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 22R1. For details about new features in the Vault Platform in 22R1, see the Vault Release Notes.
Intake
Features in this section are additions or improvements to case intake.
Case UID Manual Intake on Inbox Item
Auto-OnUsers can now manually enter the Worldwide UID and an External System UID on the Inbox Item page to facilitate case intake and duplicate search.
Duplicate Detection by Case Identifiers
Auto-OnVault Safety will now search for duplicates using Case Identifiers. Inbox Item UIDs and Case Identifiers will be cross compared with Case UIDs and Identifiers during duplicate detection.
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Identifiable Reporter and Patient Per ICH E2D on Inbox Item
Auto-OnVault Safety will now evaluate the Identifiable Patient and Identifiable Reporter fields on the Inbox Item based on the ICH Guideline Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting E2D, which looks at certain fields from the Patient and Case Contacts section. In addition, if you mark one or more of these fields as Masked, the patient or reporter will qualify as identifiable.
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Automated Case Promotion to Initial and Follow-Up Case
ConfigVault Safety now supports automated Inbox Item promotion to an Initial or Follow-Up Case for external systems (E2B/JSON using Intake API or AS2 Gateway) that have their own case processing workflows. The system verifies whether Case promotion is valid, leverages Case Identifier matching, and has selectable merging methods based on seriousness.
Learn More
- Enablement: Enable Automated Case Promotion
- Admin Help: Configure the Case Promotion Settings Page
- User Help: Automated Case Promotion
Merge Inbox Item to In-Flight Case
Admin CheckboxVault Safety now supports merging information received in Inbox Item into the latest Case version. When merged, source documents will also be added to the latest Case version. To facilitate parallel processing, Intake users can now alert the case processor that there is new case information by marking an Inbox Item as a follow-up to the latest case. Inbox Items marked as follow-up can either be merged into the latest Case version or can be used to create a Follow-Up Case.
Learn More
- Enablement: Enable Merge to In-Flight Case
- Admin Help: Configure the Case Promotion Settings Page
- User Help: Merge to In-Flight Case
Promote to Multiple Cases
ConfigVault Safety can now promote a single Inbox Item to up to 100 cases. The cases will be related and contain all the information from the Inbox Item, including source documents. This functionality is primarily intended for the intake of literature and legal cases. This feature is not supported for E2B imported Inbox Items.
Learn More
- Enablement: Promote an Inbox Item to Multiple Cases
- User Help: Promote to Case: Promote an Inbox Item to Multiple Cases
Follow-Up with Any Matching UID
ConfigAdmins can now configure Vault Safety to allow Inbox Items to be promoted to a Follow-Up Case when the Worldwide UID does not match but matches another UID, such as an External System UID or a Case Identifier.
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Import Product Matching by Company Product Substance, Trade Name, and Alias
ConfigThis release enhances product matching when importing Inbox Items or AERs from E2B and JSON files by supporting product generic names, trade names, product aliases, and substance aliases.
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Inbox Item Global Actions for Manual Intake
Auto-OnVault Safety now supports global actions to create, edit, and save all Inbox Item records in a single click during manual Inbox Item intake. The system warns users when navigating away from an Inbox Item with unsaved data.
Learn More
- User Help: Manual Inbox Item Intake
Deep Duplicate Search
SupportVault Safety will now search for potential matches using all Case Adverse Events and Company or Study Products, including non-primary records. Additionally, users will be able to confirm new case creation when no potential match is found.
Learn More
- User Help: Promote to Case: Deep Duplicate Detection
Attach Custom Child Objects to Case on Follow-Up From Inbox Item
Auto-OnWhen promoting an Inbox Item to a Follow-Up Case, custom child object records will now be added to the new Case version.
Learn More
- User Help: Inbox Item Follow-Up: Merging Child Records
Rank Suggestion and Validation for E2B-Imported Blinded Products
Auto-OnVault Safety will now suggest Rank 1 for Investigational Blinded Products (G.k.2.5 = Yes) on E2B R3 import to Inbox Item. These Case Products won’t need a Study Product or Company Product to be a primary suspect (rank 1).
