New in 22R3.5: Search improvements and more

Release Date: March 10, 2023

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

Platform

Working with Documents

Binder Display Options for Unbound Documents

The Binder Display Options for Unbound Documents setting allows Admins to configure how unbound documents display when viewing and exporting documents from binders. In this release, Admins can enable this setting through the Admin UI instead of Veeva Support.

Sort Multi-Select Field Values in Alphabetical Order

In this release, Admins can configure the setting to sort multi-select field values in alphabetical order through the Admin UI instead of Veeva Support.

Vault Objects

Person Object: Duplicate Detection on Copying Person Records

In this release, users are now also alerted of potential duplicate Person records through the Copy Record action.

Spanish Stemming Improvements

Users can now search in Spanish without acute accents. For example, searching for “Guia de documentacion” will match “Guía de documentación.” This feature also provides more flexible matching of plural/singular nouns and past, future, and present verbs.

Improves the ranking of search results when matching on document name or record name. Vault considers any extra unmatched terms in the name when determining the relevance score. For example, searching for “Deviation Review Process” would rank “Deviation Review Process - Europe” below “Deviation Review Process”. All of the search terms were found in both documents, but the document with one unmatched term appears lower in the results. This helps exact matches to appear above all other matches.

Administration

Sandbox Snapshots Enhancements

This feature allows Admins to upgrade a Snapshot on an older release to the current release of Vault.

Vault Connections

RIM/Quality: Registered Product for Change Control

The Quality to RIM Vault Connection can now transfer Registered Product records between Vaults to be used for change controls. When users create or edit Product Family, Product or Product Variant object records in their Registrations Vault, Vault creates or updates the Product Family, Product or Product Variant records in the QMS Vault.

RIM/ClinOps: Support Country to Study Country Document Field Rule Mapping

The RIM to Clinical Operations Vault Connection can now transfer Country and Study Country fields on documents when creating CrossLinks. When a user populates a Country field on a RIM document and a CrossLink is created in Clinical Operations, the connection will populate the Study Country field based on the Country field populated in RIM. Alternatively, a document authored in Clinical Operations with a Study Country will populate the Country field on the CrossLink created in RIM.

Additionally, a reference lookup has been added to Clinical Operations that maps the country UUIDs in RIM to the country names in Clinical Operations in order to facilitate the correct country naming between the two applications.

Clinical Operations

Study Startup

Site Candidate Loader

This feature introduces an action on study that allows a user to upload a properly formatted CSV to create Study Site records. Vault creates candidate site records, and relates them to Organization, Location, and Person records in the global directory based on text matching.

eTMF

Study Metadata Extraction

With this feature, the TMF Bot now attempts to set the Study field on documents loaded to the Inbox in Vaults with a deployed metadata extraction trained model. This feature will require enablement by Veeva, and will be turned on only for select early adopters.

Study Migration

With this release, Clinical Operations now offers improved capabilities to support migrating studies for customers who add additional applications.

Vault Administrators can identify individual studies to include in a study migration. Once marked in migration, study-related object data is hidden and uneditable by non-Admin users. New data can be loaded in and by leveraging Vault Platform Migration capabilities and the new Study Migration field, data can migrate in without Clinical Operations productized triggers. This allows for faster, easier data load into production and review while users can continue to update documents and data in their existing applications.

Additionally, Vault Connections respect the Study Migration flag. Studies in migration do not transfer data to external Vaults until the Study migration is completed.

Document Task Filter Changes

Study, Study Country and Site have been copied to document tasks to make filtering by these fields more performant. In Vaults where these filters were displayed as a single filter, they will now be available as 3 separate filters so users can filter by Site or Study Country without first filtering by Study. Users will need to select Study Country and Site from the filter options to apply them.

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:

The following changes were made to Clinical Operations Vaults to support the Study Metadata Extraction feature:

  • Added the Metadata Extraction (metadata_extraction__sys) value to the Trained Model Type picklist
  • Added the new Excluded Classification object
  • Added the new Field Extracted value to the Trained Model Performance Metric object
  • Added the following new Notification Templates:
    • Model Testing Success (ml_model_testing_success__sys)
    • Model Testing Failure (ml_model_testing_failure__sys)
  • Made the following changes to Page Layouts:
    • Added Layout Rules to the Trained Model Page Layout
    • Added Layout Rules to the Trained Model Performance Metric Page Layout

The following changes were made to Clinical Operations Vaults to support the Study Migration feature:

