The following applications may have different release dates: RegulatoryOne, Safety, and Veeva Claims.
| Description |
Issue No. |
|
Vault does not show the relevant Study Sites when a user runs Send Site Packages from a Country.
|
DEV-793388* |
|
The inbound job on the Clinical Operations Vault fails for new Studies.
|
DEV-794285* |
|
An error occurs when a user attempts to enable the Enable Self-Evident Corrections feature flag.
|
DEV-799669* |
|
In some cases, CDX creates excessive API calls.
|
DEV-800106 |
|
An unexpected error occurs when a user deselects a Study Site when creating Study Site records from the Milestone Study Site application section.
|
DEV-800260* |
|
When new or updated Visit Definitions and Visit Group Definitions are transferred, Vault updates the Last Run Time and Last Successful Run Time fields for the original Visit Definitions and Visit Group Definitions despite active IPEs.
|
DEV-800508* |
|
In some cases, an error occurs when the Create Milestones from Template job runs.
|
DEV-800525* |
|
The Resend Safety Distribution Emails to Recipients job fails to send to newly active Site Users.
|
DEV-800631* |
|
When users create an Agreement in CTMS or TMF, Vault may fail to set boolean fields to their default value after users toggle the Scheduled Transfer option (in CTMS) or the Include TMF Documents option (in TMF).
|
DEV-800633* |
|
The Document Fields for the default Self-Evident Corrections Quality Issue Types are incorrect.
|
DEV-800634* |
|
Vault displays both active and inactive Milestones in Subject Group Milestone schedules.
|
DEV-800647* |
|
The Subject integration's Last Successful Run Time field does not update for all connected Studies when the inbound and outbound jobs run successfully.
|
DEV-800661* |
|
Users are unable to create Milestones from the Planning tab.
|
DEV-801598* |
|
An error occurs when users add entry criteria to the Study Person object lifecycle with the Enable Sync PI Field with Study Person feature enabled.
|
DEV-803082 |
|
States on Study Site Addresses show as null when not populated.
|
DEV-803134* |
|
In some cases, reclassified target TMF documents do not update when users update the source document and run the Transfer action.
|
DEV-803413* |
|
When Vault Loader updates the Site Connect User field to True, Vault fails to send the VeevaId invitation email to Study Personnel.
|
DEV-803716* |
|
Vault displays a duplicate error when a Study Site with the same name as the previous name of a renamed Study Site which causes an error with a unique field on Study Person due to the Principal Investigator syncing feature.
|
DEV-806404 |
|
In some cases, Vault generates duplicate Payable Items for Procedure Fees for multiple Subjects.
|
DEV-808202* |
|
Statuses on Distribution Tasks with multiple Studies fail to update for all relevant Study Sites.
|
DEV-808325* |
|
Under certain circumstances, no Document Check records are created for Site Document Checks during document reconciliation.
|
DEV-812187* |
|
When a user adds a new Study Person to a Site and runs the Resend action on a Provide Original Distribution Tasks, Vault fails to send the Distribution Task to the new Study Person.
|
DEV-812271* |
|
Under certain circumstances, the Fail Stuck Distribution Tasks job may fail.
|
DEV-813459 |
|
When the Subartifacts feature is enabled, an error occurs when users create documents with classifications containing quotes and Vault searches for subartifacts.
|
DEV-814223 |
|
Site Connect PAL (Public Access Link) records are kept active for two years, well beyond their functional use. PAL records now are only active for one year.
|
DEV-816637* |
| Description |
Issue No. |
|
An incorrect error message is displayed when creating a document from a template using a deleted Document Type
|
DEV-700603* |
|
In some cases, users can use the Create Draft action on a CrossLink document even if the action is expected to fail.
|
DEV-753213* |
|
In some cases, interactive elements within a PDF rendition are not rendered successfully.
|
DEV-758973 |
|
In some cases, the formatting may be incorrect on viewable renditions with eSignature fields.
|
DEV-764583* |
|
When a PDF/A document is uploaded with an overlay or signature, the rendition status is stuck rendering.
