Beginning with 25R2 and for all subsequent releases, Safety, RegulatoryOne, and Veeva Claims release on the same date as the Veeva Vault Platform.
The issues listed below are fixed in the 25R2 release.
| Description |
Issue No. |
|
New Clinical Registry Vocabulary Mapping records can not be created when the CTN field is blank.
|
DEV-792988 |
|
Archived Studies relink to documents when users run the Streamlined Document Reuse job while the Archive Study job is in progress.
|
DEV-820290 |
|
The Generate Payable Items action fails on Study Sites that have Site Fee Payable Items with no Site Fee value and Site Fees with a Maximum Count value.
|
DEV-826130 |
|
When utilizing standard Connections, if a Platform exception is generated during the inbound job, then the user exception message may not be visible in Admin.
|
DEV-832263 |
|
An unexpected system error occurs when users run the Streamlined Document Reuse job that prevents the completion of the job.
|
DEV-832691 |
|
Custom formula fields may cause EDL items to fail to generate from Template EDLs.
|
DEV-838212 |
|
In some cases, site users receive weekly email and in-application notifications for recalled documents.
|
DEV-840852 |
|
The % Complete field does not update for Milestones with active Milestone Items missing EDL items.
|
DEV-841131 |
|
An unexpected error occurs when a user attempt to upload documents for a Placeholder but the user only has view and edit permissions for the Placeholder version of the document and not the populated Approved version of the document.
|
DEV-842893 |
|
When users create a Package to send to Site Connect and filter the list of documents by Process Name, the values in the Process Name drop-down menu do not load.
|
DEV-843501 |
|
In some cases, site users receive Document Exchange and Safety Distribution notifications for recalled documents.
|
DEV-848149 |
|
Users encounter an unexpected error when they run the Test Model from Production Data action on the new Metadata Extraction Model.
|
DEV-848522 |
|
When the RIM-Clinical connection attempts to transfer many documents to Clinical, the process can run for over 30 minutes before raising an error.
|
DEV-848716 |
|
Users with the System Admin security profile cannot save changes to the Category field on Subcategory records.
|
DEV-852883 |
|
Vault does not automatically update the Process Name field value during document reclassification when the field is editable.
|
DEV-853454 |
|
Self-Evident Corrections reflect unexpected field changes for blank text fields.
|
DEV-853484 |
|
The Global CTN Data Change Logs job may fail for any Organization used in more than 500 CTNs.
|
DEV-857076 |
|
An unexpected server error occurs when only one document exists in the Vault and users create a Quality Issue from the Business Admin tab.
|
DEV-857529 |
|
In some cases, users cannot update the visit_status__v field of custom object type Visit records to the In Progress value.
|
DEV-858011 |
|
An unexpected error occurs when users populate the Actual Finish Date field on Milestones where the Milestone Type is blank.
|
DEV-858793 |
|
When a failed Distribution Task causes the Distribution Task Recipient for a user to fail, all Distribution Task Recipients for that user across other Sites and Distribution Tasks also fail.
|
DEV-859216 |
|
In some cases for Milestones, Milestone Document records are not created and the corresponding matched documents are not linked to the Milestone.
|
DEV-863499 |
|
When users make changes to the Study Country or Study Site List Layout, Vault does not update the corresponding table columns.
|
DEV-866010 |
|
In some cases, unexpected rows for excluded records are present in Agreement Transfer.csv files.
|
DEV-867962 |
|
The Create Milestone from Template job encounters an error when users select all records for the Ad Hoc user action and have a Template Milestone Master Set with both active and inactive template milestones sets at the same level.
|
DEV-868275 |
|
Vault populates the Baseline Start Date and Planned Start Date fields on Point in Time Milestone object types when the fields are disabled on the object type configuration.
|
DEV-869854 |
|
Vault cannot create new Study Person records for users who have duplicate User records but one of them is inactive.
|
DEV-870896 |
|
Under some circumstances, the system may fail to create Milestone Items for some studies.
|
DEV-870897 |
|
Users cannot add Milestone Study Sites or Countries to a Milestone using the Object Controls if they have object lifecycles linked.
|
DEV-871473 |
|
An error occurs with the EDL_AUTOMATION_EDL_CREATION job when users create a new Study Person record with the same values as an inactive state Study Person record with an active status,
|
DEV-871502 |
|
An unexpected network error displays when a user creates a Quality Issue with a custom field, but the user can still save the Quality Issue.
|
DEV-872618 |
|
Distribution Tasks without Distribution Task Recipients are not marked as complete when viewed through the grid in Site Connect or through a PAL viewer link.