Field Limit Updates for E2B
SupportVault Safety will now support the maximum E2B length for Dose Text, Reason Text, Result Value and Age value. First, Dose Text will now accept up to 2,000 characters (E2B limit for G.K.4.r.8 / B.4.k.6) on Inbox Item, Case Product Dosage and Localized Case Product Dosage. Second, Reason Text will now accept up to 2,000 characters (E2B limit for C.1.11.2 / A.1.13.1) on Transmission. Third, Result Value on Case Test Result will now accept up to 50 digits (E2B limit for F.r.3.2 / B.3.1d). Lastly, Age Value will accept up to 5 digits (E2B limit for D.2.2a).
Learn More
- Enablement: Enable Field Limit Updates for E2B
Case Processing
Features in this section are additions or improvements to case processing, including data entry, triage, medical review, auto-calculations, and general case management.
Foreign Localized Case Synching
SupportOn a follow-up Localized case, Vault Safety now performs a one-time data sync from the global case to the localized case when the associated transmission record is created. The system also prevents user edits to the follow-up Localized Case until it is ready for transmission evaluation.
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Always Serious and Product or Study-Independent Watchlists
ConfigYou can now create watchlists without specifying a Study or Product. Additionally, you can set Seriousness criteria for adverse events on a watchlist. If a Case contains a matching adverse event(s), the Seriousness will automatically be assigned to the Case Adverse Event, if Seriousness is not already specified.
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Auto-Listedness Using Core Datasheets
ConfigVault Safety will now generate expectedness records for the product’s Core Datasheet (CCDS) to support listedness calculations during case processing. A new field will also be available for Core Datasheet roll up at the Assessment and Case level.
Learn More
- Enablement: Enable Listedness and Expectedness From Core Datasheets
- Admin Help: Manage Datasheets and Auto-Expectedness
Expectedness from Core Datasheets
ConfigWhen generating a submission, Vault Safety will evaluate expectedness for a Study Case using the Development Core Safety Information (DCSI) datasheet within the investigator brochure (IB).
Vault Safety can also calculate expectedness from a product’s Core Datasheet without additional configuration to Local Datasheets, if your product or organization does not require them.
Learn More
- Enablement: Enable Listedness and Expectedness From Core Datasheets
- Admin Help: Manage Datasheets and Auto-Expectedness
Conditional Expectedness
ConfigThis feature brings multiple enhancements to the configuration and evaluation of Datasheets for auto-expectedness. When configuring Datasheets, administrators can now specify seriousness criteria conditions, which define when a listed term is unexpected. Seriousness criteria can be configured at both the Datasheet and MedDRA Criteria (listed term) level. Admins can also now configure precise expectedness on Datasheets, which prevents the system from marking terms as unexpected if they are not listed on the Datasheet. Additionally, a new Expectedness MedDRA Criteria setting allows you to specify unexpected terms on a Datasheet.
Learn More
- Enablement: Enable Conditional Expectedness
- Admin Help: Manage Datasheets and Auto-Expectedness
Case Nullification
ConfigVault Safety now supports the ability to void a case, including the option to nullify previous Transmissions using a configurable user action at the Case-level. You must specify a reason for nullification when you run the action, which will auto-populate in new system-generated transmission records related to the case. Additionally, upon initiating the voiding process, the system automatically cancels any in-progress workflows.
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Case Validations: Control Workflow Transitions
ConfigVault Safety can now calculate the worst validation result for a case and transmission to be used in entry criteria and prevent lifecycle state changes. The system will also prevent gateway submissions for any transmissions with Hard Failures.
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Strict Case Locking
Admin CheckboxAdministrators can now enable a system setting to enforce strict case locking, which prevents users from making changes to a Case unless that user had locked the Case themselves.
Learn More
- Enablement: Enable Strict Case Locking
- Admin Help: Lock and Unlock a Case: Strict Case Locking
Provision Standard Verbatim Fields for Case Drug History and Case Diagnosis
ConfigIn this release, Vault will allow for standard fields to support migration of verbatim values for Case Drug History and Case Diagnosis records.