|
DEV-773932 |
|
The document audit trail may display inconsistencies in user and group IDs when editing or deleting configuration components, such as security overrides for document fields.
|
DEV-781375 |
|
Under certain circumstances, users receive a server error while attempting to view the Related CrossLinks section on an archived CrossLink document.
|
DEV-781414* |
|
In certain circumstances, an error is displayed when creating a draft from a CrossLink document.
|
DEV-786535 |
|
In some cases, the row limit warning message lists the incorrect value for the total number of rows.
|
DEV-787721* |
|
Under certain circumstances, download request timeouts may take longer than expected.
|
DEV-788716* |
|
In some cases, the relationship depth warning message lists the incorrect depth value.
|
DEV-789985* |
|
When multiple users apply annotation filters to a document and use the PDF with Annotations or Export Annotations action, the file downloaded by one user may use the filters selected by the other user.
|
DEV-791120* |
|
A server error may be displayed when classifying a document created from a template and the user does not have the appropriate permissions for the selected classification.
|
DEV-792399 |
|
In some circumstances, an extra error message is displayed when attempting to check in a document checked out by another user.
|
DEV-795590* |
|
In some cases, the Content Processing Viewable Status may incorrectly show as Successful for a read password protected document.
|
DEV-796142* |
|
When a user opens a checked out Collaborative Authoring document in two tabs and checks the document back into Vault in one of the tabs, an incorrect error message is displayed on the second tab when attempting the Save to Vault action.
|
DEV-796992* |
|
In some cases, Vault Displays Bookmarks for Tables/Figures incorrectly when Generate "List of ..." setting is enabled.
|
DEV-797016 |
|
In some cases, the warning dialog fails to disappear when a user re-renders a document.
|
DEV-797098* |
|
When a rendition request is initiated due to a document field update for Merge Fields, the Content Processing status is not set to In Progress.
|
DEV-797102* |
|
In some cases, the Fast Web View property of a PDF file may switch from Yes to No when uploaded to Vault.
|
DEV-797925 |
|
In some cases, the query for finding the earliest date in in a rendition status for admins page returns an error if there is no data in the table.
|
DEV-799369* |
|
In some cases, the table of contents for a document may show incorrect page numbers in downloaded renditions only.
|
DEV-799384 |
|
In some cases, the Document Readiness panel Content Processing section shows ellipses in place of the expected information.
|
DEV-799506* |
|
Under certain circumstances, users may encounter an error when attempting to Download Controlled Copy.
|
DEV-799542 |
|
In some cases, users encounter an error when attempting to convert a document to a PDF/A compliant viewable rendition.|
|
DEV-801069 |
|
When sending a request to PDFServer for a final word document, e-signatures become invalidated on multiple documents.
|
DEV-803662 |
|
Cross-Domain users are unable to link file staging servers across domains.
|
DEV-804974 |
|
Under certain circumstances, attempting to zoom in on a document in the Document Viewer may shift the document to the right instead of focusing on the document's center.
|
DEV-805816 |
|
When flattening XFA using PDFServer, Pre-processing does not correctly translate form into template and dataset.
|
DEV-806477* |
|
In some cases, users encounter a null point exception when using XFA Rendering to linearize PDFs after flattening.
|
DEV-806656* |
|
In some cases, users experience slowness in Narrative rendition when the max transient retry limit is reached.
|
DEV-806937 |
|
In some circumstances, Vault sends a notification that the Collaborative Authoring cancel checkout entry action was completed successfully even when the document is not checked out.
|
DEV-808714 |
|
Users may receive a server error while selecting a Source Binding Rule on a CrossLink if their permissions on source document versions is removed.
|
DEV-810493* |
|
In some cases, Vault displays '.' as a Bound Source Version option after users select a Source Binding Rule on a CrossLink.
|
DEV-810494* |
|
An user inactivated in the CrossLink document target Vault may be able to see information on the Related CrossLink hovercard for the document in the source Vault.
|
DEV-812386* |
|
In rare cases, Vault may fail to move a Claim record to the Draft state after a user removes the last reference.
|
DEV-813587* |
|
In the Related Crosslink section of a source document, the link in a CrossLink hovercard redirects to an incorrect CrossLink.
