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.
Vault Safety Known Issues
Cannot Generate PADER Non-Primary Suspect Product Report When the event_meddra_pt__c Field Does Not Exist
SAF-17768
The PADER Non-Primary Suspect Product Report currently requires a custom field (event_meddra_pt__c), that was added to the Vault Safety template in a past release. Vaults created from a prior version of the Vault Safety template do not have this field unless an admin manually added this field to the Case Adverse Event object and page layout.
Vaults that do not have the event_meddra_pt__c field cannot generate the PADER Non-Primary Suspect Product Report. Also, if you select this field in the PADER Documents to Generate field, the PADER enters the Error state.
Other PADER reports are not impacted by this issue and continue to generate successfully.
CIOMS I Form 7 + 13 Field Label Displays LLT When Using MedDRA PT
SAF-17762
The Vault Safety CIOMS I field label for “7 + 13 Describe Reactions” displays [Lower Level Term], including when a vault has been updated to use MedDRA Preferred Terms (PTs) instead of LLTs.
VAERS Certification Enhancement is Not Automatically Enabled
SAF-17234
In Vault Safety 21R1.0, the VAERS Certification enhancement can be enabled by request only. This feature will be automatically enabled in a future release. Contact Veeva Managed Services to request this feature.
Multi-Case E2B Import via API/AS2 Enhancement is Not Automatically Enabled
SAF-17216
In Vault Safety 21R1.0, the Multi-Case E2B Import via API/AS2 enhancement can be enabled by request only. This feature will be automatically enabled in a future release. Contact Veeva Managed Services to request this feature.
Cannot Open Case in Vault with Inactive Custom Drug Role Controlled Vocabulary
SAF-17288
In vaults with an inactive custom Drug Role Controlled Vocabulary with an E2B code of 1 (suspect), you cannot promote AERs to Cases.
Workaround
Change the inactive Drug Role Controlled Vocabulary to deprecated and rerun the Promote to Case action.
Two ACKs generated for Single E2B File Imported Manually
SAF-17428
When an E2B file containing a single ICSR is imported successfully (including successful with warnings) using the Create AER from Document vault user action, two Message Acknowledgments (ACKs) are generated.
One ACK is correct, indicating the message was successfully parsed (transmissionacknowledgementcode = 01). The other ACK is incorrect, indicating that the message cannot be parsed (transmissionacknowledgementcode = 03).
Workaround
To email the ACK for the imported E2B, use the ACK with transmissionacknowledgementcode = 01 and ignore the other ACK.
Inbound Transmission Not Generated for a Single Case In a Multi-Case E2B File in Error State
SAF-16856
When importing an E2B file containing multiple ICSRs, if one of the cases results in an error, an Inbound Transmission for that single case is not generated. Users are notified when there is an error with the E2B import. The top-level Inbound Transmission for the E2B file containing multiple ICSRs is still generated.
Cannot Generate ACK in E2B R3 Format for Multiple Case E2B Import Received from AS2 Transmission
SAF-17389
When receiving a multi-case E2B(R3) from an AS2 gateway transmission, Vault Safety creates the AERs but does not currently generate and transmit an acknowledgment message (ACK) back to the sender.
The ACKs for the individual cases within the E2B message are still generated. However, these individual ACKs are added to a Base Transmission object type instead of Inbound Transmission.
Data Element M.1.4 Value Missing from E2B Acknowledgment
SAF-17334
System-generated E2B(R2) acknowledgment messages (ACKs) are not populated with any value in the M.1.4 Message Number field.
Inconsistent ACK Filename Format
SAF-16520
E2B acknowledgment message (ACK) filenames are being generated inconsistently. Single case E2B ACKs are being named with the format unique_ID.filename-ACK.xml, and multi-case E2B ACKs are being named unique_ID-ACK.xml. This issue does not impact the contents of the ACKs.
Dose Forms (B.4.k.7) Imported from MHRA E2B R2 File Display Dose Form Term IDs
SAF-16105
Vault Safety does not currently support mapping MHRA E2B Dose Form IDs to the Dose Form Controlled Vocabulary.
As a result, when importing dose forms from an MHRA E2B R2 file, the resulting Case Dose Form field is populated with the dose form ID number. The IDs are imported and exported successfully, but the descriptive dose form name is not visible.
Correspondence Records Not Generated for Template with Combination Product
SAF-15991
When a reporter questionnaire template has a Combination Product, added either under a Watchlist or through MedDRA Criteria, Correspondence records are not generated for Cases with that Combination Product. Note that questionnaire templates associated with any Product Constituents on the Case will still be generated.
EMA Downgrade Serious to Non-Serious Individual Patient Use Follow Up Reason Evaluated as Initial
SAF-14596
When the Evaluate Reporting Obligations action runs on a follow-up Case that triggers the EMA Downgrade Serious to Non-Serious reporting rule, the Submission Reason field is incorrectly set to Initial instead of Follow Up, unless the prior version of the Case is a SUSAR.
Vault Safety.AI Known Issues
Sections Missing Header on Source Data Pop-Up
SAF-16368
After selecting Show More on the Source Data pane, the header is not displayed on the pop-up for the following sections:
- Patient
- Detail
- Custom sections