Learn More
- Enablement: (Optional) To expose the new verbatim fields to users, an administrator can add the new fields to the following page layouts, if required:
Note These fields are primarily added for data migration and are not currently supported for E2B import or export or any type of report generation. These fields do not need to be added to page layouts for migration.
- Case Drug History:
- "Indication (Reported)" (
indication_reported__v
) - "Reaction (Reported)" (
reaction_reported__v
)
- "Indication (Reported)" (
- Case Diagnosis: "Name (Reported)" (
name_reported__v
)
- Case Drug History:
- User Help: Enter Case Data
Coding
Features in this section are additions or improvements to Vault Safety medical coding capabilities.
MedDRA Hierarchy for CMQ and Vault Reporting
ConfigAdmins can now download the full active MedDRA version from the central dictionary to your vault instead of uploading dictionary .zip
files. Admins can also perform a deep copy of MedDRA queries and associated records, as well as update the MedDRA hierarchy with higher-level terms associated with all LLT terms in your vault.
Additionally, Vault Safety now supports creating Custom MedDRA Queries (CMQs) using any level of the MedDRA hierarchy (SOCs, HLGTs, HLTs, PTs, and LLTs). Previously, MedDRA Queries could only be constructed using LLTs. The MedDRA Queries with non-LLTs will be supported through standard Vault Reporting and Dashboarding.
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Safety Report Generation
Features in this section are additions or improvements to ICSR report generation.
Blind Protection Relatedness Override - CIOMS I and E2B
SupportVault Safety now provides the ability to blind protect unblinded double-blinded study cases in generated CIOMS I and E2B documents. Users can select an override for Case Assessment Results, if different from the blinded Assessment, to be displayed in the unblinded CIOMS I and unmasked E2B documents.
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Precise Inclusion of Age-Related and Medically Confirmed E2B Elements
Auto-OnThis release includes enhancements to E2B generation for precise inclusion of age-related elements (B.1 / D.2) and medical confirmation by a health professional (A.1.14 / E.i.8). This change impacts all standard E2B(R2) and (R3) formats that Vault Safety generates. The following table describes the impacted data elements:
Element Name | E2B(R2) | E2B(R3) | Changes |
---|---|---|---|
Medically Confirmed by Healthcare Professional | A.1.14 | E.i.8 | Now only transmitted when the primary Reporter is not a health professional. |
Patient Date of Birth | B.1.2.1 | D.2.1 | Now only transmitted when a full date is entered in the corresponding Vault Safety field (CCYYMMDD), except for PMDA where the Date of Birth is always masked if provided. |
Date of Birth of Parent | B.1.10.2.1 | D.10.2.1 | Now only transmitted when a full date is entered in the corresponding Vault Safety field (CCYYMMDD). |
Age at Time of Onset | B.1.2.2 | D.2.2 | Now only transmitted if the Date of Birth (D.2.1 / B.1.2.1) is not transmitted. For example, Date of Birth is partial or Masked. |
Age Group | B.1.2.3 | D.2.3 | Now only transmitted when both the Patient Date of Birth (B.1.2.1 / D.2.1) and Age at Onset (B.1.2.2 / D.2.2) are not transmitted. For example, Date of Birth is partial or Masked. |
Learn More
- User Help: E2B Generation Data Mapping
E2B(R2) Enhancements
Auto-OnThis release includes the following E2B(R2) enhancements for all E2B(R2) report formats (ICH, FDA, HC):
- When "Drug Not Administered" is selected for a Product Drug Role, include drug characterization with “Suspect” (B.4.k.1)
- Importing and exporting the <
safetyreportversion
> tag - Collating seriousness from all Case Adverse Events when transmitting Case Seriousness criteria (A.1.5.2)
- Masking E2B(R2) elements with “PRIVACY” for masked distributions
Learn More
- Enablement: Enable Safety Report Version Customization
- User Help:
E2B(R2) Partial Dates for Combination Product Expiration Date
SupportVault Safety now accepts partial dates in the Case Product “Expiration Date” field. For FDA E2B(R2) combination product reports, partial dates are exported to Expiration Date elements B.4.k.2.4.FDA.1a-b using the appropriate date format code.