|
DEV-872689 |
|
Vault displays a server error when users select the Generate CTN action for a Selected Study Organization Role record linked to a Study Organization with an existing Selected Study Organization Role record with the same Role.
|
DEV-873226 |
|
In some cases, the Trained Model displays an incorrect status for records in the grid view.
|
DEV-874697 |
|
A server error occurs when users attempt to create new document versions while EDI triggers are enabled.
|
DEV-874784 |
|
Users receive a "Page Not Found" error when they click Study Site links from the Monitoring Plan template on the CRA Homepage.
|
DEV-876276 |
|
For Vaults with event actions that automatically enable the Site Connect User field when creating Study Person records, Vault does not check for existing Study Person records at the Site using the same Person record and creates the Study Person record without error.
|
DEV-877895 |
|
An unexpected error occurs when distributing Safety Distributions with supporting documents that have no Product assigned, causing the Safety Distribution Emails job to fail.
|
DEV-881886 |
|
Site Connect displays Sent Date values in an incorrect format in the Document Exchange Open Tasks, All Sent, and Canceled grids.
|
DEV-885367 |
|
Study Announcement email notifications do not display new lines as expected.
|
DEV-886357 |
|
In some cases, active standard Study Team Role records duplicate similar custom Study Team Role records.
|
DEV-891422 |
|
Under certain circumstances, Issues may be transferred without their Subject field being set.
|
DEV-891608 |
|
When a user adds an adhoc document request via a Site Package, Site Connect displays all Classification option instead of only the Classifications mapped to Vault Clinical Docs artifacts.
|
DEV-891816 |
|
The Vault Update job does not create additional Contact Information records for OpenData Clinical Investigator records that already exist in Vault.
|
DEV-894269 |
|
Quality Control Risk Rules match based on the Organization document field and not the Contributor's Organization document field.
|
DEV-894995 |
|
Vault does not calculate eTMF Licenses when the Enable SOLR Archive Document flag disabled.
|
DEV-900406 |
|
When the Create Metrics Over Time action is run at a level different than the Recruitment Planning Level and the appropriate Milestones and Metrics are not available for the Recruitment Planning Level, then the system will not create Metrics Over Time records.
|
DEV-905299 |
| Description |
Issue No. |
|
When 'Allow viewing and annotation of Protected PDF files' is disabled, the attachment document rendition status is incorrectly marked as "Success"
|
DEV-768077 |
|
Notifications for ending collaborative authoring sessions may not display the correct date and time of when the session ended.
|
DEV-803196 |
|
Rendering RTF files in RIM may lead to the files appearing with incorrect page breaks.
|
DEV-807475 |
|
When a workflow on a previous document version attempts to upversion the document, the document version in which the workflow is on gets upversioned instead of the latest document version.
|
DEV-808617 |
|
Vault may delay rendering of CrossLinks when they are created from a bulk operation.
|
DEV-813282 |
|
Vault fails to render write password protected .doc files.
|
DEV-814168 |
|
In rare circumstances, an error is displayed when using the Download to PDF action.
|
DEV-815854 |
|
In some cases, excel renditions fail due to a merge field error.
|
DEV-815909 |
|
When uploading a document and initiating a steady state transition without an upversion entry action, the rendition generation fails.
|
DEV-816634 |
|
When a document is in the Approved state, merge field tokens display the wrong value.
|
DEV-816665 |
|
Text may not be wrapped correctly in Form 3455 PDF files.
|
DEV-818790 |
|
Line breaks are incorrectly rendered as spaces in Form 3455 PDF files.
|
DEV-818806 |
|
When creating a document version with suppressRendition as true, the previous document version has its rendition created.
|
DEV-819175 |
|
eSignatures are not displayed on downloaded Form 3455 PDF files.
|
DEV-819540 |
|
Users cannot edit or annotate an archived document, even though the Document Readiness panel indicates that the Annotation status is Successful.
|
DEV-821485 |
|
Including a leading or trailing space in the Name of a Docrelationshiptype component may result in inconsistencies in migration packages, Vault Configuration reports, and Vault Comparison reports.
|
DEV-822046 |
|
Under certain circumstances, viewable renditions may show "recoverable signature" text in place of the Date on a signature.
|
DEV-822406 |
|
In some cases, users are unable to traverse annotations or scroll to previous pages on a large document when the Line annotation tool is selected.
|
DEV-822980 |
|
The Item column in the System Audit History may display as blank for changes to a document type's Document Number Format.
|
DEV-823734 |
|
Vault incorrectly ignores the Repeat header row on top of each page Word Table property for viewable renditions, which causes them to appear differently than expected.