|
DEV-814662* |
|
In the Related Crosslink section of a source document, the link in a CrossLink hovercard redirects to an incorrect CrossLink.
|
DEV-814662* |
|
The help labels in the Create Overlay template & Create Signature Page Template display the wrong text and improper links.|
|
DEV-814785* |
|
When updating the binding rule of a CrossLink, the CrossLink information does not always resync immediately.
|
DEV-816775* |
|
When updating the binding rule of a CrossLink, the CrossLink information does not always resync immediately.
|
DEV-816775* |
|
In some cases, PDF/A fails when applying enhanced overlays or e-signatures with document logos.
|
DEV-817639* |
|
In some cases during XFA Flattening, checkbox checks are offset.
|
DEV-818898* |
|
Under certain conditions, annotation creation via REST API takes longer than expected.
|
DEV-818906* |
|
Users may receive an error when attempting to render STF XML as part of a submission.
|
DEV-820289* |
| Description |
Issue No. |
|
Vault may fail to audit updates to an object records initiated by a Vault Java SDK record trigger.
|
DEV-571741* |
|
The Retrieve Object Record User Actions API returns Object Actions in an arbitrary order rather than by label.
|
DEV-621382* |
|
In some cases, Vault Loader fails when performing updates on objects with non-default object types.
|
DEV-756181 |
|
In some cases, users can create or update Roll-up fields through MDL commands with invalid filter criteria values.
|
DEV-783325* |
|
Users may encounter an error when attempting to add a parent object reference field to a raw object through a VPK deployment.
|
DEV-785447* |
|
In some cases, users are able to update invalid Roll-up fields using MDL commands.
|
DEV-785597* |
|
In some cases, Vault may display the incorrect error message when a format mask is used on a raw object.
|
DEV-793146* |
|
Under some circumstances, Vault may fail to render files uploaded to Attachment fields.
|
DEV-796432* |
|
If the object type changes on a parent object, any Roll-up fields on the new object type are not calculated.
|
DEV-797032* |
|
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* |
|
In some cases, object reference field values controlled by picklists fail to show up in the Bulk Edit Records Field page.
|
DEV-799441* |
|
When performing a bulk edit on an object record's picklist field, the picklist values may trail off the screen when confirming changes.
|
DEV-802867* |
|
If some records fail and others succeed during an Upsert action in Vault Loader, the failure log may report that all records failed.
|
DEV-803137 |
|
Users may encounter a server error when saving a dependent picklist value with a null controlling value.
|
DEV-803372* |
|
When users click Recalculate Roll-up Field, they may not receive a Vault notification when the recalculation is complete.
|
DEV-803866* |
|
Under certain circumstances, ampersands may display incorrectly in document grid search results.
|
DEV-805448 |
|
Under certain circumstances, the system fails to respect layout profiles as expected.
|
DEV-806702* |
|
Users may encounter a server error when creating or updating an object in a cloned Vault.
|
DEV-807626 |
|
When trying to run a report involving a lookup field on a high volume object with an object reference field as its source field, users may receive a server error.
|
DEV-809350 |
|
In a Layout Profile, when configuring a page layout for a non-Base object type, if the user selects a page layout associated to the Base object type, the PageLayoutService does not return the page layouts assigned to the object type.
|
DEV-809677* |
|
Under certain circumstances, picklist overrides are reversed after making the picklist values active.
|
DEV-810022* |
|
Under certain circumstances, users receive an error when attempting to create a page layout without a controlling field present.
|
DEV-815097 |
| Description |
Issue No. |
|
The drop-down of the Create button in the Requirement Entity Version section floats when you scroll the Entity Version record detail page up and down.
|
DEV-785538* |
|
The correct error message is not displayed when you attempt to save a comment.
|
DEV-786860* |
|
You cannot clear the selected prompt when editing a Dry Run step comment.
|
DEV-786875* |
|
When users are creating a comment in the Dry Run interface, the Save button is reenabled incorrectly if users complete the required fields, click Cancel, select a category, and leave the description blank.
