24R3 Safety Maintenance Releases | Veeva Vault Release Notes

A maintenance release contains fixes for issues affecting customer Vaults in production environments. Maintenance releases can occasionally include enhancements, for example, a time-sensitive regulatory requirement. This page covers maintenance releases deployed to General Release Vaults only. We communicate 24 hours prior to a maintenance release. There may be a short service disruption during deployment.

This list only covers fixes for issues that impact 24R3 General Release versions of Safety Vaults. The list of fixed issues is subject to change until the release occurs. When we identify issues to fix in a maintenance release, we attempt to get them into the earliest release possible. Sometimes, we target a specific release but are not able to deliver a fix early enough for full testing. In situations like this, we postpone the fix for a later release and strike out the description in this list.

We number maintenance releases for Safety by appending the number of the Safety-specific maintenance release to the General Release number. The most recent Vault General Release is 24R3.0, so our maintenance releases for this version are 24R3.0.2, 24R3.0.3, and so on.

Vault frequently delivers Platform maintenance releases. Safety deploys these Platform maintenance releases at a later date, along with any required fixes to Safety. For details on Platform fixes in these maintenance releases, see 24R3 Maintenance Releases.

Last Updated: February 19, 2025

February 19, 2025

Release Number: 24R3.0.10 | Build Number: 308 | Platform: 10685

Description	Issue No.
When generating FDA E2B(R3) files for cross reporting scenarios, Vault does not map the Study Registration Numbers from applicable Study Registrations to the "FDA.C.5.6.r IND number of cross reported IND" data element.	SAF-69609
When transferring Adverse Events through the Medical-Safety Vault Connection, if an attachment file name exceeds 100 characters, Inbox Item creation fails.	SAF-73089

February 12, 2025

Release Number: 24R3.0.9 | Build Number: 305 | Platform: 10661

Description	Issue No.
For domestic Cases with foreign Localized Cases, when edits to an Adverse Event or a Case Product would result in an updated Case Assessment name, Vault displays an error message and prevents saving the Case. For domestic Cases with foreign Localized Cases, when edits to an Adverse Event or a Case Product lead to an updated Case Assessment name, Vault displays an error message and prevents saving the edited Adverse Event or Case Product record.	SAF-72265
For follow-up Cases with foreign Japan Localized Cases, when users attempt to edit the Adverse Event on the global Case, for example to code or recode the MedDRA Term, Vault displays an error message and prevents saving the Adverse Event. For follow-up Cases with foreign Japan Localized Cases, when coding an Adverse Event on the global case, Vault displays an error message and prevents saving the Adverse Event record.	SAF-72911

Description

Issue No.

For domestic Cases with foreign Localized Cases, when edits to an Adverse Event or a Case Product would result in an updated Case Assessment name, Vault displays an error message and prevents saving the Case.
For domestic Cases with foreign Localized Cases, when edits to an Adverse Event or a Case Product lead to an updated Case Assessment name, Vault displays an error message and prevents saving the edited Adverse Event or Case Product record.

SAF-72265

For follow-up Cases with foreign Japan Localized Cases, when users attempt to edit the Adverse Event on the global Case, for example to code or recode the MedDRA Term, Vault displays an error message and prevents saving the Adverse Event.
For follow-up Cases with foreign Japan Localized Cases, when coding an Adverse Event on the global case, Vault displays an error message and prevents saving the Adverse Event record.

