tool can now be extracted using the native macOS Archive Utility application. Learn more about the Vault Loader command line tool.

Administration

Audit Data Available in Scheduled Data Exports

With this release, audit data can be included in scheduled data exports, allowing customers to load their Vault audit data into their enterprise data lakes, data warehouses, or business intelligence reporting services. The audit logs that are supported are: System Audit, Login Audit, Document Audit, Object Record Audit, and Domain Audit.

Vault Configuration and Comparison Report Enhancements 

Vault now queues all Vault Configuration and Compare report requests until all configuration updates to components are completed. This means that reports generated are accurate and reflect the latest updates to components. Admins will receive a notification letting you know the report is in queue and a subsequent notification when the report is ready to download. Learn more about Vault Configuration Reports and Vault Compare.

On Behalf Of Auditing Export Enhancements

Audit entries that contain on behalf of will now have a new field populated when exported to CSV. The existing User Name column in the export will contain the user on the left side of on behalf of, while a new column On Behalf Of will contain the user on the right side. Previously, the two users were concatenated into the User Name column. 

For example, before 21R2.2 both users appeared in the User Name column:

With this 21R2.2 release, the users are now separated into two columns:

Remove Enable Document Usage Metrics Flag

This feature removes the Enable Document Usage Metrics flag from Settings and enables this functionality in all vaults. Previously, the flag controlled whether user activity on steady documents was tracked in the Document Usage object. 

Vault Java SDK

Enhancements to JSON Binding Annotations

User-defined models now support extending other user-defined models, allowing developers to create models with inherited user-defined properties. For example, an APIQueryResponse model could extend an APIResponse model. Additionally, developers can define default values for User-defined properties for the following types: BigDecimal, Boolean, String, and collections of String. Learn more about user-defined models in the Developer Portal.

Vault Connections

eTMF/RIM Connection: Conditional Transfer Support using Query Object Rules

This feature adds support for Query Object Rules for Vaults on both sides of an eTMF/RIM Connection.

Clinical Operations

Dynamic Trip Report Section Review Status

This feature makes each Trip Report grid row’s Review Status icon dynamically update when a comment is created, edited, deleted, reopened, or resolved via the Review Comment dialog. *Auto-on in Vaults with “Enable Monitoring Reviewer Comments” enabled.

Support for Resolving Orphaned Monitoring Reviewer Comments

This feature allows Admins to configure an entry action on any Monitoring Event lifecycle state that automatically resolves open Review Comments that were deleted from a Monitoring Event. Previously, these ‘orphaned’ records had to be manually resolved by an admin.

Displaying Required Trip Report Questions Logic Update

This feature will update the logic that highlights required trip report question elements to utilize the new Highlight Required field on Trip Report Question Response object. After the release, any monitoring events currently in review may experience a short period where we do not highlight missing data.

*Auto-on for Vaults using Verify Required Trip Report Questions action in Monitoring Event workflows.

TMF Bot: Model Training Enhancements

This feature enhances our TMF Bot: Model Training capabilities with the following updates:

• Always exclude Document Types mapped to “Sites Evaluated but not Selected” reference models in training
• Use “Version Created Date” instead of “Created Date” during Training Window document selection method to allow Trained Models to train on documents that are regularly up-versioned
• Populate “Training Summary Results” with the Extraction Coverage, Auto-classification Coverage and Auto-classification Error Rate to assist with validation
• Update Language Failures to use Language Labels instead of two-character ISO Codes

Synchronize Requiredness and # Expected on EDL Item

This feature introduces the option to automate updates to the # Expected field of an EDL when users update the Requiredness field. Specifically, changing Requiredness to “Not Required” will set # Expected to 0; changing Requiredness to” Required” will set # Expected to 1 in cases where it is currently 0. We expect this to halve the number of clicks required when modifying  EDL Items based on trial requirements.

