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.
Unclear Exception Error When Transmission Profile Not Specified on Transmission
SAF-17918
During the E2B Validation process, if the Transmission does not specify a Transmission Profile, exceptions appear in the validation results with an unclear error messages. For example:
Exception Error 1: cvc-complex-type.2.4.a:
Invalid content was found starting with element 'controlActProcess'.
One of '{urn:h17-org:v3:sequenceNumber, urn:h17-org:v3:attachmentText,
urn:h17-org:v3:receiver}' is expected
Exception Error 2: cvc-complex-type.2.4.b:
The content of element 'MCCI_IN200100UV01' is not complete.
One of '{urn:h17-org:v3:PORR_IN049016UV, urn:h17-org:v3:PORR_IN049017UV,
urn:h17-org:v3:receiver}' is expected
DSUR and PBRER Cumulative Tabulations Fail to Generate for Cases Missing Primary Product
SAF-20947
If you try to generate aggregate report documents for a DSUR or PBRER aggregate report on a dataset containing one or more Cases with no primary Case Product, the report fails to generate. This scenario can occur for Imported Cases created in migration mode.
This issue affects the Cumulative Tabulation of SAE for DSUR and PBRER, and the DSUR Cumulative Tabulation of Serious Adverse Reactions.
Workaround
Ensure each Case contains a Case Product with the Primary field selected.
Age at Onset and Age Group Fields are Left Blank on Promoted Case
SAF-20113
When promoting an Inbox Item to Case, the Age at Onset and Age Group fields are not being calculated and are left blank on the initial Case.
Cumulative Dose Calculated Incorrectly for Some “per day” Frequencies Scenarios
SAF-19921
On a Case Product Dosage, the Cumulative Dose is not auto-calculated correctly for some “per day” frequency scenarios.
FDA Submissions Not Generated for Non-Primary Case Assessments with SUSAR Tag
SAF-19863
When the Evaluate Submission Obligations action runs on a Case where the non-primary assessment is a SUSAR, the FDA Reporting Rule for SUSAR is not firing and submissions are not generated.
Users are able to Change the Case on Localized Case Assessments
SAF-18837
Vault is not preventing users from editing the Case field on a Localized Case Assessment. As a result, you can edit the Case Assessment to reference an unrelated global Case.
Origin Field is Left Blank on Inbound Transmission during Manual and AS2 Import
SAF-20843
When importing an E2B(R2) file manually or through an AS2 Gateway with Origin ID set to MHRAUK, if the Destination ID fields from the E2B file and transmission profile do not match, the Origin field is not populated on the Inbound Transmission
Workaround
For manually imported E2B(R2) files, you can set the Origin field on the document to MHRA(UK) before importing the E2B file to an AER, Inbox Item, or Imported Case.
For E2B(R2) import through an AS2 Gateway, you can manually set the Origin field on the Inbound Transmission.
Bulk E2B Import to AER Results in Error When Snapshotting MedDRA Terms in Vault
SAF-20871
When importing E2B files in bulk using the Create AER from Document user action, some AERs might result in an error due to the vault not having the corresponding MedDRA terms.
