The following applications may have different release dates: QualityOne client applications, RegulatoryOne, Safety, and Veeva Claims.
The issues listed below are fixed in the 25R1 release.
| Description |
Issue No. |
|
In some cases, an unexpected server error displays when a validation error occurs with a Study Person.
|
DEV-672324 |
|
In some cases, the status icons for review comments on Monitoring Events will remain orange even after users have resolved the comments.
|
DEV-720004 |
|
Under certain circumstances, Payable Items marked as excluded from adjustment will erroneously continue to be adjusted.
|
DEV-753581 |
|
An error occurs when running the Study Archive job where newly created snapshot documents no longer exist in Vault after users attempt to add audit entries.
|
DEV-764950 |
|
In some cases, a generic unexpected error occurs when transferring documents.
|
DEV-765917 |
|
A server error occurs when users create Global Milestone Mappings with empty required fields.
|
DEV-772997 |
|
The Primary Site Affiliation and State / Province / Region field labels are misaligned on the Request New Investigator tab.
|
DEV-773329 |
|
Users may encounter discrepancies when running the Update Metrics job in cases where their Vault contains duplicate metrics.
|
DEV-773950 |
|
Records selected on the OpenData Institution popup search tab are not removed when a user changes the results page or submits a new search.
|
DEV-774267 |
|
The Parent, City, and Country columns on the OpenData Sites popup appear sortable when users hover over or click on the columns.
|
DEV-774309 |
|
Users may observe incorrect information about question dependencies in Trip Reports.
|
DEV-775351 |
|
Users can query a search in the OpenData Institution popup search tab using more than the 128 maximum character limit.
|
DEV-775688 |
|
The Study Site Number field does not populate on downloaded Payments Excel files.
|
DEV-775709 |
|
Downloading a document from the Authenticated Document viewer does not update the Last Downloaded Date on the related Distribution Task.
|
DEV-780707 |
|
Under certain circumstances, Site Connect Safety Distribution jobs may fail.
|
DEV-782037 |
|
Users cannot inactivate Milestone Type picklist values configured in the Study Startup application once the application is disabled.
|
DEV-784061 |
|
Vault does not update Fee Schedules to Approved when the Approve Fee Schedule and Update Related system action is used with a Lifecycle State update.
|
DEV-785313 |
|
In some cases, DTRs remain in Pending Distribution when they have a related Study Person that has Site Connect User set to inactive.
|
DEV-785939 |
|
An unexpected error may occur with no User Exceptions when the Visit Definitions integration is inactive.
|
DEV-786446 |
|
In some cases, the Automatic Document Exchange email job creates duplicate DTRs for existing recipients.
|
DEV-788324 |
|
An SDK error message occurs when users configure an entry action to lock the Payment Request Details record once a Payment Request moves to the Approved lifecycle state.
|
DEV-789331 |
|
Updating the email address on a Study Person record does not remove the Study access in the Site Home for the old email address.
|
DEV-798709 |
|
In some cases, CDX creates excessive API calls.
|
DEV-800106 |
|
The Milestone Autocompletion feature flag cannot be enabled and will time out when there are too many milestones.
|
DEV-800460 |
|
Under certain circumstances, Vault does not correctly enforce Supporting Document requiredness for Safety Distributions with multiple document types.
|
DEV-802566 |
|
An error occurs when users add entry criteria to the Study Person object lifecycle with the Enable Sync PI Field with Study Person feature enabled.
|
DEV-803082 |
|
When Vault Loader updates the Site Connect User field to True, Vault fails to send the VeevaId invitation email to Study Personnel.
|
DEV-803716 |
|
When users download an individual Safety Distribution document, the API errors download as a JSON file instead of a PDF file.
|
DEV-805542 |
|
Vault displays a duplicate error when a Study Site with the same name as the previous name of a renamed Study Site which causes an error with a unique field on Study Person due to the Principal Investigator syncing feature.
|
DEV-806404 |
|
An unclear error message occurs when users attempt to make new updates to previously transferred documents that have already been reclassified to a different lifecycle.
|
DEV-807251 |
|
When the Actual Finish Date and another date are both set on a milestone with a Min Date Rollup and the next milestone does not have the Actual Date Field, the rollup changes fail.
|
DEV-807487 |
|
If a previously transferred document is in scope for a different study's agreement, Vault may fail to set the Study field with the new study.
|
DEV-807834 |
|
In some cases, Vault generates duplicate Payable Items for Procedure Fees for multiple Subjects.
|
DEV-808202 |
|
Statuses on Distribution Tasks with multiple Studies fail to update for all relevant Study Sites.
|
DEV-808325 |
|
Under certain circumstances, no Document Check records are created for Site Document Checks during document reconciliation.
|
DEV-812187 |
|
Under certain circumstances, the Fail Stuck Distribution Tasks job may fail.
|
DEV-813459 |
|
When the Subartifacts feature is enabled, an error occurs when users create documents with classifications containing quotes and Vault searches for subartifacts.
|
DEV-814223 |
|
If the Study field is populated before the Agreement Acceptance, the study Data Mapping will not be created.
|
DEV-814500 |
|
When entry criteria cause a Milestone to fail to transition to the Complete lifecycle state, the Milestone Autocomplete job crashes, and the Completed EDL Item Records field fails to update as expected.
|
DEV-814522 |
|
An error occurs where the zip file created when a site user selects the Download All link in a Site Connect email only contains a maximum of 15 items.
|
DEV-815803 |
|
Site Connect PAL (Public Access Link) records are kept active for two years, well beyond their functional use. PAL records now are only active for one year.
|
DEV-816637 |
|
In rare cases, Distribution Task records updated as part of the Send Safety Distribution Email fail because a user updates them within the same timeframe as the job. This results in a concurrent issue that causes the job to fail.
|
DEV-817857 |
|
In some cases, the Enable Survey Question Answer Reuse flag was not enabled.
|
DEV-818927 |
|
An unclear error message occurs when users apply VQL constraints to the Response Issue field.
|
DEV-819033 |
|
An unclear error message occurs when users enter more than the maximum number of characters allowed for the Description field on uploaded documents in Site Connect.
|
DEV-822584 |
|
TMF transfers may fail in cases where the source Vault is configured to allow multi values for the Person document field.
|
DEV-823045 |
|
The CDX Field Default does not allow the default of the Title field on Revise and Return tasks in Site Connect, instead, the Title field is always replaced with the Descriptions entered by the site user.
|
DEV-824165 |
|
Review Comments with more than 420 characters do not fully display.
|
DEV-824248 |
|
Vault notifications for successful model deployment translate to "Failure".
|
DEV-824680 |
|
Feasibility Respondents receive an unexpected error when trying to view Referenced Documents in Site Survey questions.
|
DEV-825627 |
|
Quality Issue records do not reflect the edits users make to the Assign To, Study, and Content fields on the Quality Issue List View page.
|
DEV-828494 |
|
An unexpected error occurs when site users attempt to upload additional documents and the related document type classification is using the Content Reuse feature.
|
DEV-828904 |
|
Users who have disabled the Site Connect application are unable to delete Study Sites.
|
DEV-829649 |
|
A server error occurs when a user triggers the Auto-Distribute Document action for a Study Site and a large amount of documents must be processed.
|
DEV-830051 |
|
When more than 1000 user exception items are created after a RIM-Clinical Operations job, the parent user exception message may not be inactive on the next run, leaving multiple active user exception messages.
|
DEV-830969 |
|
When users add Study Site Addresses with Save for Future Use enabled, the Study Site Address saves to the Vault but not the registry.
|
DEV-831079 |
|
Vault provides incorrect document links for Site Connect email notifications when PAL links fail to generate.
|
DEV-831567 |
|
Simple Join objects and the related object sections use the Legacy List View instead of the new Object Data Grid.
|
DEV-832464 |
|
When a user changes the Assigned To field on the Quality Issue record and then edits another field, the Assigned To field reverts to the previous user.
|
DEV-832554 |
|
Under certain circumstances, users may observe that the system creates duplicate Payable Items.
|
DEV-835922 |
|
Automate Milestone state changes may fail when an autocomplete field on the milestone is empty.
|
DEV-837150 |
|
When access is removed from a Site Home Access record, and the related update to disable the Site Connect User flag on the Study Person record fails, the records are left in a state that causes downstream Site Connect jobs to fail.
|
DEV-837229 |
|
When Autocomplete is set to All Dependencies for a Milestone, Vault fails to complete the Milestone automatically.
|
DEV-841491 |
|
In some cases, Vault incorrectly assigns responsibilities to Study Person records when users bulk enable the Site Connect User field on multiple Study Person records with the same source Person record.
|
DEV-842545 |
|
In some older Vaults, an error occurs when users configure the Securing Assigned To application control field on the Quality Issue page layout. This is due to the defaulting feature not accounting for the owner__vs internal field name in older vaults.
|
DEV-846590 |
| Description |
Issue No. |
|
Users cannot convert an advanced signature page template to a basic signature page template.
|
DEV-693835 |
|
An incorrect error message is displayed when creating a document from a template using a deleted Document Type
|
DEV-700603 |
|
Tokens are not updated correctly in Excel files when a user checks out the file, renames a Sheet in the file, and checks it back in.
