The following applications may have different release dates: QualityOne client applications, RegulatoryOne, Safety, and Veeva Claims.
The issues listed below are fixed in the 24R1 release.
| Description |
Issue No. |
|
In some cases, when users perform the "Create Site Budget Records" action, Vault fails to create Country Budget records when Site Budgets already exist.
|
DEV-520267 |
|
When users close or cancel the Site Candidate Loader dialog, Vault fails to delete the file.
|
DEV-562483 |
|
In some cases, even when an email has been configured, Vault sends reminder notification emails from a generic Vault email address.
|
DEV-623128 |
|
In rare cases, Vault incorrectly displays a document's lifecycle state in the Milestone workspace.
|
DEV-628355 |
|
In some cases, Vault displays an error when users attempt to bulk update Study Team Roles of Study Persons.
|
DEV-629765 |
|
When users download the full document audit trail for a Study, the User column is blank for system-initiated actions.
|
DEV-629806 |
|
If the Product field is set to required on a base document and is left blank, Vault displays an "Unexpected Error" message when users attempt to run the Create Document from Template action.
|
DEV-629970 |
|
When users attempt to update the Principal Investigator field for an archived Site, Vault displays an error that the field cannot be updated, but continues to successfully update the field.
|
DEV-630693 |
|
In some cases, Vault fails to create URS records for Study Person records that share Role Dependencies.
|
DEV-632118 |
|
When the Enable Recurring Milestone setting is enabled, users with read and edit permissions for the Template Milestone App Control but without read and edit permissions for the VOF Template Milestone field encounter a server error when attempting to create or access the RMST record.
|
DEV-632139 |
|
The Site Candidate Loader job notification does not contain accurate information about the success (or failure) of the job.
|
DEV-632656 |
|
If the CRA person has no User ID value, Vault fails to create or send notifications when a milestone's Actual Finish Date is updated.
|
DEV-633056 |
|
In some cases, Vault counts models in the Refreshed state against the Trained Model Limit and does not allow new models to be trained.
|
DEV-633187 |
|
In cases where a user attempts to send a document to SiteVault via both CDX and email, if the CDX transfer fails but the document is successfully delivered via email, the user is unable to reattempt the CDX transfer because the successful Email Distribution Task is seen by the system.
|
DEV-634627 |
|
Users without edit permission for Document Criteria - VQL are able to edit the Document Criteria - VQL field without an error or warning, though Vault does not save the changes.
|
DEV-634751 |
|
Users without edit permission for Document Criteria - VQL are unable to create a Train Model record.
|
DEV-634764 |
|
SiteVault invites may fail if line breaks are included in the email message field.
|
DEV-635312 |
|
When training a model, in some cases the status may unexpectedly change from In Training to Draft.
|
DEV-641506 |
|
When users move a Study in migration mode, Vault does not update the cycle time records correctly and displays an error.
|
DEV-642341 |
|
In some cases, Vault incorrectly displays a "Max # of Study Team Roles" setting in the Clinical Security section of the Application Settings admin page.
|
DEV-643097 |
|
In some cases, running the Generate Payable Items and Generate Payments Request jobs at the same time can result in incorrect information being recorded.
|
DEV-646280 |
|
When the RIM to Clinical Operations Vault Connection has an inactive integration in the source Vault, but an active corresponding integration in the target Vault, the connection transfers relevant records.
|
DEV-646832 |
|
In some cases, Vault displays a batch error when users attempt to update document dates while using Vault Loader, though the job logs report success.
|
DEV-647619 |
|
In cases where additional filters are selected in the Study Sites panel, selecting Clear all filters may not remove the filters.
|
DEV-649353 |
|
Users are incorrectly able to delete system trained model records.
|
DEV-650105 |
|
In some cases, TMF Transfer fails to transfer documents with an asterisk (*) in their names.
|
DEV-652003 |
|
If only one model is selected, the TMF Viewer does not display correctly.
|
DEV-657756 |
|
In some cases, users encounter a server error when attempting to run the Mark Recalled from Sites (Rescind Document) action.
|
DEV-660241 |
|
In some cases, when users attempt a TMF Transfer of an Archived Study, they encounter a large number of errors and duplicate documents.
|
DEV-660639 |
|
When users run a report using a prompt with a value selected in the Study Selector, the report displays results based on the Study Selector value even if the user changes the prompt before running the report.
|
DEV-661638 |
|
In certain cases, CDX creates multiple documents in the target Vault for one document in the source Vault.
|
DEV-661822 |
|
In some cases, users attempting TMF Transfer that archives a document with multiple versions results in an unexpected error.
|
DEV-662933 |
|
In some cases, the Transferred Items report includes transferred items that have been deleted and does not include transferred items that were Approved.
|
DEV-665121 |
|
In some cases, the CTMS Object Content Blinding feature does not work as expected.
|
DEV-666549 |
|
If users attempt to create an Organization record with a USN Name that includes a backslash, Vault displays an error.
|
DEV-667824 |
|
In some cases, Unblinded Follow-Up items may incorrectly remain linked to Blinded Monitoring Events.
|
DEV-668244 |
|
In some cases, users encounter errors when attempting to transfer Protocol Deviations between their CDMS and Clinical Operations Vaults.
|
DEV-673038 |
|
In some cases, Vault displays an SDK error message when users attempt to run the Recalculate Enrollment Metrics action.
|
DEV-673182 |
|
In some cases, users encounter errors when attempting to write Monitoring Event Reports.
|
DEV-673331 |
|
In some cases, Vault displays an error message with incorrect information when users attempt to create or update records via FTP.
|
DEV-674111 |
|
In some cases, TMF Transfer results in abnormally high numbers of API calls.
|
DEV-674892 |
|
If there are different documents with the same CDX ID and Version CDX ID, they cause the TMF Transfer to fail.
|
DEV-677030 |
|
In some cases, running the Recalculate Enrollment Actuals action results in errors.
|
DEV-678849 |
|
In some cases, when users attempt to train a Metadata Extraction model using production data, Vault displays a server error.
|
DEV-679992 |
|
In some cases, Subjects fail to transfer via the CDMS to CTMS connection.
|
DEV-681596 |
|
When a document is created through email ingestion, the TMF Bot applies a Study value for the document without evaluating whether the user who sent the email has View permission for that Study.
|
DEV-684391 |
|
The Metric Type field of the Global Metric Enablement object is editable.
|
DEV-684425 |
|
Users are unable to transfer documents from RIM to Clinical when the clinical_study_site_subquery__v field is set to inactive on the Clinical side.
|
DEV-685480 |
|
If users attempt to run the Send Site Survey Reminder Bulk action for more than 500 records at once, the job fails with an unexpected error.
|
DEV-687914 |
|
Site Persons with certain study team role configurations are unable to resend Safety Distributions to specific recipients.
|
DEV-688783 |
|
In order for Study, Country, and Site metadata extraction to work properly, users must enable both the "Enable Study Metadata Extraction" and the "Enable Country and Site Metadata Extraction" settings.
|
DEV-690467 |
|
Users without permission for the Prediction record are unable to complete the Document.
|
DEV-695081 |
| Description |
Issue No. |
|
Vault reports canceled renditions as Failures on the Rendition Status page.
|
DEV-564227 |
|
In rare cases, users experience a server error when uploading attachments.
|
DEV-581986 |
|
Under certain circumstances, the downloaded PDF rendition of a document with an overlay may not appear as expected.
|
DEV-612164 |
|
In some cases, Vault incorrectly updates sharing settings on documents when reclassification fails.
