New in 19R3.2: Configurable CrossLink Renditions, and more…

Release Date: December 13, 2019

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

Working with Documents

When viewing an object record’s related documents and clicking the Add button, the button on the Search: Documents dialog previously called Upload has been changed to Create. Clicking Create now allows you to create new documents either by uploading a file, or by selecting a document template without having to navigate away from the object record. The relationship to the object record will automatically populate on the new document.

Prior to this release, a CrossLink document’s viewable rendition always contained any overlays and signature pages applied to the source document’s viewable rendition. Now, there are two new checkboxes on the Admin > Settings > General Settings page that allow Admins to exclude overlays, signature pages, or both when Vault creates a CrossLink’s viewable rendition from the source document. This helps prevent duplicate overlays and signature pages when Admins have these defined in the CrossLink document’s Vault. Learn more about configuring CrossLinks.

In the Doc Info Bookmarks panel, users can view and navigate bookmarks that target external URLs. When a user clicks a bookmark, the target opens in a new tab or browser window. When the user clicks the Copy Link icon, Vault copies the URL to the clipboard.

Footnote & Endnote Linking in PDF Renditions of MS Word Files

This viewable rendition linking enhancement adds support for clickable cross-reference links for footnotes and endnotes in Microsoft Word files. This support is in addition to the other types of internal links (hyperlinks, ToC links) and embedded web links that are already supported. Learn more about viewable renditions.

Vault Objects

Dynamic Tabs

Clicking Show in Tab on the object record list page will show the related list of records in a dynamically generated tab. All related lists will now have a Show in Tab link, including related lists for those objects that don’t have a custom tab.

Vault will also show the Show in Tab link for related lists with filters, and the tab will show the filtered set of records.

Updated Record Picker Dialog

This feature introduces an updated dialog for selecting object records. In the updated single-select dialog, users select a record using radio buttons. In the updated multi-select dialog, users select multiple records using checkboxes. These radio buttons and checkboxes replace the green plus (+) and red minus (–) icons that were previously used in object record search dialogs. Users can also resize columns in the updated dialog.

The document selector dialog will also be updated in a future release.

Asynchronous Task Processing

Admins can now configure an object workflow task to complete asynchronously. We recommend using this feature for tasks that your organization regularly assigns to over 100 users. This change allows users to complete individual tasks without affecting other workflow tasks or processes. If the workflow encounters an error, it will take the configured alternate next step. Before implementing this configuration, please consult with your Vault representative.

Lookup Field on Lifecycle State

Vault Admins can now create Lookup-type fields that reference Lifecycle (lifecycle__v) and Lifecycle State (state__v) fields. With this enhancement, organizations can set up fields that allow users to view states of related objects.

Reporting

PDF Fit to Page for Reports

With default settings, Vault splits reports with long rows and more than one column onto multiple pages when exported. This feature introduces a setting to allow customers to export reports to PDF and have all columns fit onto a single page. This can make the rows in the exported report much easier to read. Admins can enable the Fit PDF export columns to one page option for all reports in Admin > Settings > General Settings. Learn more about exporting and sharing reports.

Task Verdict Comments in Reports

This feature adds support for the Task Verdict Comment field in Workflow with Object reports. Currently, Admins have the ability to configure object workflows to include task verdict comments but they can only be viewed from the workflow timeline. This feature allows report viewers to see task verdict comments directly on the report. Learn more about Creating Reports.

Auditing

Expand Time Period for Login Audit Logs

In previous releases, we limited the time period that Admins could view and export from Admin > Logs > Login Audit History to two weeks. This release removes this restriction so that Admins can enter any date range to view and export the login history.

Checklists

Enhanced Checklist Workflow Task Completion

This feature provides an important enhancement to workflow task behavior when a checklist is completed. Previously, when a user completed a checklist from the Checklist response UI, the workflow task could only be completed if workflow task prompts were not configured (Prompts for Comments, Prompts for Verdicts, Prompts for Fields). This feature now allows Admins to configure checklist workflow task prompts. When a user completes a checklist from the Checklist response UI, the behavior is now consistent with completion of a task from the Home > MyTasks page. The task popup will now always appear when a user clicks “Complete” from the Checklist response UI regardless of whether a prompt is configured.