  • Added the new Study Migration (study_migration__v) field to the following objects:
    • Activity (crm_activity__v)
    • Agreement (cdx_agreement__v)
    • Budget (budget__v)
    • Central Monitoring Event (central_monitoring_event__ctms)
    • Clinical User Task (clinical_user_task__clin)
    • Cycle Time (cycle_time__v)
    • Enrollment Status Log (enrollment_status__ctms)
    • Expected Documents (edl_item__v)
    • Expected Document List (edl__v)
    • Fee (fee__v)
    • Fee Schedule (fee_schedule__v)
    • Fee Schedule Template (fee_schedule_template__v)
    • Fee Template (fee_template__v)
    • Form Answer (form_answer__v(
    • Informed Consent Site Effective Tracking (icf_site_effective_tracking__ctms)
    • Informed Consent Tracking (informed_consent_tracking__ctms)
    • Issues (pdv__ctms)
    • Metrics (metrics__ctms)
    • Metrics Over Time (metrics_over_time__v)
    • Milestone (milestone__v)
    • Milestone Package Documents (milestone_package_document__v)
    • Monitored Informed Consent Form (monitored_informed_consent_form__ctms)
    • Monitored Metrics (monitored_metrics__ctms)
    • Monitored Subjects (monitored_subject__ctms
    • Monitored Subject Events (monitored_subject_event__ctms)
    • Monitored Subject Visit (monitored_subject_visit__v)
    • Monitoring Compliance (monitoring_compliance__ctms)
    • Monitoring Event (monitoring_event__ctms)
    • Monitoring Schedule (monitoring_schedule__v)
    • Monitoring Schedule Template (monitoring_schedule_template__v)
    • Payable Item (payable_item__v)
    • Payee Override (payee_override__v)
    • Payment (payment__v)
    • Procedure (procedure__v)
    • Procedure Definition (procedure_def__v)
    • Quality Issue (quality_issue__v)
    • Response (response__ctms)
    • Review Comment (review_comment__v)
    • Safety Distributions (safety_distribution__v)
    • Selected Site (selected_site__ctms)
    • Site Fee (site_fee__v)
    • Site Fee Definition (site_fee_def__v)
    • Site Survey Invitation (site_checklist_pal__v)
    • Study Arm (study_arm__v)
    • Study Cohort (study_cohort__v)
    • Study Communication Log (study_communication_log__ctms)
    • Study Country (study_country__v)
    • Study Critical Data (study_critical_data__v)
    • Study Critical Process (study_critical_process__v)
    • Study Organization (study_organization__v)
    • Study Personnel (study_person__clin)
    • Study Product (study_product__v)
    • Study Risk (study_risk__v)
    • Study Risk Assessment (study_risk_assessment__v)
    • Study Risk Category (study_risk_category__v)
    • Study Risk Mitigation (study_risk_mitigation__v)
    • Study Site (site__v)
    • Study Site Location (study_site_location__ctms)
    • Site Section (site_section__sys)
    • Study Team Assignment (team_assignment__v)
    • Subject (subject__clin)
    • Subject Informed Consent Form (subject_informed_consent_form__v)
    • Subject Visit (visit__v)
    • Template Expected Documents (edl_item_template__v)
    • Trip Report Question Responses (trip_report_question_response__ctms)
    • Trip Report Template (trip_report_template__ctms)
    • Visit Definition (visit_def__v)

Commercial

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 changes were made to PromoMats Vaults:

  • Added the following document fields: 
    • CRM Web Link Include ISI and PI (crm_web_link_include_isi_and_pi__v)
    • CRM Content Group (crm_content_group__v) 
  • Added the CRM Content Group (crm_content_group__v) object

Medical

Medical 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 Medical data model to support new features:

The following changes were made to Medical Vaults:

  • Added the following document fields: 
    • CRM Web Link Include ISI and PI (crm_web_link_include_isi_and_pi__v)
    • CRM Content Group (crm_content_group__v) 
  • Added the CRM Content Group (crm_content_group__v) object

Training

Study Training receives functionality and data model updates in parallel with the Quality Suite: Vault Training application.

Quality

QMS

QMS <> RIM:  Processing Enhancements

This feature updates how messages between the Quality and Regulatory Vaults are processed for the Change Control connection. This release introduces the QMS/RIM Connection Transaction object, which will be created by the source vault whenever a message needs to be sent to the corresponding target Vault. This object has a transaction status (Pending, Complete, Failure, Complete with Errors) that will be updated by the target Vault when processing is complete. If a transaction were to fail, the user on the source Vault has the option to initiate an action to reset the transaction to pending. This will allow for easier recovery in failure scenarios. The transaction object can be added to the page layouts for Change Control and Impact Assessment (in Quality) and Event and Activity (in Regulatory) for more convenient viewing of transaction statuses.

