Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.
The following features are introduced in 20R1. For details about new features in the Vault Platform in 20R1, see the Vault Release Notes.
Case Intake
Features in this section are additions or improvements to case intake.
Study Arms and Blinded Product Names
Administrators now have the ability to pre-configure Study Arms and add blinded names for products in blinded arms, for example Cholecap vs. Placebo. Users can maximize efficiency and avoid errors by selecting either open or blinded arms from the Product Library during intake.
This feature includes the ability to configure Standard of Care products and add multiple Study Products to a Case. Study Arm Cases can also be unblinded directly from the Case page without having to unblind each Case Product individually. Dosage and Indications for Study Arm Products can be automatically populated on the Case, depending on the Study Arm configuration.
An administrator must perform several system configuration updates to make this feature available in your vault. Once enabled, administrators can configure Study Arms and Blinded Product Names for selection during case data entry.
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Study Site Reporters
Vault Safety now supports the ability to configure Study Contacts for use as Site Reporters during the initial intake of Study Cases.
Once an administrator configures Study Contacts, users can select the appropriate Site Reporter during case intake. Upon Case promotion, all required details of the Site Reporter will be automatically populated on the Case, increasing data entry efficiency and accuracy.
An administrator must perform several system configuration updates to make this feature available in your vault. Once enabled, an administrator can configure Study Site Reporters for selection during case data entry.
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E2B Import: Product Matching Enhancements
During an E2B import, Vault Safety can now match non-blinded case products to the Product Library using the registration number or product name. This feature expands upon the existing functionality to match products to the Product Library using the MPID, PhPID, or Substance ID.
This feature is available automatically with no additional action required.
Case Processing
Features in this section are additions or improvements to Vault Safety case processing.
Medical Review Enhancements
This release includes multiple enhancements to support medical review activities throughout case processing.
These enhancements are available automatically with no additional action required.
Auto-Create Assessment Results Grid
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).
Auto-Designate 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.
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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.
Depending on your vault settings, the Symptom/Diagnosis and Diagnosis fields will appear automatically or may need to be added to page layouts before they appear. Contact your Veeva Services representative for more information.
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Case Level Relatedness and Automatic SUSAR/SAE Detection
Vault Safety now provides better transparency in Relatedness. Users can now view the Relatedness for the primary assessment at the Case-level.
As part of this enhancement, users can now enter the Reporter Assessment Result during Adverse Event Report intake.
In addition, new and revised Case Assessments and Cases that meet the appropriate seriousness criteria are automatically tagged as a SUSAR or SAE to aid in ad-hoc reports and data analysis.
The Relatedness filter is available automatically on the Case tab for all users with no additional action required. However, Admins must update page layouts to add the Reporter Assessment Result and Relatedness fields, as well as some other configuration changes.
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- Enable Case Level Relatedness and Automatic SUSAR/SAE Tagging
- Enter Case Data
- Enter Adverse Event Report Information
- Enter a Case Assessment
Blinded Case Previews
Vault Safety now supports the ability to generate protected views of Individual Case Safety Reports (ICSRs) during case processing with sensitive study data hidden for any blinded studies. This includes E2B, CIOMS I, and FDA 3500A generation. Users that have access to unblinded study data, such as users in the Head of Safety role, can continue to generate these reports with all study data visible.
This feature is available automatically with no additional action required.
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Controlled Vocabulary: Extended Configurability
To offer maximum flexibility when entering case data, Vault Safety now allows administrators to modify Controlled Vocabulary records while ensuring E2B compliance.
You can now customize select system-generated Controlled Vocabulary records to align with organizational safety requirements or study protocols, as well as delete or modify user-created records without impacting Vault functions or E2B transactions.
This feature is available automatically with no additional action required. However, an administrator must configure user actions to enable status changes to deactivate Controlled Vocabulary records.
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Case Product Dose and Indication Sections
This enhancement enables users to enter product dosages and indications directly on the Case Product page, ensuring faster data entry and more intuitive usability.