|
DEV-825682 |
|
In some cases,updating the description of a document's attachment on a previous document version updates the same description on the document's latest version.
|
DEV-825937 |
|
When users delete the latest version of a document attachment, the content of the deleted version is still searchable in Vault.
|
DEV-826541 |
|
When enhanced overlays are enabled, downloaded PDF/A files with a rich-text overlay and a watermark have an excessively large file size.
|
DEV-829489 |
|
In some cases, word documents with annotations time out during rendition creation.
|
DEV-830151 |
|
If a CrossLink is created by a non-source Vault user or an inactive user in the source Vault, users receive a permissions-related error message.
|
DEV-830976 |
|
In some cases, downloaded signature pages generated from a document, signature page template previews, and overlay template previews may not load immediately and have the incorrect PDF version.
|
DEV-831030 |
|
When creating an object reference field on a document, clicking the labels for the property checkboxes may fail to toggle the checkboxes.
|
DEV-831072 |
|
Re-render fails for documents with brought forward annotations created by delegate users if they were created before a certain point.
|
DEV-832255 |
|
Clicking on the sender's name in a document viewer opened from a Send as Link Vault notification or email may direct users to the incorrect destination.
|
DEV-832472 |
|
When using Download to PDF, a section may be blank when its leftmost table column exceeds the printable width.
|
DEV-833163 |
|
In some cases, when rendering an .msg file with a default hyperlink color set to white, the email links are not visible.
|
DEV-836424 |
|
In cases where a user updates the Template Document Type field of a document created from a Controlled Document Template before clicking the Save button, Vault shows an unhelpful error message.
|
DEV-836447 |
|
If a controlling field dependency is modified, the values may also be retroactively changed in system audit logs.
|
DEV-837405 |
|
When uploading a zip file, the Zip Archive file format is shown as HTML in the Doc Info Pane.
|
DEV-837874 |
|
In some cases, users were able to create new versions of Crosslinks.
|
DEV-839939 |
|
Under certain circumstances, PDF documents may fail to render.
|
DEV-840339 |
|
Some collaborative authoring notifications are displayed in English only instead of the configured language.
|
DEV-841533 |
|
Vault does not indicate whether header or footer content fits within the height limit when designing an enhanced overlay template.
|
DEV-846844 |
|
When rendering an OCR file, an unexpected error occurs.
|
DEV-847276 |
|
In some cases, Vault may fail to update the Document Number field with the correct token value from the Document Number Format field.
|
DEV-857167 |
|
In some cases, Lookup fields used in document event actions may not populate a value.
|
DEV-857496 |
|
When using the Ctrl + F (Windows) or Cmd + F (MacOS) keyboard shortcut on the Doc Info page and the document viewer is not in focus, the Find in Document search box opens and users cannot access the browser's default Find functionality using the keyboard shortcut.
|
DEV-858921 |
|
Custom note annotation titles are not retained when annotations are brought forward.
|
DEV-859020 |
|
In some cases, merge fields excel files fail to render with a chart sheet.
|
DEV-860383 |
|
When creating a record from a related records section, field auto population is inconsistent.
Issue affects the 25R2 release.
|
DEV-861111 |
|
In some scenarios, when a rendition becomes obsolete, the Viewable content processing status in the Document Readiness panel is set to Failure even when it is successful.
|
DEV-864233 |
|
When uploading documents, the GIF file renders in black and white instead of the expected color.
|
DEV-864706 |
|
In some cases, Viewable CP status remains a "SUCCESS" after deleting the rendition through the batch delete endpoint.
|
DEV-865059 |
|
Under certain circumstances, users may be unable to create viewable renditions of some documents.
|
DEV-868445 |
|
In cases where a user's email address has different capitalization in Vault than in Azure, the Collaborative Authoring Automatic @Mentioning feature fails to work.
|
DEV-873998 |
|
When Vault outputs Japanese using the function for adding text strings to generate PDFs, a Chinese font is specified.
|
DEV-876842 |
|
An error occurs when users attempt to render videos that are over 2 GB in size.
|
DEV-881032 |
|
Occasionally, MD5 checksums are not calculated for migrated document versions.
|
DEV-881796 |
|
Pressing CTRL + F on the keyboard does not open Find in Document in the external viewer.
|
DEV-881912 |
|
When opening a video in an email sent as a link from Vault, an error may be displayed.
|
DEV-882196 |
|
Write-protected excel worksheets do not have their write protection restored after merge fields on the modified source.