|
DEV-612487 |
|
When "Enable Create & Import Document Links" is disabled and a document contains multiple annotation links to the same target, deleting one annotation removes the relationship in Linked Documents until the user refreshes the page.
|
DEV-614483 |
|
Users encounter an unexpected error message when manually moving a document to the Obsolete state.
|
DEV-614809 |
|
In some cases, Vault reports renditions in Pending status as Success on the Rendition Status page.
|
DEV-617088 |
|
Vault may fail to render attachments to EML files when there is a combination of inline and non-inline attachments.
|
DEV-624590 |
|
The Submission Details section in the Doc Info panel fails to populate information when users click embedded links on Published documents.
|
DEV-624698 |
|
If a rerender request is submitted while one is in progress, the renditions become stuck in the Pending state.
|
DEV-626751 |
|
In some cases, documents with large amounts of markup fail to render.
|
DEV-626901 |
|
When using non-Latin characters such as Chinese, Japanese, or Korean within a RichText field that is used as a Merge Fields token, the data may be merged into the document as random characters.
|
DEV-627077 |
|
Some special characters do not appear in formatted output reports.
|
DEV-627740 |
|
Vault may fail to render email templates with invalid image sources.
|
DEV-627808 |
|
Vault adds an incorrect sender and sent date to the header in the viewable rendition of email documents when the source file is missing a sender.
|
DEV-628520 |
|
Some HTML files may have single lines of text split across two pages.
|
DEV-629310 |
|
In some cases, Vault incorrectly updates sharing settings on documents when reclassification fails.
|
DEV-630342 |
|
In some cases, Vault may fail to render non-latin characters including CJK (Chinese, Japanese, Korean) and Arabic characters in Microsoft Excel comments and notes.
|
DEV-630715 |
|
Under certain circumstances, Vault fails to generate PDF/A viewable renditions.
|
DEV-630794 |
|
Under certain circumstances, Vault fails to generate PDF/A viewable renditions.
|
DEV-630795 |
|
Applying an overlay to a PDF document removes the document's XML metadata.
|
DEV-631917 |
|
When users create a permalink annotation, the Select Permalink mini-browser window does not display bookmarks as expected.
|
DEV-632732 |
|
In some cases, certain document text is no longer searchable and cannot be copied after overlays are applied.
|
DEV-632881 |
|
Uploading Rich Text Format emails with inline attachments may not render attachments correctly
|
DEV-635304 |
|
If a document's Table of Contents contains links to tables, Vault may fail to render the links and tables correctly in the viewable rendition.
|
DEV-636572 |
|
In some cases, an expiration job may not expire documents in the latest steady state.
|
DEV-639304 |
|
Under certain circumstances, users are unable to download some viewable renditions, and Vault displays an unexpected error.
|
DEV-639309 |
|
Under certain circumstances, Vault fails to render merge fields documents with tracked changes.
|
DEV-641307 |
|
Large video files uploaded via Vault Loader or VFM may show an error message before rendering in Vault.
|
DEV-641496 |
|
Under certain circumstances, users cannot delete a Claim record.
|
DEV-643893 |
|
In some cases, Vault fails to extract named destinations while rendering documents.
|
DEV-644174 |
|
Users encounter a Server Having Problems error when using the Copy Section Structure action while editing a binder.
|
DEV-645478 |
|
Users without their language set to Japanese who use bold or italic formatting on CJK characters within RichText fields in a Formatted Output report will not see those characters in the generated report.
|
DEV-645490 |
|
In document renditions, links to files are not clickable when the filenames have no extension.
|
DEV-645759 |
|
In some cases, Vault fails to render XFA-based PDF documents.
|
DEV-645897 |
|
When a page link in a standardized PDF is broken, the link properties in Adobe Acrobat show a destination of Page 0 instead of nothing.
|
DEV-646201 |
|
Vault fails to generate PDF/A viewable renditions when the document contains certain control characters and the font does not have the associated glyphs.
|
DEV-647634 |
|
Users may experience performance issues when migrating a large number of documents.
|
DEV-647640 |
|
When there are multiple XML files in a zip file for SPL import, the rendition will appear the same for all documents.
|
DEV-647971 |
|
In some cases, the default value of some standard Document Fields may be removed if a user edits the field from UI.
|
DEV-648244 |
|
Vault may incorrectly update Tracked Changes on merge fields documents.
|
DEV-648266 |
|
Attachment documents may appear blank when attempting to view them on mobile devices.
|
DEV-648429 |
|
Users may receive a network error when attempting to save anchor annotations in some documents.
|
DEV-650614 |
|
In some cases, Vault may fail to populate document properties in PDF renditions of documents with custom xmp metadata properties.
|
DEV-651738 |
|
In some cases, Vault displays incorrect values in the Last Modified By field.
|
DEV-652464 |
|
In some cases, Controlled Document Templates will not up-version after a change is made to a document.
|
DEV-653030 |
|
In some cases, Vault calculates video lengths as 0:00 instead of the video's actual duration.
|
DEV-653161 |
|
Users experience an error when attempting to update a deleted annotation field using the Annotation SDK.
|
DEV-653286 |
|
Users may encounter a "Page not found" error when attempting to create a document change request or document change control record.
|
DEV-653387 |
|
Large video files uploaded via Vault File Manager may show an error message before rendering in Vault.
|
DEV-654460 |
|
In the Bookmarks and Destinations panels, searches for special characters return matches to HTML content containing the special characters.
|
DEV-656662 |
|
The Match EDL Items to Documents job running daily is logged every other day in a given EDL Item record’s audit trail (Last Matched Time).
|
DEV-657002 |
|
In some cases, overlays are included unexpectedly for some station documents when users view them in Station Manager.
|
DEV-657651 |
|
Users with certain permission sets are unable to download renditions including overlays.
|
DEV-659155 |
|
Under certain circumstances, renditions for Microsoft Word documents may fail to render.
|
DEV-659177 |
|
In some cases, Documents that were using Merge Fields prior to the 23R3.0 release may have unexpected formatting changes on Merge Fields values after 23R3.0.
|
DEV-659374 |
|
When using the Select tool in read-only document viewers such as the attachment viewer, resizing the document viewer does not resize the highlighting on the selected text.
|
DEV-659636 |
|
Under certain conditions, users may see "Unknown(.doc)" as the value for the Format document field in the File Info document section.
|
DEV-660417 |
|
In some cases, renditions with syntax errors may render incorrectly rather than failing and giving the user an error.
|
DEV-660455 |
|
Under certain conditions, the Edit button may still appear for Approved binders.
|
DEV-661030 |
|
The Document Type field does not update in the Doc Info panel when a document is reclassified to a Subtype with inactive Classifications.
|
DEV-661181 |
|
In some cases, documents may fail to render and become stuck in the rendering process.
|
DEV-662734 |
|
When users create line annotations, the infocard appears at the top of the page rather than aligned with the positioning of the pagemark.
|
DEV-662775 |
|
Tooltips on embedded links do not appear when Grab and Pan mode is disabled.
|
DEV-663380 |
|
In some cases, HTML document uploads may time out while generating renditions.
|
DEV-663901 |
|
If a new binder section is created with a name containing special characters such as single quotes (') or right angle brackets (>), the section name may appear with extraneous HTML content.
|
DEV-664511 |
|
The Firefox browser does not render info cards for document annotations with user mentions.
|
DEV-665285 |
|
Users may receive an error on eSignature pages in downloaded renditions.
|
DEV-665453 |
|
In some cases, large XML and HTML files fail to render.
