Release Date: November 22, 2024 & December 6, 2024
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.
Last Updated: December 13, 2024
Clinical Operations
| Description | Issue No. |
|---|---|
| There is a known issue with the TMF/RIM BOT multi-language models that prevents models from being retrained. The BOT will continue to classify English documents using the 24R2 models, with no change in accuracy or performance. The inability to retrain models generates a daily error message to Vault Owners that the training job has failed. This error does not impact the use of the 24R2 models. Veeva is working to restore retraining capability. | DEV-802059 |
| TMF and CTMS Transfer do not support Attachment type object fields. | DEV-753495 |
| The Vault search function searches all columns instead of only columns visible to the user. | DEV-768338 |
| For CTMS Transfer, in scope monitoring documents with multiple versions may take more time to transfer. | DEV-771103 |
| Translations are missing for the Jurisdiction object label, the Jurisdiction Country object label, and the Jurisdiction “Name field is required” error message. | DEV-772598 |
| Users see a "Server having issues" banner when they leave required fields blank on CDX Override Agreements. | DEV-773018 |
| Manual creation of CDX Scope Variable Value records may cause errors during transfer. | DEV-773021 |
| The Primary Site Affiliation and State / Province / Region field labels are misaligned on the Request New Investigator tab. | DEV-773329 |
| The Study Element object type of the study_arm__v object cannot be mapped to in the Outbound Clinical Mappings UI. | DEV-773456 |
| 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 can query a search in the OpenData Institution popup search tab using more than the 128 maximum character limit. | DEV-775688 |
| Users are not navigated to the Library tab after deleting a document with a Deletion Reason if the TMF Viewer tab is not enabled in the Vault. | DEV-776698 |
| Downloading a document from the Authenticated Document viewer does not update the Last Downloaded Date on the related distribution task. | DEV-780707 |
| 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 |
| An error occurs when users click the Search or Signup for USN hyperlink in the banner of a survey. | DEV-785351 |
| The Generate Payable Items action does not successfully create Adjustment Payable Items for Payable Items linked to a Superseded Fee Schedule | DEV-785370 |
| When a user starts a Mutli-Site Distribution workflow on two (2) different documents at the same time, the workflow is applied twice to one (1) of the documents. | DEV-785524 |
| 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 |
| Updating the email address on a Person record does not remove the Study access in the Site Home for the old email address. | DEV-787574 |
| In some cases, the Automatic Document Exchange email job creates duplicate DTRs for existing recipients. | DEV-788324 |
| Users see duplicate documents in the authenticated viewer when the same authenticated safety document is sent to a site multiple times. | DEV-792410 |
| The hourly Automated Document Distribution job for documents and the Auto Document Exchange trigger for Study Sites unexpectedly creates Revise and Return Distribution Tasks for multi-site documents. | DEV-795455 |
| Users can only select a month or year in the Datepicker selector after entering or selecting a value in the date field. | DEV-800060 |
Commercial
| Description | Issue No. |
|---|---|
| Users may experience performance issues while viewing Content Modules with more than 5,000 comments. | DEV-734863 |
| While localizing Content Modules, Vault may incorrectly display the API name of the Product and Country field on image and data Content Module Assets. | DEV-790076 |
| In Vaults using numeric date formats and bulk eCTD Compliance Package generation, Vault may display an Invalid date error on Compliance Package rows after users select a value in the Submission Date field when the user locale is not United States. | DEV-797552 |
Developer Features: API
| Description | Issue No. |
|---|---|
| Updates to picklist value labels via the Vault REST API may not be visible in the UI. | DEV-765780 |
| Users may encounter an unexpected error message when creating Permalink records with Record Migration Mode using Vault Loader or the Vault REST API. | DEV-775713 |
| Customers without document management permissions may encounter an insufficient access error when retrieving Direct Data files. | DEV-799444 |
Developer Features: MDL
| Description | Issue No. |
|---|---|
| POST RECREATE fails with error when recreating a report with a filter on cross-domain user. | DEV-742417 |
| Line break characters may differ between MDL components (LF vs CRLF), which may cause false-positives when comparing component MDL, as the compare will flag differences between components when the only difference is the line break character. | DEV-753412 |
