The following applications may have different release dates: QualityOne client applications, RegulatoryOne, Safety, and Veeva Claims.
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.
| Description |
Issue No. |
|
In some cases, when users attempt to send an email to both the Study Communications and Clinical Documents Email Processors, only one of the processors is successful, though Vault does not display any error message.
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DEV-556099 |
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Vault fails to delete CDX Overrides for Agreements via API when the Agreement is paused or deactivated.
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DEV-564468 |
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The Atomic Security: Fields and Atomic Security: Active Workflow Actions are editable on the Milestone Document Object Lifecycle.
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DEV-584845 |
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In certain cases, when you archive a document in your Source Vault, it is not properly moved to the archived state in the Source Vault when it is transferred to the Source Vault.
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DEV-585922 |
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In some cases, there is a slight lag between the time a user selects the Start Workflow action and when Vault displays the Start Workflow window. During this time the user can continue to select the action which causes Vault to eventually open multiple Start Workflow windows/dialogs.
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DEV-586034 |
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In certain cases, Vault will process EDC item deletions via the Clinical Operations to CDMS Connection even if the related connection job ended with errors.
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DEV-588975 |
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In some cases, Vault fails to update the Milestone Document when users change the EDL Item classification that the Milestone references.
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DEV-592468 |
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In some cases, when users run the Retry Failures action for an active Study Agreement after correcting any invalid values, Vault creates an additional Transfer Failure record despite transferring the information successfully.
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DEV-594645 |
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In some cases, the Rename Connection action is erroneously available on the Connection (`connection__sys`) object.
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DEV-594971 |
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In certain cases, Vault does not correctly apply the "ClinOps version not in Steady State" status to documents sent from Clinical Operations Vaults to Site Vaults.
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DEV-595266 |
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In rare cases, the ClinOps - CDMS Inbound Parent Job displays the inbound Vault ID as "null" in the Clinical Operations Vault.
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DEV-595474 |
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Users encounter errors when attempting to open videos sent from Clinical Operations Vaults to Site Vaults via CDX.
|
DEV-595505 |
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Users encounter an error when attempting to update Study Person records in batches of 500.
|
DEV-601022 |
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If users add a Milestone to a document and set the Actual Finish Date on the Milestone, Vault does not allow the corresponding Milestone Item to be deleted.
|
DEV-602344 |
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In certain cases, an unexpected error during agreement message processing for TMF transfer can result in duplicate documents.
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DEV-602647 |
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In some cases, when users attempt to reclassify a Milestone document, the document is deleted.
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DEV-603776 |
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Users encounter an error when attempting to reclassify a classified document.
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DEV-607684 |
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In the Firefox browser, users are unable to view the notification for downloading the ePRO Survey report.
|
DEV-608093 |
| Description |
Issue No. |
|
In Vault Surveillance, when a Complaint is created missing contact information, the notification email regarding the missing information may incorrectly state "Record ID must not be null" instead of a helpful error message.
|
DEV-566441 |
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Vault may display an error while transferring data from a Clinical Operations Vault to a Study Training if an object reference field rule is inactive.
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DEV-579343 |
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Vault may display a server error when a user attempts to search within a Process Navigator hierarchy with a string longer than 250 characters.
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DEV-587054 |
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In Vault LIMS, when a user attempts to hierarchical copy a test definition record, the copy may not contain child records as expected.
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DEV-590345 |
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In some cases in Vault LIMS, the system may display an error when a user attempts to create a new version of a sample plan or specification record.
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DEV-591244 |
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In some cases in Vault LIMS, the system may display a server error when the Generate Lab Tests action executes as a user or event action.
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DEV-591636 |
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Vault may display an incomplete error message when the Activate External Collaborators action executes and detects a duplicate external username.
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DEV-594107 |
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Vault may display an error when attempting to execute the Activate External Collaborators document lifecycle entry action when the Quality External User Template includes certain token combinations including the ${PersonEmailPrefix} token.
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DEV-594566 |
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In Validation Management, when a user navigates to a requirement record detail page from the Requirements Burndown View, Vault may not display a navigation breadcrumb in the top left of the detail page.
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DEV-594833 |
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In Vault LIMS test execution, the Actual amount field may be incorrectly required for Consumable inputs which don't specify an amount.
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DEV-609720 |
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The External Collaborator user that is managed by the External Collaboration for Documents feature in QualityDocs is not presented with the option to download the document that they are collaborating on even when they are granted the ‘Download Source’ permission on the appropriate Document Lifecycle State Security Settings page.