|
DEV-717480 |
|
When uploading unclassified documents to a binder, and the current node count of the binder with the number of documents uploaded do not exceed the binder limit, an error dialog appears.
|
DEV-726779 |
|
Excel documents with merge field tokens that include VQL may fail to render.
|
DEV-743039 |
|
In some cases, users can use the Create Draft action on a CrossLink document even if the action is expected to fail.
|
DEV-753213 |
|
In some cases, interactive elements within a PDF rendition are not rendered successfully.
|
DEV-758973 |
|
When using the single document create endpoint to create a CrossLink, certain object fields are auto-populated based on name matching.
|
DEV-759753 |
|
In some cases, PDF renditions fail to generate until the user manually re-renders the document.
|
DEV-761012 |
|
In certain circumstances, named destination links in files in Submissions Archive do not navigate to the expected location in the target PDF.
|
DEV-764420 |
|
In some cases, the formatting may be incorrect on viewable renditions with eSignature fields.
|
DEV-764583 |
|
In some cases, users are unable to deploy packages due to unexpected __del dependencies.
|
DEV-766295 |
|
Rendering may fail for Excel files that have Merge Fields configured in their headers or footers.
|
DEV-769640 |
|
In some cases, when users deploy a Docfielddependency and the dependent value selected in the field is "inactive", the system returns an unknown error.
|
DEV-769951 |
|
Capitalization in duplicate External IDs causes Vault Loader batch creation to fail.
|
DEV-772959 |
|
In some cases, users are able to use Rest/Java SDK Annotation APIs on protected PDFs.
|
DEV-773607 |
|
When a PDF/A document is uploaded with an overlay or signature, the rendition status is stuck rendering.
|
DEV-773932 |
|
An incorrect File Last Modified By date may be displayed on the Document Info panel for PDFs uploaded to Vault.
|
DEV-775321 |
|
In certain rare circumstances, Formatted Outputs generated by Vault may display data from objects other than the one for which the user requested the report.
|
DEV-776797 |
|
When a user edits a document field that isn't shown in the doc fields page, the hidden doc field is still displayed.
|
DEV-778006 |
|
In some circumstances, an error may be displayed when a user attempts to download a PDF with an overlay.
|
DEV-780755 |
|
The document audit trail may display inconsistencies in user and group IDs when editing or deleting configuration components, such as security overrides for document fields.
|
DEV-781375 |
|
Under certain circumstances, users receive a server error while attempting to view the Related CrossLinks section on an archived CrossLink document.
|
DEV-781414 |
|
In some cases, Users are unable to add a new Claim reference to an existing anchor annotation with a leading or trailing space in its anchor title.
|
DEV-783864 |
|
Under certain circumstances, Vault cannot render OCR images and PDFs in a binder.
|
DEV-784678 |
|
In rare cases, Vault may fail to render documents uploaded during planned infrastructure scaling events.
|
DEV-786525 |
|
In certain circumstances, an error is displayed when creating a draft from a CrossLink document.
|
DEV-786535 |
|
Under certain circumstances, download request timeouts may take longer than expected.
|
DEV-788716 |
|
When using the Export Annotations action, some annotations may be omitted from the exported PDF.
|
DEV-788758 |
|
In some cases, when the language setting is set to Korean, user receives an error message during integration.
|
DEV-789115 |
|
In rare cases, processing documents with identical names in quick succession may cause file collisions during OCR or PDF/A conversion and bookmark editing.
|
DEV-789641 |
|
When multiple users apply annotation filters to a document and use the PDF with Annotations or Export Annotations action, the file downloaded by one user may use the filters selected by the other user.
|
DEV-791120 |
|
In rare cases, processing documents with identical names in quick succession may cause file collisions during OCR or PDF/A conversion and bookmark editing.
|
DEV-791415 |
|
A server error may be displayed when classifying a document created from a template and the user does not have the appropriate permissions for the selected classification.
|
DEV-792399 |
|
When a user opens a checked out Collaborative Authoring document in two tabs and checks the document back into Vault in one of the tabs, an incorrect error message is displayed on the second tab when attempting the Save to Vault action.
|
DEV-796992 |
|
In some cases, Vault Displays Bookmarks for Tables/Figures incorrectly when Generate "List of ..." setting is enabled.
|
DEV-797016 |
|
In some cases, the Fast Web View property of a PDF file may switch from Yes to No when uploaded to Vault.
|
DEV-797925 |
|
In some cases, the query for finding the earliest date in in a rendition status for admins page returns an error if there is no data in the table.
|
DEV-799369 |
|
In some cases, the table of contents for a document may show incorrect page numbers in downloaded renditions only.
|
DEV-799384 |
|
Under certain circumstances, users may encounter an error when attempting to Download Controlled Copy.
|
DEV-799542 |
|
In some cases, users encounter an error when attempting to convert a document to a PDF/A compliant viewable rendition.|
|
DEV-801069 |
|
When sending a request to PDFServer for a final word document, e-signatures become invalidated on multiple documents.
|
DEV-803662 |
|
Under certain circumstances, Permalink Link Annotations may be orphaned during a re-render with Preserve Annotations.
|
DEV-804034 |
|
Cross-Domain users are unable to link file staging servers across domains.
|
DEV-804974 |
|
Excel files with empty columns may fail to render if merge fields are enabled.
|
DEV-805387 |
|
Under certain circumstances, attempting to zoom in on a document in the Document Viewer may shift the document to the right instead of focusing on the document's center.
|
DEV-805816 |
|
When flattening XFA using PDFServer, Pre-processing does not correctly translate form into template and dataset.
|
DEV-806477 |
|
In some cases, users encounter a null point exception when using XFA Rendering to linearize PDFs after flattening.
|
DEV-806656 |
|
In some cases, users experience slowness in Narrative rendition when the max transient retry limit is reached.
|
DEV-806937 |
|
Rendition generation fails for documents with annotations that were created by a delegate user before 24R3 and have been brought forward.
|
DEV-807457 |
|
In some cases, the Viewable Renditions of PDF documents do not retain the Fast Web View setting from their source documents.
|
DEV-808012 |
|
In some circumstances, Vault sends a notification that the Collaborative Authoring cancel checkout entry action was completed successfully even when the document is not checked out.
|
DEV-808714 |
|
Users may receive a server error while selecting a Source Binding Rule on a CrossLink if their permissions on source document versions is removed.
|
DEV-810493 |
|
In some cases, Vault displays '.' as a Bound Source Version option after users select a Source Binding Rule on a CrossLink.
|
DEV-810494 |
|
An user inactivated in the CrossLink document target Vault may be able to see information on the Related CrossLink hovercard for the document in the source Vault.
|
DEV-812386 |
|
In rare cases, Vault may fail to move a Claim record to the Draft state after a user removes the last reference.
|
DEV-813587 |
|
Users are unable to record eSignatures in documents viewed in the mini-browser.
|
DEV-814645 |
|
In the Related Crosslink section of a source document, the link in a CrossLink hovercard redirects to an incorrect CrossLink.
|
DEV-814662 |
|
When updating the binding rule of a CrossLink, the CrossLink information does not always resync immediately.
|
DEV-816775 |
|
In some circumstances, a document processing error is encountered when starting a workflow on a document.
|
DEV-817491 |
|
In some cases, users may receive an error on a document's dependent picklist fields when they edit and save any other field on the document through the Doc Info pane.
|
DEV-818292 |
|
Under certain conditions, annotation creation via REST API takes longer than expected.
|
DEV-818906 |
|
Users may receive an error when attempting to render STF XML as part of a submission.
|
DEV-820289 |
|
In some cases, Chinese characters render incorrectly in the viewable renditions of XML files.
|
DEV-821121 |
|
Users are unable to open a target document preview from the archive viewer when the viewable rendition is unavailable.
|
DEV-822043 |
|
In some cases, users are unable to extract documents created via the Email to Vault feature using Vault Loader.
|
DEV-822870 |
|
In some cases, Vault may fail to render uploaded email files that contain images.
|
DEV-824141 |
|
In some cases, Vault may fail to render Microsoft Word documents with merge field tokens in the document's header or footer.
|
DEV-825261 |
|
In Vaults with defined Document Logo images, performance is decreased when rendering a document with an overlay template that does not use Document Logo images.
|
DEV-825765 |
|
Under certain circumstances, users may receive an error when attempting to apply a file overlay.
|
DEV-825838 |
|
PDF Standardization may fail if the document contains named destinations linked to annotations or bookmarks.
|
DEV-826423 |
|
Users cannot click on comments after scrolling through multiple annotations.
|
DEV-827370 |
|
Find in document does not return results for search terms beginning with a period.
|
DEV-827844 |
|
Under certain circumstances, users are unable to bring forward anchor annotations to new document versions.
|
DEV-827946 |
|
Under certain circumstances, attempts to refresh a sandbox may fail while cloning field dependencies.
|
DEV-833154 |
|
When deleting the latest major version of a document that results in a state change, the previous state timestamp in the audit log is incorrect.
|
DEV-838936 |
|
When multiple advanced overlays are configured for a page, the rendered document does not display all configured overlays.
|
DEV-840055 |
|
Resolved page-level line annotations are incorrectly brought forward with the Bring Forward Annotations action.
|
DEV-841014 |
|
After deleting the latest version of a document, the Last Modified By value of the previous version is not updated in the Library.