|
DEV-789045* |
|
The Test Authoring UI displays a blank page when you switch from the Requirements Burndown View to the navigation panel.
|
DEV-789630* |
|
A server error can occur when you create an Inspection Request record and Dynamic Access Control is turned off for the Inspection Request object.
|
DEV-789705* |
|
The Prompt field value for the Result label is not updated when users select a Result label on a Dry Run record.
|
DEV-795811* |
|
The Rich Text Editor icon overlaps the scrollbar on the comment panel when you enter a longer comment.
|
DEV-795817* |
|
When you execute the Generate Merged PDF action on a Periodic Report record, the version number on the final report can be incorrectly reset to 0.1 after you execute the action multiple times successfully.
|
DEV-796453* |
|
An unknown error occurs when you create a Quality Team with legacy attributes or a mix of legacy and new attributes.
|
DEV-798095* |
|
A server error occurs when you create or edit a Quality Team Role that has an Application Role value that is the same as the Membership Constraint value.
|
DEV-798368* |
|
An error occurs when you update a Deviation record that triggers a custom Reason for Change record.
|
DEV-798505* |
|
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 an Inspection Request record is in the Published state, Inspectors may not be able to access some of the related records through the configured Related Object sections.
|
DEV-800201* |
|
A server error occurs when you execute the Create Record from Template action on a template that does not have Periodic Report Item records.
|
DEV-800399* |
|
Some object-level permissions in the Inspector Permission Set do not have standard object types or the Object Types Enabled checkbox selected.
|
DEV-800767* |
|
A Page Not Found error can occur when you attempt to open a Test Protocol in the In QA Approval state from the list view.
|
DEV-801944* |
|
Vault may fail to display values for custom Rich Text fields on class schedule records.
|
DEV-802525* |
|
When you execute the Generate Merged PDF action on a Periodic Report record, Vault QMS can incorrectly display a No Viewable Renditions error for documents with multiple renditions available.
|
DEV-802717* |
|
An UnsupportedOperationException Java error occurs instead of a standard error message displaying when a Lab Investigation cannot be created in Vault QMS.
|
DEV-803133* |
|
Users are redirected to the application page after editing a Test Protocol or Test Script from the list view or related object section. Users should remain on the object record detail page after editing a Test Protocol or Test Script.
|
DEV-803697* |
|
When you assign an owner to a Batch Disposition on the Batch Release Execution page, the Owner field is updated for all Batch Disposition Checks rather than being updated for the specifically selected Batch Disposition Check.
|
DEV-804244 |
|
When the Study Training to Clinical Operations Vault Connection fails to create Training Requirements in certain cases, Vault produces a generic error message instead of a User Exception Message for troubleshooting.
|
DEV-806970 |
|
In some cases, mobile users may finish an e-learning training course, but still find that the Complete Training button is greyed out.
|
DEV-808716* |
|
Entry actions on a parent record in its start state are causing the ActionStepProcessingJob to be executed twice, which causes a duplicate workflow for one change action.
|
DEV-809341 |
|
An ID is displayed instead of the Action Path name for existing Change Action records.
|
DEV-809955 |
|
An unexpected error can occur when you attempt to update the Material (quality_material__v) object via the Vault Loader or API because records are failing a unique ID check.
|
DEV-810895 |
|
Custom Yes/No fields in Risk Builder may not save a selected No value properly.
|
DEV-811755 |
|
Custom fields added to the Root Cause and Root Cause Analysis Item objects may be cleared instead of saved correctly.
|
DEV-816033 |
|
The Study Training to Clinical Operations Vault Connection does not transfer (from Clinical to Study Training) any Person records with the Manager field populated.
|
DEV-820077 |
| Description |
Issue No. |
|
When creating a multi-target link, if the first link is an internal link, the document relationships for subsequent targets are not saved.
|
DEV-695392* |
|
In some cases, Active Dossier Item Details fail to create for the same source document in multiple different content plan sections.
|
DEV-738459* |
|
The Content Plan Viewer supports the ability to Export Excel Tree with All Descendants, including Content Plans, Content Plan Items, matched documents, plus Submission, Application, and relationship record fields. Excel has a max limit of 32,767 characters per cell. If any of the included Rich Text field values exceeds this limit, the export fails.