Support for Hard Deleting Site Connect Documents

With this feature, Site Connect customers can now hard delete documents that have been sent or received via Site Connect. Previously, Distribution Task records needed to first be deleted before a hard delete could be completed.

Safety Distribution Study Site Lifecycle auto-filtering

With this feature, Site Connect customers can now auto-filter their Safety Distributions to only send safety documents to Study Sites in certain lifecycle states. This filtering can be defined on a country-by-country basis using the existing Distribution Default object.

Prior Version Value Token for Field Defaults

With this feature, Site Connect customers and customers using TMF Transfer can create Field Defaults that automatically populate the metadata field of an incoming document version with the value defined on the existing document version. This is especially useful for maintaining Person and Organization values on Profile Documents received via Site Connect.

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 component to support the Displaying Required Trip Report Questions Logic Update feature:

• Highlight Required (highlight_required__v) field (Yes/No) on the Trip Report Question Response object

Added the following component to support the TMF Bot: Model Training Enhancements feature:

• Training Summary Results (training_summary_results__sys) field on Trained Model object

Added the following component to support the Safety Distribution Study Site Lifecycle auto-filtering feature:

• Study Site States (study_site_states__v) picklist field on the Safety Distribution Default (safety_distribution_default__v) object

Commercial

Positive / Negative Lists

This feature provides standard fields for tagging content required for positive and negative lists and, when integrated with Veeva CRM through a services engagement, provides up to date information to Representatives via MyInsights indicating which documents are on a positive or negative list and when print materials have expired and must be destroyed. Representatives can then confirm when they have destroyed the print material, allowing customers to remain compliant with health authority regulations in several countries, such as France’s ‘List Positive’ regulatory requirement. Learn more about positive and negative lists.

eCTD - Additional Material Information in the eCTD Binder

This feature adds the Promotional Material Document Name and Promotional Material Document Description fields. When an eCTD binder including these fields is generated, Vault copies the value from the promotional material into the fields on the Clean Material. This allows the value to be used on Correspondence Letters and the 2253 and Supplementary Forms. These fields can also be used with the PromoMats & RIM Vault connection. This feature also updates eCTD binder functionality to add the Promotional Material ID to the Annotated Label or Annotated Reference document types, allowing Vault to automatically copy the Material ID from the promotional material onto these documents. This is required for customers using the PromoMats & RIM Vault connection.

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 PromoMats vaults:

• Added new object Positive/Negative List
• Added the following shared document fields:
  • Add to Positive/Negative List
  • Delivery to HCPs
  • Positive/Negative List Name
  • Promotional Material Document Name
  • Promotional Material Document Description
  • Promotional Material ID

Quality

Recurrence Check: Deviations

With this feature, Vault QMS introduces an intelligent and streamlined interface for end users to determine whether a Deviation is a recurrence of another Deviation. With this feature configured, the previously complex manual process is replaced with a simple user action where text search terms are automatically suggested by Vault. A set of potential Deviations are returned along with their similarity score in a new side-by-side comparison user interface. When the analysis is complete, Vault stores the results and automatically links recurrent Deviation records by creating Related Quality Event records. Learn more about configuring Recurrence Check.

External Collaboration Support for CAPA & SCAR Records

This release expands on Vault QMS’ Audit Finding External Response Collaboration feature set. Customers can now invite external collaborators for CAPA & SCAR followup similarly to invites for Audit Finding Responses. With this release,  administrators can configure additional processes to leverage external collaboration, inviting collaborators on Audit Findings, CAPAs or SCARs, or any combination of the three processes. Unique ‘Welcome…’ & ‘Goodbye…’ messages are available for each process, and Vault will intelligently select the message to send based upon the type of record that the external collaborator is first invited to work on. Collaborators invited to participate on a record from any of the available processes will only be removed from the Vault upon completion of collaboration on all records, regardless of process, that they have been invited to collaborate on.

This feature requires configuration to use. Customers currently leveraging the Audit Finding External Response Collaboration feature will want to review their security configurations for external collaborators when evaluating adoption of these new processes. Learn more about external collaboration support.

