Known Issues in 22R2 Release

Release Date: July 29, 2022 & August 5, 2022

The issues listed below may impact Vault functionality for some users. We are actively investigating all known issues and will be providing fixes and updated information in future Vault releases.

Last Updated: August 5, 2022

Admin

Description Issue No.
When using the Workdays() function in an object record layout rule, if a user passes a negative number to this function as a field value, the Vault page freezes.   DEV-505058
There is a small window between Thursday and Friday of 22R2 Phase B release that users will not be able to run Vault Configuration Report and Vault Comparison Report. This issue will be resolved after the release. Please plan accordingly.   DEV-507473

Clinical Operations

Description Issue No.
In cases where a related contact record contains an invalid email address, Vault fails to create site checklists or outreach checklists.   DEV-492414
When users update custom fields on a Crosslink Document in the Clinical Operations Vault, Vault does not update those fields on the linked document in the connected RIM Vault.   DEV-493739
The Distribution Task does not update the eReg document version to the Study Connect document version.   DEV-494195
Vault may not create an unblinded visit data record when users create a new visit that has a restricted form in EDC until SDV is updated in the EDC.   DEV-494606
When users reject a Study Agreement, Vault displays an error.   DEV-495946
In some cases, users attempting to transfer documents from RIM to eTMF receive an error stating that the study_v object does not exist in the target Vault even though there are valid study records in the target Vault.   DEV-498529
When subject is deleted by the ClinOps to CDMS Connection, if this subject has a value in the arm or cohort field, this value won't be cleared.   DEV-498553
Under certain circumstances, superseded document versions do not transfer, despite the Transfer steady state and superseded state document versions setting being enabled.   DEV-501678
In cases where multiple Clinical Operations to CDMS connections are enabled, the View in EDC link points to the incorrect record.   DEV-504164

Site Vault

Description Issue No.
Uploading documents via Setup Assistant or Source Upload results in an error.   DEV-495447

Commercial

Description Issue No.
While the MedComms OpenData connection is enabled, scrollbars in the Search: Case Contact dialog do not function as expected.   DEV-490970
Vault fails to return Case Contact records when users search without filters while using the MedComms OpenData connection.   DEV-490978
While searching Case Contacts using the MedComms OpenData connection, Vault returns results that do not meet the filter criteria.   DEV-491241
While the MedComms OpenData connection is enabled, Vault incorrectly displays inactive Case Contacts in the Case Contact drop-down.   DEV-495568
While the MedComms OpenData connection is enabled, Vault clears filter values after users collapse the Vault Filters section of the Search: Case Contact dialog.   DEV-505388
Vault fails to populate Case Contact records when users filter and add Case Contacts using the MedComms OpenData connection.   DEV-508732

Developer Features: MDL

Description Issue No.
When using MDL, running a RECREATE on the Objecttype component may have poor performance.   DEV-493777

Developer Features: SDK

Description Issue No.
When executing AFTER_DELETE record triggers, Vault does not check for missing required field values when updating related object records.   DEV-481847

Documents

Description Issue No.
In some cases, Vault fails to upload large source files using Vault File Manager.   DEV-490532
In certain cases, when applying a legal hold on a document and deleting multiple versions through the API, some versions are successfully deleted and others are stopped due to the legal hold.   DEV-493897
In some cases after a user refreshes the browser page several times, the document viewer for a locked PDF may display protected content.   DEV-493922
Under certain conditions, users are unable to delete minor document versions.   DEV-496182
In some cases, Vault reports validation error 5057 (the document contains no text) for documents that do contain text.   DEV-496415
Vault incorrectly updates document count fields on expected documents when batch matching and the EDL are inactive.   DEV-498909
In some cases, permalink destinations change when Vault upversions a document.   DEV-501583
When the EDL batch matching job is configured to exclude inactive document types and unmatches documents with these types, the Match Documents user action will still match these documents.   DEV-505727

Lifecycle & Workflow

Description Issue No.
Canceling a legacy workflow from the timeline view may result in the browser's dev console displaying an error.   DEV-478430
MDL RECREATE and inbound package deployment fail for document lifecycles with Send a notification entry actions that reference inactive users.   DEV-497201
In some cases, users experience a server error when attempting to complete a task with multi-verdict fields or apply a verdict to a multi-verdict task.   DEV-507524

Localization

Description Issue No.
In some cases, users cannot update a translation to an empty value.   DEV-507849

Multichannel

Description Issue No.
In some cases, Vault fails to copy Master Email Fragment assets when automatically creating Email Fragments, resulting in missing image files.   DEV-506360

Objects

Description Issue No.
Object records with a field pointing to the latest version of a document may show an incorrect value if the latest version of that document is deleted.   DEV-498095
After migrating a child object to HVO, the object record list may take a long time to load or may time out.   DEV-501226

