The following applications may have different release dates: RegulatoryOne, Safety, and Veeva Claims.
| Description |
Issue No. |
|
When users close or cancel the Site Candidate Loader dialog, Vault fails to delete the file.
|
DEV-562483* |
|
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* |
|
The Disclosure Page remains accessible even when the Disclosures application has been disabled in Clinical VMC.
|
DEV-651013* |
|
In some cases, TMF Transfer fails to transfer documents with an asterisk (*) in their names.
|
DEV-652003 |
|
When users update an object type in the source Vault to a custom type (custom__c), Vault does not correctly update the object type in the target Vault.
|
DEV-652160* |
|
In some cases, when Enable Site Connect is enabled, users are unable to disable the Site Connect application.
|
DEV-653104* |
|
In some cases, there are missing records on the Target Vault when transferring data over the query limit with the RIM to Clinical Operations Vault Connection.
|
DEV-655924* |
|
In some cases, the Site Candidate Loader job status displays Errors Encountered despite the job running successfully.
|
DEV-657198* |
|
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 |
|
In some cases, Unblinded Follow-Up items may incorrectly remain linked to Blinded Monitoring Events.
|
DEV-668244 |
| Description |
Issue No. |
|
In rare cases, users experience a server error when uploading attachments.
|
DEV-581986* |
|
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* |
|
In some cases, documents with large amounts of markup fail to render.
|
DEV-626901 |
|
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 |
|
EDL document counts may not immediately reflect changes caused by manual matching and unmatching.
|
DEV-651093* |
|
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, Controlled Document Templates will not up-version after a change is made to a document.
|
DEV-653030 |
|
Users may encounter a "Page not found" error when attempting to create a document change request or document change control record.
|
DEV-653387 |
|
When there are multiple rendition requests processing, the status of pre-existing rendition requests will overwrite the status of the first rendition request in line once it completes.
|
DEV-653481* |
|
Large video files uploaded via Vault File Manager may show an error message before rendering in Vault.
|
DEV-654460* |
|
While generating renditions of very large source files in token-based viewers such as the Send as Link viewer, non-Vault users see a message that the session has expired.
|
DEV-654923* |
|
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 |
|
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 |
|
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* |
|
Under certain conditions, Vault does not audit changes to document lifecycle entry action configuration.
|
DEV-664322 |
|
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* |
|
Users receive a "Document not Found" error for crosslink documents where source Vault has been deleted.
|
DEV-667521* |
|
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 |
| Description |
Issue No. |
|
Updates to the Display Section of the Lifecycle Stage field on the Lifecycle Stage object causes unintended updates to additional fields on the object.
|
DEV-633602 |
|
Translated workflow task labels and instructions are removed and replaced in English when a workflow is up-versioned.
|
DEV-640407 |
|
In rare cases, Vault sends additional tasks to assigned users after the completion of a controlled copy workflow.
|
DEV-641353 |
|
If Check In from Microsoft and Set new major version entry actions are configured on the same workflow state, Check In from Microsoft fails when executed.
|
DEV-644611 |
|
When creating a raw data store object and an associated lifecycle from the object configuration page, Vault does not save the lifecycle on the page, and subsequent attempts to update it result in an error.
|
DEV-651188 |
|
Values for Task Type and Task Items for legacy workflows may not be visible on the Home page.
|
DEV-653102* |
|
After cancelling a multi-document workflow, users may experience a server error when manually changing the document's state in the multi-document viewer.
|
DEV-656162* |
|
In rare cases, users experience a server error when attempting to complete a task.
|
DEV-657015 |
|
Vault may fail to display available user actions for specific records in the appropriate lifecycle state.
|
DEV-658058* |
|
The Update Sharing Settings action for the task completion event in an optional task step resolves groups in addition to individual users, which may cause roles to be added to an entire group rather than only individual users.
|
DEV-659011 |
|
Under certain circumstances, workflows with specific configurations may not execute correctly at join and decision steps.
|
DEV-659320 |
|
Under certain conditions, users may incorrectly receive an error that they do not have permission to check-in a document with Collaborative Authoring when the do actually have permission.
|
DEV-664085 |
|
In some cases, Vault shows a Server having problems error when users attempt to access the Timeline View.
