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.
For details about known issues in the Vault Platform in 23R1, see the Vault Release Notes.
Intake
| Category | Description | Issue Number |
|---|---|---|
| E2B Import | The information entered in the Parent Medical History Text field is incorrectly mapped to the Patient Medical History Text field on Cases imported from E2B files with the Localization Type set to "Local". | SAF-41540 |
| E2B Import | The value entered in the Medical History Text field on Parent Information is not imported to inbox items if the inbox item is created from an E2B file.
Workaround: In Safety General Settings, clear the Enable Localization-based Mapping on Import checkbox for Domestic Cases. |
SAF-41209 |
| E2B Import | Users encounter a server error if the creation of an inbox item from an E2B file fails and the inbox item is in the Import Error state. | SAF-40138 |
| E2B Import | Users encounter a server error if an inbox item is opened while it is still in the Importing state when it is being created from an E2B file. | SAF-40118 |
| E2B Import | The value entered in the Origin field in the Case information section is not imported to inbox items if the inbox items are created from multiple E2B files. | SAF-40033 |
| E2B Import | When creating an AER from an E2B file, document import will fail if the "Always: Set new major version" entry action is added to the Imported state for AERs.
Workaround: Delete the "Always: Set new major version" entry action from the Imported state for AERs. |
SAF-39796 |
| E2B Import | If an inbox item is opened while it is still in the Importing state when it is being created from an E2B file, several fields are prevented from being imported to the inbox item. | SAF-39092 |
| Duplicate Detection | When conducting deep duplicate detection, Study and Study Number matching is completed within Reporter matching and is also assigned the same priority as Reporter matching. | SAF-41329 |
| Duplicate Detection | When conducting deep duplicate detection, some cases with matching Gender and Country fields are ranked higher, while some with matching Patient Initials are ranked lower than others on the Potential Matches page. | SAF-40847 |
| Duplicate Detection | When conducting deep duplicate detection on inbox items, the Potential Matches page does not display matching Patient MRNs. | SAF-40846 |
| Duplicate Detection | When conducting deep duplicate detection on inbox items that have custom lifecycle states, the Potential Matches page does not display the lifecycle states of the matching inbox items. | SAF-40594 |
| Duplicate Detection | When conducting deep duplicate detection on inbox items, the Potential Matches page may display some Japanese characters even if the user's language is set to English. | SAF-39845 |
| Data Entry | Users with the Case Processing security profile receive a job error notification when they perform actions such as "Create New Case" or "Promote to Follow-Up" on the Case Compare page. | SAF-40827 |
| Data Entry | When Localization-based Mapping on Import is enabled for Domestic Cases, populating the English text values for the Patient RoA and Dose Form fields will cause the local text values for these fields to disappear.
Workaround: When the local text values disappear, populate them once again before populating the English text values. |
SAF-40710 |
| JSON Import | Custom fields are not imported to inbox items if the inbox item is created from a JSON file.
Workaround: Import custom fields at least five (5) hours after creating them to allow for a cache refresh. |
SAF-40936 |
| Translation | When the Complete state of a Localized Case is changed in the Intake Translation Settings, the corresponding Inbox Item remains in the Translation Requested state. | SAF-37509 |
Case Processing
| Category | Description | Issue Number |
|---|---|---|
| Localization | Users encounter an error when creating Follow-Up Cases from the Case Compare page for Japan Localized Cases with Primary Case Product Registration records and Local Reporting Details included. | SAF-41372 |
| Localization | Users encounter an error when creating Follow-Up Cases from Japan Localized Cases that are imported from PMDA E2B files with Case Product Registrations, Local Reporting Details, and Local Reporting Details records or Product Join records included. | SAF-41371 |
| Localization | If the Default Localization field on a User Profile is blank or set to "Global", users will encounter a server error when opening a Case adverse event.
Workaround: Set the Default Localization field on the User Profile to a specific language. |
SAF-36860 |
| Case Assessment | When a suspected and unexpected assessment is added to a Case created from a Clinical Trial study, the Assessment Tag does not change from SAE to SUSAR. | SAF-41079 |
| Follow-Ups | When Follow-Up Cases are created from blinded studies with open-label or unblinded Standard of Care products, the Blinded field on Case Products is incorrectly set to "Yes". | SAF-39149 |
| Data Entry | Users may encounter a server error when adding or editing an adverse event on a Case.
Workaround: To edit an adverse event, make changes directly on the Case page instead of selecting the adverse event to open it separately. |
SAF-36873 |
Transmissions
| Category | Description | Issue Number |
|---|---|---|
| Gateway Transmissions | If a gateway transmission fails, the error notification email does not include a reason for the error. | SAF-39280 |
| Gateway Transmissions | Transmissions may not be prevented from submission if the gateway connection is inactive. | SAF-39238 |
| Reporting Rules | For general reporting and I–> X cross reporting, reporting rules generate transmissions for Non-Study Case Products instead of just for Study Case Products with Suspect or Interacting drug roles in Clinical Trial Study Cases. | SAF-40180 |
Coding
| Category | Description | Issue Number |
|---|---|---|
| MedDRA | The Coding Method fields for Indication and Event are populated on inbox items even when the Enable Smart MedDRA Autocoding and Enable Smart MedDRA Coding Predictions settings are disabled. | SAF-41674 |
| MedDRA | For Japan Localized Cases with Multilingual MedDRA enabled, English translations are not updated when Indications, adverse events, or Medical History information is updated, and translations and codes are missing when a new Indication is added. | SAF-41603 |
| MedDRA | When the user's language is set to French, the Event Reported field on Cases and Case adverse events displays the French translation of the LLT code. | SAF-40656 |
| MedDRA | When browsing for a MedDRA term on an adverse event, the MedDRA Browser appears in English even if the user's language is set to Japanese.
Workaround: Switch the MedDRA browser's language from English to Japanese. |
SAF-37696 |