|
DEV-757723* |
|
When 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* |
|
When a Content Plan Viewer user attempts to view a record which is already deleted in another browser tab, Vault displays a red error banner with a timestamp.
|
DEV-775664* |
|
When multiple fields are edited in the Edit Selections popup, blank values do not display on the submission cell.
|
DEV-776228* |
|
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* |
|
System-managed fields are not editable in the Active Dossier Editor popup after the Read/Edit for All Object Fields is disabled.
|
DEV-787091* |
|
The constraint message doesn't display in the Active Dossier Editor Edit popup Product Variant field when the Regulatory Objective doesn't contain product join and the constraint is still applied when the Regulatory Objective is blank.
|
DEV-788116* |
|
In some cases the ordering of folders is incorrect in a published binder and the regional xml is not rendered in the Submissions Archive veiwer.
|
DEV-788167* |
|
The Exclude Matched Documents checkbox is present even if the Content Plan template values are different between the source and target submissions and the user does not have view permission to Content Plan template field
|
DEV-791921* |
|
The binder is not up-versioned when the country value is added on the Expected Document List.
|
DEV-793339* |
|
The “Mark Activity Labeling Concepts as inactive during bundling” setting label should instead read as “...during splitting”, and the related Learn more link navigates to content on Splitting Regulatory Objectives (instead of Splitting Activities).
|
DEV-795591* |
|
Users may receive a false negative on Rule 4.7.1a.
|
DEV-798066* |
|
When creating Registrations in bulk, the Confirmation page displays a network issue error if the user previously selected a large number of detail records (2MB or approximately 500 records).
|
DEV-798244 |
|
Users may receive a false negative on US Rule 1442 and US Rule 1102.
|
DEV-798721 |
|
Vault incorrectly reports US Rules 1734, 1735, and 1736.
|
DEV-798935 |
|
Users do not receive an error message when multiple targets are replaced.
|
DEV-799521* |
|
When the global application and submission does not have a value for Region and Lead Market, the documents that are matched to Content Plan Items with different value for Region/Country are also dispatched.
|
DEV-800383* |
|
When the user does not have view permission to the Comparison Action field an error banner is displayed on the comparison viewer page.
|
DEV-800402* |
|
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* |
|
When an Active Dossier Item Detail is moved, the Active Substance token does not display in the Active Dossier Structure.
|
DEV-801055* |
|
In some cases, the Submissions Archive Delete Orphaned Files job does not delete placeholders.
|
DEV-801057 |
|
The Content Plan Viewer does not display the filter icon for Yes/No fields configured with the Show as checkbox option.
|
DEV-801084* |
|
When displaying a content plan dispatch comparison from a Dispatch Message, the resulting mini-browser window partially obscures the header with instructions and content plan details.
|
DEV-801213* |
|
Country records with null eCTD Country Codes cause publishing to fail.
|
DEV-802565* |
|
In some cases, the XML Element Name defaulting does not work properly.
|
DEV-802573 |
|
Users receive a red error banner and Page Not Found when opening the comparison viewer on the Submission only vault.
|
DEV-802856* |
|
Users may receive a false negative on ZA 3.5.4.
|
DEV-803079 |
|
Users may receive a false positive Report Level Content Plan publishing error.
|
DEV-803105 |
|
When system managed naming is disabled, Health Authority Questions and Health Authority Commitments cannot be created.
|
DEV-803394* |
|
In cases where users do not have the Ready For Publishing field set on document types contained in an RLCP publish, the RLCP has no published output.
|
DEV-803650 |
|
Users may receive a false positive on EU 11.2
|
DEV-804059 |
|
Users may receive a false positive on US Rule 1735.
|
DEV-804295 |
|
When Vault fails to load Application relationships, the resulting error files miscalculates the total number of record failures.
|
DEV-804299* |
|
When users search Content Plans in match documents mode, Vault excludes documents configured to use a Classification with apostrophes.
|
DEV-804388 |
|
When the Table of Contents has too many rows, the publishing status gets stuck at “In Progress.”
