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 21R1. For details about new features in the Vault Platform in 21R1, see the Vault Release Notes.
Safety
Vault Safety 21R1 introduces the following new features.
Intake
Features in this section are additions or improvements to Vault Safety case intake.
E2B R2 ACK for Inbound Transmission
The system now supports the generation and transmission of Acknowledgment Message (ACK) in the E2B(R2) format for inbound single-case or multi-case E2B(R2) transmissions.
This feature is available automatically with no additional action required.
Learn More: Receive an E2B Transmission
Multiple Case E2B Import
Vault Safety now supports the import of EMA E2B(R3) files that contain multiple cases. When an Inbound Transmission’s Origin field is EMA, the system skips the auto-generation of Submissions with Destination to the EMA during the evaluation of case reporting obligations.
This feature is available automatically with no additional action required.
Learn More: Create an Adverse Event Report
Multi-Case E2B Import via API/AS2
Vault Safety now supports the ability to import multi-case XML files in E2B(R2) and (R3) format via AS2 Gateway or API. Additionally, multi-case E2B(R2) files can be imported manually through the UI.
This feature will be available automatically in a future release for vaults with AS2 Gateway or API Transmissions already configured. In 21R1, contact Veeva Managed Services to request this feature.
Learn More:
Duplicate Detection Using External System UID
Vault Safety will now use the External System UID for duplication detection. It will return potential matches for cases that only have this field matching the Inbox Item or AER.
This feature is available automatically with no additional action required. However, an administrator must configure the External System UID field to capture this data on AER and Case page layouts if it was not already added in 20R3.
Learn More: Duplicate Case Detection
Case Processing
Features in this section are additions or improvements to Vault Safety case processing.
Promote to Case Follow-up: Set Follow-up Receipt Date to Initial Receipt Date
With this release, when an AER is promoted to a Follow-Up Case, the receipt date on the Follow-Up defaults to the Initial Receipt Date. This change in behavior resolves an issue where the New Information Date (C.1.5 in E2B R3) was possibly earlier than the Receipt Date (C.1.4 in E2B R3) if the Receipt Date was incorrectly entered on the AER.
This feature is available automatically with no additional action required. This new default behavior takes effect for new cases when they are created from an AER. This feature does not update existing cases.
Learn More: Enter Case Data
Support VAERS Reason Omitted “Other”
With this feature, customers can select “Other” as a reason omitted value for the Race (FDA.D.11) and Vaccination Facility (FDA.G.k.4.r.14.8) fields. Nullflavor “OTH” is also mapped to reason omitted “Other” as part of the FDA VAERS E2B R3 export.
This feature is available automatically with no additional action required.
Learn More:
Japan (PMDA) Local Fields
With this release, Japanese local data elements required by PMDA (Japan regulatory authority) become available for data entry.
An administrator must configure the new regional fields to make them available for data entry.
Learn More:
- Prepare a Localized Case: Enter Regional Data on Localized Cases
- Set Up the Localized Business Admin Library
Korea (MFDS) Local Fields
With this release, Korean local data elements required by MFDS (Korean regulatory authority) become available for data entry.
An administrator must configure the new regional fields to make them available for data entry.
Learn More: Prepare a Localized Case: Enter Regional Data on Localized Cases
Pregnancy and Parent-Child Case Data Collection Enhancements
Pregnancy and Parent-Child cases have been enhanced for the collection of child information with the introduction of the new Child Information object type for cases. This allows non-submittable pregnancy cases to be more easily tracked.
To improve data entry for follow-ups to collect pregnancy outcomes, Child Information records will automatically generate test result placeholders for APGAR scores (1, 5, and 10-minute), Birth Outcome, and Head Circumference.
In the event that the pregnancy outcome results in an adverse event in the neonate, the information is captured as a regular Case with a reference to the Parental (Pregnancy) Information.
An administrator must perform configuration to make this feature available. See Enable Pregnancy and Parent-Child Case Data Collection for instructions
Learn More: Add a Pregnancy Case
Case Version and Transmission Sequence Numbers
Vault Safety will now stamp every new case and transmission with an internal sequence number. The sequence number can be used in conjunction with Vault platform reporting capabilities to create custom multi-pass reports to retrieve the latest version of a Case or Transmission for a given reporting period.
This feature is available automatically. However, this will not stamp previously created cases or transmissions. A buffer of 10,000 unused numbers has been provided for previously created cases; however, this is not automatically applied. Contact Veeva Services to apply this buffer to existing Cases and Transmissions.
Learn More: Use Case or Transmission Unique Numbers in Reporting
Coding
Features in this section are additions or improvements to Vault Safety coding capabilities.