Learn More
- Enablement: Contact Veeva Support to enable this feature. Once enabled, an admin must replace the existing "Expiration Date" field with the new Expiration Date control on the Product and Case Product page layouts.
Note If you enable this feature, you must manually migrate any existing Expiration Date data after adding the new control.
- User Help:
Reporter Masking for Post-Market Non-Literature Cases
Admin CheckboxVault Safety provides a system-level setting to support masking reporter information in all outbound Submissions and Distribution for post-market non-literature Cases (E2B(R2), E2B(R3), CIOMS I, MedWatch3500A). If an admin enables this setting, reporter masking applies to all post-market non-literature Cases.
Learn More
- Enablement: Enable Reporter Masking System Setting
- User Help: Reporter Masking for Postmarket Non-Literature Cases
Generate Assessment Results With Clinical and Post Market Source Defaults
Auto-OnThis release enhances EMA E2B(R3) file generation by ensuring that the Source Type on system-generated Case Assessment Results is accurately set for postmarket submissions to the EMA EVHUMAN module. Table constraints for the DSUR Interval Line Listings of Serious Adverse Reactions have also been updated with further protections to ensure only related adverse events are listed. Additionally, administrators can now edit the name of system-provided Controlled Vocabulary records, if required.
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Submissions and Distributions
Features in this section are additions or improvements to Vault Safety Submissions and Distributions.
Transmission Product Types
ConfigThis feature enables products to be registered as different product types in different markets. For example, a product may be registered as a combination product with the FDA, and a drug with the EMA. This feature is controlled by a new Transmission Product Type setting, which can be set on a Transmission or at the Product or Study Registration level by an admin.
One scenario this feature supports is omitting device constituents from combination product E2B Reports. Because certain jurisdictions do not accept combination product submissions, you can exclude Device-type product constituents from E2B files generated for Combination Product reports. Unless this feature is enabled, E2B files generated for a Combination Product Case continue to include both Device-type and Drug-type Product Constituents.
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Health Canada Transmission Profiles and Message Types
Auto-OnVault Safety now supports the Health Canada gateway for electronic submissions of clinical and post-market cases. A valid Health Canada E2B(R2) file with correct header information is also generated.
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PHI Masking on Foreign Submissions
ConfigVault Safety can now generate safety reports with PHI masking for Submissions. Masking can be configured at the reporting rule level to apply to all cases or only foreign cases.
Learn More
- Enablement:
- To allow users to manually select masking for a Submission, an admin can add the "Patient Content Protection" and "Exceptions to Patient Content Protection" fields to the Submission Page Layout.
- To automatically apply masking with reporting rules, an admin can configure the Mask PII rule parameter.
- Admin Help: Reporting Rule Parameter Reference
- User Help:
Configurable Validation Criteria
ConfigVault Safety now supports additional custom validation criteria using the standard validation criteria syntax, which will run as part of the Case validations. In addition, the Vault Safety validation engine now supports E2B(R2) formats.
Learn More
For assistance in configuring custom validation criteria, contact Veeva Services.
Ignore Validation Rule
Auto-OnValidation Results on a Case or Transmission can now be changed to the Ignored state. This allows users to proceed with case processing and submissions while ignoring certain validation failures. Subsequent validation evaluations will not execute on ignored results.
Learn More
- Enablement: Enable Ignore Validation Rule
- User Help: Case and Submission Validation: Ignore Validation Results
Reporting Rules
Features in this section are additions or improvements to the Vault Safety reporting rules engine.
FDA Submission Automation: Relatedness Assessment Source Parameter
Auto-OnThe FDA does not require a study submission if a sponsor assesses a case as Not Related while the investigator assesses the case as Related for a SUSAR in a clinical trial. With this release, users will no longer have to inactivate the submission to the FDA, as it will not be generated due to now evaluating the relatedness for FDA SUSAR cases based on the Sponsor’s Assessment. Additionally, the Assessment Source parameter will be introduced for use in Custom Rulesets.
