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 23R3 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 23R3.0, so our maintenance releases for this version are 23R3.0.1, 23R3.0.2, 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 23R3 Maintenance Releases.
Last Updated: April 22, 2024
April 22, 2024
Release Number: 23R3.0.20 | Build Number: 327
This release includes only Platform fixes.
April 18, 2024
Release Number: 23R3.0.19 | Build Number: 324
This release includes only Platform fixes.
April 9, 2024
Release Number: 23R3.0.18 | Build Number: 323
| Description | Issue No. |
|---|---|
| When Submission files are greater than 5 MB, the AS2 Connection does not send the file. | SAF-56606 |
April 2, 2024
Release Number: 23R3.0.17 | Build Number: 321
| Description | Issue No. |
|---|---|
| After setting a Transmission to the Ready for Submission state, the AS2 Connection to a Health Authority or Partner does not send the file. | SAF-55736 |
| During high-volume activity in a Vault, in some instances, Product Registration records cannot be created or edited. | SAF-56194, SAF-56972 |
| When loading record detail pages, users may experience slow system performance. | DEV-700095 |
March 26, 2024
Release Number: 23R3.0.16 | Build Number: 317
| Description | Issue No. |
|---|---|
| After setting a Transmission to the Ready for Submission state, the AS2 Connection does not send the file. | SAF-49240 |
| If Dose information is blank on both a Case Product and the associated Product Registration record, when running the Retrieve Reportable Case Product Registrations action, the system does not prioritize the Product Registration designated as the Default Registration. | SAF-52164 |
| When the Suppress File Generation reporting rules parameter is set to Yes, after running the Async Submit to Gateway action on Cases that should receive validation errors, in some instances, Transmissions are generated and remain in the Sending ICSR state. | SAF-56033 |
March 19, 2024
Release Number: 23R3.0.15 | Build Number: 314
| Description | Issue No. |
|---|---|
| When the Suppress File Generation reporting rule parameter is set to Yes, after running the Evaluate Reporting Obligations action, in some instances Transmission Creation Messages are appended to the incorrect Transmission. | SAF-55303 |
| When a Localized Case includes a Special Adverse Event of the Non-reportable Event type that is linked to a Case Assessment with a Reaction Recurrence, Vault Safety exports an invalid PMDA E2B(R3) file. | SAF-55442 |
| When a Case Medical History record does not have a start or end date and the Continuing field is set to Yes, after running the Evaluate Regulatory Conformance action, validation fails for rule PMDA.D.7.1.r.3-2. | SAF-55443 |
March 12, 2024
Release Number: 23R3.0.14 | Build Number: 309
| Description | Issue No. |
|---|---|
| When bulk unblinding Cases under a Study, Imported Cases are not included. | SAF-50172 |
| During import to Inbox Item, when E2B files include serious Adverse Events that do not have Assessment Results, Vault Safety creates placeholder Assessments. | SAF-51092 |
| After creating a Follow-up Case for a Clinical Trial Case for a blinded Study, the lifecycle state of open-label Case Products updates to Blinded. | SAF-52311 |
| During import of custom E2B formats using SDK, in some instances, Assessment Results are not created for Follow-up Cases. | SAF-52433 |
| When generating PMDA E2B(R3) files for Cases with Combination Products that include a Device constituent, the Device is exported to the G.k Drug(s) Information section of the report. | SAF-53401 |
| When exporting PMDA E2B(R3) reports, the D.8.r.2a and b and D.8.r.3a and b data elements are populated when the PMDA Reporting Category is "AA", "AB", "DA", or "DB". | SAF-54609 |
March 5, 2024
Release Number: 23R3.0.13 | Build Number: 304
| Description | Issue No. |
|---|---|
| In Vaults with strict Case Locking enabled and some Case Unlocking workflow configurations, when a Study Case Product is unblinded and the related blinded Study includes Study Arms, the Case Product lifecycle does not transition from Unblinding to Unblinded. | SAF-52035 |
| When a Localized Case does not have a Narrative document, Vault Safety prevents completion of the Revision / Follow-up task on Domestic Cases. | SAF-52175 |
| When evaluating regulatory conformance on PMDA E2B(R3) reports, Validation Criteria PMDA.D.9.4.r.1b-2 fails when the Cause of Death type is "Reported Cause of Death" and the Autopsy field is set to "No". | SAF-53872 |