| The order of the fields returned by the MDL are inconsistent for the Lifecyclestatetypeassociation component. | DEV-783252 |
Developer Features: SDK
| Description | Issue No. |
|---|---|
| When using a single select message catalog search bar in the Message Editor, users may experience a brief delay before the results appear. | DEV-766910 |
| When a user does not have Read permission on the source object for a record trigger that creates an object record attachment, Vault displays a server error when the user updates a record that executes the trigger. | DEV-777079 |
| When a user does not have Read permission (via dynamic access control) on the source document for a record trigger that creates a document attachment, Vault displays a server error when the user updates a record that executes the trigger. | DEV-777379 |
eCOA
| Description | Issue No. |
|---|---|
| When a site staff member using Study Connect quickly disables and reenables ePRO for a participant that has recently had group changes, multiple instances of the same survey may be available to the participant. | MYVC-18462 |
| When creating a survey with a time block, leaving the minValue time empty defaults it to 00:00 in the JSON. If the survey is opened again and has a dynamic maxValue, this causes an error and prevents the survey from being saved. As a workaround, to save the survey, delete the minValue time. | MYVC-22729 |
| The user may be unable to update a participant's caregiver information after a new study version introduces a study group type. | MYVC-25290 |
| The system does not create a site record in the MyVeeva database if the user tries to create a site without specifying a timezone. | MYVC-26139 |
| No JSON validation message is displayed to inform users that they cannot add answerSet to dateTime blocks. As a workaround, do not add answerSet when creating a dateTime block. | MYVC-26842 |
| No JSON validation messages are displayed to inform users that they cannot add blockSettings to numberEntry and text blocks. As a workaround, do not add blockSettings when creating numberEntry or text blocks. | MYVC-27022 |
| In some cases, an inactive participant in a connected study cannot be reactivated, and an error message is displayed. | MYVC-27315 |
| Studies with large numbers of surveys and languages result in missing images in the collection document when viewed in a region that is different from the sponsor. | MYVC-28983 |
| The Remove Group action remains disabled after a group is removed from a schedule. This behavior occurs only with schedules and not with events. As a workaround, remove the ID from the schedule so that the system recognizes it as a new schedule. | MYVC-30984 |
Medical
| Description | Issue No. |
|---|---|
| In some cases, clicking the FAQ drop-down clears the previously selected Standard Response. | DEV-800418, DEV-802065 |
Multichannel
| Description | Issue No. |
|---|---|
| After a user uploads a new version of a Multichannel Slide, attempting to download the Presentation results in an error. | DEV-789330 |
| The Learn More link when selecting a Master Email Fragment and manually creating an Email Fragment is incorrect and results in an error. | DEV-797577 |
MyVeeva for Patients
| Description | Issue No. |
|---|---|
| Question responses in eConsent forms may not be saved if the user enters only special characters, such as "..." in the answer field. As a workaround, you can also enter alphanumeric characters when adding special characters in answer fields. | MYVC-27555 |
Platform: Admin
| Description | Issue No. |
|---|---|
| When configuring an event action through SDK, users may receive a server error. | DEV-733869 |
| When a custom sharing rule uses the FILENAME() function on an attachment field, navigating to the Sharing Rules tab results in a server error. | DEV-750965 |
| Cross-domain User Names are displayed incorrectly on the User record. | DEV-766471 |
Platform: Authentication
| Description | Issue No. |
|---|---|
| In some cases, when a user with Delegate access to a Vault clicks Return to your account, they are directed to the wrong Vault. | DEV-753014 |
Platform: Documents
| Description | Issue No. |
|---|---|
| Some document fields with the __del namespace are not properly flagged as Deleted. | DEV-360729 |
| Performance may be decreased when generating viewable renditions of Excel files (.xlsx) using Windows 2022. | DEV-742264 |
| On viewable renditions generated with an overlay and eSignature template, the Time field is not populated using the user locale or system locale as expected. | DEV-768437 |
| Users cannot download a PDF of Join Object and Parent Object records even when they have the appropriate access. | DEV-786889 |
| Rendition generation fails for .XLSX files when the header or footer are close to Excel's maximum header or footer character limit, as well as when the file has tokens that resolve to a blank value. In addition, blank tokens in headers or footers are not merged even when the rendition is generated successfully. | DEV-795085 |
