Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.
You may encounter the following known issues or limitations in certain environments or configurations. Where possible, workaround instructions are provided to solve the issue.
We actively investigate all known issues and will be providing fixes and updated information in future releases.
Localized Case Narrative Preview is Not Updating with Local Language Text
SAF-23668
On a localized Case, when updating the Case narrative document with text in the local language, the localized Case narrative preview is not being updated to display the text in the local language and instead displays it in English.
Unrelated Cases are Included on the DSUR Cumulative SAR Log Sheet when Indicate Unexpected Terms is Enabled
SAF-23459
The DSUR log sheet for Cumulative Summary Tabulation of Serious Adverse Reactions includes unrelated Cases when the Indicate Unexpected Terms is enabled. The total number of events is not impacted in the tabulation.
Duplicate Product Substance is Created from E2B Imported Inbox Item
SAF-23617
When creating a Case from an E2B imported Inbox Item, a duplicate Case Product Substance is being created.
EMA Validation Rule Not Available in Vault Safety
SAF-23136
Vault Safety is missing EMA E2B(R3) business validation rule G.k.9.i.2.r.1.EU.1 (EU Source of Assessment).
Case Seriousness Incorrectly Populated When Promoting an AI-Generated Inbox Item
SAF-22841
When promoting an Inbox Item to Case, an incorrect Seriousness was being populated on the Case.
Incorrect Imported Narrative Documents from E2B are Used on Localized Cases
SAF-22746
When you run the Evaluate Submission Obligations action on a Case created from an E2B imported Inbox Item with a registration in a foreign country, the system creates a new English narrative document on the generated localized Case instead of using the existing narrative document in the local language.
Unable to Remove Edit Permissions from Standard Roles
SAF-23823
When removing Edit permissions for standard roles on the Case Lifecycle, users are unable to save the updated permissions.
Company Products Not Mapped for Inbox Item E2B Import
SAF-22402
When importing an E2B file to Inbox Item, if there is a Study and a Company Product in the library, only the Study is mapped whereas the Company Product is not.
Single Letter Search in WHODrug and MedDRA Browser Does Not Return Any Results
SAF-21706
When searching in the WHODrug or MedDRA browser with a single letter, no results are returned.
English Translation in Case Medical History is Overwritten by the Native MedDRA Language Term
SAF-22821
When promoting an Inbox Item with Localization set to a non-global value, the English translation on the Case Medical History is overwritten by the reported term in the native MedDRA language.
Term Incorrectly Marked as Expected on PSUR Report
SAF-23736
In PSUR, when the Product Family contains an odd number of drug products, some terms in the generated PSUR report for the Product Family are incorrectly marked as Expected.
AS2 Connection Between Vault Safety and CDMS Returns Intermittent Failures
SAF-15573
When submitting an E2B XML file through an AS2 gateway to CDMS, there are intermittent failures where the AER is not imported and an error ACK is returned.
Missing Dynamic Translations in Domestic Case Processing
SAF-23539
Some dynamic labels, such as field labels and picklist values, are not being translated during domestic Case processing.
MedDRA Dictionary With Multiple Languages Selected Stuck at Importing Status
SAF-23812
When running the Fetch Dictionary Releases action on the MedDRA dictionary, the dictionary is stuck at Importing status when multiple languages are selected.
Workaround
Remove the languages in the Languages field and run Fetch Dictionary Releases. You can set the languages in the field again after the action runs.
Localized Text Field Values Are Not Copied to Follow-Up Upon Promoting Inbox Item with Non-Global Localization
SAF-23714
For an Inbox Item with a non-global localization, newly added localized text field values are not copied over to the follow-up domestic Case during promotion. The record is still created on both Global and Localized Cases, but the user will need to re-enter the localized text field values on the follow-up domestic Case.
Initial Verification for Inbox Item Details Section Displays Blank New Value on Audit Trail
SAF-24452
When verifying the Details section on an Inbox Item for the first time, the audit trail is displaying a blank New Value.
Null Error Message Appears When Trying to Complete QC Task
SAF-24525
When trying to complete the QC task and send the Case to Approved state, users are receiving an error message stating the operation could not be completed successfully.
Old Value and New Value are Updating on Inbox Item Audit Trail With No New Changes to Saved Sections
SAF-24451
When saving the Details or Products section on an Inbox Item but with no new changes, the audit trail is still logging passthrough objects into the Old Value and New Value columns.
Server Error Appears When Verifying Awareness Details Due to Duplicate Field Entries
SAF-24564
When verifying the Awareness Details, a server error appears if there are duplicate entries for one field.
ICH E2B(R2) Header Contains FDA
SAF-24548
When generating an ICH E2B(R2) regulatory report, the header in the generated report contains “FDA”.