SAF-72911

February 9, 2025

Release Number: 24R3.0.8 | Build Number: 303

Description	Issue No.
When a user runs the Re-evaluate Submissions / Distributions action on a Case that causes a Rule Engine error, Vault displays an unexpected error message.	SAF-69439
For Cases created using tabular data format import, in some instances, Vault populates the Patient RoA field on Case Product Dosage records with the Route of Administration ID instead of the term.	SAF-72077
For imported Inbox Items, Vault displays the Blinded field value in the Product section only when a user is editing the Inbox Item.	SAF-72079
After merging an Inbox Item to an in-flight Japan domestic Case, Vault clears the Expected values from previously existing global Case Assessments.	SAF-72435
When processing a follow-up to a Japan foreign Case, if the related Japan Localized Case has multiple Case Product Registrations related to the same Adverse Event, after the Evaluate Regulatory Obligations action runs on the Case, Vault displays an error and fails to sync from the global Case to the Localized Case.	SAF-72604

February 4, 2025

Release Number: 24R3.0.7 | Build Number: 295

Description	Issue No.
Vault Safety now supports including Transmissions generated by Transmission Output Templates during One Last Time (OLT) reporting for follow-up Cases. For more information, contact Veeva Support. Enablement: Support	SAF-69421
In Vaults with the Generate Assessments for both Serious and Non-Serious Adverse Events application setting enabled, when Vault cannot generate Case Assessments during Case promotion, Vault now promotes the Inbox Item and creates the Case with no Case Assessments. This enables users to run the Generate Assessments action on the Case to generate Case Assessments, Case Assessment Results, and Case Assessment Expectedness records for Case Adverse Event and Case Product pairs. Previously, when Vault could not generate Case Assessments during Case promotion, Vault did not promote the Inbox Item and voided the Case.	SAF-69688
When the Superseded By field on a MedDRA term is updated by users coding a MedDRA term on a Case, whether through auto-coding or the MedDRA Browser, the audit trail now includes a clear event description about why Vault updated the Superseded By field.	SAF-72061
This release improves the performance of auto-coding multilingual MedDRA terms during Inbox Item intake and Case promotion.	SAF-72067
Vault evaluates Localized Case Assessment Expectedness for Study Products with a Study Product Role of Investigational or Comparator, instead of for any Study Product Role.	SAF-60246
If the Data Entry (Initial) state of the Case Lifecycle object lifecycle is configured with an entry action that transitions Narrative documents to a different state, after successful Case promotion, Vault does not update the state of localized Inbox Items to Promoted.	SAF-66949
When generating FDA VAERS E2B(R3) reports for Cases with blank Date of Birth, Age at Vaccination, Age, Gestation, and Age Group values, Vault generates the XML with no D.2 Age Information section values, instead of exporting the nullFlavor NI to the D.2.3 Patient Age Group (as per reporter) data element.	SAF-71107
When generating FDA VAERS E2B(R3) reports, Vault does not populate the G.k.2.2 Medicinal Product Name as Reported by the Primary Source data element for Case Products with Similar Device in the Drug Role field, resulting in NACKs.	SAF-71360
When Transmissions that reference the CBER or CDER Transmission Profile are sent to the FDA through the FDA AS2 Connection, Vault names attachment files with the name of the E2B file, instead of the attachment file name.	SAF-71524
When users run the Copy Case action on a Japan Domestic Case, Vault links copied Case Product Registration records to the original Localized Case instead of the copied Localized Case.	SAF-71875
When auto-coding MedDRA terms on Cases referencing MedDRA dictionary versions that are older than the latest available version, for terms with Name changes only, Vault creates a new MedDRA term record instead of updating the Name on the existing record.	SAF-72069
When creating a follow-up Case for a Case with multiple previous versions that include Case Child Information records, Vault copies Case Child Information records from every Case version instead of just the previous Case version, resulting in duplicate records on the follow-up Case.	SAF-72083
When generating FDA E2B(R3) and FDA VAERS E2B(R3) reports for Cases with a Combination Product that has the Drug Role field set to Suspect and another Combination Product that has the Drug Role field set to Similar Device, for the Similar Device product Vault populates 5 in the G.k.1 Characterisation of Drug Role data element, instead of 4 for Drug Not Administered.	SAF-72108