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DEV-614439 |
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Vault Validation Management displays a server error when a user attempts to delete or replace an attachment on a completed Execution Step during the test step change process when both action security is enabled for attachments and atomic security permissions to delete and upload attachments are not configured to execute in the lifecycle state. To mitigate this issue, you can configure atomic security on the Completed lifecycle state of the Validation Test Step Lifecycle to grant execute permissions for the attachment actions, and configure a layout rule on the Execution Step detail page to hide the attachments section to prevent users bypassing the Test Step Change process for attachments.
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DEV-615360 |
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In some cases, when the Cascade Document Roles system action is used in the Document Change Control workflow, the Users/Groups in the Document Change Control Roles that are cascaded down to the associated documents are not audited on the Document Change Control records. This occurs if the Users/Groups in the Document Change Control received their roles via Custom Sharing Rules.
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DEV-626023 |
| Description |
Issue No. |
|
In some cases, users cannot load the Configuration page in the Admin area.
|
DEV-565959 |
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In some cases, the HACCP Flow Diagram displays and allows users to create HACCP Plan Process Steps using custom object types that should not be allowed on the diagram.
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DEV-576920 |
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In some cases, the HACCP Flow Diagram displays and allows users to create HACCP Plan Process Step Connections using custom object types that should not be allowed on the diagram.
|
DEV-576922 |
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If users lose repositioning permissions while moving process steps on a HACCP Flow Diagram, the timestamp updates but the action fails and no error message displays.
|
DEV-577146 |
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In some cases, users are not able to select the closest connection between two process steps on a HACCP Flow Diagram if they are overlapping or close together.
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DEV-582622 |
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When a user selects a picklist value that has no corresponding value on the target document’s field while syncing a document from QualityOne to a Training Vault, the error message in the job log contains incorrect information.
|
DEV-583804 |
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In some cases, users are able to view the HACCP Flow Diagram even if they do not have the necessary field permissions.
|
DEV-586876 |
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In some cases, users can enter Edit mode on a HACCP Flow Diagram even if they do not have the required permissions to create or view elements on the diagram.
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DEV-586885 |
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In some cases, the action fails and an unexpected error message displays when attempting to delete a process step from the HACCP Flow Diagram.
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DEV-587202 |
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In some cases, an error message displays and no edit option is available when users attempt to launch a HACCP Flow Diagram with a large number of process steps and connections.
|
DEV-589643 |
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When attempting to launch the HACCP Flow Diagram, users that do not have Read permissions for the Diagram Locked (diagram_locked__v) field see an error message and the action fails.
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DEV-590125 |
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Some of the HACCP Flow Diagram's functionality does not work properly in the Safari™ browser.
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DEV-590863 |
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In some cases, after dismissing an error dialog the process step nodes on a HACCP Flow Diagram all shift to the left, but their position values do not change.
|
DEV-590894 |
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In some cases, load times for the HACCP Flow Diagram are longer than expected.
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DEV-592682 |
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In some cases, users are seeing an unexpected error message when attempting to view information for an element of the HACCP Flow Diagram for which they do not have the required permissions.
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DEV-593224 |
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In some cases, COA Inspection files submitted externally through email intake display unexpected information in the Created By field.
|
DEV-594045 |
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In some cases, the Below Detectable Limit Variant is not behaving as expected when users run COA Analysis.
|
DEV-599797 |
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In some cases, Comment Type creation fails with an unexpected error.
|
DEV-602438 |
| Description |
Issue No. |
|
When a user attempts to select an unpublished Submission, the Submission Archive Viewer displays the warning message in English only.
|
DEV-566668 |
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When a user attempts to select an unpublished Submission, the Submission Archive Viewer displays the warning message in English only.
|
DEV-566668 |
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In some cases, the RIM Email Processor fails to detect duplicate documents in email attachments.
|
DEV-574914 |
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When a dispatched content plan’s Content Plan field is blank, users encounter an error when navigating to the Review Comparison page from a link.
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DEV-576443 |
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Vault cannot automatically create Labeling Deviations when there are more than ten (10) related Country Dependency records.