|
DEV-884805 |
|
With AVAP off, manual renditions will now receive overlays even if the original source is restricted
|
DEV-886046 |
|
An error is displayed when attempting to archive a CrossLink document with an inactive source Vault.
|
DEV-886432 |
|
In some cases, users are unable to use bulk delete API for deleting renditions of encrypted PDF source files.
|
DEV-893400 |
|
When creating a new version of a document with a Certified Copy value and enhanced document insert functionality is enabled, the Certified Copy value is not removed as expected.
|
DEV-901623 |
| Description |
Issue No. |
|
Users cannot set or update default values on system-managed fields.
|
DEV-781942 |
|
In some cases, EDL batch jobs may cause performance issues by failing repeatedly.
|
DEV-803771 |
|
Users may receive the incorrect error message when attempting to delete an object that does not exist via the API.
|
DEV-817633 |
|
Users may encounter duplicate picklist values and the inability to select values after editing.
|
DEV-823271 |
|
When changing the uniqueness of a field using an online alter, the change may not be applied correctly.
|
DEV-825471 |
|
In dialogs with a two-column layout, selected values in multi-value picklists stretch across the entire width of the picklist. In addition, the Date, Time, and DateTime fields appear out of alignment.
|
DEV-825549 |
|
In some cases, the width of Number fields with a format mask may cut off the formatted value.
|
DEV-826276 |
|
If there is an action trigger associated with an object, it can not be deleted.
|
DEV-826557 |
|
Users may experience errors caused by custom objects and standard objects that share the same name.
|
DEV-827472 |
|
If a Document Change Control section includes a document with a CrossLink, the Actions menu may not display.
|
DEV-828865 |
|
In some cases, users receive a null response when updating an object layout profile.
|
DEV-835578 |
|
Under certain circumstances, the system may change the status of child records when their parent record's status is changed during data migration.
|
DEV-839127 |
|
In some cases, users may encounter a server error when clicking a layout profile name on the Admin > Users & Groups > Layout Profiles page.
|
DEV-841912 |
|
Enabling custom or matching sharing rules on an object may result in incorrect attachment field data in list views and VQL query results.
|
DEV-843165 |
|
Refreshing a sandbox from a snapshot may fail if the snapshot contains a system-managed object name with special characters.
|
DEV-844126 |
|
In some cases, users may encounter a server error when editing details on an object with a Source value of Application and when changing the Source value from Custom to Application.
|
DEV-846852 |
|
When users click the Fields using this picklist link on a Status picklist field, they are directed to a blank page.
|
DEV-847266 |
|
Users may encounter a server error when attempting to copy a record that contains a Local Currency field with Do not copy this field in Copy Record enabled.
|
DEV-852903 |
|
When copying a record, if a controlling field does not allow copying, the controlled field is still copied, preventing the user from saving.
|
DEV-854569 |
|
Under certain circumstances, when a user attempts to create an object that has an Organization object field on it, they may receive a server error.
|
DEV-856358 |
|
When editing a multi-value picklist, the picklist field may appear out of alignment on screen in Mozilla Firefox browsers.
|
DEV-858599 |
|
Default values for expressions referencing multiple object levels may not function as expected.
|
DEV-859492 |
|
Under certain circumstances, validation errors fail to appear for checkbox and certain format mask fields within the Workflow Task Dialog.
|
DEV-859917 |
|
In some cases, users may encounter picklist errors when performing an inline edit on an EDL Template in the Hierarchical Viewer.
|
DEV-860121 |
|
Under certain circumstances, object records may be displayed with the default layout rather than the layout indicated in their layout profiles.
|
DEV-860210 |
|
When users delete a Lookup field or Roll-up field on a child object, the field becomes inactive rather than deleted, and a Roll-up field calculation occurs and fails on the parent object.
|
DEV-861517 |
|
When changing the Verdict in a workflow task, picklist values may behave in unexpected ways such as unexpectedly repopulating and giving a Field Required error when already populated.
|
DEV-862374 |
|
Direct Data API files may contain deletions that do not fall within the expected 15 minute time frame of the file.
|
DEV-862993 |
|
In some cases, an object record detail page may display as blank when a section in the object's layout becomes invalid based on a lifecycle state.
|
DEV-864488 |
|
In legacy related object sections for Expected Document records with validation rules on a picklist field, the picklist may open when a save fails, which obscures the error message.
|
DEV-865189 |
|
In some cases, users may experience unexpected load time when adding, deleting, or reordering fields on an object layout.
|
DEV-866139 |
|
In some cases, users may experience an error when deleting an object record that is part of an object hierarchy.