Enable Checklists Feature in All Vaults

In previous releases, the Checklists feature was introduced for all Vault applications. In this release, we’ve extended checklist functionality, allowing Admins to enable checklists for any Vault application.

Administration

Spark Message Delivery Event Handler

The Spark Message Delivery Event Handler provides a mechanism for Admins and Spark-integration developers to handle undelivered Spark messages. Once a developer implements the class in custom code, an Admin has the option of assigning that handler and a user to an outbound queue. When an undeliverable message is encountered, Vault executes the actions coded in the handler. For example, if the target Vault is unavailable, a developer may choose to put the message back on the queue in 24 hours, notify a specific user, or take other actions. Learn more about Spark Message Delivery Event Handlers.

Document Type Support for Reference Lookups

This feature is intended to help developers building Spark integrations. It is common to have Vaults with document types that are the same but with different names, especially across Vault application families. With document type reference lookups, Spark Integration developers can map source document types to target document types, avoiding the need to hard code the mappings. Learn more about Creating & Managing SDK Reference Lookups.

Record Migration Mode for Configuration Migration Packages

Record Migration Mode allows Admins to use outbound packages with dataset items to create object records in non initial state.

This feature introduces a new field, Record Migration Mode (record_migration_mode__sys) to the Inbound Package Data (vault_data_package__v) and Dataset Item (dataset_item__sys) objects. Learn more about Using Configuration Migration Packages.

Run Job on Latest Steady State Version

With this feature, any document state change job can be configured to run on the latest Steady state version of a document rather than the absolute latest state. This allows the state change job to run on a document that has advanced to a later draft state. The prior Steady state version will be expired by the job.

PromoMats

Auto Claims Linking: Match Text Variations

This feature extends the efficacy of Automated Claims Linking by allowing users to add multiple approved match text variations (alternate phrases) to each Claim record, and for the Automated Claims Linking feature to find and link each variation to the defined set of references on the Approved Claim.

This feature introduces the Match Text Variation (match_text_variation__sys) object to PromoMats Vaults. Learn more about Match Text Variations.

This feature introduces the Suggested Links (annotations_suggested__v) document field to aPromoMats Vaults with Automated Claims Linking enabled This field contains the count of pending state Suggested Link annotations. Once a user accepts, rejects, or removes a suggested link, that link is no longer included in the count. This field can be added as a column in document tabular views, as a filter criteria in document reporting, as a lifecycle state entry criteria and as a condition for a lifecycle state entry action.

Auto Claims Linking: Wildcard in Match Text Strings

Users can now include “wildcards,” formatted as {*}, in a claim’s match text string.Wildcards enable matching when variable words and characters exist. As a result, Vault will find and match text regardless of the content that may exist in the position of the wildcard. For example, “Cholecap is {*} good” would match “Cholecap is good” and “Cholecap is very good.” Learn more about Wildcards in Match Text Strings.

This feature allows users to perform the Remove Suggested Links action, which removes all Suggested Link annotations on the document. The Remove Suggested Links action only appears to users with permission in annotate mode when Suggested Link annotations exist. Learn more about the Remove Suggested Links action.

Platform Data Model Changes

This release introduces the Suggested Links (annotations_suggested__v) document field to all Vaults to support future functionality.

Quality

Station Manager: Document Categorization

An organization may share a Station Manager tablet across multiple roles, products, assays, or pieces of equipment. This feature allows the categorization of documents assigned to a Station. Categories are defined and managed in Vault and surfaced on the mobile app so operators can pick a category and browse only the documents relevant to their current task. Learn more about Learn more about Station Manager Document Categorization.

Note: This feature supports future versions of the Station Manager mobile apps.

Quality 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 Quality data model:

  • Added the following field to the Station (station__v) object:
    • Station Configuration (station_configuration__v)

QualityOne

Enhanced Configurability for QualityOne

With every release, we update the data model to better support evolving needs and new feature functionality. These data model updates are automatically included in all QualityOne Vaults.