|
DEV-842550 |
|
When filtering by the Queued status on the Rendition Status page, Vault may fail to display documents in the Queued status.
|
DEV-845781 |
|
Users may receive a page no longer available error when attempting to click a checklist reference document link after the first attempt.
|
DEV-846122 |
| Description |
Issue No. |
|
A server error can occur when users attempt to add a document with an active legacy workflow to a Document Change Control record.
|
DEV-647461 |
|
The Show Associated Process Documents checkbox can cause an unexpected error to occur if the Parent field is hidden from users.
|
DEV-660132 |
|
A server error can occur when users do not have object-level permissions assigned and attempt to create a new Change Authorization record.
|
DEV-681538 |
|
When you use a custom state for a Quality Teams entry criteria, the error message is displayed in English instead of the expected translation.
|
DEV-702763 |
|
The Replace With option is missing from the Manage Invalid Team Members dialog in Quality Teams.
|
DEV-742402 |
|
When a Document Change Control related document (for example, Documents to be made Effective with Workflows) is in an active workflow and a user selects all documents within the section via the top checkbox, the user cannot de-select it in some cases.
|
DEV-743568 |
|
A server error occurs when a user attempts to access a Change Control record with an Action Steps custom control.
|
DEV-749650 |
|
A server error can occur when users execute Add Disposition on a batch with no material.
|
DEV-767317 |
|
In some cases, the Facilitated Training job fails with insufficient error information when attempting to cancel an Evaluation Training Assignment and related Evaluation Checklist.
|
DEV-771402 |
|
An error message is displayed when users attempt to approve a Document Change Control.
|
DEV-771976 |
|
The Quality-LIMS Reference Object Integration is missing from some Quality Vaults.
|
DEV-772440 |
|
A difference occurs in the logs when you test the Quality Teams Public API endpoint.
|
DEV-773522 |
|
Due to an issue with the Update Document Change Control State entry action, an error message is displayed when users attempt to update the Release Change Control for a Document Change Control record.
|
DEV-773558 |
|
When users create a Change Control record with an improperly imported Quality Team, a server error can occur when they attempt to assign the Quality Team.
|
DEV-774833 |
|
When custom sharing or custom matching rules are not enabled on the Audit object, a server error can occur when users attempt to add or remove a person from an Inspection or update an Inspect Request.
|
DEV-775255 |
|
The Deep Copy action fails when the Validation Team Assignment record is inactive or deleted.
|
DEV-775288 |
|
When rich text is marked as required on the Root Cause object, updated values in the Rich Text field are not saved.
|
DEV-776552 |
|
Custom application roles with a Label (label__v) value that conflicts with a standard Veeva Validation Management application role's Label value can prevent the required standard application roles from being created in Vault.
|
DEV-777975 |
|
When a Document Periodic Review-type job (for example, DtE: Auto-Start Periodic Review) fails to create Periodic Review records for certain documents, the job log does not include sufficient document details for troubleshooting.
|
DEV-780043 |
|
Users experience issues copying and deleting additional prompts while creating and saving a new step.
|
DEV-782416 |
|
In some cases, the Update Training Assignments job does not cancel open Classroom Training Assignments when the related Classroom Training Requirement is no longer included in a Learner’s training matrix.
|
DEV-784611 |
|
In some cases, users receive an internal error when attempting to launch E-Learning content.
|
DEV-787181 |
|
An unexpected error can occur when users attempt to open any Quality Event record.
|
DEV-787946 |
|
Longer attachment names are being truncated in the Edit Attachments dialog.
|
DEV-788102 |
|
When users are creating a comment in the Dry Run interface, the Save button is reenabled incorrectly if users complete the required fields, click Cancel, select a category, and leave the description blank.
|
DEV-789045 |
|
The Test Authoring UI displays a blank page when you switch from the Requirements Burndown View to the navigation panel.
|
DEV-789630 |
|
A server error can occur when you create an Inspection Request record and Dynamic Access Control is turned off for the Inspection Request object.
|
DEV-789705 |
|
The E-Learning player does not play courses packaged with a Windows-style directory separator instead of a forward slash.
|
DEV-790695 |
|
Learners and Admins receive an internal error when attempting to view an Evaluation Training Assignment created before the Training Material section was configured on the related object page layout.
|
DEV-795332 |
|
Users can create a comment with a default or additional prompt, but when they edit the comment to change the default prompt to an additional prompt or vice versa, Vault may display the previously selected prompt.
|
DEV-800098 |
|
Vault may fail to display values for custom Rich Text fields on class schedule records.
|
DEV-802525 |
|
When you assign an owner to a Batch Disposition on the Batch Release Execution page, the Owner field is updated for all Batch Disposition Checks rather than being updated for the specifically selected Batch Disposition Check.
|
DEV-804244 |
|
Vault may allow users to exceed the limit for the number of attachments per test step when they upload attachments to a Test Step record. For example, if the limit is set to ten (10), the executor uploads ten (10) attachments, then the executor uploads another attachment before the original files have finished loading, and then Vault does not display an error message indicating that the limit is exceeded.
|
DEV-805354 |
|
Users do not receive a notification that the QMS Change Related Object Lifecycle State Job entry action has run when the Risk Assessment moves to the In Approval state.
|
DEV-805643 |
|
When the Study Training to Clinical Operations Vault Connection fails to create Training Requirements in certain cases, Vault produces a generic error message instead of a User Exception Message for troubleshooting.
|
DEV-806970 |
|
Users may incorrectly see unsaved changes for a test script that does not have any saved steps when opening a Test Authoring UI.
|
DEV-807670 |
|
In some cases, mobile users may finish an e-learning training course, but still find that the Complete Training button is greyed out.
|
DEV-808716 |
|
Entry actions on a parent record in its start state are causing the ActionStepProcessingJob to be executed twice, which causes a duplicate workflow for one change action.
|
DEV-809341 |
|
An ID is displayed instead of the Action Path name for existing Change Action records.
|
DEV-809955 |
|
An unexpected error can occur when you attempt to update the Material (quality_material__v) object via the Vault Loader or API because records are failing a unique ID check.
|
DEV-810895 |
|
Custom Yes/No fields in Risk Builder may not save a selected No value properly.
|
DEV-811755 |
|
The Risk Builder tool displays a blank page when users enter data into the Initial Risk Response and Initial Rationale fields while creating a new record.
|
DEV-814513 |
|
Custom fields added to the Root Cause and Root Cause Analysis Item objects may be cleared instead of saved correctly.
|
DEV-816033 |
|
When an Admin configures a long error message for a validation rule for a prompt label, Vault displays a scrollbar under the action icons.
|
DEV-816411 |
|
An unexpected error occurs when users add a test step with a blank field and the validation rule requires that the field not be blank.
|
DEV-816415 |
|
The Study Training to Clinical Operations Vault Connection does not transfer (from Clinical to Study Training) any Person records with the Manager field populated.
|
DEV-820077 |
|
The Deep Copy Test Script action fails due to a permissions error when the Do Not Copy option is enabled for standard user reference fields, and the user lacks read permissions for those fields.
|
DEV-820316 |
|
Under certain circumstances, users may receive an error when editing a Related Event in the app section.
|
DEV-820635 |
|
When Learner Role-Person records are created in migration mode without associated Persons and then are later deleted, the Update Training Assignments job fails when it attempts to associate or disassociate valid Person and Learner Role records.
|
DEV-821033 |
|
Vault does not display all of the required field columns in the Requirements dialog in the Test Script Authoring UI.
|
DEV-822886 |
|
When a Clinical user in a Study Training-connected Vault attempts to save a Study Person record with blank required fields (Person, Study Team Role), Vault does not inform the user and instead displays a generic Server Having Problems error.
|
DEV-823199 |
|
In some cases, Vault displays a Server having problems error to users attempting to complete a workflow task for a Document Change Control with a related Periodic Review record.
|
DEV-824590 |
|
Admins can configure all standard objects, including non-QMS objects, under the Reason for Change Configurations.
|
DEV-826992 |
|
Items are not created for input batches when Vault joins a deviation to an input batch.
|
DEV-828406 |
|
When the inspection Request field is added to the List layout, the field is not displayed in the Inspection Request list in the Inspector Portal.
|
DEV-829138 |
|
No values are listed in the Action Step drop-down for an Action Path.
|
DEV-830476 |
|
Users attempting to view Document Relationships experience a loading delay when accessing the panel for the first time after the Enable Document Relationships in the Quality Relationships Panel setting is enabled.
|
DEV-830697 |
|
Vault does not load the Document Relationships panel for users attempting to add a relationship for the first time after the Enable Document Relationships in the Quality Relationships Panel setting is enabled.
|
DEV-832092 |
|
In cases where multiple Self-Enrollment based Assignment Detail records are associated to the same Training Assignment, learners may receive an Unexpected Error when accessing the Completed tab on their Learner Details page.
|
DEV-834258 |
|
Users attempting to clear a Direct Assignment’s Due Date field receive a server error.
|
DEV-835877 |
|
In some cases, Learners attempting to complete a Training Assignment with related substitute rules receive a Server having problems error.
|
DEV-836274 |
|
When the Email Body section control is configured on one of the layouts for the Quality Event object, an unexpected error occurs when a user attempts to view a standard Quality Event record.
