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: January 17, 2025
January 21, 2025
Release Number: 24R3.0.5 | Build Number: TBD
| 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. | 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 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 |