|
DEV-665397 |
|
When a lifecycle is deleted and re-created with the same name, users receive an SDK error when attempting to access the lifecycle’s Active state.
|
DEV-667375 |
|
When users select a multi-item workflow task from a Tab Collection’s Home tab, verdicts are not visible in the workflow timeline view.
|
DEV-668757 |
|
Users may be unable to view all available system actions when configuring a workflow step.
|
DEV-669071* |
|
Users may be unable to save their settings for document workflow cancel states.
|
DEV-670046* |
| Description |
Issue No. |
|
When an object record detail page reloads after a state change, Vault does not execute Focus On layout rules.
|
DEV-644608* |
|
In rare cases, users will encounter a server error when copying object records.
|
DEV-649750* |
|
In some cases, Admins cannot save when adding a layout to an inactive object in a layout profile.
|
DEV-652638* |
|
In some cases, users cannot filter by "Created By" when searching for object reference field values on the Doc Info page.
|
DEV-652941* |
|
For objects that allow duplicate records and have only one editable field, users may inadvertently create duplicate records if they hit ENTER while creating a record.
|
DEV-653125* |
|
Vault may display an inaccurate error message when a user attempts to save an inactive layout.
|
DEV-653135* |
|
When populating a document field, users encounter a server error when entering a number value as a filter in the Select Document dialog.
|
DEV-653276* |
|
Vault does not update object reference field values on the source object record when the target object record name is edited.
|
DEV-653510 |
|
When a user collapses a Help Section while creating an object record, Vault expands the section when reloading the page, clicking links in the Pavigation Panel, or navigating back to the page from elsewhere in Vault.
|
DEV-653879* |
|
Vault scrolls past Help Sections that are placed before the first Details section when loading the Create Object Record page.
|
DEV-653883* |
|
When creating a record from a document through a document action, latest version document reference field values are not successfully defaulted if the field is not configured in the page layout.
|
DEV-654553* |
|
Vault may display an incorrect error when a user attempts to edit an object record during its conversion to a raw object.
|
DEV-655249* |
|
When a user changes language, favoriting an object that does not have localized data results in a server error.
|
DEV-656873* |
|
In some cases, users experience a blank screen after executing an object record state change action.
|
DEV-659021* |
|
In rare cases, Vault becomes unavailable after an Admin deletes an object that is referenced in a Tab that is referenced in a Tab collection.
|
DEV-660977 |
|
Users may encounter a server error if they attempt to view or delete duplicate layout records.
|
DEV-661889 |
|
Users may be unable to populate required object reference fields when creating a related record.
|
DEV-662406 |
|
Vault may populate picklists with invalid default values upon record creation.
|
DEV-662940* |
|
In rare cases, users with certain security profiles may encounter a system error when saving an object record.
|
DEV-663207 |
| Description |
Issue No. |
|
Users are able to apply more Document Numbers than the intended maximum to an Advanced Search, which may cause errors.
|
DEV-576348* |
|
When a user visits a custom tab, Vault may open the Recents view instead of the All view.
|
DEV-602089* |
|
Date and Number search filters always appear above other filters in Pill Section when they should appear in alphabetical order.
|
DEV-605618* |
|
In some cases, views fail to update when new filters are applied.
|
DEV-618165* |
|
In some cases, users are unable to view certain tabs due to related objects for which they do not have view permissions.
|
DEV-638435 |
|
Search filters may not return the correct results if the search terms contain an umlaut.
|
DEV-640682 |
|
In some cases, Suggest Links may match twice, with one match containing a second sentence.
|
DEV-642699* |
|
In some cases, Smart Filtering does not work as expected.
|
DEV-646688 |
|
In cases where the Library tab is not available, the Search Tab Selector may default to a non-searchable tab.
|
DEV-649492* |
|
When a user adds a filter to the left navigation, the newly added filter do not appear until after a refresh.
|
DEV-652111 |
|
Search Limit Language hover text is not correctly translated.
|
DEV-652622* |
|
In some cases, attempting to expand a hierarchical column header filter without a left navigation filter added results in a server error.
|
DEV-655781* |
|
Column header filter facets are not filtered correctly when the filter for that field is not included in the left navigation.