|
DEV-806438 |
|
When users drag and drop Report Level Content Plan sections with tokens, Vault copies records to the target RLCP with the Report Level Content Plan Clinical Study field empty, instead of producing an error.
|
DEV-807233* |
|
Link resolution is unnecessarily performed on all targets of a document that was up-versioned.
|
DEV-807568 |
|
"The Submissions Archive Viewer displays sections out of order for imported submissions where the index.xml contains blank values for excipients, for example `excipient=""`."
|
DEV-807928 |
|
In some cases, the Copy From Content Plan failure notification fails to be sent to user.
|
DEV-807933 |
|
When a user completes the Content Plan Sign-Off Workflow for the root content plan of the submission, the Submissions Content Plan gets stuck in the "Sign-Off in Progress" state.
|
DEV-809739 |
|
When a user selects documents on the comparison viewer and the documents are deselected by another user, the matched documents are not synced to the target and the notification success count only includes the synced Content Plan/Content Plan Item count.
|
DEV-810096* |
|
Users may receive a false negative on US Rule 1553.
|
DEV-811467* |
|
When creating Registrations in bulk from a Regulatory Objective, the Registration Details page loads continuously for users without permission for the Application Regulatory Objective object.
|
DEV-813787* |
|
Users may receive false negatives on AU 3.13 and AU 4.1.13.
|
DEV-813987 |
|
Global-to-local mapping does not support standard Application object types.
|
DEV-814225* |
|
Users receive an error when a binder is added as a matched document to a Content Plan Item.
|
DEV-815606 |
|
When a user merges matched documents, Vault attempts to merge non-pdf files, causing the merge to fail.
|
DEV-815858* |
|
During GCP validation, locked document validation may fail if there are unlocked excluded matched documents.
|
DEV-817440 |
|
The Submissions Archive Viewer displays duplicate STF root sections when an imported submission’s study-id XML value is blank.
|
DEV-819950* |
|
The Submissions Archive Viewer does not display content when multiple Submissions are open in different browser tabs.
|
DEV-820319* |
| Description |
Issue No. |
|
If the Age at Onset exists on a Case and then a user updates the Onset value of the Case Adverse Event, Vault does not recalculate the Age at Onset.
|
SAF-55924 |
|
When validating PMDA E2B(R3) files, Vault fails the PMDA.C.1.9.1.r.1-1 validation criteria when a Source field value exists on the Localized Case Identifier record of the Localized Case but is blank on the Case Identifier record of the global Case.
|
SAF-62871 |
|
The WorkbenchReport message group does not have Translation values for all messages.
|
SAF-65212* |
|
The Bulk Translation export file does not include Translated Labels for all Safety Workbench objects.
|
SAF-65215* |
|
For domestic Cases, after deleting an Adverse Event on the Inbox Item to Case Compare page and then merging to an in-flight Case, Vault does not reevaluate Case Tags.
|
SAF-65577* |
|
If the Data Entry (Initial) state of the Case Lifecycle object lifecycle is configured with an entry action that transitions Narrative documents to a different state, after successful Case promotion, Vault does not update the state of localized Inbox Items to Promoted.
|
SAF-66949 |
|
When promoting a follow-up to a Japan Localized Case with multiple Case Products, if a user deletes the primary Case Product Registration on the Inbox Item to Case Compare page, after promotion Vault creates two (2) Local Reporting Details records with the same Destination Case ID for the deleted Case Product Registration.
|
SAF-66963 |
|
After a user updates a global Case Assessment, Vault does not apply the update to related Localized Case Assessments.
|
SAF-67495 |
|
When sending follow-up email questionnaires to Case Reporters, in some instances, Vault sends emails without attaching the questionnaire documents from the Correspondence record.
|
SAF-67811 |
|
After a MedDRA dictionary version update, Vault does not update the Primary SOC value for all terms in the hierarchy.
|
SAF-67816 |
|
After promoting an Inbox Item with new adverse events as a follow-up through the Inbox Item to Case Compare page, when syncing data from the global Case to a Japan Localized Case, Case Assessments and Case Assessment Results are not synced.