This release introduces Enhanced Configurability to various components in QualityOne Vaults. Enhanced Configurability adds the ability for applications to determine which field attributes in a standard object’s configuration an Admin should be able to edit. Depending on your Vault application’s data model, you may be able to edit additional settings, such as system-managed naming or if the field is required, or editing may be blocked on some of these attributes.

On QualityOne Vaults:

  • Added the ability for Admins to enable system-managed naming using the attribute System manages field value for the Name (name__v) field on the following objects:
    • Audit-Context (auditcontext__qdm)
    • Audit-Organization (auditorganization__qdm)
    • Context-Organization (context_organization__qdm)
    • Context-Quality Event (context_qualityevent__qdm)
    • Organization (qms_organization__qdm)
    • Product-Quality Event (productquality_event__qdm)
    • Related Quality Event (related_quality_event__qdm)
  • Added the ability for Admins to configure the attribute User must always enter a value (required) for the following fields and objects:
    • the Due Date (due_date__qdm) field on the Action Item (action_item_qdm) and Effectiveness Check (effectiveness_check__qdm) objects
    • the Department Number/Code (number__v) field on the Department (department__v) object
    • the Date Requested (date_requested__qdm) field on the Extension Request (extension_request__qdm) object
    • the Facility Address (address__v) and Facility Number/Code (number__v) fields on the Facility (facility__v) object
    • the Quality Event (quality_event__qdm) and Priority (priority__qdm) fields on the Investigation (investigation__qdm) object
    • the Category (category__v), Description (brief_description__v), Long Description (long_description__v), Risk Event (risk_event_name__v), Risk Matrix (risk_matrix__v), and Risk Owner (risk_owner__v) fields for the Risk Event (risk_event__v) object
    • the Description (brief_description__v), Title (title__v), and Type (type__v) fields on the Risk Register (risk_register__v) object
    • the Quality Event (quality_event__qdm) field on the Root Cause (root_cause_analysis__qdm) object
  • Added the ability for Admins to configure the attribute Maximum length for the number__v field on the Department (department__v) and Facility (facility__v) objects.
  • Added the ability for Admins to configure the attribute Allow user to select multiple values for the Category (category__v) field on the Risk Event (risk_event__v) object.
  • Added the ability for Admins to configure the attribute Status for the fields Rank (rank__v) and Trigger (trigger__v) on the Risk Event (risk_event__v) object.

Regulatory

With this release, Vault can now publish CrossLink documents that are matched to Content Plan Item records during submissions publishing and report level content plan publishing. For organizations with multiple Vaults, this allows users to create and manage submission content within the appropriate Vaults. Users no longer need to copy documents to the RIM Vault manually to include those documents in the published submission.

Enablement Change: Allow Multi-Select on Standard Document Fields

This feature is postponed to a future release.

Safety

Safety features are targeted for tentative availability on December 19, 2019.

Configurable Watchlists and AESI Configuration

Vault Safety now supports the ability to maintain watchlists for Adverse Events of Special Interest (AESI) and other Important Medical Events (IMEs) that require monitoring. Administrators can configure watchlists to expedite Cases, regardless of expectedness or causality.

Watchlists can be created for both marketed products and studies. Cases with an adverse event that matches a watchlist MedDRA term are automatically tagged with the watchlist name during case processing.

Administrators can configure the Case Processing workflow to always transition a Case with a watchlist tag, such as AESI, to the Medical Review stage, regardless of seriousness, in accordance with Good Pharmacovigilance (GVP).

Medical Review Enhancements Auto-on

This release includes multiple enhancements to support medical review activities throughout case processing.

Case Assessment Result Generation

When a Case is opened, Vault Safety now automatically generates two placeholder Assessment Result records under each Case Assessment. The system generates one Assessment Result for the sponsor’s assessment, and another for the reporter’s assessment (investigator, HCP/non-HCP).

Reporting Source Qualification

Vault Safety now automatically populates the HCP Confirmed field on the primary adverse event, based on the qualification of the reporting source specified on the initial Adverse Event Report. In turn, for reporter Assessment Results generated for post-market cases, Vault Safety automatically assigns the Source as either HCP or non-HCP, as appropriate.