|
DEV-665783 |
|
Bulk re-renders executed from the Bulk Re-Render API and Loader encounter performance issues when a large number of documents are rendered at one time.
|
DEV-666622 |
|
Under certain conditions, users recieve a "server having problems" error when creating a new draft document.
|
DEV-668165 |
|
In some cases, merge fields fail to update correctly before documents go into the Steady State.
|
DEV-669051 |
|
Users may receive an error message when attempting to download a viewable rendition with an eSignature page.
|
DEV-669359 |
|
In some cases, if a required field dependency is created with a controlling CrossLink field, Vault fails to update the dependent field as required.
|
DEV-670969 |
|
IF fields may render incorrectly if the content controls are empty or have multiple words.
|
DEV-672149 |
|
Under certain circumstances, all superseded document versions may become stuck rendering and require manual re-rendering.
|
DEV-673520 |
|
When hovering over an embedded link in a document with the Select cursor mode enabled, there is a delay before the link's URL displays.
|
DEV-673946 |
|
The Today button on document Date fields may not populate the current date if the timezone on the user's computer is different from their Vault's timezone.
|
DEV-675433 |
|
In some cases, updates to a document lifecycle can result in erroneous data on the associated document type.
|
DEV-678981 |
|
In some cases, the Bulk Reclassify API encounters performance issues.
|
DEV-682611 |
|
In some cases, rendition uploads may fail for PDF documents and users will need to manually re-render them.
|
DEV-682973 |
|
Document content in the RIM Submissions Archive viewer becomes obstructed if the browser window is resized.
|
DEV-686676 |
|
Bulk Reclassify renditions may take longer than expected to render.
|
DEV-689123 |
|
In some cases, users may encounter a server error when deleting sub-binders from a parent binder.
|
DEV-689748 |
|
When selecting text on a document in the RIM Submissions Archive viewer, the cursor highlights the left side of the document instead of the intended text.
|
DEV-691118 |
|
Under some circumstances, the Table of Contents for a document may not generate correctly.
|
DEV-691233 |
|
In some cases, Table of Contents fail to render on documents.
|
DEV-691988 |
| Description |
Issue No. |
|
In the QMS Risk Builder, if an edit box is open when saving the assessment risks, any changes to content within that edit box may not be saved.
|
DEV-585304 |
|
In some cases, when a user views assignments on page 2 or later in the My Learning tab and adjusts their browser window size, Vault redirects them to the first page.
|
DEV-624220 |
|
Users without permission to reassign workflows are able to view the Reassign option for Training Assignment workflows.
|
DEV-630772 |
|
In some cases, users may observe that tests incorrectly move to the Reviewed lifecycle state after marking Testing Complete.
|
DEV-632535 |
|
Under certain circumstances in Validation Management, the Executor field may not be visible in the authoring review interface.
|
DEV-633485 |
|
When updating a Study Team Role to use VeevaID and the role has 15,000 associated Study Persons, users receive a Server Having Problems error message.
|
DEV-635964 |
|
In some cases, the QMS the Relationship field on the record check interface may not display all expected values for selection.
|
DEV-637159 |
|
Inactive fields may incorrectly be available for selection in the Fields to Display section of a Visual Hierarchy Configuration.
|
DEV-637956 |
|
When configuring entry actions, entry criteria, or user actions on a lifecycle state, the Quality Event Type selection may disappear upon saving.
|
DEV-639238 |
|
In Vaults using the Quality to Clinical Operations connection, attempting to transfer a large number of protocol deviations from the Clinical Operations Vault to the Quality Vault may result in the job being unable to complete.
|
DEV-639886 |
|
Users receive a network error when attempting to add more than 340 Training Assignments to a Facilitated Training Request.
|
DEV-641147 |
|
Under certain circumstances in Vault LIMS, when viewing a result's changes, the time may incorrectly be displayed in the Vault's timezone.
|
DEV-644575 |
|
Automated creation of Supplier Change Notification records may not function as expected if the sender's email address contains more than one period.
|
DEV-646122 |
|
In some cases in Vault LIMS, a calculated lab result may incorrectly be able to updated via its record details page or via the API.
|
DEV-647166 |
|
In Vault LIMS, when Vault Loader is used to create new Spec Data records, Change Analysis records are only created for the first single record out of the number included.
|
DEV-647342 |
|
In Vault LIMS, in some cases the Create New Versions for Change Analysis Items action may fail on a Change Analysis may fail if it contains a resolved Change Analysis Item without a new version.
|
DEV-647675 |
|
In Vault LIMS, in some cases a version check on a Change Analysis may fail if it contains a resolved Change Analysis Item without a new version.
|
DEV-647676 |
|
In Vault LIMS, the editability of the Name field on the Sample object may incorrectly be unchangeable.
|
DEV-648213 |
|
Under certain circumstances in Vault LIMS, a version check on a Change Analysis may result in incorrect validation errors.
|
DEV-648383 |
|
In some cases in the QMS Record Check interface, Vault displays an incorrect creation date on records for users in certain time zones.
|
DEV-649935 |
|
Vault may fail to export some column values when extracting Quality Event records.
|
DEV-651514 |
|
Users are unable to create or update ILT classes if there are custom lookup fields configured on the class schedule.
|
DEV-652486 |
|
In some cases in Validation Management, a user clicking on a filter on a test script review page may see a blank page instead of the filtered results.
|
DEV-652549 |
|
In Validation Management, the review interface content panel may not show the latest change on a new test step after a user clicks on the back button to add a new revision on a new test step, then navigates back to the review interface.
|
DEV-653022 |
|
When Manager Groups are enabled, Vault prevents users from updating a class to the Class Scheduled state.
|
DEV-653386 |
|
Persons without Vault user accounts do not appear in direct assignment.
|
DEV-659683 |
|
When attempting to generate a heat map, users may become stuck on a blank screen.
|
DEV-660061 |
|
In rare cases, users experience a server error when creating Quality Teams.
|
DEV-662213 |
|
In cases where external Training Assignment verification is set up to potentially include blank users in Tasks, learners may be blocked from re-completing that Training Assignment.
|
DEV-666164 |
|
Vault Configuration Reports may be missing a sub-section label for the "Only display steady state documents when viewed in Process Navigator" setting.
|
DEV-666689 |
|
In some cases, when a manager and their direct report’s Person records are to be created in the same Auto Manage Persons job run, Vault does not set the Manager field on the direct report’s record.
|
DEV-667688 |
|
Depending on browser zoom settings, some Learners are unable to select the Take Quiz button from the Class Details page if the session name length exceeds approximately 90 characters.
|
DEV-671656 |
|
Users who are not registered for a Class are able to see and receive an error when using the Add to Calendar dropdown in the Session Details.
|
DEV-673203 |
|
In Validation Management, field labels in the Test Script Authoring interface may not reflect changes made to field labels in configuration by Admins.
|
DEV-673411 |
|
In certain cases when cloning a Vault, Root Cause records may be cloned even though the Cloning Rule of the Root Cause object is set to False.
|
DEV-677685 |
|
In some cases, plaintext emails sent via Supplier Change Notifications functionality may appear with a blank body.
|
DEV-682253 |
|
After clicking Create in an Audit Checklist with Findings, the + Section and + Question option labels may not display as expected.
|
DEV-686387 |
|
In Validation Management, if there is an object that has more than 500 records associated with the same inventory item, the asynchronous process started by enabling the Tag Security Migration setting may fail.
|
DEV-687393 |
|
In some cases, Vault incorrectly calculates Curriculum Prerequisites and the Learner Homepage does not load.