Generate Quality Document from Record: Support for Documents Based on Document Templates

This release expands upon 21R2’s Generate Quality Document from Object Record Action feature for QMS Audits and Quality Events, now allowing the generated document to be based on any Document Template within the Vault. Like the existing document generation feature in QMS Vaults, this can be leveraged either manually as a user action or automatically as part of a record’s lifecycle. When generating a document from a document template, Vault will automatically link the newly created document to the record, and vice-versa. Used in conjunction with entry criteria on both document and object lifecycles, this enables new robust, risk-mitigated processes to be modeled in Quality vaults.

Vault sets metadata for the document based on the metadata of the record for fields with the same name. This means that fields which drive security on the record can be added to the generated document, allowing for either broad or granular security configurations of the generated content, fitting your business needs.

In addition to the functions enabled by the 21R2 feature, this exciting enhancement enables additional functionality such as:

• Generating non-PDF documents from Audits or Quality Events, allowing post-creation editing of the artifact
• Using the best practice document template when generating key Audit or Quality Event artifacts
• Leveraging Merge Fields in generated documents so that the template’s content can be defaulted based on the record from which it was generated
• Prohibiting the advancement of an audit until the related Audit Report has been reviewed and approved

This feature requires configuration to be used. Learn more about configuring document generation.

Process Navigator: Steady State Only Flag

This feature, enabled by an Admin checkbox, will allow customers to display the latest steady state version of a document when viewed through Process Navigator.  This setting is helpful when a user has access to later minor, or Draft, versions of a work instruction but should only utilize the latest Effective version of the work instruction when performing a procedure. Learn more about the Process Navigator.

Process Navigator: Adjustable Hierarchy Limits

This feature allows a customer to increase the maximum number of hierarchies per object type and child process records per parent with Product Management approval. Learn more about managing hierarchies.

Station Manager: Picklist Based Categorization Deprecated

In this release, Station Manager deprecates the use of picklist-based document categorization. Configuration options for selecting a picklist to coincide with categorization are no longer available under Station Configurations. Customers using picklist-based categorization, or considering enabling document categorization, should look to use record-based categorization instead. Such customers should also remove Station Configurations from page layouts. Learn more about document categorization for Station Manager.

Station Manager App Update Enforcement: Data Model Update

With this update, a new field has been provisioned to support the mobile application’s App Update Enforcement feature which is targeted for a future release. This feature provisions the Days Left to Upgrade (days_left_to_upgrade__v) field on the Station Device object as a reportable field that customers can use to track devices that need to be upgraded before they are logged out.

Adverse Event Reports for TGA (Australia)

With this data model update, Vault Product Surveillance customers are able to create Adverse Event Report records for TGA (Australia). Learn more about Vault Product Surveillance.

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:

Click here to view the data model changes

Regulatory

Sourcing Active Dossier from Submission Content Plans

With this update, Active Dossier will also scan through Submission Content Plans to collect document candidates to match with the Active Dossier template. This approach helps to increase the documents added to Active Dossier when the source document relationship is missing from the Submissions Archive document. The content plan leaf lifecycle information is used in calculating the Current status of these documents within the Active Dossier.

Label Concept Management

This release expands the Vault RIM data model to better support labeling change management. The feature includes the addition of two new objects: Labeling Concept and Labeling Deviation. New fields will be added to existing objects to identify impacted labeling documents and better facilitate planning and tracking for changes with labeling impact.

Content Plan filter for Current User

With this enhancement, a new Current User value is available to filter on User columns in the Content Plan Hierarchy Viewer. This filters the Content Plan by the logged-in User and can be saved in Content Plan views.

Dossier Format Support with Non-eCTD Publishing

With this release, when publishing Non-eCTD submissions, the published output folder structure respects the parameter value of the Non-eCTD Dossier Format value. 