Previously, the QMS RIM: Submission Activity Update integration point only allowed for updating of existing Impacted Country records from Activity records in RIM. In this release, this integration point has been updated to also allow creation of Impacted Countries as well. In order to leverage the create function of this integration point, the Integration Rule QMS RIM: Submission Activity Update will need a field rule for every required field on the Impacted Country object. For example, Country is a required field on Impacted Country. In order to allow creation of Impacted Countries at the QMS RIM: Submission Activity Update _integration point, a new field rule will be needed to map the _Country field on the Impacted Country record to the Impacted Market field on the Activity record in RIM. The QMS RIM: Completed Regulatory Assessment integration rule can be used as a reference since that integration point creates Impacted Countries as well.

Additionally, a new action has been added to the Activity object in RIM. The ‘Update Impacted Country Details’ action is now available as both a user action and an entry action. This action will create an impacted country record in Quality if one does not exist or will update the connected impacted country if it was previously created.

QualityDocs

Audit Trail Behavior Update for Station Documents

This update changes the audit trail behavior of Station Documents and displays the username instead of ‘System’ or ‘System on behalf of <username>’ in the User Name field of the Station Document audit trail when a document is removed from a Station using the Quality Relationships document information panel. 

Training

Curriculum Sequencing on Learner Homepage

This feature enables Training Admins to suggest an order by which curricula should be completed by Learners.

Learners are provided with a new grouping option in the Learner Homepage where they can group Training Assignments by Learner Role. Learners can also access a new Learner Role Detail Page, where they get an overview of the selected Learner Role and view all associated curricula.

Training Admins can now access a new page by which they can reorder curricula within a specific learner role. The order defined in this page is displayed to Learners via the new Learner Role Detail page.

Tracking Curriculum Completions

This feature provides a new reportable object, Curriculum Completion Status, that records the completion status of every Curriculum in the Training application per Learner and Learner Role. This new object will track the completion percentage of curricula as Learners are assigned and complete training. Fully completed curricula are also marked as “Complete” on the corresponding Curriculum Completion Status record so that Admins can easily determine qualification of Learners. In addition, the system also tracks certain dates to give customers the ability to view a historical record of the curriculum’s completion. The system tracks the dates assignments were first and last assigned, and the dates the curriculum was first and last completed.

To support this feature, we’ve also added a new Training Requirement field on the Assignment Detail object. This field is a lookup to the Training Requirement field on the Training Assignment associated with the Assignment Detail record.

Enable Vault Training Mobile Interface in All Training Vaults

The “Enable Vault Training Mobile Interface” application setting is enabled on all Quality Vaults with the Vault Training or Study Training applications enabled. This allows users to view and complete training on mobile-optimized pages from mobile browser or the Vault Mobile app.

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 to support new features:

Added the following objects to support the QMS <> RIM: Processing Enhancements feature:

  • QMS-RIM Transaction (qms_rim_transaction__v) object
  • QMS-RIM Transaction Log (qms_rim_transaction_log__v) object

Added the following components to support the Tracking Curriculum Completions feature:

  • Added the Curriculum Completion Status (curriculum_completion_status__v) object.
  • Added the Training Requirement (training_requirement__v) lookup field to the Assignment Details object.

Added the following components to support the Curriculum Sequencing on Learner Homepage feature:

  • Added the Learner Role-Curriculum Order (learner_role_curriculum_order__v) object.
  • Added the Learner Homepage Card Image (learner_homepage_card_image__v) field to the Learner Role (learner_role__v) object.

Regulatory

RIM Registrations

IDMP Data Migration

This feature enables users to migrate data from the Registered Site Role to the related registered detail using Vault Loader. The management of manufacturing information was updated to support IDMP per IG v2.1.1. See About the Authorised Pharmaceutical Form & Registered Site Role Data Migrations for more information.

23R1 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 or updated the following components to the Regulatory data model:

  • Added the following objects to support the QMS <> RIM: Processing Enhancements feature:
    • QMS-RIM Transaction (qms_rim_transaction__v) object
    • QMS-RIM Transaction Log (qms_rim_transaction_log__v) object
  • Added the following components to RIM Vaults to support the RIM/Quality: Registered Product for Change Control feature:
    • Added the RIM-Quality: Product Integration (standard_product_integration__v) to the QMS RIM Connection (qms_rim_connection__v)
    • Added the following integration points to the RIM-Quality: Product Integration (standard_product_integration__v):
      • RIM-Quality: Product Family (product_family_int_point__v) Integration Point
      • RIM-Quality: Product (product_int_point__v) Integration Point
      • RIM-Quality: Product Family Product (product_family_product_int_point__v) Integration Point
      • RIM-Quality: Product Variant (product_variant_int_point__v) Integration Point
      • RIM-Quality: Complex Product Component (product_component_int_point__v) Integration Point
    • Added the RIM to QMS Product Outbound queue (rim_qms_product_outbound_queue__v)

Safety

Safety features are targeted for tentative availability on March 16, 2023.