Symptom Classification for Adverse Events

You can now classify Case Adverse Events as symptoms. Multiple symptoms can be connected by a MedDRA-coded diagnosis, whether provided by the reporting source or determined during medical review.

EMA E2B R3 Notification Enhancements Auto-on

To ensure successful submissions of study-based ICSRs to the EudraVigilance EVCTM Gateway, Vault Safety now sends pre-submission warning notifications if the generated EMA E2B file does not include an EMA-specific E2B Code in one or more of the following case assessment result fields:

  • Method of Assessment
  • Result of Assessment
  • Source of Assessment

Frequency Control Enhancement Auto-on

This release features an updated Frequency control, which provides a more user-friendly data entry process. This enhancement allows you to capture standard medication administration intervals in a more structured way, using common, everyday words.

In a future release, the Frequency control will be further enhanced to add a third frequency data entry option. With this enhancement, the system will automatically calculate the E2B-compliant value.

UI Control Enhancements Auto-on

User interface controls have been enhanced to improve legibility and data entry efficiency.

Import Narrative API Auto-on

This feature introduces a publicly accessible API for importing a Vault Safety Case narrative. This will assist with non-E2B database migrations to Vault Safety.

Learn more about the import narrative REST API on the Vault Developer Portal.

SiteVault

SiteVault Family Data Model Changes

We have added the Investigator? field to the Person object as an alternative to using existing Person object types.

Additionally, we have added three fields to the Study object to provide a quick link to the study’s CDMS system.

Vault File Manager

Vault File Manager Access without API Permissions

Users logging in to the Vault File Manager desktop application no longer need to have API access in their security profile’s permission sets. If the user does not have API Access, Vault File Manager will not display their profile picture and will display their username instead of their full name. Learn more about Vault File Manager.

Enablement Details

Name Enablement Application
Working with Documents
Create From Template in a Record's Related Document Section Auto-On Platform
Configurable CrossLink Renditions Admin Checkbox Platform
Navigate External Bookmarks Auto-On Platform
Footnote & Endnote Linking in PDF Renditions of MS Word Files Auto-On Platform
Platform Data Model Changes Auto-On Platform
Vault Objects
Dynamic Tabs Auto-On Platform
Updated Record Picker Dialog Auto-On Platform
Asynchronous Task Processing Configuration Platform
Lookup Field on Lifecycle State Configuration Platform
Reporting
PDF Fit to Page for Report Admin Checkbox Platform
Task Verdict Comments in Reports Auto-On Platform
Auditing
Expand Time Period for Login Audit Logs Auto-On Platform
Checklists
Enhanced Checklist Workflow Task Completion Auto-On Platform
Enable Checklists Feature in All Vaults Configuration Platform
Administration
Spark Message Delivery Event Handler Auto-On Platform
Document Type Support for Reference Lookups Auto-On Platform
Record Migration Mode for Configuration Migration Packages Auto-On Platform
Run Job on Latest Steady State Version Configuration Platform
PromoMats
Auto Claims Linking: Match Text Variations Auto-On PromoMats
Auto Claims Linking: Add Suggested Links Document Field Auto-On PromoMats
Auto Claims Linking: Wildcard in Match Text Strings Auto-On PromoMats
Auto Claims Linking: Remove Suggested Links Auto-On PromoMats
Quality
Station Manager: Document Categorization Configuration Quality
Quality Data Model Updates Auto-On Quality
QualityOne
Enhanced Configurability for QualityOne Auto-On QualityOne
Regulatory
Publish Crosslinks Auto-On RIM Submissions,
RIM Submissions Publishing
Enablement Change: Allow Multi-Select on Standard Document Fields Configuration RIM Publishing,
RIM Submissions,
RIM Registrations,
RIM Submissions Archive
SiteVault
SiteVault Family Data Model Changes Auto-On SiteVault Enterprise
Vault File Manager
Vault File Manager Access without API Permissions Auto-On Vault File Manager

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.