|
DEV-689157 |
|
After making edits to columns in the Risk Builder, users may need to refresh their browser in order to see the changes.
|
DEV-689369 |
|
In some cases, Classroom Training Assignment links do not display in Apple and Outlook calendar users’ invitations.
|
DEV-691228 |
|
Following performance improvements, the Learner Homepage's Explore tab now displays up to 1,000 self-enrollment Training Requirements, and Learners can use search or filter to browse the full catalog.
|
DEV-691707 |
|
In the Validation Management test authoring interface, when a user makes an update in the execution step, discards the changes, and selects the setup step from the navigation panel, the "Add instruction" add "Add Response" buttons may be incorrectly disabled. The user can reload the page to enable them.
|
DEV-692569 |
|
In Vault Product Surveillance, a validation icon may incorrectly be displayed for the "1.3.2 c-d Manufacturer Contact Name" field when the validation error actually exists in the "1.3.2 e-m Manufacturer Contact Information" field.
|
DEV-695434 |
|
In Vaults with certain country settings, the Quality-RIM Connection may fail to create CrossLinks and fail to provide a User Exception Message or Item for the failure.
|
DEV-696233 |
|
In some cases, Vault may display an error when a system Admin changes object types while creating or editing Visual Hierarchy Configurations.
|
DEV-700089 |
| Description |
Issue No. |
|
Content Plan Items with filenames over 100 characters do not publish.
|
DEV-564344 |
|
Vault cannot automatically create Labeling Deviations when there are more than ten (10) related Country Dependency records.
|
DEV-576899 |
|
In some cases, users may receive a server error using drag and drop without a value on the application field.
|
DEV-597005 |
|
In some cases, the No Files shown in the Export dialog displays when using the export option on the Submission record.
|
DEV-615304 |
|
In some cases, the Set Reference Leaf dialog automatically expands to folders which do not exist in a Submission.
|
DEV-615760 |
|
When the Quality-RIM Vault Connection attempts to process Quality updates made in quick succession in RIM, it generates duplicate RIM records and User Exception Messages in some cases.
|
DEV-616009 |
|
Vault incorrectly reports Rule 5100 when attempting to on-demand publish and merge PDFs with external bookmarks.
|
DEV-619956 |
|
Vault does not display Study Tagging Files in the Submissions Archive Viewer when there are multiple submissions.
|
DEV-620620 |
|
When the Enable Application Relationships setting is enabled, Vault does not populate the Product field on Regulatory Inactive Ingredient records created in bulk for preview.
|
DEV-625202 |
|
In some cases, Vault does not properly refresh the Content Plan viewer grid while in match document mode.
|
DEV-629020 |
|
In some cases, the Split Content Plan Item action counts excluded matched documents in the All Document Count value.
|
DEV-629814 |
|
Vault incorrectly displays the Submission Archive section name “1.15 Promotional material - Consumer."
|
DEV-629842 |
|
When a user opens the Active Dossier Editor from an Event and adds a document via drag and drop, Vault creates the related Active Dossier Item Detail record with the custom (__c) Country value from the document.
|
DEV-629847 |
|
Items with duplicate validation criteria cause publishing job errors which are not reflected in the Publishing Progress Indicator.
|
DEV-630267 |
|
In some cases, publishing jobs error when a matched document includes a broken embedded relative link targeting a matched document in a different Submission.
|
DEV-630317 |
|
When generating two or more IDMP Manufactured item records for the same Packaging record, Vault does not successfully generate the related FHIR message.
|
DEV-631156 |
|
In PromoMats-connected RIM Vaults where a CrossLink has never been matched to a content plan, the connection errors and the resulting User Exception Message does not specify Enable Continuous Publishing as the field causing the error.
|
DEV-631420 |
|
Users cannot add the Regulatory Objective column in the Active Dossier Editor.
|
DEV-631828 |
|
Reference leafs within the same submission are not updated with overrides when a link retarget is applied.
|
DEV-631836 |
|
Correspondence document sections in the Submissions Archive Viewer are not translated. Additionally, the section’s title is [No title] and appears empty for users who do not have Read permission for the Document Type Detail object.
|
DEV-631894 |
|
In some cases, updates to an item’s Published Output Location or rendition do not trigger continuous publishing.
|
DEV-632111 |
|
When creating only Activity records in bulk, the wizard creates but does not allow users to preview records if multiple countries are selected.
|
DEV-632534 |
|
The XML Application Number is mapped incorrectly for Jordan (JO).
|
DEV-632810 |
|
In some cases, when users access a dispatch comparison via URL and select an action (e.g., Accept, Reject), Vault navigates back to the blank browser tab.
|
DEV-632832 |
|
Vault displays an error when users create link retargets in the Link Evaluator.
|
DEV-633442 |
|
When users filter a dossier by a Submission related object, the Submissions Archive Viewer calculates the current view by including all Submissions, including those outside the range of the Submission related object grouping.
|
DEV-634561 |
|
Users may receive an error when creating the Active Dossier Item Detail.
|
DEV-634563 |
|
Vault displays the 3.2.P sections in the Submissions Archive Viewer in the incorrect order.
|
DEV-634819 |
|
When updating the MRP-DCP-EMEA Number via bulk xEVMPD update, Vault only references the Application Name field on related Registrations and does not consider the IDMP Procedure Name field.
|
DEV-635661 |
|
When generating IDMP elements, Vault produces a false error indicating the Registration’s completed Registration Holder field is blank.
|
DEV-636494 |
|
On-demand publishing fails when a Vault permalink targets a named destination in a corrupted document for which Vault cannot generate a rendition.
|
DEV-636624 |
|
In some cases, the Generate XEVPRM Job generates Product Data Messages with a null Message Number/Date, and the results file indicates viewable renditions cannot be retrieved.
|
DEV-636927 |
|
Vault incorrectly reports Rule 3.13 for leaves set with Leaf Operation as delete when the regional.xml checksum is “ “.
|
DEV-636964 |
|
Users cannot filter by the Country column in the Active Dossier Editor.
|
DEV-638241 |
|
Publishing fails with a nonspecific internal error when a STF section is missing a Submission Clinical Study or Submission Nonclinical Study join.
|
DEV-638443 |
|
When creating Registrations in bulk, the "Create separate Registrations for any selected Complex Products and their selected component Products" checkbox is not visible on the Product Details page.
|
DEV-638696 |
|
Grids within the Activity bundling and registered details wizards do not respect the list layout configuration for the Registration object.
|
DEV-638888 |
|
In some cases, the Submissions Archive Viewer displays an incorrect banner message for JP submissions in an application.
|
DEV-639216 |
|
The Submissions Archive Viewer’s Submission filter dialog displays with the incorrect size for JP submissions.
|
DEV-639878 |
|
In some cases, Vault fails to report US Validation Results 1306 and 1323.
|
DEV-640545 |
|
In some cases, validation fails when deleting an SVR that had just been deleted from inactivating an EDL item.
|
DEV-640957 |
|
In some cases, published documents are not rendering and Rendition Diagnostic is missing options to re-render.
|
DEV-641305 |
|
Vault incorrectly passes Rule 2025 when Submission ID and Sequence Number values are identical, but Submission Type and Subtype values are an invalid combination.
|
DEV-641547 |
|
Vault does not initiate continuous publishing when users update the Regulatory Activity Lead field.
|
DEV-641548 |
|
In some cases, the delete operation is not reflected in the XML after Continuous Publishing unless On-Demand publishing is ran.