Recode Badge for MedDRA Terms
Users are now made aware with a visible indicator when a coded term’s MedDRA Version is not in sync with the Case MedDRA Version.
This feature is available automatically with no additional action required.
Learn More: Recode a MedDRA Term
Aggregate Reports
Features in this section are additions or improvements to Vault Safety Aggregate Reports.
PADER Transmission Date Filter
Vault Safety now filters PADER reports based on Transmission Date by default, which allows a firm cutoff date for including cases in the report. Cases with multiple versions for initial, follow-up or amendment reasons within the same reporting period are counted as initial in the PADER. In the 15 Day Summary Reports, the system considers additional criteria to identify fatal cases.
This feature is available automatically with no additional action required for customers who have configured PADER aggregate reports. This feature will not impact previously generated reports. Reports must be re-generated to take effect.
Learn More: Create PADER Aggregate Reports
Postmarket Studies and Literature enhancements for PADER, PBRER, PSUR, CIOMS and 3500A
PADER, PBRER, PSUR, CIOMS I, and 3500A have been enhanced to leverage Study Type to account for Post Market studies. To improve the data entry experience, administrators can now configure Study Type on Studies so that new study cases can automatically default the Study Type.
A new literature flag has been added to Report Type to classify literature. This will be automatically turned on for our standard Literature Report type and can be configured on custom report types to drive literature classification in PADER, PBRER, PSUR, CIOMS I, and 3500A.
This feature is available automatically for customers who are using PADER, PBRER, PSUR, CIOMS I, or 3500A. However, there is some page layout configuration for the Study Type field. See Enable Postmarket Studies for instructions. This feature will not impact previously generated reports. Reports must be re-generated to take effect.
Learn More:
- CIOMS I Generation Data Mapping
- FDA 3500A Generation Data Mapping
- Create PBRER Aggregate Reports
- Create PSUR Aggregate Reports
- Create PADER Aggregate Reports
PADER Subtotal/Grand Total and New Appendices
PADER now includes two new appendices: Non-Primary Suspect Product Report, and List of Death Cases. Additionally, Subtotals and Grand totals are now displayed in the Summary Tabulation of ADRs.
While this enhancement is introduced automatically, an Administrator must upload the templates for the new appendices and replace the existing PADER Summary Tabulation of ADRs template before generating PADER reports after the 21R1 release. Also, to generate appendices, the Documents to Generate field must be added to the Aggregate Report Page Layout to allow users to generate the new appendices. See Enable PADER Authoring and Table Generation for instructions.
Learn More: Create PADER Aggregate Reports
PBRER, PSUR, DSUR Case Approval Date Filter
Vault Safety now provides the option to filter PBRER, PSUR, and DSUR reports by Case Approval Date, this allows a firm cutoff date for including cases in the report. The system will continue to use the Case Receipt Date / New Info Date by default.
This feature is available automatically in vaults with the Filter Cases By field. If this field is not on the Aggregate Report Page Layout, it must be added to the page layout for users be able to specify the Case Approval Date. Enable Filter Cases by Approval Date in Aggregate Reports provides instructions. Reports must be re-generated for this feature to take effect.
Learn More:
PBRER, PSUR, DSUR, PADER Timezone Awareness and Enhancements
PBRER, PSUR, DSUR and PADER report filters have been enhanced to recognize timezones for more precise case inclusion. In addition, the ability to run PADER reports based on the Case Receipt Date / New Info Date has been replaced by running the reports solely based on Transmission Date. Also, the Non-Primary Suspect Product Report will now be generated by default. Lastly, the PBRER Cumulative ADRs from Postmarketing “Interval” column has been enhanced to respect the Case Approval Date when that option is selected in the PBRER “Filter Case By” field.
This feature is available automatically with no additional action required for customers who have configured the corresponding aggregate report (PBRER, PSUR, DSUR, and PADER). This will not impact previously generated reports. Reports must be re-generated to take effect.
Learn More:
- Create DSUR Aggregate Reports
- Create PBRER Aggregate Reports
- Create PSUR Aggregate Reports
- Create PADER Aggregate Reports
PSUR Time to Onset and Group by PT
PSUR reports have been updated to use MedDRA Preferred Terms (PT) for grouping adverse events. This replaces the previous verbatim term grouping mechanic. Additionally, the PSUR Line Listing now includes Time to Onset information.
While this feature is auto-on, we recommend that you upload the new 21R1 PSUR report templates, which have updated labels. See Enable PSUR Cumulative Tabulations and CIOMS II Line Listings for instructions. This feature will not impact previously generated reports. Reports must be re-generated to take effect.