January 28, 2025

Release Number: 24R3.0.6 | Build Number: 278

Description	Issue No.
Vault Safety now supports masking exceptions when reporting to Swissmedic. If Mask PII is configured on a Transmission, when exporting an EMA E2B(R3) with a transmission destination of Swissmedic, Vault will not mask the following Case fields: Date of Death Last Menstrual Period (Patient or Parent) Medical History Text Sex (Patient or Parent) If the field contains a manually entered MSK value, then the field is omitted from the transmission. Enablement: Auto-on	SAF-71031
Vault Safety now supports evaluating expectedness based on Study Product Datasheets for Study Products with any Study Product Role. Previously, Vault generated expectedness only for Study Products with a Study Product Role of Investigational. Enablement: Auto-on	SAF-71094
After promoting an Inbox Item with new adverse events as a follow-up through the Inbox Item to Case Compare page, when syncing data from the global Case to a Japan Localized Case, Case Assessments and Case Assessment Results are not synced.	SAF-67979
When users manually delete products or adverse events referenced in assessments on E2B-imported Inbox Items, after domestic Case promotion Vault does not generate all expected Localized Case child records.	SAF-68167
For E2B-imported Inbox Items with follow-up information that generates new assessments for an existing Japan domestic Case, after merging to the in-flight Case, Vault does not generate all expected Localized Case Assessment Result records based on the global Case Assessment Result records.	SAF-68710
Generated FDA E2B(R3) files for postmarket reports do not include EDQM terms for the G.k.4.r.9.2a, G.k.4.r.9.2b, G.k.4.r.10.2a, and G.k.4.r.10.2b data elements.	SAF-68929
In some instances, Vault does not display some Case fields to users with view-only access.	SAF-70179
In Vaults configured to isolate blinded clinical trial information, when users run the Evaluate Reporting Obligations action on a Localized Case related to a Localized Case for a different locale that has a blinded and unblinded Localized Case Assessment record pair, an error message appears.	SAF-70982

January 21, 2025

Release Number: 24R3.0.5 | Build Number: 264

Description	Issue No.
If the Age at Onset exists on a Case and then a user updates the Onset value of the Case Adverse Event, Vault does not recalculate the Age at Onset.	SAF-55924
After a user updates a global Case Assessment, Vault does not apply the update to related Localized Case Assessments.	SAF-67495
After a MedDRA dictionary version update, Vault does not update the Primary SOC value for all terms in the hierarchy.	SAF-67816
During Inbox Item import, when Vault is evaluating user access based on Case Access Group security settings, the import fails if a user whose access evaluation is pending attempts to view the document being imported. During Inbox Item import, if a user who has access to the Inbox Item is in the Pending state, then the import will fail.	SAF-69098
A system error occurs when a user without permission on the Localization object attempts to create, open, or edit a Case Product on an existing Case with the WHODrug or JDrug control field.	SAF-69896