|
DEV-641846 |
|
Vault incorrectly passes Rule 1734 when a ts.xpt file with errors is appended or replaces a previous ts.xpt file.
|
DEV-642130 |
|
In some cases, Rule EU: 9.7 fails and Vault displays the error “This criterion will test whether the UUID is well-formed.”
|
DEV-642373 |
|
In some cases, Vault fails to render XFA PDF files in the Submissions Archive viewer.
|
DEV-642862 |
|
When a published document matched to two reference leaf Content Plan Items is up-versioned, continuous publishing up-versions only one instance of the matched document.
|
DEV-643908 |
|
Users receive a server error and are unable to View/Edit Active Dossier.
|
DEV-645146 |
|
In some cases, Vault fails to report EU 11.02.
|
DEV-645439 |
|
When creating Application relationship records via RIM Maintenance, the job encounters a runtime error and fails if record Names contain special characters.
|
DEV-646779 |
|
When the XML Manufacturer field includes a value with two blank spaces (e.g., 'All_ _Manufacturers', where underscores are spaces), the Submissions Archive Viewer grid displays the value with one space ('All Manufacturers').
|
DEV-647016 |
|
Migrating large quantities of Application records using Loader may result in multiple records failing with a batch error.
|
DEV-647208 |
|
Vault incorrectly passes Rule 5045 for matched PDF documents with invalid opening settings.
|
DEV-647219 |
|
In some cases, Vault incorrectly reports CA B48.
|
DEV-647237 |
|
Vault incorrectly creates IDMP Manufactured Item records when a Registered Device Product record's Co-packaged or Integral Device field is set to Yes.
|
DEV-647359 |
|
When splitting or copying Content Plan Items via drag & drop, the system incorrectly removes document metadata from the new Content Plan Items.
|
DEV-647591 |
|
PDF validation occurs for all published documents instead of only the current linking batch, which causes performance issues.
|
DEV-647616 |
|
When splitting Activities, Vault does not apply the Activity naming pattern configured in Application Settings.
|
DEV-648212 |
|
Continuous publishing fails with a nonspecific internal error when the Submission’s XML Sequence ID field is blank.
|
DEV-648229 |
|
When a Content Plan Hierarchy Viewer mini-browser window is open behind a user’s main browser window and the user opens a second document, the mini-browser window remains hidden.
|
DEV-648253 |
|
In some cases, Vault fails to report US 1734.
|
DEV-648489 |
|
When an Active Dossier Item is dispatched, Vault does not set the record’s Dispatch Status, nor display the corresponding icon for the related country in the Active Dossier Viewer.
|
DEV-648753 |
|
When continuous publishing is triggered via Published Output Location update and on-demand publishing is subsequently triggered in quick succession, links are not properly resolved.
|
DEV-648971 |
|
When a user opens the Active Dossier Editor from an Event and adds a document via drag and drop, the Add to Active Dossier dialog pre-populates the Country field, hiding the Event and Activity fields.
|
DEV-649115 |
|
In some cases, a hierarchy state change conflicts with continuous publishing if continuous publishing finishes before the end of the job.
|
DEV-649148 |
|
In some cases, Vault displays an internal error when users initiate a Submissions Archive import.
|
DEV-649931 |
|
In some cases, file extensions are incorrectly applied to the Published Output Location.
|
DEV-650317 |
|
When a Vault annotation link and another link type target a reference leaf within the same Submission and the annotation link is retargeted, Vault does not resolve the annotation link during publishing and on-demand publishing fails.
|
DEV-650940 |
|
In some caes, Vault incorrectly reports US 1736.
|
DEV-651134 |
|
In some cases, Vault does not attach the merged PDF to the Submission Ready Binder when using the Report Level Content Plan Publish and Merge action.
|
DEV-651541 |
|
Vault incorrectly creates Registered Product records during bulk registration creation when a Product join record (e.g., Event Product, plus Application, Submission, and Regulatory Objective joins) is indicated as a Co-Packaged or Integral device.
|
DEV-651896 |
|
The Content Plan Viewer incorrectly renders some special characters.
|
DEV-652184 |
|
In some cases, Vault fails to report US 1276.
|
DEV-652293 |
|
Vault fails to report US 5200.
|
DEV-652320 |
|
When a document contains two hyperlinks (A and B) to the same location and one (A) is retargeted, Vault successfully retargets link A and publishes both A and B accordingly, however it does not allow retargeting of link B.
|
DEV-653223 |
|
In some cases, state transition fails if the lifecycle name has been modified.
|
DEV-657213 |
|
When a user removes an embedded link to replace it with a Vault permalink, the link is not resolved in the published document.
|
DEV-657277 |
|
The Product Code field does not populate properly into product reports.
|
DEV-657712 |
|
When a field is configured with EmailFormat, if a user enters a field value with HTML formatting, it appears incorrectly.
|
DEV-658034 |
|
In some cases, Vault fails to report CN 4.2.3.
|
DEV-658547 |
|
When filtering content plans, users may observe that the filtered text includes visible format tags and incorrect special character formatting, rather than properly formatted text.
|
DEV-658945 |
|
In some cases, Vault incorrectly reports EU Rules 11.2 and 15.8.
|
DEV-659129 |
|
When managing registered details, Vault does not create Registered details records if source record Names contain 120 or more characters, and system-managed naming is not enabled for the target object.
|
DEV-659544 |
|
When an Active Dossier Item is dispatched, Vault does not set the record’s Dispatch Status, nor display the corresponding icon for the related country in the Active Dossier Viewer.
|
DEV-660126 |
|
In some cases, jobs processing imports or removals in Submissions Archive continue to run and do not finish.
|
DEV-660207 |
|
Users matching documents in Match Document Mode may experience performance issues.
|
DEV-660452 |
|
When a user applies filters on the Submission Wizard, they may see strong HTML tags rather than bold formatting in the resulting rows.
|
DEV-660475 |
|
In some cases, users receive an error when setting a reference leaf on a draft Content Plan Item.
|
DEV-661680 |
|
In some cases, when a user has EDL Items with identical POL and matched documents, then quickly unmatches and matches a new document to one of the EDL Items, the published document ID may be reused incorrectly.
|
DEV-661891 |
|
In some cases, submissions took longer than expected to begin publishing.
|
DEV-661893 |
|
In some cases, the Index.xml is not publishing as expected.
|
DEV-661934 |
|
In some cases, the Vault link annotation to permalink does not work after updating the published output location.
|
DEV-662131 |
|
In some cases, Vault incorrectly reports US 1737.
|
DEV-662149 |
|
When the Enable Application Relationships setting is enabled, users cannot edit the Use for Registrations field on Regulatory and Submission relationship records.
|
DEV-662307 |
|
When users search for records with special characters, the Submission Wizard does not highlight the search term.
|
DEV-662827 |
|
In some cases, Vault incorrectly reports US 1789.
|
DEV-663716 |
|
In the Create Relate Record and bundling wizards, the creation of target join records for Application, Submission, or Regulatory Objective may fail if their corresponding source records have text fields with values containing special characters, such as \ " ' ( ) * %.
|
DEV-663872 |
|
In some cases, the Create Related Records wizard creates records but does not include them in the results CSV file.
|
DEV-664284 |
|
When a user attempts to clear the picklist field value on the Registration or Registered Join pop-up on the Edit & Verify page, the page may go blank.
|
DEV-664983 |
|
In some cases, the continuous publishing event is not triggered when the document is matched to the Content Plan Item.
|
DEV-665570 |
|
When the target document is upversioned with RFP=No, the broken link resolution doesn't work correctly.