WHO Added as a Country to the Active Dossier Item Object

With this release, the World Health Organization (WHO) has been added as a country to the Active Dossier Item object to allow for appropriate tracking of content submitted. 

Content Plan Creation Logic Updates

With this release, the Region and Lead Market Country can be specified on the Content Plan Item Template. When you create a content plan, Vault reads the Lead Market Country field on the submission’s related Application record and creates the Content Plan Items corresponding to the matching Region and Lead Market Country, if specified on the template.

21R3 RIM Data Model Changes

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

Click here to view the data model changes

Safety

Safety features are targeted for tentative availability on August 26, 2021.

Inbox Item Follow Up Support

When promoting an Inbox Item, duplicate detection now presents an option to create a Follow-Up Case that compares all the data on the previous Case version with the new data on the Inbox Item. Users can select any information they want to update based on the Inbox Item. Upon Case promotion, the system merges the data from the previous Case version and the Inbox Item. This feature supports Inbox Item passthrough fields received through the API and atomic security on fields from the previous Case version.

Learn More: Inbox Item Follow-Up

Auto-Expectedness Roll Up Changes Auto-on

Updated logic ensures that overriding expectedness on a Case Assessment does not stop the Case-level Expectedness field from updating to match that of the primary assessment. The Case Expectedness field will not automatically update if it has been explicitly overridden.

Learn More: Manually Override the Case Expectedness

PT Aggregation in Periodic Reports Auto-on

When a Case contains multiple Case Adverse Events coded to MedDRA Lower Level Terms (LLTs) that are under the same Preferred Term (PT), aggregate report summary tabulations now count the adverse events as one PT instead of multiple. This behavior has been updated for summary tabulations across DSUR, PBRER, PSUR and PADER.

Learn More:

• Create DSUR Aggregate Reports
• Create PADER Aggregate Reports
• Create PBRER Aggregate Reports
• Create PSUR Aggregate Reports

SiteVault

Products in the Agreement Wizard

When reviewing a Connected Study Agreement, Regulatory users are now prompted to reconcile the products on the study. This enables users to choose whether to merge the study agreement product with an existing product in SiteVault or to create a new product if it does not already exist.

Connected Studies: Exchangeable Organization Profile Document Update

With this feature, Organization Profile documents for Central Labs or Central IRB/IECs no longer are transferred automatically to a Sponsor or CRO’s vault when the document reaches a Steady state.

SiteVault 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 Access Start Date (access_start_date__v) and Access End Date (access_end_date__v) fields to the Study Assignment (study_person__v) object.

QualityOne

Task Cancellation and Reassignment - Sharing Settings Update

This feature updates QualityOne Teams to automatically cancel an active and assigned task for a user that is removed from a Sharing Settings role. The user is removed from any workflow participant group that is set up to use participants from a configured role. Learn more about QualityOne Teams sharing settings update.

Veeva Claims

Note that Veeva Claims features are targeted for tentative availability on August 31st.

Translator View Enhancement

Translator View is an object page layout section for Pack Copy object which allows Translators to enter translations for multiple local Elements for country-specific languages. Previously after Translators entered all missing translations, the completed element rows disappeared from the view and the user needed to navigate to each Element to review the translations. This enhancement enables users to review all fully completed translations because the completed translations persist in the view for all defined lifecycle states. Learn more about translating pack copy elements.