| 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 |
Platform: Lifecycle & Workflow
| Description | Issue No. |
|---|---|
| Users may encounter a server error when they navigate to the User Action or Atomic Security page from a document lifecycle state. | DEV-740461 |
| When a job fails, Deep Copy job log and email notifications show an SDK exception. | DEV-751782 |
| Users may encounter a server error when starting a Legacy workflow with an eSignature prompt in the Start or Task step. | DEV-762820 |
| For user actions that trigger asynchronous jobs, if two different users click the same user action at almost the same time, the two user action jobs are incorrectly attributed to a single user, causing Vault to send notifications for both jobs to user 1 and the audit trail shows "on behalf of user 1" instead of properly mentioning user 2 who was the initiating user for one of the user action jobs. | DEV-766409 |
| In some cases, Start step rules with formula exceptions have an incorrect error message. | DEV-767860 |
| When starting a workflow with a user from a different locale, the workflow start dialog appears blank. | DEV-767905 |
| If an entry criteria is configured to use the Formula is True condition and contains a user-defined error message, the error message displays in the UI but not API responses. | DEV-788313 |
Platform: Objects
| Description | Issue No. |
|---|---|
| Users cannot use system layout rules in standard layouts. | DEV-752568 |
| In some cases, when filtering on time field in the record advanced search dialog, the equals filter only matches on the time field value with a seconds value of `00`. | DEV-769692 |
| In the Hierarchy Viewer, the Rich Text field for an EDL Item object does not have a Show More link. | DEV-775347 |
| When changing a record’s object type, Vault cannot save the record if the target object type includes an object reference field with constraints. | DEV-785930 |
| Users without the View User Information permission can view User object records. | DEV-791724 |
| In some cases, when a formula field uses a format mask to reference another object field, the field value does not display during record creation. | DEV-798702 |
| Some objects may have had all records updated by the System user if a new checkbox field was added as part of data model changes, even though no field values have actually been changed. | DEV-799180 |
| In some cases, users do not receive an error message when the default value for a single value Picklist field references the Picklist field itself. | DEV-800761 |
Platform: Performance & UI
| Description | Issue No. |
|---|---|
| In inline copy mode, users are able to edit cells during a save, but the changes are ignored. | DEV-769542 |
| Search-based selectors on raw objects do not display the warning message that search terms are case-sensitive for raw objects. | DEV-791299 |
| When editing a Long Text field, the Show More icon may overlap the field's scrollbar if it is present. | DEV-801394 |
| In some cases where Vaults use the Hungarian language, users are unable to start workflows that use the alphanumeric format on Workflow Due Dates. | DEV-802019 |
Platform: Reporting
| Description | Issue No. |
|---|---|
| An error is displayed when running Multi-Pass Ladder reports with a Name grouping in the primary view, and the report either has no filters or filters with advanced logic. | DEV-776771 |
| Users may encounter a server error when attempting to run a Multi-pass report with the Target Document ID or Source Document ID set as the relationship for the report type. | DEV-782630 |
Platform: Search & Filter
| Description | Issue No. |
|---|---|
| Users can select a Formula field that references a Text field when adding a searchable object field to an object. | DEV-745088 |
| Under some circumstances, the dropdown menu for the Document Type field may be missing in the Document Selector. | DEV-752284 |
| Vault may not apply tab filters correctly when a field is hidden using permission sets. | DEV-767027 |
| Saved views for dynamic tabs incorrectly appear in configuration reports. | DEV-767750 |
| While attempting to favorite a document, users may incorrectly receive an error saying that they have exceeded the favorite document limit. | DEV-776798 |
| Document External Text similarity checks always return blank results. | DEV-778839 |
Platform: Vault Mobile
| Description | Issue No. |
|---|---|
| When a user opens a binder in the in-app browser and attempts to add a document, the Add dropdown menu automatically closes. Issue fixed in 24R3 release | DEV-762302 |
Quality
| Description | Issue No. |
|---|---|
| A server error and an unexpected error are displayed if users enter and, or, or a comma as the search term in the search box in Vault. | DEV-735811 |
| When creating a discrepancy from the test execution UI, selected attachments may not upload if action security is enabled on the val_discrepancy__v object and the user does not have Execute permission for the Attachments: Upload atomic security setting. | DEV-753049 |