|
DEV-666584 |
|
Users attempting to reimport a Submission from the same Application receive an error if the Application references an earlier version of the same document.
|
DEV-667080 |
|
In some cases, email notifications are not sent for submissions.
|
DEV-667340 |
|
When using the {samefolder}, links to the target are not working correctly.
|
DEV-667341 |
|
When an embedded permalink is linked to a target that is part of a merged document, the link status is validated against the source document instead of the merged document, and Vault incorrectly reports 5202.
|
DEV-668753 |
|
When a user inline edits a rich text field to add a space, the Content Plan Viewer displays the HTML entity for non-breaking spaces.
|
DEV-669258 |
|
When a user adds or removes columns in the Content Plan Viewer, previously-hidden matched documents are duplicated in the viewer.
|
DEV-669357 |
|
Some users may experience an error on renditions when PDF Standardization is enabled.
|
DEV-669492 |
|
In some cases, the empty section indicator is shown when sub join filter is applied.
|
DEV-671259 |
|
In some cases, Vault incorrectly reports EU 16.BP7.
|
DEV-671403 |
|
The 'publishing_metadata__v' field fails to deploy as a standard source type.
|
DEV-671664 |
|
When a document becomes ineligible for matching (e.g., it is up-versioned) while match document mode is active, then a user attempts to match it, Vault displays the incorrect error banner.
|
DEV-672397 |
|
In some cases, Vault does not synchronize the Submission Import Status and Dossier Status fields on Submissions imported via Vault File Manager, preventing subsequent import attempts.
|
DEV-672694 |
|
Users assigned to a security profile with one of the following permission sets may not be able to add filters in match document mode: Submission Content Planning - Contributor, Submission Planning and Tracking - Contributor, Document User - Read.
|
DEV-674466 |
|
In some cases, users receive an error when using drag and drop in the Active Dossier editor if they don’t have permission to the Event and Activity object.
|
DEV-675036 |
|
When non-Vault owners use report level content plan publish and merge functionality with a Default Overlay, they receive the error message "PDF merge process encountered an error creating the merged PDF. You do not have sufficient permissions for the Merged PDF Document Number field on the Report Level Content Plan object".
|
DEV-675097 |
|
In some cases, the UDI data generation algorithm does not separately assess certain values on related Regulatory Objective and Registered Nomenclature Code records.
|
DEV-675345 |
|
During Activity bundling, users without Create permission for the Submission Authorization and Regulatory Objective Authorization objects receive misleading warnings and errors in the CSV results file, even if those objects were not selected for bundling.
|
DEV-675359 |
|
When a user updates the expected steady state, the EDL item does not update.
|
DEV-676090 |
|
When a document becomes ineligible for matching (e.g., it is up-versioned), then a user attempts to match it via drag and drop, Vault displays the incorrect error banner.
|
DEV-676877 |
|
In some cases, users receive a header validation error.
|
DEV-678311 |
|
In some cases, users receive an error when using special characters in the application folder name.
|
DEV-678439 |
|
When processing regional XML for related Submission records, Vault extracts the Application Contains Files value from the base related Submission instead of the current Submission.
|
DEV-679320 |
|
When a document becomes ineligible for matching (e.g., it is up-versioned), then a user attempts to reorder it via drag and drop, Vault displays the incorrect error banner.
|
DEV-679324 |
|
When a document becomes ineligible for matching (e.g., it is up-versioned) while match document mode is active, then a user attempts to unmatch it, Vault does not allow unmatching and displays the incorrect error banner.
|
DEV-679329 |
|
When users add text over the 500-character limit to a rich text field in the Content Plan Viewer, the resulting error message overlaps with the cell below it and is not easily readable.
|
DEV-680388 |
|
When a Submission relationship object is not configured to use object types, users without Create permission for that object are able to create records using the bundling wizard.
|
DEV-680841 |
|
Incorrect Registered Clinical Study records may be created through the Create Bulk Registrations wizard when the Registration scope is any of the Marketed Scopes.
|
DEV-680852 |
|
When EU Rules 11.10 and 11.BP2 fail for different section XML attributes, the corresponding validation error message does not include the attributes.
|
DEV-681652 |
|
In some cases, Vault incorrectly reports EU 16BP.4.
|
DEV-681897 |
|
After publishing, the cross reference leaf of section 1.3.1 does not appear in the archive viewer.
|
DEV-682775 |
|
Users can receive an error when attempting to replace a reference leaf within Set Leaf Operation where the target leaf has a valid lifecycle view.
|
DEV-682833 |
|
Vault does not continuously publish Content Plan Item records if a user manually creates the record while the content plan is in a non-Draft state.
|
DEV-683900 |
|
Vault displays two warning headings in the submission export result file.
|
DEV-684535 |
|
When managing Submission Administrative Information, users with a slower network connection are able to click Save multiple times, sometimes resulting in duplicate records.
|
DEV-685651 |
|
When merging Report Level Content Plans, Vault populates the System user instead of the Published Content Owner or Initiator as the document Owner.
|
DEV-686530 |
|
Users without permissions for the Metadata API object cannot create and manage Event details in bulk.
|
DEV-686647 |
|
Imports to Submissions Archive Viewer with 30 or more form-type sections that use the same country code value may fail.
|
DEV-689771 |
|
When an object lifecycle state change fails for a record which was not edited in the Manage Registered Details wizard, Vault does not include the result in the CSV file.
|
DEV-691336 |
|
When selecting verification workflow participants in the Manage Registered Details wizard, the drop-down search is case-sensitive for verification groups (user groups).
|
DEV-691765 |
|
Vault creates duplicate records during bundling and splitting when the Use for Registrations field on Regulatory Objective relationship records is populated.
|
DEV-695168 |
|
When a user attempts to clear any date field in the MRD Wizard, the Wizard screen also clears the Registration record being updated in the Registration Details Tab.
|
DEV-696770 |
| Description |
Issue No. |
|
When a suspect Product includes multiple Product Dosage records and Batch/Lot Numbers, only the first Batch/Lot Number is included on CIOMS I and FDA MedWatch 3500A forms.
|
SAF-45985 |
|
When promoting an Inbox Item with an Open Label Study Arm Product within a blinded Study, the Product (Reported) field on the Case is not populated for the Open Label Study Product.
|
SAF-46882 |
|
When deleting Product Dosage and Indication records from Domestic Cases, users receive an incorrect error message that their unsaved changes will be lost even when the changes have been previously saved.
|
SAF-48420 |
|
Strength + Unit values that include a forward slash (/) do not appear correctly in the Product Coding browser.
|
SAF-48499 |
|
On newly created Vaults, MedDRA dictionary version 26.0 is not available.
|
SAF-48767 |
|
On Follow-up Cases created from Inbox Items, Case Relatedness field values are missing.
|
SAF-48776 |
|
When importing an E2B(R2) file for a blinded Study, if no match is found for the Study Product, Study Product masking is set to blank instead of Blinded.
|
SAF-48878 |
|
Manual Correspondence records are not generated for Follow-up Rule and Watchlist questionnaire templates on certain Cases even when the Reporter Country matches the Country field on the configured template.
|
SAF-49024 |
|
When an Inbox Item Products section includes unsaved changes, if Study Products are added through the Specify Study Product dialog, the unsaved changes are cleared.
|
SAF-49739 |
|
In Vaults with a default value configured for the Blinded field on Study records, when a different value is entered when adding a record, the system applies the default value upon record creation.