Enablement Details

Name	Enablement	Application
Working with Documents
Overlay Override Page Size Tolerance	Configuration	Platform
Lifecycle & Workflow
Remove Create for Legacy Workflow	Auto-on	Platform
Email Participants Action	Auto-on	Platform
Single Verdict: Any Lifecycle Workflow	Auto-on	Platform
Support Reference Constraints in Workflows	Configuration	Platform
Support for Today("user") Function	Configuration	Platform
Set Reference Field to Blank	Configuration	Platform
Read & Understood Workflows: Restrict Task Completion by Delegate Users	Auto-on	Platform
Asynchronous Related Object Change State Entry Action	Admin Checkbox	Platform
Reporting & Dashboards
Distinct Count in Reports	Auto-on	Platform
Remove Links in Report Exports	Auto-on	Platform
Checklists
Checklists: Specify Version for Attached Documents	Auto-on	Platform
Vault File Manager
Vault File Manager: New Icon	Auto-on	Platform
Vault Loader
Vault Loader Command Line Tool Zip File Improvements	Auto-on	Platform
Administration
Audit Data Available in Scheduled Data Exports	Configuration	Platform
Vault Configuration and Comparison Report Enhancements	Auto-on	Platform
On Behalf Of Auditing Export Enhancements	Auto-on	Platform
Remove Enable Document Usage Metrics Flag	Auto-on	Platform
Vault Java SDK
Enhancements to Json Binding Annotations	Auto-on	Platform
Vault Connections
eTMF/RIM Connection: Enable Query Object Rules	Auto-on	ClinOps<>RIM
Clinical Operations
Dynamic Trip Report Section Review Status	Auto-on	CTMS
Support for Resolving Orphaned Monitoring Reviewer Comments	Configuration	CTMS
Displaying Required Trip Report Questions Logic Update	Configuration	CTMS
TMF Bot: Model Training Enhancements	Auto-on	eTMF
Synchronize Requiredness and # Expected on EDL Item	Admin Checkbox	CTMS, Clinical Operations - All, Study Startup, eTMF
Support for Hard Deleting Site Connect Documents	Auto-on	CTMS, SiteConnect, Study Startup, eTMF
Safety Distribution Study Site Lifecycle auto-filtering	Configuration	CTMS, SiteConnect, eTMF, Study Startup
Prior Version Value Token for Field Defaults	Configuration	SiteConnect, eTMF
Clinical Operations Data Model Changes	Auto-on	CTMS, SiteConnect, Study Startup, Vault Payments, eTMF
Commercial
Positive / Negative Lists	Configuration	PromoMats
eCTD: Additional Material Information in the eCTD Binder	Configuration	PromoMats
Commercial Data Model Changes	Auto-on	MedComms, PromoMats
Quality
Recurrence Check: Deviations	Configuration	QMS
External Collaboration Support for CAPA & SCAR Records	Configuration	QMS
Generate Quality Document from Record: Support for Documents Based on Document Templates	Configuration	QMS
Process Navigator: Steady State Only Flag	Admin Checkbox	QualityDocs
Process Navigator: Adjustable Hierarchy Limits	Support	QualityDocs
Station Manager: Picklist Based Categorization Deprecated	N/A	QualityDocs, Station Manager
Station Manager App Update Enforcement: Data Model Update	Auto-on	Station Manager
Adverse Event Reports for TGA (Australia)	Auto-on	Surveillance
Quality Data Model Changes	Auto-on	QMS, QualityDocs, Station Manager, Surveillance, Training
Regulatory
Sourcing Active Dossier from Submission Content Plans	Auto-on	RIM
Label Concept Management	Configuration	RIM Registrations
Content Plan filter for Current User	Auto-on	RIM Submissions
Dossier Format Support with Non-eCTD Publishing	Auto-on	RIM Publishing
WHO Added as a Country to the Active Dossier Item Object	Auto-on	RIM
Content Plan Creation Logic Updates	Configuration	RIM Submissions
21R3 RIM Data Model Changes	Auto-on	RIM
SiteVault
Products in the Agreement Wizard	Auto-on	SiteConnect, SiteVault Enterprise, SiteVault Free
Connected Studies: Exchangeable Organization Profile Document Update	Auto-on	SiteVault Enterprise, SiteVault Free
SiteVault Data Model Changes	Auto-on	SiteVault Enterprise, SiteVault Free
QualityOne
Task Cancellation and Reassignment - Sharing Settings Update	Auto-on	QualityOne
Veeva Claims
Translator View Enhancement	Auto-on	Veeva Claims

See the following explanations for enablement options:

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