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DEV-576899 |
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Permalinks to named destinations within a target document published as a viewable rendition resolve to the first page of the document rather than the named destination.
|
DEV-577927 |
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In some cases, when two published documents contain embedded permalinks to the same named destination within a source document, the links resolve to the first page of the document rather than the named destination.
|
DEV-580715 |
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When a user refreshes the Submissions Archive Viewer page, Vault displays the viewer tab in the default style, rather than in orange text.
|
DEV-581168 |
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When a user refreshes the Submissions Archive Viewer page, Vault displays the viewer tab in the default style, rather than in orange text.
|
DEV-581168 |
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When Submission metadata is updated, the related hovercard message informing the user to refresh the browser appears in English only.
|
DEV-582805 |
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When Submission metadata is updated, the related hovercard message informing the user to refresh the browser appears in English only.
|
DEV-582805 |
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When a document is published using a custom rendition, permalinks are not resolved.
|
DEV-587204 |
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When the Published Output Location is updated on a linked target document, continuous publishing fails to properly update inbound permalinks to named destinations when locking the target document.
|
DEV-587599 |
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When an Admin navigates to the dispatch comparison viewer from a Dispatch Message record in Business Admin and clicks an action (e.g., Accept, Reject), the comparison viewer freezes and does not navigate back to the Dispatch Message record.
|
DEV-592299 |
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When a Submission has multiple Clinical Study or Nonclinical Study relationship records, the Set Leaf Operation dialog does not auto-expand to the section containing both records.
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DEV-592800 |
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When the “Show inactive Applications and Submissions in Viewer” Submissions Archive Application Setting is disabled, users cannot filter by inactive Submissions, however Vault still displays inactive Submission data in the viewer grid.
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DEV-594285 |
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When the “Show inactive Applications and Submissions in Viewer” Submissions Archive Application Setting is disabled, users cannot filter by inactive Submissions, however Vault still displays inactive Submission data in the viewer grid.
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DEV-594285 |
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The Submission column filter in the Submissions Archive Viewer displays values for all Submissions under the Application, rather than only those visible in the viewer.
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DEV-594453 |
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The Submission column filter in the Submissions Archive Viewer displays values for all Submissions under the Application, rather than only those visible in the viewer.
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DEV-594453 |
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When managing registered details, the Summary page “Finish” button is disabled when the request exceeds the number of records allowed for creation or update.
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DEV-595772 |
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When copying into a Content Plan, the success and failure counts in the resulting notification do not include the total number of matched documents.
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DEV-596193 |
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When copying into a Content Plan, the success and failure counts in the resulting notification do not include the total number of matched documents.
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DEV-596193 |
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When a user expands a content plan section at the bottom of the tree within the Active Dossier and Content Plan viewers, the view jumps back to the first expanded section in the tree.
|
DEV-598627 |
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The Submissions Archive Viewer does not load when the index.xml file is archived.
|
DEV-599736 |
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The Submissions Archive Viewer does not load when the index.xml file is archived.
|
DEV-599736 |
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The Submissions Archive Viewer does not display unshared Views in the drop-down to System Administrator users with permissions to manage all Views.
|
DEV-600581 |
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When a user without Read permission for the Submission Metadata object selects Where Used in Archive, the Submissions Archive Viewer does not load. For users with Read permission, the viewer loads but does not automatically expand to the selected location.
|
DEV-601968 |
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When setting a leaf operation for multiple Submissions, users must apply filters for a specific Submission in order to view STF XML files in the dialog.
|
DEV-603493 |
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When multiple users are selected for the verification task when managing registered details, Vault sends the task and notification to only one user.
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DEV-604385 |
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When transferring Content Plan data from a PromoMats Vault to a connected RIM Vault where the Content Plan does not exist, Vault does not create a corresponding User Exception Message record with the described error.
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DEV-605288 |
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When a user drags and drops a document without a subtype in the Active Dossier Editor, Vault displays an error and does not create Active Dossier Item and Active Dossier Item Detail records.
|
DEV-605788 |
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For China (CN) eCTD submission records, there are typographical errors in the labels of sections 1.4, 1.4.6, and 1.8.1.