Learn More:
Submissions and Distributions
Features in this section are additions or improvements to Vault Safety Submissions and Distributions.
EMA E2B R3 Submission Validation
This feature introduces full EMA E2B R3 conformance rules, extending the ICH E2B R3 validation capabilities delivered in 20R3. Validation is automatic when the EMA E2B R3 file format is generated or regenerated for a reporting destination. Validation Result records are created based on each evaluated Validation Criteria and can have an outcome of Pass, Fail, or Warning.
Note: MHRA uses the EMA E2B R3 format and will be validated for EMA E2B R3 conformance.
This feature is Auto-On. However, if ICH Submission Validation was not previously enabled in the 20R3 release, this feature requires configuration on the Transmission (Submission and Distribution) to add the Validation Results section to the Page Layout.
Learn More: Case and Submission Validation
FDA E2B R2 - Support “FDA Safety Report Type” (A.1.FDA.16) Field
Vault Safety now supports adding the FDA Safety Report Type (A.1.FDA.16) element to FDA E2B(R2) Transmissions.
This feature only impacts the Transmission file format FDA E2B(R2). Only the FDA Safety Report Type tag is being added to support postmarket submissions (E2B Code=3). Other IND Safety Report tags are not yet supported.
This feature won't take effect until the FDA E2B (R2) mandated date requiring the new regional data element A.1.FDA.16 (FDA Safety Report Type). After this date, FDA E2B (R2) files generated from Vault Safety will include this field automatically.
Local Expedited, Downgrade, and Postmarket Study Submissions
Vault Safety is extending its agency submission and distribution capabilities to configure rules-driven local expedited criteria, downgrades (one last time rule), and non-interventional postmarket studies. These updates have been reflected in the EMA and FDA rulesets. In addition, the FDA and EMA rule names have been refreshed to be more business-friendly names.
This feature is available automatically with no additional action required for customers who have enabled the Evaluate Reporting Obligations action, which was introduced in 19R3 as part of the EMA Submissions feature.
Learn More:
Configurable Back Reporting
Vault Safety now supports configurable back reporting for agencies, licensed partners and other reporting destinations. Back reporting means that a report will be sent back to the original sender. By default, back reporting will be turned off (i.e. prevented) for all reporting destinations, except Health Canada. Enabling back reporting for specific destinations can be done via Transmission Profiles. For an example, after importing an E2B downloaded from EVWEB, if that case is further processed and approved, a submission to the EMA isn’t generated (unless back reporting is enabled for EMA).
Contact Veeva Support to request this feature be enabled.
Learn More: Configure Back Reporting
VAERS Certification Enhancements
Vault Safety has enhanced collection, verification, and generation of data as part of VAERS E2B (R3) Guidance-Compliant Testing. Scenarios include, postmarket study cases with combination products, support for similar devices, support for VAERS specific units of measurement, display of VAERS related dosage fields for external vaccines, support for patient as non-primary reporter, fixes for malfunction-only cases, and fixes for transmission of blinded study flag.
This feature will be available automatically in a future release for vaults with Vaccines and VAERS Submissions enabled. In 21R1, contact Veeva Managed Services to request this feature. To display VAERS related dosage fields for external vaccines, the External Product Type field must be added to the External Case Product Page Layout.
Learn More:
- Prepare Vaccine Submissions
- E2B Generation Data Mapping
- Generate Masked Distributions
- Enter Case Data
VAERS E2B R3 Submission Validation
This feature introduces full VAERS E2B R3 conformance rules, extending the ICH E2B R3 validation capabilities delivered in 20R3. Validation is automatic when the VAERS E2B R3 file format is generated or regenerated for a reporting destination. Validation Result records are created based on each evaluated Validation Criteria and can have an outcome of Pass, Fail, or Warning. Additionally, at the case level, an extra safeguard has been added for Vaccines to display a warning if the most severe adverse event is not set as the primary.
This feature is Auto-On. However, if ICH Submission Validation was not previously enabled in the 20R3 release, this feature requires configuration on the Transmission (Submission and Distribution) to add the Validation Results section to the Page Layout.
Learn More: Case and Submission Validation
Tracking Non-Submittable Cases (Suppress Submission)
When enabled this feature prevents automatic ICSR submission record generation for cases designated as non-submittable (i.e. Invalid, Pregnancy cases, etc). These cases will also be excluded in aggregate reports.
An administrator must configure the Suppress Submissions field to make this feature available. See Enable Suppress Submissions for instructions.