|
SAF-49782 |
|
In some cases, the Vault Section field on Validation Results does not contain a hyperlink to the affected record.
|
SAF-49802 |
|
When Follow-up Cases that are reportable to the PMDA do not have Localized Case Assessments, the system prevents Case voiding.
|
SAF-49855, SAF-50468 |
|
After importing an E2B(R3) file, the system-generated CSV rendition is missing information in the Assessment Results section.
|
SAF-49958 |
|
When bulk unblinding Cases under a Study, Imported Cases are not included.
|
SAF-50172 |
|
When using an AS2 Connection with certain certificates, E2B files are not successfully received in Vault Safety.
|
SAF-50267 |
|
When multiple languages are enabled in the MedDRA dictionary, the incorrect language sometimes appears in the hovercard of MedDRA fields for Cases with non-English Localization.
|
SAF-50268 |
|
When the Localization value is defined, the Comments field on Case Medical History records and the Comments and Result (Text) fields on Case Test Result records are cleared upon saving.
|
SAF-50288 |
|
When generated from a Child Rule Set, Safety Rule Set Configuration reports do not include Rule Set Parameters for inherited Child Rules.
|
SAF-50349 |
|
In some instances, system performance is slower than expected when generating CSV renditions of imported E2B files, blocking subsequent E2B intake.
|
SAF-50360 |
|
In some instances, merging Inbox Items to In-flight Cases is prevented and this error message appears: "Case creation is already in progress. Please wait for it to complete."
|
SAF-50474 |
|
If a migrated Case does not include an Organization value and then is updated manually to include an Organization, during Case promotion, Cases with a UID that match the migrated Case are not returned as a likely match.
|
SAF-50482 |
|
When saving an Inbox Item created from an email source, users receive an error message stating that they must select a Study Product even when one is already selected.
|
SAF-50500 |
|
When Strict Case Locking is enabled on a Case, users cannot create a Child Information Case from it even if the Case is locked to them.
|
SAF-50525 |
|
The G.k.2.3.r.1 (Substance / Specified Substance Name) Validation Criteria for the PMDA fails for Cases with Device Products that are not expected to have substances.
|
SAF-50538 |
|
For Localized Cases, E2B(R3) generation fails when a localized narrative document template does not exist.
|
SAF-50612 |
|
Group Rows By selections are not applied to Excel files generated from documents with the PSMF Generated Report document classification.
|
SAF-50671 |
|
When the Mask Reporter for PM Non-Literature Case setting is enabled, FDA VAERS E2B(R3) reports with the Reporter Country set to USA end up in the Validation Error state.
|
SAF-50674 |
|
The J2.15.r (Country of publication) and J2.17.r (Classification of trial/research) values of a PMDA E2B(R3) file are not exported when the Retransmit field is set to No or Literature Documents are set to be excluded from the Transmission.
|
SAF-50676 |
|
When creating a Follow-up Study Case with no change to Relatedness from the initial Case, in some instances the Case Tag is incorrectly updated.
|
SAF-50805 |
|
When creating an aggregate report, if the Aggregate Report Template field is left blank, tasks are created for all aggregate report templates.
|
SAF-50823 |
|
When users configured with a Case Access Group Override create Follow-up Cases, the system doesn't assign the expected Case Access Group.
|
SAF-50840 |
|
When exporting custom E2B formats, the system runs Case-level validations for the custom format but not for the standard format that is the basis for the custom format.
|
SAF-50989 |
|
When a Transmission from an earlier Case version includes an inactive user in the Sender (User) field, newer Case versions cannot be approved.
|
SAF-51006 |
|
After upgrading the MedDRA dictionary to the latest version, Business Admins are unable to update the Active MedDRA Version field to the latest version.
|
SAF-51034 |
|
On PMDA E2B(R3) reports, the D.7.3 Concomitant Therapies data element is set to False when the Concomitant Therapies field is set to No on the Case, resulting in Negative Acknowledgement (NACK) messages because True is the only accepted value for this data element.
|
SAF-51374 |
|
When importing custom E2B file formats, the G.k.4.r.10.1 Route of Administration (free text) data element is not mapped to the Patient RoA Text field on the Case Product Dosage.
|
SAF-51476 |
|
E2B import fails if the file includes a data element with more than 1,500 characters and the Case is Localized.
|
SAF-51519 |
|
For JSON-imported Cases, Vault does not validate the date fields for the Medical Drug History object.
|
SAF-51617 |
|
In some instances, system performance is slower than expected when generating PSMF PDFs.
|
SAF-51658 |
|
The C.1.9.1 Other Case Identifiers in Previous Transmissions data element is populated as True when there are no E2B-transmittable Case Identifier objects associated with the Case, resulting in Negative Acknowledgement (NACK) messages.
|
SAF-51661 |
|
When creating Follow-up Cases through a user action, in some instances, multiple versions of the same Case appear in the Interval Line Listings of Serious Adverse Reactions (from Clinical Trials) for PBRERs.
|
SAF-51727 |
|
On E2B(R2) reports, the A.1.11 Other Case Identifiers in Previous Transmissions data element is populated as True when the Case includes only non-transmittable Case Identifiers.
|
SAF-51737 |
|
When importing Cases through Safety Inbox Loader, the Action Taken field on Case Products is not populated.
|
SAF-51739 |
|
In Vaults licensed for only Vault SafetyDocs, the Auto-Translation Framework cannot be configured.
|
SAF-51922 |
|
When importing multi-Case CSV files through the Safety Inbox Loader and using automated Case promotion, some Inbox Items are left in a Processing state.
|
SAF-51928 |
|
Combination Product device constituents are exported to CIOMS I forms.
|
SAF-51938 |
|
On foreign Localized Cases, when a new version of the Narrative document is uploaded, the content in the Narrative Preview does not update.
|
SAF-51988 |
|
For Vaults without PT Aggregation enabled, when generating a PBRER, the Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources counts the same Adverse Event multiple times, once for each Product on a Case, instead of counting each Adverse Event only once.
|
SAF-52034 |
|
In Vaults with strict Case Locking enabled and some Case Unlocking workflow configurations, when a Study Case Product is unblinded and the related blinded Study includes Study Arms, the Case Product lifecycle does not transition from Unblinding to Unblinded.
|
SAF-52035 |
|
The system imports E2B files without Case Identifier names to Inbox Items, resulting in errors during Case promotion.
|
SAF-52055 |
|
After updating the Origin value on an Inbox Item Inbound Transmission record and then running the Calculate Inbox Item Access Group action, Vault does not recalculate the Case Access Group on the Inbound Transmission.
|
SAF-52099 |
|
Watchlist questionnaires are not generated for matching MedDRA Preferred Terms (PTs).
|
SAF-52124 |
|
For domestic Cases, the system prevents creating Follow-up Cases or merging to In-flight Cases from the Case Compare page in Vaults with a configured entry action that moves Narrative documents to the In Review state .
|
SAF-52154 |
|
If Dose information is blank on both a Case Product and the associated Product Registration record, when running the Retrieve Reportable Case Product Registrations action, the system does not prioritize the Product Registration designated as the Default Registration.
|
SAF-52164 |
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When a Localized Case does not have a Narrative document, Vault Safety prevents completion of the Revision / Follow-up task on Domestic Cases.
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SAF-52175 |
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When an Inbox Item has more than 500 Assessments, the system prevents merge to In-flight Case and promote to Follow-up Case.
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SAF-52180 |
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If Smart MedDRA Coding is enabled, in rare cases, importing a high volume of Inbox Items causes the "Number of Requests in Current Month" counter on the MedDRA Coding Settings record to lock and the associated files to enter the Import Error state.