|
DEV-838762 |
|
A validation error occurs when users select multiple options from shared multi-picklist fields and execute the Run Validation action.
|
DEV-839019 |
|
When using the new Document Change Control tokens in an Email Summary, users may encounter broken URLs that do not lead them to the intended document.
|
DEV-839343 |
|
The Document Relationships panel does not load results for relationship types which have been edited to exclude its namespace, for example excluding __vs from supporting_documents__vs.
|
DEV-839760 |
|
Users assigned a Read-only Application License receive an Unexpected Error message when attempting to load the Quality Relationships Panel.
|
DEV-847497 |
| Description |
Issue No. |
|
In some cases when users launch or refresh a HACCP Flow Diagram, the diagram does not adjust to display within the canvas.
|
DEV-686525 |
|
When selecting CCP Library records to create PRPs or Control Measures for a Process Step on the HACCP Flow Diagram, users see an unexpected error message upon clicking Save in the selection dialog if any of the selected CCP Library records were subsequently deleted after selection.
|
DEV-720089 |
|
In some cases, there are color and color contrast inconsistencies between icons and their backgrounds in the section headers of the Information panel on the HACCP Flow Diagram.
|
DEV-723219 |
|
When configuring an event action through SDK, users may receive a server error.
|
DEV-733869 |
|
When the Inherit From Events field on a Team Role record references multiple objects, clicking on the object labels in the field directs users to the incorrect object.
|
DEV-760292 |
|
When a user sends an API request to update Team assignments, Vault does not translate the resulting email notification if the user's language is not English.
|
DEV-772540 |
|
If users attempt to launch the HACCP Flow Diagram while Matching Sharing Rules are enabled on the User (user__sys) object, Vault displays a server error and does not launch the diagram
|
DEV-776301 |
|
In some cases, when users edit the CCP (ccp__v) field value on a Process Hazard Analysis record and then attempt to save the record, Vault displays a server error.
|
DEV-776399 |
|
If users attempt to expand a deleted Process Hazard Analysis record in the Information panel of the HACCP Flow Diagram while the Hazard Analysis Completeness Check icon is enabled, Vault displays an unexpected error message.
|
DEV-777676 |
|
In some cases, the Process Step records available to select are not filtered properly in the record selection drop-down on newly created process steps and logistics steps on the HACCP Flow Diagram’s canvas.
|
DEV-783896 |
|
In some cases, newly created Process Hazard Analysis records do not display in the Information panel of the HACCP Flow Diagram; if the user then attempts to refresh the Process Hazard Analyses section, the new records do not display and Vault displays a dialog prompting the user to refresh.
|
DEV-783947 |
|
In some cases, an inaccurate number displays in the Information panel of the HACCP Flow Diagram indicating the total Process Hazard Analysis records associated with a Process Step or Process Step Group.
|
DEV-786896 |
|
In some cases when using MDL RECREATE with HACCP Translated Field Criteria components, Admins can enter invalid attribute values.
|
DEV-787635 |
|
When users are missing required field permissions and enable the Hazard Analysis Completeness Check icon on the HACCP Flow Diagram, Vault displays an incorrect error message.
|
DEV-787749 |
|
In some cases, when users are editing the HACCP Flow Diagram and attempt to deselect more than 500 records in the Search: Hazard dialog, Vault displays an unexpected error message.
|
DEV-790322 |
|
When users first expand a recently deleted PRP/CM - Hazard Analysis record in the Information panel of the HACCP Flow Diagram, Vault displays a server error.
|
DEV-793440 |
|
In some cases, when a user enters text into a long text field and then clicks Cancel, the field continues to display the unsaved input.
|
DEV-796921 |
|
When users are editing the HACCP Flow Diagram and rapidly click multiple times on a Material Step’s placeholder text or on Edit in a Material Step’s Actions menu, Vault displays multiple Search: HACCP Plan Ingredient dialogs.
|
DEV-800042 |
|
When users attempt to edit a section of the HACCP Flow Diagram’s Information panel while another section is already in edit mode, Vault displays a warning dialog but does not redirect users to the section currently in edit mode after dismissing the dialog.
|
DEV-803470 |
|
When users make changes to an object record through the Hazard Flow Diagram Side Panel, all of the record's fields are updated, including attributes that were not changed and are not visible in the side panel.
|
DEV-805528 |
|
When users update the object_type__v field value and remove the translation_source__v field value on HACCP translation companion records, Vault displays a server error instead of the expected error message.
|
DEV-806621 |
|
Vault incorrectly displays a prompt to refresh the HACCP Flow Diagram when users create or add a record from the Information panel, immediately select another Process Step, and then subsequently reselect the first Process Step.
|
DEV-808024 |
|
In certain circumstances, Vault prevents users from entering edit mode on all sections of the HACCP Flow Diagram’s Information panel and incorrectly displays a "Section may have unsaved changes" warning message.
|
DEV-808026 |
|
When printing an audit report PDF file from a printable view, some elements do not display properly on the Safari browser’s print preview and on the paper hard copy (printed from any browser).
|
DEV-817653 |
|
After opening the HACCP Flow Diagram and attempting to open the Actions menu, the menu takes an unexpectedly long time to appear.
|
DEV-819463 |
|
When an Admin attempts to save an Audit Report Configuration record with an XML Configuration that contains an invalid value for the objectType attribute on a TARGET_OBJECT section element, Vault displays a server error and does not save the record.
|
DEV-820609 |
|
When users attempt to update the Status of Risk Matrix records using a bulk action, not all records are updated and the job log for the bulk action displays an unknown error.
|
DEV-820702 |
|
If an Admin attempts to save an Audit Report Configuration with invalid attributes configured on a TARGET_OBJECT section, Vault displays a server error; if invalid attributes are configured on a TEAM section instead, no error message displays and the Admin can save the Audit Report Configuration.
|
DEV-821158 |
|
When a user without Read permission on the HPPSC Position (hppsc_position__v) object attempts to launch the HACCP Flow Diagram, Vault displays an error message and does not launch the diagram.
|
DEV-828046 |
|
In some cases when the Activate External Collaborator action is triggered via a workflow, the associated job appears to fail in the job queue but the action still executes. When the action is triggered in Vaults with legacy applications such as Training enabled, in some cases the associated job fails and Vault does not activate the External Collaborator.
|
DEV-840150 |
|
In some cases, when Admins attempt to save a HACCP App Controls for Related Section record after setting the Enable App Control on Section checkbox to Yes, Vault displays a server error.
|
DEV-840288 |
The QualityOne Client Applications release is targeted for tentative availability on April 22, 2025.
| Description |
Issue No. |
|
When creating a multi-target link, if the first link is an internal link, the document relationships for subsequent targets are not saved.
|
DEV-695392 |
|
The results of Active Dossier calculation can be inconsistent depending on what order Active Dossier Item Details are processed in.
|
DEV-697522 |
|
When a user selects the parent secion from a breadcrumb, the global filter is not refreshed.
|
DEV-727658 |
|
When the Sequence ID is missing from the Submission record and a user attempts to enable Continuous Publishing, the RIM-PromoMats Vault Connection generates a User Exception Message: "The Sequence ID field cannot be cleared while Dossier Status is Publishing Active".
|
DEV-733933 |
|
In some cases, Active Dossier Item Details fail to create for the same source document in multiple different content plan sections.
|
DEV-738459 |
|
When a user tries to reorder match documents, an error banner displays a message: "Unable to reorder."
|
DEV-750268 |
|
The Content Plan Viewer supports the ability to Export Excel Tree with All Descendants, including Content Plans, Content Plan Items, matched documents, plus Submission, Application, and relationship record fields. Excel has a max limit of 32,767 characters per cell. If any of the included Rich Text field values exceeds this limit, the export fails.
|
DEV-757723 |
|
When merging a Table of Contents in a section, if the Table of Content item's parent is not the section root and has preceding merged items, the page numbering is incorrect.
|
DEV-767215 |
|
The published file name does not update if the published output location is changed when there is already a published output file.
|
DEV-767823 |
|
Some regions do not trigger validation rules when the index.xml is inactive.
|
DEV-768088 |
|
Source and Target Content Plan links are not present on the Comparison Viewer page when the user does not have view access to the Content Plan object.
|
DEV-768177 |
|
In some case, util files are placed in an incorrect location due to application folder name updates.
|
DEV-768319 |
|
In some cases, there are two instances of the same document in Submissions Archive Viewer.
|
DEV-772489 |
|
When creating records in bulk, Vault removes format masks from all fields when a user adds a Time subtype field with an invalid value.
|
DEV-772591 |
|
Users may receive a false positive on US Rule 1374.
|
DEV-773230 |
|
The document column is not populated in the exported file for Active Dossier Country View layout and Item Detail layout.
|
DEV-773969 |
|
The Active Dossier Details File Count does not match the Submission File Count if documents are matched on EDLItems as part of continuous publishing.
|
DEV-774490 |
|
When a Content Plan Viewer user attempts to view a record which is already deleted in another browser tab, Vault displays a red error banner with a timestamp.
|
DEV-775664 |
|
The empty sections indicator displays incorrectly in the Viewer for all existing EAEU imports.