|
DEV-655787* |
|
In some cases, users are unable to remove filters from the left navigation.
|
DEV-655879* |
|
In some cases, when an admin attempts to change another user's search language settings, the changes are not saved.
|
DEV-656514* |
|
In some cases, users may receive a server error when clearing a subtype filter from a column header if an advanced filter has been applied from the left navigation.
|
DEV-659603* |
|
When a user sets a grid to Truncate Cells, the filter icon and sort arrows may appear out of alignment.
|
DEV-661318* |
|
No data is available in the downloaded Excel/CSV file when a user attempts to download custom tab views with filters.
|
DEV-661640 |
|
Cross Vault search does not work as expected on Microsoft Edge.
|
DEV-662952* |
|
In some cases, some filters do not appear on Vault Mobile.
|
DEV-666595 |
|
In some cases, claims incorrectly separate into fuzzy matches with individual words when users introduce a thesaurus into their Vault.
|
DEV-668242 |
|
In some cases, users receive a server error when attempting to export search collections to Excel.
|
DEV-670011 |
|
In some cases, the Recent view for object tabs may only show recently viewed records that the user owns.
|
DEV-671342 |
| Description |
Issue No. |
|
In some cases, the QMS the Relationship field on the record check interface may not display all expected values for selection.
|
DEV-637159 |
|
The Recurrence Check interface may incorrectly allow users that lack the View permission for a field to see that field's label in the interface.
|
DEV-637241* |
|
The Duplicate Check interface may incorrectly allow users that lack the View permission for a field to see that field's label in the interface.
|
DEV-638427* |
|
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 |
|
The verdict section of a record check configuration may not display all configuration field labels.
|
DEV-648411* |
|
Vault may fail to export some column values when extracting Quality Event records.
|
DEV-651514 |
|
On Validation Management's Test Authoring Review UI, the additional prompts do not show up for the Setup Steps upon initial load of the UI. They only show when the user navigates away and then come back to the Setup Steps.
|
DEV-652537* |
|
Users receive an SDK error when attempting to set a Class record’s Instructor field.
|
DEV-652538* |
|
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 |
|
Vault may display an error message with an unresolved token when a user attempts to change the data entry method on a Lab Test Result.
|
DEV-655272* |
|
In some cases, the QRM Heatmap visualization's Final Risk Score tab may not function as expected.
|
DEV-658055* |
|
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 some cases in Vault LIMS, system actions may incorrectly be unable to affect records which are locked.
|
DEV-664581* |
|
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 |
|
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 |
| Description |
Issue No. |
|
In some cases, Vault does not properly refresh the Content Plan viewer grid while in match document mode.
|
DEV-629020* |
|
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, 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* |
|
In some cases, Vault fails to report EU 11.02.
|
DEV-645439 |
|
Migrating large quantities of Application records using Loader may result in multiple records failing with a batch error.
|
DEV-647208 |
|
In some cases, Vault incorrectly reports CA B48.
|
DEV-647237 |
|
The file name for submissionunit.xml is displaying incorrectly.
|
DEV-647612* |
|
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* |
|
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, on-demand publishing creates Content Plan Items as placeholders and does not populate eCTD 4.0-specific Submission Metadata fields.
|
DEV-650137* |
|
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, documents do not merge for report level content plans if the Content Plan Item node type is blank.
|
DEV-651389* |
|
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 |
|
In some cases, users receive an error when creating a binder when a “Read Only Text Field" custom text field is created.
|
DEV-651909* |
|
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 the Active Dossier checkbox is enabled, Vault displays inactive picklist values in the picklist fields.
|
DEV-652640* |
|
Links in the Table of Contents for a merged section are not navigating to the published merged document.
|
DEV-653048* |
|
When the Active Dossier status is Pending Current/Pending Superseded/Pending Deprecated, the status is updated to Submitted.
|
DEV-653091* |
|
When section merge published output location or xml title are not populated in the merged section, Section Merge jobs fail.
|
DEV-653103* |
|
The Submissions Archive Document field does not populate in Active Dossier Item Detail.
|
DEV-653158* |
|
Users without Read permission for the Activity object’s Impacted Market field receive a server error when attempting to dispatch Global Content Plans.