|
DEV-866789 |
|
Some EDL batch jobs may complete with errors.
|
DEV-867618 |
|
When a large number of Layouts exists in a Vault, users may experience slow performance while trying to create a new Layout.
|
DEV-869926 |
|
Under certain circumstances, read-only users may be able to see the Create and Reorder buttons for picklists.
|
DEV-872350 |
|
When records are created or updated in Record Migration Mode, Vault generates an audit entry even if auditing is disabled for that object.
|
DEV-882680 |
|
Users may encounter an error when performing an Upsert or Update operation (Vault Loader and API) on an object with idParam set to a system-managed field.
|
DEV-886173 |
|
Under certain circumstances, users may have access to sharing reports, but receive an error when they click on the sharing settings.
|
DEV-890556 |
|
Users may receive an error when requesting the Layout for an object type using default layout if they do not have permission to read the base object type.
|
DEV-894125 |
|
Under certain circumstances, Picklist value default label resolution may result in performance issues and job failures.
|
DEV-894554 |
|
A component only used by internal Veeva teams is visible when configuring Vault Compare and Vault Configuration reports.
|
DEV-895960 |
|
Under certain circumstances, auto number sequencing may skip a number when numbering records.
|
DEV-897975 |
|
When attempting to set Lookups to Lifecycle State fields in migration mode, users may end up with bad data in their database, which can cause unexpected issues.
|
DEV-902322 |
| Description |
Issue No. |
|
When users revise a Batch Disposition Plan, Vault copies the Batch Disposition Plan Check Requirement records but not the Owner field from the existing record. This can cause users to have to manually set the Owner field for each Batch Disposition Plan Check Requirement record.
|
DEV-732246 |
|
Vault does not show an error message to Document Control Homepage users attempting to execute user actions for which they do not have permission.
|
DEV-769725 |
|
The Auto-Start Periodic Review job fails to run when attempting to process more than 1,000 eligible documents.
|
DEV-780001 |
|
Vault does not start External Collaboration workflows when the number of selected users exceeds the number of available external user licenses.
|
DEV-783584 |
|
When the TRIA object page layout is configured with the Training Requirement Training Matrix section, Vault displays a server error to users attempting to manually create a TRIA record in Business Admin.
|
DEV-792933 |
|
Vault displays an Unexpected error instead of a Page Not Found error to users who do not have View permissions for the Batch, Batch Disposition, Batch Disposition Check, or Batch Disposition Item objects.
|
DEV-804351 |
|
A server error occurs when users attempt to resubmit a Spark message from a User Exception Item.
|
DEV-819139 |
|
The Save functionality on the Reassign External Collaborator dialog seems to respond slowly when users reassign a task to a different external collaborator. If a user clicks the Save button again, an unexpected error occurs.
|
DEV-822362 |
|
An unexpected error occurs when users attempt to create a Related Event record without a related record.
|
DEV-826542 |
|
If an Action Step has no Read permission for the Step ID, Step Status, or Step Name fields, an unexpected error occurs when a user executes the Download as PDF action.
|
DEV-829211 |
|
If a user selects a comment from a dry run, which relates to a step on another page which has been deleted after the page was loaded, the user may receive a warning message twice that the step has been deleted.
|
DEV-831279 |
|
When users execute the Run Quality Record Check user action, Vault sorts the Type list alphabetically by API name rather than alphanumerically by label.
|
DEV-831355 |
|
The Risk Builder tool is not respecting the Create permissions for the Assessment Risk Mitigation object.
|
DEV-832807 |
|
When the Email Body section control is configured on one of the layouts for the Quality Event object, an unexpected error occurs when a user attempts to view a standard Quality Event record.
|
DEV-833248 |
|
When users edit a cell using the Tab key in the Risk Builder in edit mode, the cursor moves to the next row and column before moving to the correct cell.
|
DEV-836797 |
|
When users select a person who is not an existing user and run the Reassign External Collaborator action, Vault reassigns the task but does not update the External Collaborator field with the reassignment.
|
DEV-839238 |
|
A server error occurs when users execute the Deep Copy action for template test scripts and the action is configured without the Copy to New Deliverable option.
|
DEV-842967 |
|
The Risk Builder tool can perform slowly when more than 20 records are added or edited and saved at a time.
|
DEV-843116 |
|
An unexpected error occurs when users search for single or multiple space characters in the Risk Builder.
|
DEV-843358 |
|
Vault displays the object API name instead of the record name in the subject heading for notification emails created with the Create Record from Template Job Complete template.