|
DEV-776039 |
|
When multiple fields are edited in the Edit Selections popup, blank values do not display on the submission cell.
|
DEV-776228 |
|
When attempting to access a custom Impact Assessment Report from an Event, users receive a server error when the report is configured with a prompt.
|
DEV-777468 |
|
An internal system error occurs when importing submission out of order.
|
DEV-777590 |
|
In some cases, Vault fails to report a validation error.
|
DEV-777877 |
|
Users without Create Document Permission on a given document type, subtype, or classification cannot filter using that type within match document mode.
|
DEV-778197 |
|
Reordering match document is successful even though there is no orange line visible on the drop zone.
|
DEV-781767 |
|
A newly created view is cleared from the Active Dossier Viewer when a user navigates away from the viewer.
|
DEV-784807 |
|
When a user opens the viewer from Edit Active Dossier, the Edit Mode Type view is displayed under View Manager.
|
DEV-784873 |
|
Vault allows users without sufficient permissions to select the Submission Wizard action.
|
DEV-784949 |
|
In some cases, running On-Demand Publishing from an M5 Content Plan Item has delayed processing.
|
DEV-785802 |
|
Users may receive a F09 error when sequence descriptions have lower case letters.
|
DEV-787349 |
|
Users receive a server error when applying the update pending action on Active Dossier Item Detail if the country code field value in the Country object record is invalid.
|
DEV-788213 |
|
Users receive a pre-validation error If the Given name (GIV) tag with qualifier is missing for the contact party.
|
DEV-790098 |
|
When users split Activity Labeling Concepts and/or Activity Change Items and apply filters in the wizard, filter options include every value populated in this field across all records instead of just those in the records included in the table.
|
DEV-791902 |
|
Users may receive a false positive on ZA Rule 6.3.7.
|
DEV-792463 |
|
When displaying existing Application records in a Create Related Records preview (e.g., Application Product), Vault does not display the record’s object type field (Application Product Type).
|
DEV-792488 |
|
When Vault fails to create Application Country or Submission Country records when creating or updating Global Content Plans, the CSV file indicates a warning instead of an error.
|
DEV-792684 |
|
The binder is not up-versioned when the country value is added on the Expected Document List.
|
DEV-793339 |
|
Users may receive a false positive F09 validation result.
|
DEV-793341 |
|
In some cases, when users run the Update Global Content Plan action from a modified but inactive Event relationship record, Vault updates the corresponding Submission relationship record field values.
|
DEV-793433 |
|
When running the Dispatch Global Content Plan action, the Application Extended eCTD join record is not activated and the Application Source field is Blank.
|
DEV-794123 |
|
In some cases, Vault fails to report EU 11.02.
|
DEV-794308 |
|
The calculation Active Dossier entry action is not rolled back if the Regulatory Objective lifecycle state change fails due to the other failure entry action.
|
DEV-794540 |
|
The “Mark Activity Labeling Concepts as inactive during bundling” setting label should instead read as “...during splitting”, and the related Learn more link navigates to content on Splitting Regulatory Objectives (instead of Splitting Activities).
|
DEV-795591 |
|
When creating Registrations in bulk, the Confirmation page displays a network issue error if the user previously selected a large number of detail records (2MB or approximately 500 records).
|
DEV-798244 |
|
Users may receive a false negative on US Rule 1442 and US Rule 1102.
|
DEV-798721 |
|
Vault incorrectly reports US Rules 1734, 1735, and 1736.
|
DEV-798935 |
|
In some cases, Vault transitions Active Dossier Item Detail records to the Dispatched, Not Submitted (instead of Submitted) state when generating the Active Dossier from a Submission.
|
DEV-800557 |
|
In some cases, the Submissions Archive Delete Orphaned Files job does not delete placeholders.
|
DEV-801057 |
|
The Content Plan Viewer does not display the filter icon for Yes/No fields configured with the Show as checkbox option.
|
DEV-801084 |
|
In some cases, the XML Element Name defaulting does not work properly.
|
DEV-802573 |
|
Users may receive a false negative on ZA 3.5.4.
|
DEV-803079 |
|
Users may receive a false positive Report Level Content Plan publishing error.
|
DEV-803105 |
|
When system managed naming is disabled, Health Authority Questions and Health Authority Commitments cannot be created.
|
DEV-803394 |
|
In cases where users do not have the Ready For Publishing field set on document types contained in an RLCP publish, the RLCP has no published output.
|
DEV-803650 |
|
Users may receive a false positive on EU 11.2
|
DEV-804059 |
|
In some cases, the approval type is incorrectly populated after the Regulatory Objective entry action for version tree calculation for the originated document.
|
DEV-804211 |
|
Users may receive a false positive on US Rule 1735.
|
DEV-804295 |
|
When Vault fails to load Application relationships, the resulting error files miscalculates the total number of record failures.
|
DEV-804299 |
|
When users search Content Plans in match documents mode, Vault excludes documents configured to use a Classification with apostrophes.
|
DEV-804388 |
|
When the Table of Contents has too many rows, the publishing status gets stuck at “In Progress.”
|
DEV-806438 |
|
When users drag and drop Report Level Content Plan sections with tokens, Vault copies records to the target RLCP with the Report Level Content Plan Clinical Study field empty, instead of producing an error.
|
DEV-807233 |
|
Link resolution is unnecessarily performed on all targets of a document that was up-versioned.
|
DEV-807568 |
|
"The Submissions Archive Viewer displays sections out of order for imported submissions where the index.xml contains blank values for excipients, for example `excipient=""`."
|
DEV-807928 |
|
In some cases, the Copy From Content Plan failure notification fails to be sent to user.
|
DEV-807933 |
|
When a user completes the Content Plan Sign-Off Workflow for the root content plan of the submission, the Submissions Content Plan gets stuck in the "Sign-Off in Progress" state.
|
DEV-809739 |
|
When a user selects documents on the comparison viewer and the documents are deselected by another user, the matched documents are not synced to the target and the notification success count only includes the synced Content Plan/Content Plan Item count.
|
DEV-810096 |
|
In some cases, US Rule 1697 may report a false positive.
|
DEV-810563 |
|
Users may receive a false negative on US Rule 1553.
|
DEV-811467 |
|
When the Content Plan Viewer is open in two tabs and a user reparents a record in one tab, attempts to rearrange the reparented record’s siblings in the other tab results in a blank page.
|
DEV-811513 |
|
When the Registration object lifecycle’s Atomic Security is configured to hide the Start Registration Data Verification workflow action, Vault executes the workflow for single-record verification, and does not execute the workflow (with CSV errors) for multiple-record verification.
|
DEV-812675 |
|
When creating Registrations in bulk from a Regulatory Objective, the Registration Details page loads continuously for users without permission for the Application Regulatory Objective object.
|
DEV-813787 |
|
Users may receive false negatives on AU 3.13 and AU 4.1.13.
|
DEV-813987 |
|
Users may receive false negatives on ZA Rules 2.1.1, 3.4.12, 3.5.4, 6.3.5, and 6.4.7.
|
DEV-814002 |
|
Global-to-local mapping does not support standard Application object types.
|
DEV-814225 |
|
Users receive an error when a binder is added as a matched document to a Content Plan Item.
|
DEV-815606 |
|
During GCP validation, locked document validation may fail if there are unlocked excluded matched documents.
|
DEV-817440 |
|
The Create Related Records wizard does not create Registered Packaged Product records when a user proceeds through the wizard before allowing the Packaging Details page to fully load.
|
DEV-818281 |
|
Publishing jobs fail when Report Level Content Plan field is added to a Submission Content Plan.
|
DEV-818886 |
|
In some cases, CH 1.5 may report a false positive.
|
DEV-819323 |
|
The Submissions Archive Viewer displays duplicate STF root sections when an imported submission’s study-id XML value is blank.
|
DEV-819950 |
|
The Submissions Archive Viewer does not display content when multiple Submissions are open in different browser tabs.
|
DEV-820319 |
|
In some cases, Vault reclassifies documents on Legal Hold and does not fail publishing.
|
DEV-821873 |
|
When a user opens more than one record in the comparison viewer, Vault opens a separate mini-browser window instead of reloading the original window.
|
DEV-822208 |
|
The bundling and splitting results CSV file does not include translated column headers for non-English users.
|
DEV-823150 |
|
In some cases, ZA 4.8.1 may report a false positive.
|
DEV-823303 |
|
The Document Extraction job fails when users include an OR clause in VQL criteria for their Trained Model.
|
DEV-824036 |
|
In some cases, ZA 4.5.29 and ZA 4.5.32 may report a false positive.
|
DEV-824642 |
|
In some cases where there is an active field rule with 'Query Object = document_study_country_vr' and the 'Query Field' is not equal to "countryvr.name_v", then the Clinical-RIM Inbound Worker jobs fail with an unexpected error.
|
DEV-825266 |
|
When viewing Submission Administrative Information in EU 3.1 submissions, incorrect agency names or subtypes names may be displayed although the XML is correct.
|
DEV-825268 |
|
Inactive Regulatory Objectives affect the generation of Active Dossier records.
|
DEV-825712 |
|
In some cases, Vault loads a blank page when users copy and paste a Comparison Viewer URL from a dispatch message.
|
DEV-826398 |
|
The Submissions Archive Viewer displays a Server having problems error when users attempt to filter by more than 75 Submission records.