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DEV-606182 |
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When a user splitting Activities navigates back from the Summary page to the Define Relationships page and de-selects a record, Vault directs them to a blank Define Relationships page instead of the Summary page.
|
DEV-608164 |
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Users without Read permission for the Application object are able to view but not execute the Create Registrations action.
|
DEV-610772 |
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When a user splitting Activities navigates back from the Summary page to the Define Relationships page and de-selects a record, Vault directs them to a blank Define Relationships page instead of the Summary page.
|
DEV-611011 |
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When a user selects Expand All from an Application, the Submissions Archive Viewer displays duplicate Correspondence folders and contents.
|
DEV-611794 |
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The Learn More link from the Training Summary Results field within Trained Model records incorrectly resolves to the Clinical Vault Help page for the TMF Bot (page ID: 72739). The link should resolve to the Regulatory Vault Help page, Evaluating RIM Bot Auto-Classification Models (ID: 518092).
|
DEV-615638 |
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When the XML Manufacturer field includes a value with two blank spaces (e.g., 'All_ _Manufacturers', where underscores are spaces), the Submissions Archive Viewer grid displays the value with one space ('All Manufacturers').
|
DEV-647016 |
| Description |
Issue No. |
|
The Active MedDRA Version dropdown on the MedDRA Dictionary record of the Dictionaries object does not display any active MedDRA versions.
|
SAF-40045 |
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When creating Follow-up Cases, Expectedness values from initial Cases are changed on the Assessments and Case Assessment Expectedness sections of Follow-up Cases.
|
SAF-40548 |
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Validation results generated on Cases are displayed on Transmission records and validation results generated on Transmissions are displayed on Case records.
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SAF-41634 |
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An inbox item cannot be merged to an In-flight Case if users delete a record from the inbox item without deleting its Localized child records first.
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SAF-42242 |
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When a product cannot be auto-coded, the system does not display a message to indicate that the action could not be completed.
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SAF-42431 |
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The audit trail on Inbox Items created from E2B files displays picklist names instead of labels.
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SAF-42631 |
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Users with the Case Processing security profile are unable to view data in the Medical Review Timeline of an inbox item that has been promoted to a Case.
|
SAF-42713 |
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Inbox Items cannot be created from JSON files if the values entered in Controlled Vocabulary fields are invalid.
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SAF-42899 |
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When the Show Drug History and Show Medical History fields are set to "False", the pagination on Inbox Items imported from E2B files still reflects entries and pages for items that are not shown.
|
SAF-43364 |
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Child and parent ages are not automatically calculated on Child and Parent Information Cases even if the Auto-Calculate checkbox is selected.
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SAF-43450 |
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When creating Follow-up Cases from the Case Compare page, Unblinded or Open Label products are incorrectly created as Blinded products.
|
SAF-43492 |
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Cases are sent to the "Voided" state immediately after promotion when there are no Primary Products or Primary Assessments in their source E2B files.
|
SAF-44406 |
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When a PMDA Case has multiple LRDs, the values entered in some J2 fields and Localized Case Comments are mapped from the wrong LRD upon export.
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SAF-44906 |
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The system does not correctly identify whether Company-Product Combination Products have Device-type Product Constituents or other types of Product Constituents when generating FDA MedWatch 3500A, FDA E2B(R2) and E2B(R3), and EMA E2B(R3) files.
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SAF-45308 |
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When the Localization record for Japanese (Japan) is set to generate Localized Assessments for Case Product Registrations, Domestic Case creation fails for Inbox Items with Localization set to "Japanese".
|
SAF-45649 |
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Inbox Items imported from E2B files or documents incorrectly retain their initial Case Access Groups even when relevant information is changed.
|
SAF-45709 |
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When Localization Type is "Local" and Localization Language is set to "English", the Patient RoA and Dose Form values are mapped to the translated English fields rather than the local fields on Inbox Items imported from JSON files.
|
SAF-45824 |
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When a case narrative is updated, the narrative preview and generated XML file do not reflect these changes.
|
SAF-46100 |
|
The Product dropdown on Cases displays products of all types instead of filtering for the product type selected on creation.
|
SAF-46131 |
|
The "Product" Reporting Rule Parameter does not evaluate whether Cases contain Company Products.
|
SAF-46175 |
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The Due Date field on Localized Cases is not set to the earliest due date from their Localized Case Assessments.
|
SAF-46301 |
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PMDA.J2.2.2 fails and causes a validation error even on Follow-up cases.
|
SAF-46710 |
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When Combination Products made up of drug and device constituents are added to a Case, the device constituent is incorrectly included in the Most Conservative Product/Assessment (MCP/A) on the submission.
|
SAF-46711 |
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When a non-Admin user clears the Country field on an Inbox Item, the field is not automatically cleared in the Case Validity and Source section.
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SAF-46737 |
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Values entered in the Source field are mapped to the Localized Source field upon case promotion even when the "Enable Localization-based Mapping on Import" setting is turned off.
|
SAF-46772 |