|
DEV-843887 |
|
Vault does not populate the Creation Reason field on Training Assignments generated as a result of the Require Retraining action.
|
DEV-845049 |
|
When a customer enables dry run for test scripts and uses the Dry Run Authoring Review state as part of their pre-approval workflow, and an Author or Co-Author who is assigned a task uses the Author Test application page, the workflow Complete button does not appear.
|
DEV-846057 |
|
When users remove some Suggested Match Terms while running a new recurrence check, Vault incorrectly displays the removed terms in the View Match Criteria and the Refresh Results dialogs. However, the search results are correct and do not consider any of the removed Suggested Match Terms. This issue occurs only when terms are removed and does not apply to the Refresh Results process.
|
DEV-847946 |
|
Clicking Save in the Risk Builder tool does not trigger the Save functionality until some other cell is double-clicked.
|
DEV-854893 |
|
When a Batch Disposition Check Item Requirement references a classified document, Vault fails to create the Batch Disposition Item because the classified document cannot be copied.
|
DEV-857157 |
|
Two new DocTypes and Standard Reports, Matrix Assignment: Trial Team Evidence of Training and Matrix Assignment: Site Evidence of Training, were incorrectly provisioned as Active instead of Inactive in all Quality Vaults. As of the 25R2 General Release (25R1.3 Limited Release), the DocTypes are Inactive in all Quality Vaults (including all Study Training Vaults) and can be re-activated as required. Customers not using Study Training can ignore the Standard Reports.
|
DEV-857470 |
|
Generating the Adverse Event Report PDF for Complaints can fail with an error.
|
DEV-857860 |
|
When users enter the Risk Builder in edit mode, Vault skips ahead and does not load an entire page of risks.
|
DEV-858607 |
|
An unexpected error occurs when users click Save in the Select Columns to Display dialog in the Risk Builder.
|
DEV-858650 |
|
Vaut performs a lifecycle state change on Quality object records synced with RIM object records when the RIM records do not have a lifecycle state.
|
DEV-861786 |
|
An unexpected error occurs when users search for a numeric value in the Risk Builder.
|
DEV-862349 |
|
The Import Template Requirement Set action fails with an error when the target Validation Entity belongs to a Validation Entity Family.
|
DEV-862917 |
|
When a user executes the Generated Merged PDF Document user action, Vault generates the document but does not assign the user as the Owner, leaving the user unable to view the document.
|
DEV-866284 |
|
When the Do Not Copy checkbox is enabled on the Validation Requirement object, the Requirement Owner field displays the source Requirement Owner instead of being blank.
|
DEV-868211 |
|
Users are unable to remove documents from a Batch Disposition Check if the document name is too long.
|
DEV-868336 |
|
A server error can occur on a cloned Vault when you configure the Quality Team section on a Deviation or Complaint object.
|
DEV-868489 |
|
Items are created for a Change Control Check when the Change Control is not in a configured state for the genealogy batch.
|
DEV-869127 |
|
Health Effect Clinical Codes and terms are not rendered in the PMDA Form 8 XML.
|
DEV-869681 |
|
A Validation Error record is created for Health Authority Section Number Ca.2.1 when the Current Status of Medical Devices value is set to Not Collected or Unknown.
|
DEV-869686 |
|
In the Risk Builder, the process step selector may not consistently appear after clicking the reorder button.
|
DEV-870637 |
|
In some cases, Vault does not properly capitalize nouns in German translations.
|
DEV-870862 |
|
In some cases, Learners are unable to complete a classroom training Confirm Attendance task.
|
DEV-872038 |
|
A server error occurs when users delete a Quality Team Role and then click Manage Team to update the Quality Team.
|
DEV-873463 |
|
Users attempting to manually close a TRIA record receive an SDK error related to the record’s Execution Date field.
|
DEV-873914 |
|
Vault experiences a batch size error after services run the Determine Reportability action when a Reportability Assessment reaches the Complete state.
|
DEV-873972 |
|
In some cases, Vault does not cancel Training Assignments when a Learner Role is removed from a Person.
|
DEV-875190 |
|
If users have permissions granted only through App Security, they cannot edit the Owner field on a Check Task. Vault displays an unexpected error instead.
|
DEV-875944 |
|
In some cases, the risk builder crashes for users attempting to update the Date or Date & Time fields.
|
DEV-876693 |
|
In some cases, Vault moves Adverse Event Report records to the Draft state instead of the Closed state.
|
DEV-878626 |
|
Some standard notification templates for recomputing the risk matrix do not contain labels.
|
DEV-881350 |
|
The Learner Homepage does not load for Learners when their assigned Curricula are associated with a large number of open Assignment Detail records.