|
DEV-826539 |
|
Submission Active Substances are not created on Submission record and users receive the error fails with this error: "Batch Error: an unexpected error occurred."
|
DEV-828133 |
|
In some cases, PDF validation rules are not updated on source when the target is up-versioned continuously.
|
DEV-828543 |
|
When a user selects a large number of Product and Product Variant records (~300), the Create & Manage Event Details wizard does not properly filter Packaging fields.
|
DEV-829405 |
|
When a user adds a new valid Registered Detail in the Manage Registered Details wizard and the record has a system-managed picklist populated, the Add Registered Details dialog continuously loads and produces a console error.
|
DEV-831776 |
|
OR logic may not work as expected when using the CRR Validation enhancement.
|
DEV-832668 |
|
Under certain circumstances, Event Change Detail fields may appear as required when they should not be.
|
DEV-833643 |
|
Users may receive a false negative on rule 5045.
|
DEV-834147 |
|
When a user adds a new valid Registered Detail in the Manage Registered Details wizard that meets the criteria of the Registration Scope and the record has a system-managed picklist populated, Vault displays a blank summary page and does not create the new record.
|
DEV-836442 |
|
Under certain circumstances, Shelf Life Dynamic Validation rules do not behave as expected.
|
DEV-837928 |
|
In some cases Content Plan on-demand publishing completes when some tasks are still processing.
|
DEV-839478 |
|
When running on-demand publishing, embedded links are resolved instead of suppressed by the link evaluator.
|
DEV-841603 |
|
Vault incorrectly generates UDI DI Identifier XML, preventing successful MDD submissions in EUDAMED.
|
DEV-846337 |
|
When using the Create Related Records wizard, the records are not created as expected and a result notification is not displayed.
|
DEV-848927 |
| Description |
Issue No. |
|
After merging to an in-flight Case or promoting to a follow-up Case, Vault does not recalculate Last Dose Latency values on Case Assessments.
|
SAF-47056 |
|
If the Age at Onset exists on a Case and then a user updates the Onset value of the Case Adverse Event, Vault does not recalculate the Age at Onset.
|
SAF-55924 |
|
Users with the Case Processing security profile are able to edit Cases in the Approved state and they receive an incorrect error message when trying to edit Cases in the Closed state.
|
SAF-56890 |
|
Frequency values entered in decimals on Inbox Items are rounded off to the nearest whole number upon Case promotion.
|
SAF-59830 |
|
Vault evaluates Localized Case Assessment Expectedness for Study Products with a Study Product Role of Investigational or Comparator, instead of for any Study Product Role.
|
SAF-60246 |
|
The Age of Vaccination field does not populate when promoting an Inbox Item to a Case.
|
SAF-62167 |
|
When validating PMDA E2B(R3) files, Vault fails the PMDA.C.1.9.1.r.1-1 validation criteria when a Source field value exists on the Localized Case Identifier record of the Localized Case but is blank on the Case Identifier record of the global Case.
|
SAF-62871 |
|
When searching for a code with any letters in the JDrug Browser, no results appear.
|
SAF-63669 |
|
When a user enters zero (0) in the Age field with any Age Unit value, Vault populates "Fetus" for the patient's Age Group, instead of Neonate.
|
SAF-65137 |
|
The WorkbenchReport message group does not have Translation values for all messages.
|
SAF-65212 |
|
The Bulk Translation export file does not include Translated Labels for all Safety Workbench objects.
|
SAF-65215 |
|
For domestic Cases, after deleting an Adverse Event on the Inbox Item to Case Compare page and then merging to an in-flight Case, Vault does not reevaluate Case Tags.
|
SAF-65577 |
|
In Vaults with the Generate Assessments for both Serious and Non-Serious Adverse Events application setting enabled and Automated Case Promotion configured with the Override merge method, when promoting an Inbox Item with follow-up information that includes a new primary product and adverse event pair, Vault does not generate new Case Assessments and Case Assessment Results on the follow-up Case.
|
SAF-65611 |
|
When the Submission and Distribution Settings setting is enabled, Vault does not populate all applicable fields with the Product (Reported) value on CIOMS I and FDA MedWatch 3500A reports.
|
SAF-65664 |
|
In Vaults with an active MedDRA dictionary version that was not configured using the Upgrade to Latest action, Vault populates the Superseded By field on superseded MedDRA terms with the previous MedDRA dictionary version instead of the latest version.
|
SAF-65834 |
|
After receiving Message Delivery Notifications (MDNs) or Acknowledgments (ACKs) through AS2 Connections, Vault does not populate Correlation IDs on Transmission Messages.
|
SAF-65868 |
|
In the Patient section of Inbox Items, the label of the Sex field is "Gender".
|
SAF-65880 |
|
When an error occurs while generating Health Canada E2B(R2) files that use custom SDK, Vault does not generate the file and provides an unclear description of the issue in the error message.
|
SAF-65912 |
|
When a user without the required permissions to create PSMF PDFs approves a PSMF binder using delegated access, Vault displays a successful PDF generation notification but does not generate the PDF.
|
SAF-65918 |
|
If the Data Entry (Initial) state of the Case Lifecycle object lifecycle is configured with an entry action that transitions Narrative documents to a different state, after successful Case promotion, Vault does not update the state of localized Inbox Items to Promoted.
|
SAF-66949 |
|
When promoting a follow-up to a Japan Localized Case with multiple Case Products, if a user deletes the primary Case Product Registration on the Inbox Item to Case Compare page, after promotion Vault creates two (2) Local Reporting Details records with the same Destination Case ID for the deleted Case Product Registration.
|
SAF-66963 |
|
Vault does not map Study Names from global Cases to related foreign Localized Cases.
|
SAF-66986 |
|
After a user updates a global Case Assessment, Vault does not apply the update to related Localized Case Assessments.
|
SAF-67495 |
|
In some cases when users run the Run Bulk Unblind action on a blinded Case with an unblinded Product and at least one (1) blinded Product, Vault generates another unblinded Product record.
|
SAF-67497 |
|
If a user enters extra spaces before or after a MedDRA Term, Vault cannot autocode from the System Organ Class (SOC), High-Level Group Terms (HLGT), or High-Level Terms (HLT) level of the MedDRA hierarchy.
|
SAF-67536 |
|
For Inbox Items generated from the Safety-EDC Vault Connection, subject information for patient height history, weight history, last menstruations, and pregnancy information does not reflect the onset date of the primary adverse event.
|
SAF-67549 |
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When setting up a Workbench Report layout, Vault does not prevent users from grouping fields by a full-width field.
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SAF-67559 |
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When sending follow-up email questionnaires to Case Reporters, in some instances, Vault sends emails without attaching the questionnaire documents from the Correspondence record.
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SAF-67811 |
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After a MedDRA dictionary version update, Vault does not update the Primary SOC value for all terms in the hierarchy.
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SAF-67816 |
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After promoting an Inbox Item with new adverse events as a follow-up through the Inbox Item to Case Compare page, when syncing data from the global Case to a Japan Localized Case, Case Assessments and Case Assessment Results are not synced.
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SAF-67979 |
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When users manually delete products or adverse events referenced in assessments on E2B-imported Inbox Items, after domestic Case promotion Vault does not generate all expected Localized Case child records.
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SAF-68167 |
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When the Gender field on a Case is blank, Vault automatically selects the "Decline to answer" checkbox on the generated MedWatch 3500A form.
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SAF-68232 |
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When generating PMDA E2B(R3) reports, Vault populates the J2.14 Expectedness data element based on the Localized Case Assessment with the earliest creation date instead of from the Localized Case Assessment related to the primary PMDA product.
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SAF-68284 |
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For users in the All Access Case Access Group, Vault does not limit access to Localized Cases based on the Localization value in the User Access Group Assignment record.
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SAF-68285 |
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After merging an Inbox Item to an in-flight Case, Vault generates Case Assessments for device constituents of Combination Products.
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SAF-68309 |
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Row height formatting defined in custom Excel templates for Workbench Reports does not carry over to the generated report output.
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SAF-68543 |
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The Generate E2B Readable Rendition action does not appear on Transmission documents in Vaults where the generated__v document subtype is not labeled "Individual Case Safety Reports (ICSR)".
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SAF-68576 |
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For Cases that include multiple Products with the same Case Product Registration and at least one (1) Local Reporting Details record that references the Case Product Registration in the Primary Case Product Registration field, Vault prevents creating follow-up Cases from Inbox Items.
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SAF-68648 |
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Vault does not export standalone devices with a Drug Role of "Similar Device" and a Device Report Type of "Malfunction" to FDA VAERS E2B(R3) reports.
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SAF-68653 |
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Deprecated Dose Form, Route of Administration, and Unit of Measurement records appear in the associated picklists for users to select on a Case.
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SAF-68699 |
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For E2B-imported Inbox Items with follow-up information that generates new assessments for an existing Japan domestic Case, after merging to the in-flight Case, Vault does not generate all expected Localized Case Assessment Result records based on the global Case Assessment Result records.
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SAF-68710 |
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When a user runs the Re-evaluate Submission/Distribution action on a Case that causes a Rule Engine error, Vault displays an unexpected error message.
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SAF-68731 |
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In some instances, Vault codes Localized MedDRA terms in English instead of the local language.