|
SAF-67979 |
|
When users manually delete products or adverse events referenced in assessments on E2B-imported Inbox Items, after domestic Case promotion Vault does not generate all expected Localized Case child records.
|
SAF-68167 |
|
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 |
|
After merging an Inbox Item to an in-flight Case, Vault generates Case Assessments for device constituents of Combination Products.
|
SAF-68309 |
|
Row height formatting defined in custom Excel templates for Workbench Reports does not carry over to the generated report output.
|
SAF-68543* |
|
For Cases that include multiple Products with the same Case Product Registration and at least one (1) Local Reporting Details record that references the Case Product Registration in the Primary Case Product Registration field, Vault prevents creating follow-up Cases from Inbox Items.
|
SAF-68648 |
|
Vault does not export standalone devices with a Drug Role of "Similar Device" and a Device Report Type of "Malfunction" to FDA VAERS E2B(R3) reports.
|
SAF-68653 |
|
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* |
|
For E2B-imported Inbox Items with follow-up information that generates new assessments for an existing Japan domestic Case, after merging to the in-flight Case, Vault does not generate all expected Localized Case Assessment Result records based on the global Case Assessment Result records.
|
SAF-68710 |
|
For JSON-imported Cases, when the Primary Source value is Yes, Vault overwrites any Rank value to 1 in the Source Data pane of the Inbox Item.
|
SAF-68880* |
|
Generated FDA E2B(R3) files for postmarket reports do not include EDQM terms for the G.k.4.r.9.2a, G.k.4.r.9.2b, G.k.4.r.10.2a, and G.k.4.r.10.2b data elements.
|
SAF-68929 |
|
On the Inbox Item to Case Compare page, when either the Inbox Item or the Case includes Parent Information records and the user manually matches any records, updates page filtering, or switches pages, Vault displays the Parent Information records in the Case Drug History or Case Medical History & Concurrent Conditions sections and prevents merging the Inbox Item to an in-flight Case.
|
SAF-68953* |
|
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 generating the Non-Primary Suspect Workbench Report, Vault excludes some Cases with a blinded study and unblinded study product.
|
SAF-69063* |
|
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* |
|
During Inbox Item import, if a user who has access to the Inbox Item is in the Pending state, then the import will fail.
|
SAF-69098 |
|
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 copied Case to the generated record instead of creating the new record in v0.1.
|
SAF-69153 |
|
For imported Inbox Items, Vault displays the Blinded field value in the Product section only when a user is editing the Inbox Item.
|
SAF-69296 |
|
In some instances, system performance issues result in Vault not generating Correspondence when expected. In these instances, Vault appears to generate Correspondence but displays an error message when users try to access the document from the Correspondence record.
|
SAF-69354 |
|
When Synonym Candidate Auto-Creation is enabled, Vault generates MedDRA Synonym records with blank MedDRA Languages field values.
|
SAF-69371* |
|
When generating Health Canada E2B(R2) reports for Cases with multiple diagnoses, Vault exports multiple values to the B.5.3a and B.5.3b data elements, resulting in NACKs from Health Canada.
|
SAF-69399 |
|
Vault does not copy the Compare ID field value to Study Registrations for follow-up Cases.
|
SAF-69407 |
|
In Vaults configured with Case Access Group Security, users without unblinded access cannot view or edit open-label Study Products on study Cases with blinded Study Arms.
|
SAF-69480 |
|
When generating E2B reports for Cases with an EDQM Term that has multiple EDQM Term records, Vault generates a validation warning.
|
SAF-69739 |
|
In Vaults not configured with Case Access Group security, an error occurs when a user runs the Copy Case action.
|
SAF-69743 |
|
In instances where a One Last Time report to the PMDA exists on a Case and the follow-up Case would generate reports only for investigational to investigational cross reporting scenarios, after a user runs the Evaluate Reporting Obligations action on the follow-up Case, Vault does not generate the expected PMDA Transmissions.
|
SAF-69867 |
|
In Vaults that include MedDRA dictionary versions prior to those in central MedDRA (versions before 19.1), server errors occur that prevent displaying Case Product detail pages and auto-coding MedDRA terms that have previously undergone a cyclical hierarchy change on Case objects.