An administrator must add the Case Product Dose and Indication sections to page layouts to enable these enhancements.
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Frequency: Multi-Option Control
This release features an enhanced Frequency control option that allows for a more efficient and user-friendly data entry process. Users can capture standard medication administration intervals in a more structured way using common, everyday words. Vault Safety will then automatically calculate and enter the respective E2B values, ensuring accuracy and compliance.
This feature is available automatically with no additional action required.
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Uniform Control Enhancements
User interface controls have been enhanced to improve legibility and data entry efficiency.
These enhancements are available automatically with no additional action required.
Precise Naming for Assessment Matrix, Case Product, and Adverse Event
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-#####).
This feature is available automatically with no additional action required.
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Case Product Drug Role: Treatment
Users can now assign the drug role of a Case Product to be a treatment of the adverse event.
Contact Veeva Services to request configuration upgrades to enable this feature.
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Auto-Expectedness: Expedited Field Default Setting
The system no longer sets the Case Expedited field to No for serious and expected Cases. Instead, the system leaves the Expedited field blank.
This feature is available automatically with no additional action required.
Coding
Features in this section are additions or improvements to Vault Safety coding capabilities.
MedDRA Auto-Coding
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.
An administrator must replace the old reported term and MedDRA fields with the new combined auto-code control on page layouts to make this feature available in your vault.
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xEVMPD Dosage Forms
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).
An administrator must perform system configuration updates to make the xEVMPD dictionary available in your vault.
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Non-Standard Dose Units
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.
This feature is available automatically, however, an administrator must grant the Case Entry Actions permission set access to edit new fields.
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Monitoring
Features in this section are additions or improvements to Vault Safety's event monitoring capabilities.
AESI and Configurable Watchlists
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. As part of this feature, the Watchlist Tags field now supports a Case being tagged with multiple watchlists.
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).
An administrator must update fields, page layouts, and rules on the Watchlist object to make this feature available in your vault. Once enabled, administrators can configure Adverse Event Watchlists to use this feature.
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Standardized MedDRA Queries and Custom Queries
Vault Safety now supports Standard MedDRA queries (SMQs) and Custom MedDRA queries (CMQs) as safety signal detection tools. You can utilize comprehensive search options to generate query reports for specific organizations, products, and studies to identify safety signals.
An administrator must perform several configuration upgrades and import a MedDRA dictionary to make this feature available in your vault.
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Submissions and Distributions
Features in this section are additions or improvements to Vault Safety Submissions and Distributions.
Masked Content Distributions
Vault Safety now supports the ability to selectively mask sensitive information on Individual Case Safety Reports (ICSRs). For each study or product, you can choose to protect confidential or blinded data, such as all of a patient’s identifiable and health information, only identifiable information, and/or general study data.
Through this feature, you can generate masked distributions for partner organizations while continuing to generate unblinded records for agency submissions.
This feature also includes a new blinded narrative template that can be configured for blinded studies, to protect all information that needs to be masked.
An administrator must perform several system configuration updates to make this feature available in your vault. Once enabled, administrators configure reporting rules and distribution managers can configure ad-hoc distributions that leverage this feature.
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CIOMS I Form Update and Comprehensive Overflows
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).
Note The new CIOMS format will only be used for newly generated or re-generated documents.
These updates are available automatically with no additional action required. However, the new CIOMS Remarks field must be added to the Case Detail Page Layout to be available for data entry.
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FDA 3500A Comprehensive Overflows
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.
Note The new FDA format will only be used for newly generated or re-generated documents.
These updates are available automatically with no additional action required. However, the new National Drug Code field must be added to the Product Registration Detail Page Layout to be available for data entry.
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E2B Notification Links
This release improves the handling of errors and warnings during E2B import and export actions. These improvements include direct links to the relevant Case or AER referenced in the E2B notification messages.
This feature is available automatically with no additional action required.
Integrations
Features in this section are new integrations with Vault Safety or enhancements to existing integrations.
Import Narratives API Endpoint
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.
This feature is available automatically with no additional action required.
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