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 22R2, see the Vault Release Notes
Intake
MedDRA Language Does Not Respect Inbox Item Localization Setting
SAF-31844
This issue may impact Vaults with the “Enable auto-set Inbox Item Localization by Reporter Country” setting enabled and the Localization field hidden on the Inbox Item layout. On Case Adverse Events, the Event (Reported) Language field defaults to English even when there is a non-English Localization specified. This issue is scheduled to be fixed in the 22R2.0.2 release.
Workaround
Add the Localization field to the Inbox Item layout and ensure the MedDRA Language field matches the local language.
Follow-Up From Inbox Item Fails When Merging Primary Source Field to Patient Contact
SAF-31436
When performing a Case Compare, if a Reporter Type is merged in as a Patient Type and the Primary Source field is selected to be kept, the merge fails because the Primary Source field does not exist for a Patient Type.
Follow-Up Case Cannot Be Created if Inbox Item Case Identifiers Include Leading or Trailing Spaces
SAF-31206
When an Inbox Item contains Case Identifiers with leading or trailing spaces (for example, “NN-ABCD-123 ”), during promotion to a Follow-Up Case, on the Case Compare page the system cannot match the Case Identifier to the record on the original Case. When Create Follow-Up is selected, an error message appears and the system prevents Follow-Up Case creation.
Inbox Item Slow to Load
SAF-31972
When there are a large number of Studies, the loading time for an Inbox Item can be negatively impacted.
Inbox Item Promotion to Case Does Not Snapshot Route of Administration Dosage Record Term ID for Combination Products
SAF-32059
When promoting an Inbox Item to a Case, the system does not snapshot the Patient RoA TermID and TermID Version to the first Case Product Dosage record for Combination Products.
Follow-Up Action Fails for Cases With Missing Study or Mismatched Study Arm
SAF-32368
Performing a Follow-Up action for a Case that has either a missing Study or a mismatched Study Arm, will result in the following error:
“A system error has occurred. Additional details have been logged. Please contact your administrator.”
Workaround
Perform the following actions to ensure the Study is present and accurate, then perform the Follow-Up action again:
- If the Study is missing, enter the details of the Study.
- If the Study is present, enter the correct Product for the Study.
Case Processing
Cannot Execute Case-Level Validation While an ICSR Preview Document is Being Generated
SAF-31710
When an Evaluate Regulatory Conformance action is run at the same time that an ICSR preview document is being generated from the Case, then the case validations will fail to run.
Field Controls not Respecting Page Layout Rules
SAF-29964
Page layout rules with field-level conditions are not immediately executed in the same edit session when a field is part of a control. For example, when a case is promoted for a male patient, and then the Gender field is subsequently changed to Female, the gender-specific fields such as pregnancy information do not appear immediately. The record must first be saved and then edited again for the page layout rule to execute.
This issue affects the following controls:
- Gender (impacts rule
menstrual__c) - Remedial Action (impacts rule
remedial_action_other__c) - Study (impacts rule
case_study_rule_v__c)
Incorrect SUSAR Criteria Tagging Logic
SAF-32056
The SUSAR tagging logic does not consider certain situations, such as postmarket studies or clinical trials, resulting in incorrect Case Assessment tagging. This issue is scheduled to be fixed in the 22R2.0.2 release.
Case Study Field Contents Sometimes Cleared in Edit View
SAF-33151
When editing a Case, sometimes any previously-entered value in the Study field is cleared and the field is left blank. This occurs when the System section takes too long to load causing the initial value of the Organization field (which the Study field depends upon) to be empty. This issue will be fixed in the 22R3 Vault Platform release.
Missing Global Case Data on Follow-up Foreign Localized Case When Transmission Records Created By Rules Evaluation
SAF-36713
Global Case data is not synchronized to follow-up foreign Localized Cases when the associated Transmission records are created by rules evaluation.
Workaround
Manually copy over the new information from the global Case to the foreign Localized Cases.
Follow-Up Creation Fails for E2B-Imported Inbox Items Having Assessments Without an Adverse Event
SAF-35437
Follow-up Case creation for Inbox Items created from an E2B import file will fail if the Inbox Item has Assessments without an Adverse Event.
Workaround
Ignore any Assessments without an Adverse Event on the Case Compare page and manually merge in the updates to the Case.