|
SAF-69870 |
|
A system error occurs when a user without permission on the Localization object attempts to create, open, or edit a Case Product on an existing Case with the WHODrug or JDrug control field.
|
SAF-69896 |
|
In Vaults with custom Case Assessment Method picklist values, Vault does not export the G.k.9.i.2.r.2.EU.1 EU Method of Assessment data element when generating EMA E2B(R3) reports.
|
SAF-69942 |
|
For Cases created from Literature Articles in Vault SafetyDocs, when generating non-PMDA E2B(R3) reports, Vault maps the value in the Vancouver Citation field instead of the Vancouver Citation (English) field to the Literature Reference(s) data elements, C.4.r.1 for E2B(R3) formats and A.2.2 for E2B(R2) formats, resulting in negative acknowledgments (ACKs).
|
SAF-69944 |
|
Vault prevents navigating to Case Product pages if users do not have Read permission on the MedDRA, MedDRA (Localized), and Reason Omitted objects and all fields of the MedDRA Dictionary object type of the Dictionary object.
|
SAF-70000 |
|
In Vaults with Blind Protection Relatedness Override enabled, when users generate blinded CIOMS I or E2B previews or Transmissions, Vault exports values in the Assessment Result (Override) field instead of the Assessment Result field.
|
SAF-70004 |
|
In some instances, Vault does not display some Case fields to users with view-only access.
|
SAF-70179 |
|
On MFDS E2B(R3) reports, Vault formats the G.k.2.1.KR.1b and G.k.2.3.r.1.KR.1b data elements incorrectly.
|
SAF-70636 |
|
When Transmissions that reference the CBER or CDER Transmission Profile are sent to the FDA through the FDA AS2 Connection, Vault names attachment files with the name of the E2B file, instead of the attachment file name.
|
SAF-70811* |
|
When processing a foreign Case and an External Product is coded through the WHODrug Cross Reference Tool (CRT) Japan, Vault does not add the Japan Product Code Type to the Localized Case Product.
|
SAF-70837 |
|
When creating a follow-up Case for a Case with multiple previous versions that include Case Child Information records, Vault copies Case Child Information records from every Case version instead of just the previous Case version, resulting in duplicate records on the follow-up Case.
|
SAF-70859 |
|
When auto-coding MedDRA terms on Cases referencing MedDRA dictionary versions that are older than the latest available version, for terms with Name changes only, Vault creates a new MedDRA term record instead of updating the Name on the existing record.
|
SAF-70978* |
|
In Vaults configured to isolate blinded clinical trial information, when users run the Evaluate Reporting Obligations action on a Localized Case related to a Localized Case for a different locale that has a blinded and unblinded Localized Case Assessment record pair, an error message appears.
|
SAF-70982 |
|
For Cases created using tabular data format import, in some instances, Vault populates the Patient RoA field on Case Product Dosage records with the Route of Administration ID instead of the term.
|
SAF-71014 |
|
On domestic Cases, the Dose Text dual-entry field on Case Product Dosage records displays localized values as read-only and hides the global value, preventing global users from editing the field.
|
SAF-71026 |
|
After running the Copy Case action, Vault does not copy Case documents with the Literature > Literature Article classification to the new Case.
|
SAF-71075 |
|
When generating FDA VAERS E2B(R3) reports for Cases with blank Date of Birth, Age at Vaccination, Age, Gestation, and Age Group values, Vault generates the XML with no D.2 Age Information section values, instead of exporting the nullFlavor NI to the D.2.3 Patient Age Group (as per reporter) data element.
|
SAF-71107 |
|
After running a signal calculation, the preview of all results does not reflect applied filters.
|
SAF-71190* |
|
When generating E2B(R3) formats, the link to the EMA XSD references "http://", instead of the updated link to "https://".
|
SAF-71346 |
|
When creating a follow-up Case from a copied Case with Child Information details from the prior Case, Vault copies only newly added Child Information Case data to the follow-up Case.
|
SAF-71653* |