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SAF-68781 |
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Generated FDA E2B(R3) files for postmarket reports do not include EDQM terms for the G.k.4.r.9.2a, G.k.4.r.9.2b, G.k.4.r.10.2a, and G.k.4.r.10.2b data elements.
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SAF-68929 |
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On the Inbox Item to Case Compare page, when either the Inbox Item or the Case includes Parent Information records and the user manually matches any records, updates page filtering, or switches pages, Vault displays the Parent Information records in the Case Drug History or Case Medical History & Concurrent Conditions sections and prevents merging the Inbox Item to an in-flight Case.
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SAF-68953 |
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When an Inbox Item generated from an imported E2B file is promoted to a Case, the Case Assessment has a Blinding Type value of Open.
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SAF-68966 |
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When the Sex field on a Case is blank, Vault automatically selects the "Decline to answer" checkbox on the generated MedWatch 3500A form.
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SAF-69013 |
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Generated MedWatch 3500A forms include the Concomitant Medical Products and Therapy Dates section for non-device Cases.
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SAF-69014 |
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Section B in generated MedWatch 3500A forms includes repeated Relevant Tests/Laboratory Data, Including Dates details.
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SAF-69015 |
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When generating the Non-Primary Suspect Workbench Report, Vault excludes some Cases with a blinded study and unblinded study product.
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SAF-69063 |
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When users without Read permission on the API field of the Connection object run the Add Relevant Subject Information action and select items to add to the Case, Vault displays an error and records are not added.
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SAF-69091 |
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During Inbox Item import, if a user who has access to the Inbox Item is in the Pending state, then the import will fail.
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SAF-69098 |
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Overflow pages on generated FDA MedWatch 3500A (August 2024 Version) forms display some incorrect labels in the "Treatment Dates/Therapy Dates" and "Diagnosis for use" sections.
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SAF-69101 |
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In some cases after running the Copy Case action, Vault copies the version of the copied Case to the generated record instead of creating the new record in v0.1.
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SAF-69153 |
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In Vaults with the One Last Time Reporting for all Destinations application setting enabled, for Cases with the Transmission Reason set to Amendment, Vault does not copy the value to the Reason field of One Last Time (OLT) report Transmissions.
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SAF-69224 |
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For imported Inbox Items, Vault displays the Blinded field value in the Product section only when a user is editing the Inbox Item.
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SAF-69296 |
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For open-label study Cases, primary Case Product rollup is inconsistent depending on whether it occurs after promoting an Inbox Item or creating a follow-up through the Inbox Item to Case Compare page.
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SAF-69332 |
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In some instances, system performance issues result in Vault not generating Correspondence when expected. In these instances, Vault appears to generate Correspondence but displays an error message when users try to access the document from the Correspondence record.
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SAF-69354 |
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When Synonym Candidate Auto-Creation is enabled, Vault generates MedDRA Synonym records with blank MedDRA Languages field values.
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SAF-69371 |
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When generating Health Canada E2B(R2) reports for Cases with multiple diagnoses, Vault exports multiple values to the B.5.3a and B.5.3b data elements, resulting in NACKs from Health Canada.
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SAF-69399 |
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Vault does not copy the Compare ID field value to Study Registrations for follow-up Cases.
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SAF-69407 |
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In Vaults configured with Case Access Group Security, users without unblinded access cannot view or edit open-label Study Products on study Cases with blinded Study Arms.
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SAF-69480 |
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In some instances, Vault does not execute entry actions configured to occur when an Inbox Item moves to the Promoted state.
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SAF-69575 |
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When generating FDA E2B(R3) files for cross reporting scenarios, Vault does not map the Study Registration Numbers from applicable Study Registrations to the "FDA.C.5.6.r IND number of cross reported IND" data element.
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SAF-69609 |
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When generating E2B reports for Cases with an EDQM Term that has multiple EDQM Term records, Vault generates a validation warning.
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SAF-69739 |
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In Vaults not configured with Case Access Group security, an error occurs when a user runs the Copy Case action.
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SAF-69743 |
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When generating E2B readable renditions, Vault does not map Case data to some data elements correctly.
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SAF-69857 |
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In instances where a One Last Time report to the PMDA exists on a Case and the follow-up Case would generate reports only for investigational to investigational cross reporting scenarios, after a user runs the Evaluate Reporting Obligations action on the follow-up Case, Vault does not generate the expected PMDA Transmissions.
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SAF-69867 |
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In Vaults that include MedDRA dictionary versions prior to those in central MedDRA (versions before 19.1), server errors occur that prevent displaying Case Product detail pages and auto-coding MedDRA terms that have previously undergone a cyclical hierarchy change on Case objects.
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SAF-69870 |
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A system error occurs when a user without permission on the Localization object attempts to create, open, or edit a Case Product on an existing Case with the WHODrug or JDrug control field.
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SAF-69896 |
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In Vaults with custom Case Assessment Method picklist values, Vault does not export the G.k.9.i.2.r.2.EU.1 EU Method of Assessment data element when generating EMA E2B(R3) reports.
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SAF-69942 |
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For Cases created from Literature Articles in Vault SafetyDocs, when generating non-PMDA E2B(R3) reports, Vault maps the value in the Vancouver Citation field instead of the Vancouver Citation (English) field to the Literature Reference(s) data elements, C.4.r.1 for E2B(R3) formats and A.2.2 for E2B(R2) formats, resulting in negative acknowledgments (ACKs).
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SAF-69944 |
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Vault prevents navigating to Case Product pages if users do not have Read permission on the MedDRA, MedDRA (Localized), and Reason Omitted objects and all fields of the MedDRA Dictionary object type of the Dictionary object.
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SAF-70000 |
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In Vaults with Blind Protection Relatedness Override enabled, when users generate blinded CIOMS I or E2B previews or Transmissions, Vault exports values in the Assessment Result (Override) field instead of the Assessment Result field.
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SAF-70004 |
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In some instances, when a user attempts to delete a Case Assessment from the Assessment grid while Vault is reevaluating and generating Case Assessments, Vault displays an error message and cannot delete or display the record.
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SAF-70033 |
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When a follow-up Inbox Item for a Case reportable to the PMDA includes a new adverse event, after merging to an in-flight Case or promoting to a follow-up Case, new Localized Case Assessment names include the Case Product instead of the Case Product Registration.
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SAF-70040 |
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In some instances, Vault does not display some Case fields to users with view-only access.
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SAF-70179 |
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In Vaults configured to isolate blinded clinical trial information and with the Generate Assessments for both Serious and Non-Serious Adverse Events application setting enabled, Vault displays an error when trying to promote JSON-imported Cases through the Intake Inbox Item API endpoint.
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SAF-70368 |
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When the Generate Assessments action is running as part of a workflow and another workflow to reset the Locked By field runs, when the Generate Assessments action finishes, Vault locks the Case to the initial user instead of the current user.
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SAF-70626 |
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On MFDS E2B(R3) reports, Vault formats the G.k.2.1.KR.1b and G.k.2.3.r.1.KR.1b data elements incorrectly.
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SAF-70636 |
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When Transmissions that reference the CBER or CDER Transmission Profile are sent to the FDA through the FDA AS2 Connection, Vault names attachment files with the name of the E2B file, instead of the attachment file name.
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SAF-70811 |
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When creating a follow-up Case for a Case with multiple previous versions that include Case Child Information records, Vault copies Case Child Information records from every Case version instead of just the previous Case version, resulting in duplicate records on the follow-up Case.
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SAF-70859 |
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When auto-coding MedDRA terms on Cases referencing MedDRA dictionary versions that are older than the latest available version, for terms with Name changes only, Vault creates a new MedDRA term record instead of updating the Name on the existing record.
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SAF-70978 |
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In Vaults configured to isolate blinded clinical trial information, when users run the Evaluate Reporting Obligations action on a Localized Case related to a Localized Case for a different locale that has a blinded and unblinded Localized Case Assessment record pair, an error message appears.
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SAF-70982 |
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For Cases created using tabular data format import, in some instances, Vault populates the Patient RoA field on Case Product Dosage records with the Route of Administration ID instead of the term.
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SAF-71014 |
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On domestic Cases, the Dose Text dual-entry field on Case Product Dosage records displays localized values as read-only and hides the global value, preventing global users from editing the field.
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SAF-71026 |
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After running the Copy Case action, Vault does not copy Case documents with the Literature > Literature Article classification to the new Case.
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SAF-71075 |
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When generating FDA VAERS E2B(R3) reports for Cases with blank Date of Birth, Age at Vaccination, Age, Gestation, and Age Group values, Vault generates the XML with no D.2 Age Information section values, instead of exporting the nullFlavor NI to the D.2.3 Patient Age Group (as per reporter) data element.
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SAF-71107 |
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For follow-up online questionnaires configured with Question Field Mapping for the Event Country of the (Primary) Case Adverse Event, when respondents access and submit questionnaires that include a country name through public access links (PALs), Vault maps the country ID instead of the name and displays an error when users attempt to open the generated Inbox Item.
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SAF-71180 |
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After running a signal calculation, the preview of all results does not reflect applied filters.
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SAF-71190 |
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If a Case Translator's permission set does not include Read access to the Country object, when they try to open a Case Drug History record, Vault displays an error message.