|
DEV-881655 |
|
Users are unable to open downloaded QR code PDF files from .docx documents with a new-line character in the document name.
|
DEV-881871 |
|
The label and help text for the Application Setting which enables Vault to delete Extensible Controlled Copy-related records inadequately describe the setting’s behavior.
|
DEV-887577 |
|
When a workflow increments the major version of Organization History records, users may not be able to view those records from the History layout section.
|
DEV-888655 |
|
Training Assignments may not be assigned or cancelled properly when a duplicate association for the same Learner role and Person is created.
|
DEV-888950 |
|
The External ID field is not available on the Product Family and Product Variant objects.
|
DEV-894010 |
|
In Validation Management, if a user tries to delete a reference table and the requirement owner (via a Validation Team Assignment) is an inactive user, the deletion may fail without displaying an error message.
|
DEV-895533 |
|
When Vault attempts to delete document fields referenced by Visual Hierarchy Configurations, the resulting error does not include the configuration’s name.
|
DEV-903718 |
|
Vault displays Document Association Criteria configuration errors with field names instead of labels.
|
DEV-903720 |
| Description |
Issue No. |
|
Vault annotation links with override or without override are still resolved when Source for Published Document is changed from VR to SD on source EDLItem.
|
DEV-667439 |
|
When the target is up-versioned with a corrupted document, the Permalink navigates to an older version of the target document
|
DEV-726451 |
|
In some cases, direct data manger jobs fail due to an error in processing the active_dossier_loader__v object.
|
DEV-825791 |
|
When the comparison viewer is opened on an existing browser tab where a different comparison is already opened, Page Not Found is displayed.
|
DEV-826405 |
|
An error occurs when a user accesses the Activity record if the related Event record is not accessible by using the sharing rules.
|
DEV-827498 |
|
When a user opens the comparison viewer by directly copy and pasting the URL, the user is redirected to the dispatch message detail page.
|
DEV-828469 |
|
In some cases, Vault generates an exception when creating Edit API Requests.
|
DEV-829116 |
|
In some cases, Vaults displays an empty Data Listing Data Definition folder in the Submissions Archive Viewer.
|
DEV-835671 |
|
Vault incorrectly clears filtered records for users selecting Drug Product Details while creating Registrations in bulk.
|
DEV-838556 |
|
When application triggers are applies, a loading batch error is displayed
|
DEV-843597 |
|
In some cases, a placeholder is published on Deduplication scenario when a user matches an existing document to a Content Plan Item with a duplicate Published Output Location.
|
DEV-845314 |
|
The Split Activity wizard allows users to advance past Activity records with blank custom required Activity object fields.
|
DEV-845492 |
|
Publishing may fail when large PDFs are matched to Content Plan Items and the Source For Published Document field is set to Source Document.
|
DEV-845566 |
|
Users encounter a misleading error message when the Merged Document field is not available.
|
DEV-845713 |
|
Under certain circumstances. users may not receive validation errors on ZA v3.1 - Rule 2.2.1 when they should.
|
DEV-845794 |
|
The Object/User search picklist in the Content Plan Viewer is returning incorrect results.
|
DEV-846453 |
|
When a user selects a Change Item to be created but does not select an Application, the Create Related Records wizard creates Activity Change Items according to the results CSV, but does not display them in the preview.
|
DEV-846485 |
|
In some cases, the file extension in the Published Output Location is removed for MP4 files created by the RIM-PromoMats Connector.
|
DEV-846918 |
|
In some cases, duplicate on-demand publishing jobs are not cleared from the queue.
|
DEV-846958 |
|
In some cases, a user interface error occurs in the Active Dossier Viewer if the Boolean field is hidden from atomic security lifecycle state.
|
DEV-847368 |
|
When a parallel on-demand publishing job fails, the job name is not populated.
|
DEV-847932 |
|
In some cases, Vault Admins cannot remove a verification group from the corresponding sub-setting on the “Send manage registered details for verification” Application Setting.
|
DEV-848047 |
|
When the placeholder which refers to the cross application document is corrected after the harmonization job is run, the corrected placeholder document is not displayed in the viewer.
|
DEV-848222 |
|
In some cases, users receive validation error 1850 due to leaf life cycling between multiple publishing active submissions.
|
DEV-850454 |
|
When generating a UDI Submission and Publishing validation rule BR-UDID-722a is violated, the results CSV indicates a generic unexpected error instead of detailing the specific failure.
|
DEV-850668 |
|
Users may receive a false negative on EU 11.10 in cases where source and target CPIs for non-new operations have different language attributes.