Learn More: Suppress Case Submissions
Use Adverse Event PT on CIOMS and MedWatch 3500A
Vault Safety now supports the option to display adverse events using the MedDRA Preferred Term (PT) on CIOMS I and MedWatch 3500A forms.
Contact Veeva Support to request this feature be enabled. Once enabled, all new CIOMS I and MedWatch 3500A forms will use the MedDRA PT for adverse events. This will not impact previously generated reports, they must be re-rendered to take effect.
Learn More:
Show Assessment Results on CIOMS I
This feature reintroduces Case Assessment Results on the CIOMS I form, replacing the system-generated identifiers for Product names with readable names. As always, this section respects study masking and will show the blinded name on blinded forms.
This feature is available automatically with no additional action required. This feature will take effect for any newly generated CIOMS I form. This will not impact previously generated reports. Reports must be re-generated to take effect.
Learn More: CIOMS I Generation Data Mapping
Safety.AI
Vault Safety.AI 21R1 introduces the following new features.
Intake
Features in this section improve Safety.AI's intake capabilities.
Inbox Item PHI/PII Encryption
This feature adds an extra layer of protection for standard personal identifiable Information (PII) on the Inbox Item. This prevents Veeva from viewing encrypted fields unless they are assigned Delegate Access for 20+ Inbox Item fields and 20+ Case fields when received via API pass-through.
This feature is available automatically with no additional action required.
Learn More: Manage Field Encryption: PHI and PII Field Encryption
Inbox Item Manual Data Entry Enhancements
Manual Inbox Item intake has been enhanced for better usability. When a user manually creates an Inbox Item, the record will now have sections for the Primary Reporter, Suspect Product, and Adverse Event by default. When a user creates additional Case Contacts, Products, or Medical Events, the new section will be opened at creation. Additionally, when viewing a section with multiple products, events, or contacts, the first item will be expanded by default.
This feature is available automatically with no additional action required.
Learn More: Create an Inbox Item Manually
Inbox Item Manual Study Intake
Users are now able to select the Study and Study Arm on the Inbox Item to perform manual study case intake. On case promotion, Study and Study Arm information will be downloaded from the Vault Safety Library, including the Study Registration and Study Products, to reduce data entry effort. This enhancement supports open and blinded Studies with Arms.
Study intake capabilities are available automatically. However, an administrator must update the case validity criteria in the Inbox Item Lifecycle and the Case page layout to show Study information.
NLP and Data Extraction
Features in this section improve Safety.AI's NLP and data extraction capabilities.
Automatic PDF Form Intake
Safety.AI will automate intake from PDF forms using Artificial Intelligence and Machine Learning. A new User Action on Vault library documents will allow users to start the extraction process from the document text.
Upon successful completion, an Inbox Item will be created with the extracted case information for the Reporter, Patient, Adverse Events, and Products and prioritized (P1 to P3) based on the detected seriousness.
Dosage Extraction
Safety.AI will now automatically extract the dose and administration dates from unstructured text and PDF forms, and link them to their associated Case Products. The dosage information will be populated with a confidence icon and the source text will show in the Source Data pane to facilitate human verification.
This feature is available automatically with no additional action required.
MedDRA Auto-Coding for Intake API and PDF Forms
When an Inbox Item is created from data received through the Intake API or extracted from a PDF form, Safety.AI initiates MedDRA auto-coding. MedDRA auto-coding extends to all MedDRA fields on an Inbox Item with corresponding verbatim (“as reported”) fields. Auto-coding is based on an exact match (case insensitive) search across all MedDRA PTs/LLTs.
This feature is available automatically with no additional action required. Your vault must have an active MedDRA dictionary to use this feature.
Learn More:
Multiple Candidates for Date and Country Fields
Safety.AI will now show up to 4 candidates for Date and Country fields supported for extraction from text. Safety.AI will show the confidence level icon for each value and populate the one with the highest confidence score.
This feature is available automatically with no additional action required.
Checkboxes and Fields Recognition and Verification from PDF Forms
Safety.AI will automatically extract and map Seriousness checkboxes from a source PDF document to suggest the Inbox Item Priority. The Source Data pane will show this information to facilitate human verification. Also, Safety.AI will now extract document field labels for values found in the document text and will show them the Source Data pane along with the source text.
Drug/Biologic/Vaccine-Led Combination Product Intake
Safety.AI supports intake for Drug, Biologic, and Vaccine Combination Products on the Inbox Item. On case promotion the combo product information will be mapped to the product constituents and product constituents’ information will be downloaded from the library.
This feature is available automatically with no additional action required.
Learn More: Manage Combination Products