|
DEV-653212* |
|
The Content Plan Viewer displays the incorrect error message when users without appropriate permissions attempt to reorder matched documents.
|
DEV-653216* |
|
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, Vault allows Submission imports for scenarios which should be blocked from import.
|
DEV-653480* |
|
The Submissions Archive Document field does not populate in Active Dossier Item Detail.
|
DEV-653518* |
|
In some cases, the Server Having Problems banner displays when saving a record after drag & drop.
|
DEV-653603* |
|
In some cases, publishing fails for Content Plan Item merge when the same document is matched to two different Expected Document List items.
|
DEV-654402* |
|
Vault generates new UUIDs and does not populate Submission Metadata fields during publishing when Content Plan Items are matched to documents from a different Submission.
|
DEV-654538* |
|
When metadata is udpated, the outbound job is not triggered.
|
DEV-654545* |
|
Vault displays the incorrect error message when users attempt to remove an Extended Metadata record from an Application.
|
DEV-654768* |
|
Vault prevents users from removing Extended Metadata records from an Application when the related Submission’s current lifecycle state is not configured in the Exclude Submission Lifecycle States application setting.
|
DEV-654774* |
|
Users receive a Server having problems error when attempting to restore default columns in the Submission Wizard.
|
DEV-654803* |
|
While splitting Activities, the Summary page incorrectly displays information for new records when the Relate Bundled and Split Regulatory Objectives and Submissions to Events setting is enabled.
|
DEV-655382* |
|
In some cases, state transition fails if the lifecycle name has been modified.
|
DEV-657213* |
|
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* |
|
When creating records in bulk or during bundling, Vault does not create Application Inactive Ingredient relationship records when there is an existing Application Product record.
|
DEV-661043* |
|
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, Vault incorrectly reports US 1737.
|
DEV-662149 |
|
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 |
|
Some users may experience an error on renditions when PDF Standardization is enabled.
|
DEV-669492* |
|
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 |
|
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 |
| Description |
Issue No. |
|
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 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* |
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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.
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SAF-49739 |
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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.
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SAF-49782* |
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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."
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SAF-50474 |
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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.
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SAF-50482 |
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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.
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SAF-50500 |
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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.
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SAF-50525 |
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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.
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SAF-50538 |
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For Localized Cases, E2B(R3) generation fails when a localized narrative document template does not exist.
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SAF-50612 |
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Group Rows By selections are not applied to Excel files generated from documents with the PSMF Generated Report document classification.
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SAF-50671 |
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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.
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SAF-50674 |
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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.
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SAF-50676 |
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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.
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SAF-50805 |
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When users configured with a Case Access Group Override create Follow-up Cases, the system doesn't assign the expected Case Access Group.
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SAF-50840* |
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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.
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SAF-50989 |
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When a Transmission from an earlier Case version includes an inactive user in the Sender (User) field, newer Case versions cannot be approved.
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SAF-51006 |
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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.
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SAF-51374 |
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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.
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SAF-51476 |
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In some instances, system performance is slower than expected when generating PSMF PDFs.
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SAF-51658* |
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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.
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SAF-51661 |
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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.
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SAF-51737* |
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When importing Cases through Safety Inbox Loader, the Action Taken field on Case Products is not populated.
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SAF-51739 |
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When editing a Localized Case Product on a Case for Japan, if a change is entered but then cancelled instead of saved, the change is still applied to values coded with the JDrug Browser.
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SAF-51859* |
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In Vaults licensed for only Vault SafetyDocs, the Auto-Translation Framework cannot be configured.
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SAF-51922* |
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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.
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SAF-51928 |
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Combination Product device constituents are exported to CIOMS I forms.
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SAF-51938 |
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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.
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SAF-52034 |
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The system imports E2B files without Case Identifier names to Inbox Items, resulting in errors during Case promotion.
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SAF-52055 |
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Watchlist questionnaires are not generated for matching MedDRA Preferred Terms (PTs).
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SAF-52124 |
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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 .
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SAF-52154 |
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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.
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SAF-52164 |
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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 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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When importing Inbox Items through the Safety Inbox Loader, import fails if the Tabular Data Format does not include field mapping to Worldwide UID (WWUID), even when it does contain mapping to External System UID.
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SAF-52279 |
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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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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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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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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 |