January 14, 2025

Release Number: 24R3.0.4 | Build Number: 254

Description	Issue No.
Vault does not export standalone devices with a Drug Role of "Similar Device" and a Device Report Type of "Malfunction" to FDA VAERS E2B(R3) reports.	SAF-68653
On the Inbox Item to Case Compare page, when either the Inbox Item or the Case includes Parent Information records and the user manually matches any records, updates page filtering, or switches pages, Vault displays the Parent Information records in the Case Drug History or Case Medical History & Concurrent Conditions sections and prevents merging the Inbox Item to an in-flight Case.	SAF-68953
In some cases after running the Copy Case action, Vault copies the version of the copied Case to the generated record instead of creating the new record in v0.1.	SAF-69153
Vault does not copy the Compare ID field value to Study Registrations for follow-up Cases.	SAF-69407
For Vaults configured to use Case Access Group security, users in the All Access Group who have a value in the Localization field of their User Access Group Assignment record can see all Localized Cases instead of just those for the specified Localization.	SAF-69440
When generating PMDA E2B(R3) reports, Vault populates the J2.14 Expectedness data element based on the Localized Case Assessment with the earliest creation date instead of from the Localized Case Assessment related to the primary PMDA product.	SAF-69441
In some cases when users run the Run Bulk Unblind action on a blinded Case with an unblinded Product and at least one (1) blinded Product, Vault generates another unblinded Product record.	SAF-69443
In instances where a One Last Time report to the PMDA exists on a Case and the follow-up Case would generate reports only for investigational to investigational cross reporting scenarios, after a user runs the Evaluate Reporting Obligations action on the follow-up Case, Vault does not generate the expected PMDA Transmissions.	SAF-69867
For Cases created from Literature Articles in Vault SafetyDocs, when generating non-PMDA E2B(R3) reports, Vault maps the value in the Vancouver Citation field instead of the Vancouver Citation (English) field to the Literature Reference(s) data elements, C.4.r.1 for E2B(R3) formats and A.2.2 for E2B(R2) formats, resulting in negative acknowledgments (ACKs).	SAF-69944
PSMF PDF creation fails for users without the required permissions to create PSMF PDFs.	SAF-70069

January 7, 2025

Release Number: 24R3.0.3 | Build Number: 235

Description	Issue No.
When sending follow-up email questionnaires to Case Reporters, in some instances, Vault sends emails without attaching the questionnaire documents from the Correspondence record.	SAF-67811
For Cases that include multiple Products with the same Case Product Registration and at least one (1) Local Reporting Details record that references the Case Product Registration in the Primary Case Product Registration field, Vault prevents creating follow-up Cases from Inbox Items.	SAF-68648
In some instances, system performance issues result in Vault not generating Correspondence when expected. In these instances, Vault appears to generate Correspondence but displays an error message when users try to access the document from the Correspondence record.	SAF-69354
~~This fix addresses the following previously reported issues affecting the August 2024 version of the FDA MedWatch 3500A form: SAF-68232, SAF-69013, SAF-69014, SAF-69015, SAF-69101.~~ This fix addresses the following previously reported issues affecting the FDA MedWatch 3500A: August 2024 Version feature: SAF-68232, SAF-69013, SAF-69014, SAF-69015, SAF-69101. Removed because specific details for each previously known issue is provided in the following rows.	SAF-69760
When the Gender field on a Case is blank, Vault automatically selects the "Decline to answer" checkbox on the generated MedWatch 3500A form.	SAF-68232
When the Sex field on a Case is blank, Vault automatically selects the "Decline to answer" checkbox on the generated MedWatch 3500A form.	SAF-69013
Generated MedWatch 3500A forms include the Concomitant Medical Products and Therapy Dates section for non-device Cases.	SAF-69014
Section B in generated MedWatch 3500A forms includes repeated Relevant Tests/Laboratory Data, Including Dates details.	SAF-69015
Overflow pages on generated FDA MedWatch 3500A (August 2024 Version) forms display some incorrect labels in the "Treatment Dates/Therapy Dates" and "Diagnosis for use" sections.	SAF-69101

December 19, 2024 (Postponed) December 20, 2024

Release Number: 24R3.0.2 | Build Number: 226

~~This release includes only Platform fixes.~~

Description	Issue No.
In Vaults that include MedDRA dictionary versions prior to those in central MedDRA (versions before 19.1), server errors occur that prevent displaying Case Product detail pages and auto-coding MedDRA terms that have previously undergone a cyclical hierarchy change on case objects.	SAF-69870
In Vaults with custom Case Assessment Method picklist values, Vault does not export the G.k.9.i.2.r.2.EU.1 EU Method of Assessment data element when generating EMA E2B(R3) reports.	SAF-69942
In Vaults with Blind Protection Relatedness Override enabled, when users generate blinded CIOMS I or E2B previews or Transmissions, Vault exports values in the Assessment Result (Override) field instead of the Assessment Result field.	SAF-70004