Safety

PII Masking on Potential Matches Page Admin Checkbox

With this release, Admins can enable personally identifiable information (PII) masking on the Potential Matches page where Atomic Security is not enforced.

Learn More

Indexing of New Migrated Cases for Duplicate Search Admin Checkbox

With this release, Admins can initiate indexing of newly migrated Cases to include them in duplicate detection.

Learn More

Simplified Case Intake for Studies Auto-on

Inbox Items now support manual intake for unarmed studies. Based on the selected Study, Study Product selection will use either Study Arms or Study Products. In addition, Case Products can now be marked as Blinded, Unblinded, or Open-Label when a blinded Study is selected.

Learn More

Case Access Group Security Configuration

With Case Access Groups, Vault Safety significantly simplifies security around access to Cases based on Case data, including Sponsor, Report Type, Country, and Market Segment. In addition, this feature provides more granular control over unblinded information and personally identifiable information (PII) at the object and field levels. For example, Admins can manage access to non-sensitive data for specified open and non-Study Products, Drug Roles, and Study Product Roles.

Learn More

Case Access Groups: Workflow Participants by Role Auto-on

When using Case Access Groups, Vault Safety can now assign workflow tasks by role on the Case, Localized Case, and Transmission.

Learn More

Case Compare: Descriptive Error Messages Auto-on

This feature introduces more descriptive error messages on the Case Compare page. These enhanced messages help users understand issues that may occur when merging an Inbox Item to an in-flight Case or creating a Follow-Up Case.

Learn More

All Product Types Available for FDA 3500A and CIOMS I Generation Support

With this release, Vault Safety supports generating MedWatch 3500A and CIOMS I forms for device-only Cases. To accommodate reporting on additional classes of Products (for example, Over the Counter and Cosmetics), exporting Company Product types is also supported.

Learn More

MedWatch 3500A and CIOMS I Preview Generation for Open Label Study Arms Auto-on

With this release, Vault Safety supports generating MedWatch 3500A and CIOMS I preview forms for Cases that use an Open Label Arm from a Blinded Study.

Learn More

PMDA Multi-Submission with Localized Case Auto-on

With this release, Vault Safety supports multiple PMDA Submissions from a single Case.

Learn More

Enablement Details

Feature Enablement Application
Working with Documents
Binder Display Options for Unbound Documents Admin Checkbox Platform
Sort Multi-Select Field Values in Alphabetical Order Admin Checkbox Platform
Vault Objects
Person Object: Duplicate Detection on Copying Person Records Auto-on Platform
Search
Spanish Stemming Improvements Auto-on Platform
Improved Name Search Auto-on Platform
Administration
Sandbox Snapshots Enhancements Auto-on Platform
Vault Connections
RIM/Quality: Registered Product for Change Control Configuration QMS<>RIM
RIM/ClinOps: Support Country to Study Country Document Field Rule Mapping Auto-on ClinOps<>RIM
Clinical Operations
Site Candidate Loader Configuration Study Startup, eTMF
Study Migration Configuration CTMS, Study Startup, Vault Payments, eTMF
Study Metadata Extraction Support eTMF
Document Task Filter Changes Auto-on CTMS, Study Startup, Vault Payments, eTMF
Clinical Operations Data Model Changes Auto-on CTMS, Study Startup, Vault Payments, eTMF
Commercial
Commercial Data Model Changes Auto-on PromoMats
Medical
Medical Data Model Changes Auto-on MedComms
Quality
QMS <> RIM: Processing Enhancements Configuration QMS<>RIM
Audit Trail Behavior Update for Station Documents Auto-on QualityDocs
Curriculum Sequencing on Learner Homepage Auto-on Training
Tracking Curriculum Completions Auto-on Training
Enable Vault Training Mobile Interface in All Training Vaults Auto-on Training
Quality Data Model Changes Auto-on LIMS, QMS, QualityDocs, Station Manager, Surveillance, Training, Validation Management
Regulatory
IDMP Data Migration Admin Checkbox RIM Registrations
23R1 RIM Data Model Changes Auto-on RIM Publishing, RIM Registrations, RIM Submissions, RIM Submissions Archive

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.