When exporting PMDA E2B(R3) reports, Vault Safety does not correctly validate nullFlavors in the following data elements:
|
SAF-54179 |
February 27, 2024
Release Number: 23R3.0.12 | Build Number: 300
| Description | Issue No. |
|---|---|
| When creating Domestic Follow-up Cases for localizations other than Japan, if the number of Products on an Inbox Item and matched Case differ, an unequal number of global and localized Case Assessments and Case Assessment Results is generated. | SAF-52715 |
| For Cases with a localization of Japan, a system error occurs when Inbox Items with new Products or Adverse Events are merged to In-flight Cases or promoted to Follow-up Cases. | SAF-53670 |
| During import of custom E2B formats using SDK, some Parent Information is not imported. | SAF-53882 |
| After Gateway or manual E2B import, Case Access Groups are not populated on Inbound Transmissions. | SAF-54132 |
February 20, 2024
Release Number: 23R3.0.11 | Build Number: 296
| Description | Issue No. |
|---|---|
|
Vault Safety now supports exporting International Medical Device Regulators Forum (IMDRF) device codes to section H6 - Event Problem and Evaluation Codes of FDA MedWatch 3500A forms. When Admins enable the IMDRF Dictionary feature, the system now exports codes from Annex E: Health Effects - Clinical signs and Symptoms or Conditions, Annex F: Health Effects - Health Impact to the Patient Code fields, and Annex G: Medical Device Component to the Device Code fields. This improves data quality and compliance when reporting to the FDA. Enablement: Auto-On |
SAF-48959 |
| When Strict Case Locking is enabled on a Case, users cannot create a Child Information Case from it even if the Case is locked to them. | SAF-50525 |
| E2B import fails if the file includes a data element with more than 1,500 characters and the Case is Localized. | SAF-51519 |
|
For Device-related Cases, the Device Report Type field now includes a Product Problem value, which is mapped to the B.1 - Product Problem field of FDA MedWatch 3500A forms. Enablement: Auto-On |
SAF-49263 |
| When E2B(R3) ACKs are generated on the Inbound Transmission record, Vault maps the ACK.B.r.3 ICSR Message ACK Receiver data element to the Destination ID field and the ACK.B.r.4 ICSR Message ACK Sender data element to the Origin ID field, instead of the reverse. | SAF-53624 |
| When generating FDA MedWatch 3500A forms, Vault maps Company Product type products registered as a device in the country of its destination to section C. Suspect Products, instead of D. Suspect Medical Device and H. Device Manufacturers Only. | SAF-54000 |
February 8, 2024
Release Number: 23R3.0.10 | Build Number: 287
| Description | Issue No. |
|---|---|
| When Inbox Items with blinded Products are merged to In-flight Cases or promoted to Follow-up Cases through the Case Compare page, if the matched Case is unblinded, the Case-level Product field is set to the primary Case Product. | SAF-53191 |
February 6, 2024
Release Number: 23R3.0.9 | Build Number: 283
| Description | Issue No. |
|---|---|
| On newly created Vaults, MedDRA dictionary version 26.0 is not available. | SAF-48767 |
| When coding MedDRA Conditions on Datasheets, Lowest Level Terms (LLTs) are now the only MedDRA level available. Previously, the system supported coding this field at any level of the MedDRA hierarchy, although the system matches MedDRA terms for Product Indications on Cases at the LLT level only. | SAF-49545 |
| When an Inbox Item Products section includes unsaved changes, if Study Products are added through the Specify Study Product dialog, the unsaved changes are cleared. | SAF-49739 |
| When the Localization value is defined, the Comments field on Case Medical History records and the Comments and Result (Text) fields on Case Test Result records are cleared upon saving. | SAF-50288 |
| When importing custom E2B file formats, the G.k.4.r.10.1 Route of Administration (free text) data element is not mapped to the Patient RoA Text field on the Case Product Dosage. | SAF-51476 |
| On the Case Compare page, in some instances, attempting to select a matching Case Product manually causes an error message to appear. | SAF-51651 |
| When importing E2B file formats without an Inbound Format value, the G.k.4.r.10.1 Route of Administration (free text) data element is not imported to Inbox Items. | SAF-52914 |