| For the Auto-Start Periodic Review workflow, unchecking the Create Draft maintains current version setting does not change the behavior of the workflow. This workflow is intentionally designed to always bind to the Steady State version of the document. | DEV-764051 |
| A server error occurs when you execute Add Disposition for a batch without a specific material listed. | DEV-767317 |
| Ingested Supplier Change Notification email records in Vault QMS may not render Email Body correctly in cases where the email body is very large. | DEV-772315 |
| The Quality Event - Batch join object does not have a Batch Impact field. | DEV-772703 |
| A difference occurs in the logs when you test the Quality Teams Public API endpoint. | DEV-773522 |
| If a Quality Team is imported incorrectly, a server error occurs when you create a Change Control record and attempt to assign the partially imported Quality Team. | DEV-774833 |
| If users have permissions granted only through App Security, they cannot move a Batch Disposition Check task to a different lifecycle state. | DEV-776268 |
| An unexpected error occurs 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 |
| In some cases. the Create option may incorrectly be available in the Document Change Request section of the Quality Relationships panel when the user is on a minor version of the document. | DEV-793322 |
| Users may be unable to see Document Change Request records from all versions of a given document in the DCR section of the Quality Relationships Panel. | DEV-793327 |
| The Date Pre-Approved field on Test Script and Test Protocol objects is a date data type field instead of a date/time data type field. | DEV-796003 |
| 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 |
| When a user is viewing steps on page 1 of the Dry Run interface and then edits a comment for a step on another page, the Prompt field in the Edit a Comment panel is blank. | DEV-800704 |
| 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 and then the executor uploads another attachment before the original files have finished loading, Vault does not display an error message indicating that the limit is exceeded. | DEV-805354 |
QualityOne
| Description | Issue No. |
|---|---|
| When users expand the Process Hazard Analysis section of the Information panel while a Process Step is selected on the HACCP Flow Diagram, the section briefly displays placeholder cards for Process Hazard Analysis records before displaying the expected loading indicator and Process Hazard Analysis records. | DEV-750937 |
| 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 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 |
| Clicking and dragging line segments of Connections between Process Steps on the HACCP Flow Diagram is difficult on tablet devices. | DEV-777711 |
| 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, related object sections take longer than expected to load. | DEV-787264 |
| 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 a user enters text into a long text field and then clicks Cancel, the field continues to display the unsaved input. | DEV-796921 |
| In some cases if the Create Related Record action runs while configured with Related Record Setups created prior to the 21R2 release, record creation fails and the job log displays an "Object reference not found" error message. | DEV-802507 |
Regulatory
| Description | Issue No. |
|---|---|
| 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 |
| In some cases, CP Viewer Multi Document Workflow fails to start. | DEV-772914 |
| Users are not able to expand a field's drop down using the caret icon in the Drag and Drop popup. | DEV-779660 |
| 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 |
| In the EDL Matching Field picklist, users are unable to set the doc_type_details__v value (created to replace the _c value) to Active. | DEV-785999 |
| When there is a missing eCTD country code on the country record, the published binder doesn't have country folder created with cover letter. | DEV-789515 |
| 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 |
| 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, DEV-797844 |
| When the Registration Data Verification workflow’s Start step is configured to use roles as participants, the Manage Registered Details wizard does not display users in the Registration Change Detail’s Verification Workflow Details section. | DEV-797317 |
| When running Create Related Records, if Application Relationships have been enabled, the Related Change Type value populated on the Event Relationships are only copied to resulting Activity, Regulatory Objective, and Submission relationships when the "Enable dynamic validation for Create Related Records" Application Setting is enabled. | DEV-799069 |
| 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 |
RegulatoryOne
The RegulatoryOne release, including all Platform known issues, is targeted for tentative availability on December 17, 2024.