Quality

Description Issue No.
In some cases, Vault fails to translate the Process Navigator dropdown into the proper language when viewing documents.   DEV-484389
In some cases, Vault restricts users without Objects: Lab Test Set: Edit permission from adding Lab Tests to a Test Set.   DEV-488450
While attempting to execute a test in Vault LIMS, Vault fails to prevent user from editing test results.   DEV-488725
In rare cases, Vault fails to evaluate test results on behalf of users without a Vault Owner security profile.   DEV-496141
When executing Recurrence Checks in QMS, Vault fails to preserve the order of related objects upon saving.   DEV-498772

QualityOne

Description Issue No.
When running the "Send CoA Upload Workflow Task Email" record action while DAC is not enabled on the Inspection object, an error message is partially translated according to the user's non-English profile language.   DEV-495772
When an external user fails to upload a COA file by email intake, the error message received is partially translated according to the user's non-English profile language.   DEV-495828
In some cases when the Fields sync job fails, some object and field labels in notification emails are not translated.   DEV-499902
When users attempt to view a 5 Whys diagram in Vaults with Supplier Portal enabled, Vault displays a blank page.   DEV-501231
When closing out the Hazard Create dialog with the ESC key, the page is no longer accessible and displays error messages.   DEV-503915
When adding a Why item to a 5 Whys diagram, the "Why" text color is not displayed as expected.   DEV-504808
In some cases after deleting a Why item from a 5 Whys diagram, users cannot click into any other items in the digram.   DEV-504987

QualityOne Mobile

The QualityOne Mobile release is targeted for tentative availability on August 16, 2022.

Description Issue No.
In some cases, the QualityOne Mobile Android application crashes after a user submits an HSE Incident.   OLS-12460

Regulatory

Description Issue No.
Vault incorrectly reports CN rule 6.26 as passed in Content Plan sections 2.7.4, 3.2, 4.2, and 5.3 when a matched PDF document contains unembedded non-standard fonts.   DEV-477350
When the Brand Name or Generic Name field values in a Japanese Submission are edited after initial publishing, Vault fails to sort them lexiographically in the UI and regional XML.   DEV-481558
In some cases, Submissions Archive users are unable to access the Submission Archive Viewer.   DEV-482334
When a user adds columns to the Submissions Archive Viewer, only the Name and Submission columns are preserved if the page is refreshed.   DEV-485765
When the Enable Application Relationships setting is on, Vault does not meet performance expectations during bulk record creation from an Impact Assessment Report.   DEV-490069
Continuous publishing tasks fail when Vault attempts to add annotation links to a target document while it is locked to a lower version.   DEV-490647
In some cases, Vault intermittently fails to resolve or update links during continuous and on-demand publishing.   DEV-495459
Vault does not meet performance expectations when extracting Application relationships.   DEV-496024
Vault displays an internal error on the Manage Submission Administrative Information screen if a Submission Country record set to be used for content planning after country-specific overrides are already excluded.   DEV-500556
On-demand publishing fails when Vault re-generates a merged Submission Content Plan’s updated Table of Contents.   DEV-500900
Under certain circumstances, Vault fails to publish submissions documents while Continuous Publishing is enabled.   DEV-501117
When submitting via the gateway to the EMA, if publishing has not yet completed, the system does not prevent the transmission.   DEV-504020
After clicking Edit in the Action menu, users are unable to edit job fields.   DEV-504784
Under certain circumstances, split regulatory objectives display warnings and fail to specify fields for some records with multiple matching records.   DEV-505439
Vault fails to publish Study Tagging Files during Continuous Publishing while EDL is active.   DEV-505565
The Content Plan Viewer indicator is not updated with asynchronous state changes in Vaults where the Copy Into Content Plan feature is not enabled.   DEV-505898

Reporting

Description Issue No.
Under certain circumstances, Vault fails to execute Multi-Pass reports with advanced logic.   DEV-495552

Safety

The Safety release, including all Platform known issues, is targeted for tentative availability on August 4, 2022 & August 12, 2022.

Description Issue No.
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.   SAF-27081
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)
   		SAF-29964
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.   		SAF-30486
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.   		SAF-30980
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.   SAF-31206
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.   SAF-31436
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).   SAF-31689
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.   SAF-31710
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.   SAF-31742
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.   		SAF-31844
When there are a large number of Studies, the loading time for an Inbox Item can be negatively impacted.   SAF-31972
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.   SAF-32056
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.   SAF-32059
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.   		SAF-32087
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.   		SAF-32135
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.
   		SAF-32368
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.   		SAF-32657
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.   SAF-33151
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.   		SAF-33158
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.   SAF-34486
  • 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.
   		SAF-34978
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.   		SAF-35437
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.   		SAF-36713

Search & Filter

Description Issue No.
The Suggest Links document action creates suggested links for single words rather than correctly matching the entire sentence.   DEV-489215
After performing a bulk action on a document section on the expanded search page, the user is redirected to the 'All' view instead of back to the expanded search results.   DEV-490734
If a user doesn't have read permission on an object in a search collection, attempting to navigate to the expanded search page results in a "Page not found" server error.   DEV-498921
When a user clicks through views too quickly in the tabular layout, Vault switches back and forth between views indefinitely rather than eventually stopping on the last clicked view.   DEV-500251