Learn More
- Admin Help: Reporting Rule Parameter Reference
Submission Automation: Upgrade and Downgrade Parameters
Auto-OnVault Safety will introduce new parameters to calculate whether a Case is an upgrade or a downgrade in order to support additional submissions scenarios for the FDA, EMA, ROW, and custom rule sets. This feature will also support the one-last-time and one-more-time reporting rules, while considering the appropriate due date and local expedited criteria.
Learn More
- Admin Help: Reporting Rule Parameter Reference
Submission Rules: Support for MedDRA Queries (SMQs and CMQs)
ConfigWith this release, Vault Safety will extend the Safety Rule Engine to allow greater configurability for Custom Rule Sets. New rule parameters will be introduced to support the selection of specific Products and/or Studies when deciding if a rule should be executed. Additionally, MedDRA Queries (SMQs and CMQs) can be used to determine if a case should be reportable in order to support situations such as “Lack of Efficacy” or customer-managed lists of non-reportable terms.
Learn More
- Enablement: Enable Support for MedDRA Queries in Submission Rules
- User Help: Use MedDRA Queries
- Admin Help: Reporting Rule Parameter Reference
Safety Rule Version Management
Admin CheckboxAdmins can now configure an Active Version of the system-provided standard rulesets. When new rules are introduced into a standard ruleset (for example, FDA, EMA, and PMDA) as part of a release, admins can set the rule version to allow for adoption of the most recent version of a standard ruleset on a configurable basis.
Learn More
- Enablement: Manage Reporting Rule Versions: Prerequisites
- Admin Help: Manage Reporting Rule Versions
Automated Cross Reporting
ConfigIn this release, Vault Safety extends the evaluation of reporting obligations to include cross-reporting (investigational to marketing registration) scenarios. Vault Safety evaluates the investigational and marketing registrations of study products, then identifies any additional reporting destinations for products and studies. Administrators can also specify destination overrides on product licenses.
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Identifiable Patient Definition Ruleset Parameter
ConfigIn this release, Vault Safety allows submission rules to evaluate the Identifiable Patient Definition ruleset parameter to determine whether or not a case contains an Identifiable Patient as defined by E2D (ICH standard), or less strict “Patient Known to Exists” - a newly introduced case field. This allows greater specificity in submission to health authority and partners with less strict definitions of patient (i.e. FDA) while minimizing the potential for over reporting to destinations that have more strict definitions of patient (i.e. EMA).
Learn More
- Enablement: To leverage the "Patient Known to Exist" field, an admin can add the field to the Case and Imported Case page layouts.
- Admin Help: Reporting Rule Parameter Reference
- User Help: Enter Case Data (Patient Known to Exist field)
Study Administration
Features in this section are additions or improvements to managing Studies in Vault Safety.
Bulk Unblind
ConfigVault Safety can now bulk unblind multiple cases in a given study. This includes both the removal of blind protection for previously unblinded cases and snapshotting study arm product information for blinded cases. Cases currently in workflow will not be modified by this action.
Learn More
- Enablement: Enable Bulk Unblind
- Admin Help: Bulk Unblind a Study
Organized Data Collection of Reports from Patient Support Programs and Market Research Programs
ConfigVault Safety now supports organized data collection of reports from PSPs (Patient Support Programs) and MRPs (Market Research Programs). Admins can create Study placeholders for Studies with unspecified products and intake users can select Company Products as Suspect Products. Upon case promotion, reporting obligations are evaluated using Product Registrations for the suspect Company Products.
Learn More
- Enablement: Enable Organized Data Collection
- Admin Help: Create a Study with Unspecified Products
Integrations
Features in this section are new integrations with Vault Safety or enhancements to existing integrations.
Bulk Narrative Import and Status Check API Endpoints
N/ATwo new Vault Safety API endpoints are available to import multiple case narrative documents and translations in one operation. This is to improve case migration performance in Vault Safety. The Vault Developer Release Notes provide more information.
Custom Safety Rules SDK
N/AVault Safety now has an SDK entry point to allow customized logic for submission rules.
Learn More
For assistance with the custom safety rules SDK, contact Veeva Services.
Custom Safety Validations SDK
N/AVault Safety now has an SDK entry point to extend Case validation with custom criteria and evaluation logic.
Learn More
For assistance with the custom validations SDK, contact Veeva Services.