| Description | Issue No. |
|---|---|
| In some cases after a user upversions a document, the Requirement Hierarchy Viewer may not display the correct version number. | OLS-33075 |
| In Vaults with Spanish as the Base Language, when users click the binoculars icon next to the Matching Registrations field to select a Registration, the text in the Search Registration dialog is not fully translated. | OLS-33265 |
| In some cases, the Generate Requirements action takes longer to complete than expected when users run it on a Registration Objective. | OLS-34253 |
| When users run the Create Registration and Objective action on a Registration Item with a Regulatory Process Type value of New, Vault may relate the incorrect Registration Objective. | OLS-35030 |
Safety
The Safety release, including all Platform known issues, is targeted for tentative availability on November 27, 2024 & December 13, 2024.
| Description | Issue No. |
|---|---|
| Component names displayed in Workbench Dashboards do not wrap to 2 lines. | SAF-64286 |
| 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 |
| 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 |
| When promoting an Inbox Item with a Catalog number value, Vault does not populate the Catalog Number field on the generated Case. Further investigation revealed this to be working as designed. | SAF-66652 |
| 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 |
| 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 |
| When setting up a Workbench Report layout, Vault does not prevent users from grouping fields by a full-width field. | SAF-67559 |
| When the Gender field on a Case is blank, Vault automatically selects the "Decline to answer" checkbox on the generated MedWatch 3500A form. | SAF-68232 |
| Row height formatting defined in custom Excel templates for Workbench Reports does not carry over to the generated report output. | SAF-68543 |
| 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). | SAF-68576 |
| Deprecated Dose Form, Route of Administration, and Unit of Measurement records appear in the associated picklists for users to select on a Case. | SAF-68699 |
| When a user runs the Re-evaluate Submission/Distribution action on a Case that results in a Rule Engine error, Vault displays an unexpected error message. | SAF-68731 |
| Generated FDA E2B(R3) files do not include EDQM terms for the G.k.4.r.9.2a and G.k.4.r.9.2b elements. | SAF-68929 |
| In some cases, generated FDA E2B(R3) files contain incorrect values for the FDA.G.k.10a FDA Additional Information on Drug (coded) element. Further investigation revealed this to be working as designed. | SAF-68930 |
| 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. | SAF-68966 |
| When the Sex field on a Case is blank, Vault automatically selects the "Decline to answer" checkbox on the generated MedWatch 3500A form. | SAF-69013 |
| Generated MedWatch 3500A forms include the Concomitant Medical Products and Therapy Dates section for non-device Cases. | SAF-69014 |
| Section B in generated MedWatch 3500A forms includes repeated Relevant Tests/Laboratory Data, Including Dates details. | SAF-69015 |
| 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. | SAF-69091 |
| 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. | SAF-69101 |
| In some cases after running the Copy Case action, Vault copies the version of the coped Case to the generated record instead of creating the new record in v0.1. | SAF-69153 |
| When Synonym Candidate Auto-Creation is enabled, Vault generates MedDRA Synonym records with blank MedDRA Languages field values. | SAF-69371 |
| Vault does not copy the Compare ID field value to Study Registrations for follow-up Cases. | SAF-69407 |
Vault Connections
| Description | Issue No. |
|---|---|
| The PromoMats - Medical Vault connection may incorrectly create steady state CrossLinks for superseded documents. | DEV-789634 |
| The PromoMats - Medical Vault connection may incorrectly create steady state CrossLinks for superseded documents. | DEV-800341, DEV-800342 |