| When sending an ACK2 message from an AS2 Connection, the system sends the original E2B back to the destination. | SAF-52928 |
January 30, 2024
Release Number: 23R3.0.8 | Build Number: 263
| Description | Issue No. |
|---|---|
| When creating Product-Event Combinations, coding MedDRA terms at any level of the MedDRA hierarchy is not supported. | SAF-49530 |
| When exporting custom E2B formats, the system runs Case-level validations for the custom format but not for the standard format that is the basis for the custom format. | SAF-50989 |
| Combination Product device constituents are exported to CIOMS I forms. | SAF-51938 |
| During E2B import, custom E2B tags mapped using SDK are not imported to the Case Assessment Result object. | SAF-52613 |
January 23, 2024
Release Number: 23R3.0.7 | Build Number: 259
| Description | Issue No. |
|---|---|
| On Follow-up Cases created from Inbox Items, Case Relatedness field values are missing. | SAF-48776 |
| When Follow-up Cases that are reportable to the PMDA do not have Localized Case Assessments, the system prevents Case voiding. | SAF-49855, SAF-50468 |
| When creating a Follow-up Study Case with no change to Relatedness from the initial Case, in some instances the Case Tag is incorrectly updated. | SAF-50805 |
| When Localization is added to a Case that was initially promoted as Global, the system prevents Follow-up Case creation from a Localized Inbox Item. | SAF-52271 |
January 16, 2024
Release Number: 23R3.0.6 | Build Number: 255
| Description | Issue No. |
|---|---|
| When generated from a Child Rule Set, Safety Rule Set Configuration reports do not include Rule Set Parameters for inherited Child Rules. | SAF-50349 |
|
Devices can now be exported to sections D and H of FDA MedWatch 3500A forms regardless of Product Registration destination. Enablement: Auto-On |
SAF-50600 |
|
When the Retrieve Reportable Case Product Registrations action is run on a Localized Case and reportable Case Product Registrations are retrieved, if a marketing Case Product Registration is created for general reporting the system does not create another Case Product Registration for cross reporting. Enablement: Auto-On |
SAF-50726 |
|
The Date of Death field on Inbox Items now includes the following Reasons Omitted values: "Not Asked" and "Asked but Unknown". Previously, the only available Reason Omitted for this field was "Masked". Enablement: Auto-On |
SAF-50777 |
January 9, 2024
Release Number: 23R3.0.5 | Build Number: 238
| Description | Issue No. |
|---|---|
| When sending Submissions to the Chinese Health Authority (NMPA CDE) through AS2 Connections, expected Acknowledgements (ACKs) are not received. | SAF-49930 |
| After importing an E2B(R3) file, the system-generated CSV rendition is missing information in the Assessment Results section. | SAF-49958 |
| In some instances, system performance is slower than expected when generating CSV renditions of imported E2B files, blocking subsequent E2B intake. | SAF-50360 |
| When importing Cases through Safety Inbox Loader, the Action Taken field on Case Products is not populated. | SAF-51739 |
| When the JDrug field is added to External Product page layouts, External Products cannot be viewed or created on Domestic Cases for Japan. | SAF-51991 |
| For Vaults without PT Aggregation enabled, when generating a PBRER, the Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources counts the same Adverse Event multiple times, once for each Product on a Case, instead of counting each Adverse Event only once. | SAF-52034 |
| When an Inbox Item has more than 500 Assessments, the system prevents merge to In-flight Case and promote to Follow-up Case. | SAF-52180 |
December 22, 2023
Release Number: 23R3.0.4 | Build Number: 223
This release includes only Platform fixes.
December 21, 2023
Release Number: 23R3.0.3 | Build Number: 221
This release includes only Platform fixes.
December 18, 2023
Release Number: 23R3.0.2 | Build Number: 220
| Description | Issue No. |
|---|---|
| In some instances, merging Inbox Items to In-flight Cases is prevented and this error message appears: "Case creation is already in progress. Please wait for it to complete." | SAF-50474 |
| The C.1.9.1 Other Case Identifiers in Previous Transmissions data element is populated as True when there are no E2B-transmittable Case Identifier objects associated with the Case, resulting in Negative Acknowledgement (NACK) messages. | SAF-51661 |