Safety Report Generation
PMDA E2B(R3) Submission Excludes Custom Dose Text
SAF-27081
When processing a Domestic Case with a custom dose and the Localization field set to Japanese (Japan), data elements G.k.4.r.1 and G.k.4.r.8 are excluded from PMDA E2B(R3) files.
E2B(R3) Export Populates Domestic Localized Narratives in Global E2B R3 Files
SAF-31689
Current E2B(R3) export logic exports global narrative and all supporting document narratives into the H.1 tag. For a domestic case, this means the localized narrative would be included in the H.1 tag as well (in addition to the English narrative), where it should only be included in the H.5.r.1 tag (from the localized narrative).
Incorrect Route of Administration Value in E2B R2 Export
SAF-32087
For E2B(R2) exports, Vault Safety uses the TermID and Version from the Case Product Dosage object (case_product_dosage__v) for the B.4.k.8 “Route of administration” tag in the E2B(R2) export file. In some cases, this leads to an incorrect value being sent for this field.
This issue is scheduled to be fixed in the 22R2.0.2 release by using the TermID code from the Route of Administration (route_of_administration__v) object to populate the B.4.k.8 data element.
Localized Submissions Generating HC E2B(R2) Files Do Not Respect Localization Scope
SAF-32135
For a Submission with a linked Localized Case and a File Format of HC E2B(R2), the system always exports the data from the Global Case, regardless of the Localization Scope setting.
This occurs only for HC E2B(R2). ICH and FDA E2B(R2) are working as expected.
This issue is scheduled to be fixed in the 22R2.0.2 release.
Submissions and Distributions
Issue with Evaluate Regulatory Conformance action for Japan domestic case
SAF-31742
This issue applies to Inbox Items that are created with the Localization set as ‘Japan’ and then promoted to a Case. When the Evaluate Regulatory Conformance action is executed, any PMDA errors that appear in the Validation Results (Failures & Warnings) section cannot be cleared, even if the correct PMDA information is subsequently entered and the Evaluate Regulatory Conformance action is executed again.
H.1 Validator Not Triggered if EMA Submission Exists
SAF-32657
This issue applies to Cases that are reportable to both the EMA and one or more other destinations with a non-EMA E2B(R3) file format (ICH E2B(R3) for example), and that have an empty Case Narrative.
When Evaluate Regulatory Conformance runs on such Cases, the following results occur:
- The H.1 validation rule passes for the EMA destination. This is correct behavior as this field is optional for EMA.
- The H.1 validation rule also passes at the case level. This is incorrect behavior. The rule should fail as this is a mandatory field for non-EMA E2B(R3) destinations.
This is scheduled to be fixed in the 22R3 release.
Workaround
If you are affected by this issue, deactivate the EMA-H.1 validation rule in your Vault.
EMA Submissions Fail When PII Masking is Enabled and MSK Flag is Submitted for an MSK-Exempt Field
SAF-30486
The Patient Content Protection masking options selectively mask sensitive information on Individual Case Safety Reports (ICSRs). Currently, this is masking a number of E2B elements that the EMA does not accept as masked, such as Date of Death (D.9.1). This can cause an EMA submission that includes one or more of these fields to be rejected.
This is a known limitation and will be addressed in an upcoming release.
Inbound AS2 Transmission Messages Do Not Capture Body and Code Details
SAF-33158
In Vault Safety, the system does not populate E2B ACK details on the Transmission Message for inbound AS2 transmissions. Outbound AS2 Transmission Messages capture these details correctly.
This is scheduled to be fixed in the 22R3 release.
Email Submission Records in ‘Queued for Submission’ State Do Not Change to Error State After 24 Hours
SAF-34486
If an Email Submission record remains in the ‘Queued for Submission’ state for more than 24 hours (due to incomplete Renditions, for example), then the Email Submission record’s state remains stuck in the ‘Queued for Submission’ state instead of changing to the Error state.
Aggregate Reporting
CIOMS II Standalone Does Not Support Blinded Studies
SAF-34978
- The CIOMS II report does not currently support blinded Studies. Any cases for blinded studies will not be included in the report.
- Open Studies are only supported if the Study Product is also added to the Reporting Family.
CIOMS II Standalone Report Does Not Calculate Expectedness for Study Cases
SAF-30980
The optional Indicate Unexpected Terms setting does not support Study Cases on the CIOMS II report. If enabled, the CIOMS II report marks all study events as Unexpected.
Note This setting supports non-study cases.