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SAF-52189 |
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When merging an Inbox Item into an In-flight Case through the Case Compare page, custom records from the matched Case are duplicated.
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SAF-52233 |
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When a Follow-up Case is created for a Japanese Localized Case, Vault does not generate the expected Localized Case Assessment Result records.
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SAF-52259 |
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When Localization is added to a Case that was initially promoted as Global, the system prevents Follow-up Case creation from a Localized Inbox Item.
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SAF-52271 |
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If an Adverse Event is deleted immediately after it is added to a Case, in some instances, related Case Assessment Results cannot be edited or deleted.
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SAF-52274 |
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When a Localized Case Assessment Event (LLT) is blank, Case Product Registrations cannot be created or updated.
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SAF-52310 |
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After creating a Follow-up Case for a Clinical Trial Case for a blinded Study, the lifecycle state of open-label Case Products updates to Blinded.
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SAF-52311 |
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During import of custom E2B formats using SDK, in some instances, Assessment Results are not created for Follow-up Cases.
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SAF-52433 |
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When merging an Inbox Item with a Reporter Country value to an In-flight Case with no Reporter Country value, the Case-level Reporter Country field is not updated.
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SAF-52444 |
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When importing an E2B file, when matching Study Products, the Company Product field is left blank if the Study Product Registration is not mapped.
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SAF-52477 |
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In rare cases, when importing an E2B file during intake, the system displays a "Message cannot be parsed" error message.
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SAF-52523 |
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During E2B import, custom E2B tags mapped using SDK are not imported to the Case Assessment Result object.
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SAF-52613 |
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After merging an Inbox Item to an In-flight Japan Domestic Case, Vault does not generate Localized Case Assessments for new Adverse Events from the Inbox Item.
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SAF-52774 |
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When sending an ACK2 message from an AS2 Connection, the system sends the original E2B back to the destination.
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SAF-52928 |
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When a Product is added to a Case and Assessments are generated, although Case-level Expectedness is auto-calculated, Vault Safety sets the Expected (Status) field to Overridden.
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SAF-53111 |
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When Inbox Items with blinded Products are merged to In-flight Cases or promoted to Follow-up Cases through the Case Compare page, if the matched Case is unblinded, the Case-level Product field is set to the primary Case Product.
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SAF-53191 |
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When generating PMDA E2B(R3) files for Cases with Combination Products that include a Device constituent, the Device is exported to the G.k Drug(s) Information section of the report.
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SAF-53401 |
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If two (2) Country records are set up with the same 2-letter code and one (1) record is inactive, during E2B import, the Reporter's Country Code is not mapped to the active record.
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SAF-53449 |
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When E2B(R3) ACKs are generated on the Inbound Transmission record, Vault maps the ACK.B.r.3 ICSR Message ACK Receiver data element to the Destination ID field and the ACK.B.r.4 ICSR Message ACK Sender data element to the Origin ID field, instead of the reverse.
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SAF-53624 |
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When a Localized Transmission does not include a destination, after running the Evaluate Regulatory Conformance action, the Validation Status on the Case is set to Error.
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SAF-53651 |
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When a non-migration user creates Case Assessments through Vault Loader, Vault Safety generates duplicate Case Assessment Results.
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SAF-53702 |
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When promoting an Inbox Item with a blank Product (Reported) field, Vault maps the Blinded Name (Placeholder) field value, if it exists, from the Inbox Item to the Product (Reported) field on the Case.
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SAF-53810 |
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When evaluating regulatory conformance on PMDA E2B(R3) reports, Validation Criteria PMDA.D.9.4.r.1b-2 fails when the Cause of Death type is "Reported Cause of Death" and the Autopsy field is set to "No".
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SAF-53872 |
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During import of custom E2B formats using SDK, some Parent Information is not imported.
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SAF-53882 |
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After importing Inbox Items with custom E2B file format and promoting to Case, Vault designates Patient-type Case Contacts as Base-type Case Contacts.
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SAF-53899 |
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When generating FDA MedWatch 3500A forms, Vault maps Company Product type products registered as a device in the country of its destination to section C. Suspect Products, instead of D. Suspect Medical Device and H. Device Manufacturers Only.
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SAF-54000 |
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After Gateway or manual E2B import, Case Access Groups are not populated on Inbound Transmissions.
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SAF-54132 |
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When exporting PMDA E2B(R3) reports, Vault Safety does not correctly validate nullFlavors in the following data elements: D.7.1.r.3 Continuing, D.7.1.r.4 End Date, D.9.1 Date of Death, D.9.3 Was Autopsy Done?, F.r.1 Test Date.
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SAF-54179 |
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When a Custom MedDRA Query (CMQ) uses the same name as a Standard MedDRA Query (SMQ) and the Import SMQ action is run, in some instances, terms are duplicated.
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SAF-54185 |
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For Localized Cases, when Local Case Processors code External Products with the JDrug Browser, the manufacturer and Local MPID details remain blank and the record cannot be saved.
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SAF-54363 |
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During import of custom E2B formats using SDK, some Case Product Dosage information is not imported.
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SAF-54560 |
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When exporting PMDA E2B(R3) reports, the D.8.r.2a and b and D.8.r.3a and b data elements are populated when the PMDA Reporting Category is "AA", "AB", "DA", or "DB".
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SAF-54609 |
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When generating PBRERs that include Cases with Study Products that have some blank Product (Coded) fields, the Cumulative Tabulation of Serious Adverse Events (from Clinical Trials) report enters an Error state.
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SAF-54736 |
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Inbox items cannot be created through the Intake JSON API if the resolved_idate_v field is blank.
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SAF-55080 |
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When reporting to the PMDA for a Case where the Product being evaluated is a component of a Combination Product, the Registration Type reporting rule parameter evaluates the registration of the Combination Product instead of a Constituent Product, and the rule fails.
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SAF-55097 |
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When the Suppress File Generation reporting rule parameter is set to Yes, after running the Evaluate Reporting Obligations action, in some instances Transmission Creation Messages are appended to the incorrect Transmission.
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SAF-55303 |
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When a Localized Case includes a Special Adverse Event of the Non-reportable Event type that is linked to a Case Assessment with a Reaction Recurrence, Vault Safety exports an invalid PMDA E2B(R3) file.
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SAF-55442 |
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When a Case Medical History record does not have a start or end date and the Continuing field is set to Yes, after running the Evaluate Regulatory Conformance action, validation fails for rule PMDA.D.7.1.r.3-2.
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SAF-55443 |
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After setting a Transmission to the Ready for Submission state, the AS2 Connection to a Health Authority or Partner does not send the file.
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SAF-55736 |
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When the Suppress File Generation reporting rules parameter is set to Yes, after running the Async Submit to Gateway action on Cases that should receive validation errors, in some instances, Transmissions are generated and remain in the Sending ICSR state.
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SAF-56033 |
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After importing Inbox Items through the Safety Inbox Loader, if the text is not an exact match, the Highlighted Term field is blank although Import Code Mapping exists for the Controlled Vocabulary type and for the Case Adverse Event object.
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SAF-56131 |
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During high-volume activity in a Vault, in some instances, Product Registration records cannot be created or edited.
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SAF-56194, SAF-56972 |
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When Submission files are greater than 5 MB, the AS2 Connection does not send the file.
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SAF-56606 |
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When evaluating reporting rules on a Case that is reportable to Japan through a cross-reportable product, the due date calculation fails.
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SAF-58034 |