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SAF-71217 |
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When generating E2B(R3) formats, the link to the EMA XSD references "http://", instead of the updated link to "https://".
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SAF-71346 |
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When generating FDA VAERS E2B(R3) reports, Vault does not populate the G.k.2.2 Medicinal Product Name as Reported by the Primary Source data element for Case Products with Similar Device in the Drug Role field, resulting in NACKs.
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SAF-71360 |
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When creating a follow-up Case from a copied Case with Child Information details from the prior Case, Vault copies only newly added Child Information Case data to the follow-up Case.
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SAF-71653 |
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When generating FDA E2B(R3) files, if the Result (code) field on the Case Test Result is blank, Vault does not map values to the "F.r.3.2 Test Result (value / qualifier)" and "F.r.3.3 Test Result (unit)" data elements.
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SAF-71661 |
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If Case Assessment Result controlled vocabulary labels are changed from the Vault-provided values, when generating MFDS E2B(R3) reports for domestic study Cases, Vault does not populate the G.k.9.i.2.r.3.KR.2 KRCT Result of Assessment data element.
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SAF-71663 |
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When generating FDA E2B(R3) and FDA VAERS E2B(R3) reports for Cases with a Combination Product that has the Drug Role field set to Suspect and another Combination Product that has the Drug Role field set to Similar Device, for the Similar Device product Vault populates 5 in the G.k.1 Characterisation of Drug Role data element, instead of 4 for Drug Not Administered.
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SAF-72108 |
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When users code a MedDRA Preferred Term (PT) that has undergone a hierarchical change across dictionary versions through the MedDRA Browser, if duplicate records exist for the term in the MedDRA dictionary in the Business Admin library, Vault adds the dictionary version to the non-primary PT.
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SAF-72216 |
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In Vaults with MedDRA Criteria records created before Vault introduced the Standard MedDRA Query (SMQ) Hierarchy Update feature in 24R1, after a MedDRA dictionary version update, those records remain linked to non-primary SOC MedDRA terms.
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SAF-72221 |
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For domestic Cases with foreign Localized Cases, when edits to an Adverse Event or a Case Product lead to an updated Case Assessment name, Vault displays an error message and prevents saving the edited Adverse Event or Case Product record.
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SAF-72265 |
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After merging an Inbox Item to an in-flight Japan domestic Case, Vault clears the Expected values from previously existing global Case Assessments.
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SAF-72435 |
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When processing a follow-up to a Japan foreign Case, if the related Japan Localized Case has multiple Case Product Registrations related to the same Adverse Event, after the Evaluate Regulatory Obligations action runs on the Case, Vault displays an error and fails to sync from the global Case to the Localized Case.
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SAF-72604 |
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When transmitting custom E2B formats to the Therapeutic Goods Administration (TGA) of Australia, file names sometimes exceed the character limit, resulting in NACKs.
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SAF-72623 |
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In Vaults configured to auto-set Inbox Item localization by reporter country, for email intake associated with an inbound email Transmission Profile that has a value in the Pre-Populate Country field but a blank Pre-Populate Report Type field, Vault does not populate the Localization value on Inbox Items. When users edit the Inbox Item to add Localization and Report Type values, the Localization field remains blank after saving.
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SAF-72813 |
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Vault does not prevent promoting a migrated initial Case that fails validation due to different Receipt Dates and New Info Dates, and then holds the Case in the "System Only: Coding Verification" state.
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SAF-72866 |
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For follow-up Cases with foreign Japan Localized Cases, when coding an Adverse Event on the global case, Vault displays an error message and prevents saving the Adverse Event record.
|
SAF-72911 |
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When a user removes a Case Assessment on a Japan domestic Case and then runs the Generate Assessments action, Vault generates a duplicate of existing Localized Case Assessments on the Localized Case.
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SAF-73012 |
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During E2B import, when executing custom SDK code, in some instances Vault does not process all Case Assessments, which prevents completing the import.
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SAF-73065 |
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When transferring Adverse Events through the Medical-Safety Vault Connection, if an attachment file name exceeds 100 characters, Inbox Item creation fails.
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SAF-73089 |
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When generating PMDA E2B(R3) reports for Cases created with migrated data, if the Patient RoA TermID and Patient RoA TermID Version values are blank on Case Product Dosage records, Vault exports "2.0" as the CodeSystemVersion for the G.k.4.r.10.2b data element, instead of "2.2", resulting in Submissions being rejected by the PMDA.
|
SAF-73194 |
|
For users with Read-only access to the Case Product object, the Name column on Case Products does not link to the Product record in the Product library.
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SAF-73248 |
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In some instances, when a user deletes a Case Product while Vault is reevaluating and generating Case Assessments on an initial Case, Vault prevents creating a follow-up Case.
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SAF-73326 |
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For a Case related to a Study with both biologics and drugs where the Case includes either a biologic or a drug but not both, Vault does not select the correct Transmission Profile when generating FDA E2B(R3) reports. Optionally, for clinical trial study Case submissions with no Transmission Profile specified on the Study Registration, you can now configure your Vault to always use the CBER Study Transmission Profile when the Study Product Type is Biologic and the CDER Study Transmission Profile for any other Study Product Type. For more information, contact Veeva Support.
|
SAF-73458 |
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When generating FDA E2B(R3) reports for premarket Cases, Vault populates the G.k.9.i.2.r section for non-sponsor Case Assessment Results.
|
SAF-73645 |
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For postmarket Cases for Studies configured with the Study Has Unspecified Products setting, Vault does not generate expected manual correspondence that uses the AESI Questionnaire (Template) document type.
|
SAF-73773 |
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In Vaults configured to isolate blinded clinical trial information, after users run the Create Follow Up Case action, Vault populates the Blinded Reference ID on unblinded Case Assessment Expectedness records, which prevents follow-up Case creation.
|
SAF-74110 |
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When importing multi-Case CSV files to create Inbox Items, Vault does not correctly link Case Adverse Events to Case Assessments, which causes an error message to appear and import to fail.
|
SAF-74194 |
|
This release aligns the Document Type Definition (DTD) on Vault's Health Canada E2B(R2) file format with Health Canada's updates to its production environment ICSR DTDs and ACK DTDs.
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SAF-74437 |
|
Vault exports MPIDs, instead of NDC codes, to the D.8.r.2b, D.10.8.r.2b, G.k.2.1.1b, and FDA.G2.k.2b data elements of FDA VAERS E2B(R3) reports, resulting in NACKs from the FDA.
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SAF-74439 |
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In Vaults configured to isolate blinded clinical trial information, when processing a follow-up with a new adverse event or product to an unblinded Case, Vault prevents entering blind-sensitive information on blinded records, resulting in missing values on blinded Distributions to partners and ethics committees.
|
SAF-74746 |
|
When generating FDA E2B(R3) reports for study Cases where the study is unblinded and the unblinded Case Product does not have the Rank set to 1, Vault does not order suspect Case Products before Case Products with other drug roles in the G.k section of the report.
|
SAF-75033 |
|
In some instances, long EU Convention E2B(R2) file names result in Submission rejections from agencies.
|
SAF-75053 |
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When generating PMDA E2B(R3) reports for Cases created with migrated data, if the Parent RoA TermID and Parent RoA TermID Version values are blank on Case Product Dosage records, Vault does not export a CodeSystemVersion for the G.k.4.r.11.2b data element, instead of exporting "2.2", resulting in Submissions being rejected by the PMDA.
|
SAF-75095 |
|
When generating Health Canada E2B(R2) files, Vault Safety now supports exporting the Product (Coded) value from Case Products to the B.4.k.2.1 data element and the Name value from Case Product Substances to the B.4.k.2.2 data element. If these values are blank, Vault exports the Product (Reported) and Substance Name values. To export Product (Coded) and Name, you must enable the "Use Product Coded for HC E2B(R2)" Submission and Distribution Settings application setting.
|
SAF-75237 |
|
When Connections are created or updated, in some instances, Vault does not populate the URL/IP fields, requiring reconfiguration of static IPs through the Safety System Settings.
|
SAF-75618 |
|
When generating FDA E2B(R3) files with a value in the F.r.3.1 Test Result (code) data element, Vault exports the F.r.3.2 Test Result (value / qualifier) data element tag but does not export existing values in the Test Result (Qualifier) and (Number) fields on the Case Test Result.
|
SAF-75672 |
|
When generating FDA E2B(R3) reports for cross reporting obligations for studies not registered in the United States, Vault does not map a Study Registration Number to the "FDA.C.5.5a IND Number where AE Occurred" data element.
|
SAF-75896 |
|
When generating FDA E3B(R3) reports, if an unsupported Unified Code for Units of Measure (UCUM) code exists in the Strength (Unit) field of the Case Product Substance, the Dose (unit) field of the Case Product Dosage, or the Cumulative Dose (unit) field of the Case Product record, Vault exports tags with no values to the G.k.2.3.r.3a, G.k.2.3.r.3b, G.k.4.r.1a, G.k.4.r.1b, G.k.5a, and G.k.5b number and unit data elements.
|
SAF-76115 |
|
In Vaults configured to isolate blinded clinical trial information, Vault does not support commas in cell values of CSV files prepared for bulk unblinding Cases.
|
SAF-76309 |