|
DEV-851011 |
|
In the Submissions Archive Viewer for ICH eCTD 4.0 submissions, when a Clinical Study section (identified by a sender-defined keywords using ICH Keyword Definition Type 'study id_study title') was expanded manually level-by-level, columns such as 'XML Clinical Study', 'ICH Document Type', or 'XML Clinical Site' could appear blank for documents and sub-sections within that study. A similar issue occurred if these columns were added to the view after the study sections were already expanded.
|
DEV-852007 |
|
Users may receive a false positive for US rules 1734 and 1738.
|
DEV-852375 |
|
When previewing Activity Change Item records created in bulk, the results CSV displays “Not Applicable” instead of the Event Change Item ID.
|
DEV-852633 |
|
Dispatch comparison includes the CPI since it is under a parent section which has CPT Constraint and dispatch status is Ready for Review.
|
DEV-852841 |
|
CMED wizard users are unable to select the Apply button when the Contains Core Safety Information field on the Labeling Concept object is configured to be required and selected as “No” (false).
|
DEV-853767 |
|
The doc_type_detail_v object is queried to get document information during drag and drop population.
|
DEV-854306 |
|
In some cases, the Active Substance name does not update appropriately.
|
DEV-856016 |
|
Required custom DateTime fields display as optional within the Create and Manage Event Details wizard.
|
DEV-856153 |
|
Users without Create and Edit permissions for the Content Plan and Content Plan Item objects receive a generic unexpected error when attempting to generate a Global Content Plan comparison.
|
DEV-856287 |
|
Previously, after expanding / collapsing a section and or applying a sort order to an expanded section (such as 'Sort By Descendants A-Z') within a section of the Submissions Archive Viewer, performing actions like scrolling the screen could cause the sort functionality to behave erratically. This could result in the sort options becoming unresponsive to clicks and the incorrect sort option appearing as disabled (greyed out).
|
DEV-856416 |
|
When using the Download Notes action from a document in Submissions Archive Viewer, the message "403. Sorry you do not have permission to view this page. Contact us if you feel you have reached this page in error" would appear.
|
DEV-856997 |
|
When managing registered details, users may experience extended wait times while Vault commits unverified data.
|
DEV-857182 |
|
In some cases, publishing fails when the "Related Submission Id" field is empty.
|
DEV-857848 |
|
When the Enable Labeling Automations setting is enabled and the Activity object does not have a configured lifecycle, users updating Activity records receive a generic Server having problems error.
|
DEV-858765 |
|
When multiple page layouts apply to a Registration or Registration join record, the first created page layout determines the input fields displayed for the record on the Edit and Verify page instead of the default page layout.
|
DEV-860397 |
|
Users may receive false positives for CA region rules B35 and B37 on published documents with the .docx extension.
|
DEV-861547 |
|
The Submission Type filter is not displayed when when View_isEmpty is applied.
|
DEV-861889 |
|
Users without Read permissions for the Activity object’s Event or Local Disposition fields receive a generic Server having problems error when attempting to dispatch a Global Content Plan.
|
DEV-862020 |
|
When generating an Excel file from the Content Plan Viewer, Vault does not include Global ID values for matched documents.
|
DEV-862392 |
|
In some cases, when presentation strength values are blank on a source record, Vault miscalculates the corresponding PLL Denominator field values on the resulting idmp_manufactured_item_ingredient__v records.
|
DEV-862410 |
|
Vault does not resolve tokens in translated help text for unmapped documents in the Content Plan comparison view when the user’s Vault language is not English.
|
DEV-862561 |
|
Single submission export may fail for submissions if a metadata field that forms part of the submission's source file path (per the Dossier Format: Parameter field, which could contain for e.g., Submission Name, Application Folder Name, Sequence ID) ends with an ellipsis ('...'). Users may encounter an error such as 'Unable to Export Submission, The selection contains zero (0) files.' As a workaround, submissions affected by this issue can typically be exported using the bulk export feature.
|
DEV-863029 |
|
When Vault cannot dispatch a Global Content Plan due to an inactive document set, users incorrectly receive a message that results are attached to Dispatch Message records.
|
DEV-863448 |
|
Submission publishing may fail when a Published Output Location contains special characters.
|
DEV-863775 |
|
Users with limited permissions may become stuck on the page while attempting to use the Registration Wizard.
|
DEV-864647 |
|
In some cases, users without permission for the Activity object’s Related Application field receive errors when attempting to create Regulatory Objective records in bulk.
|
DEV-865393 |
|
When automatically generating a Content Plan in RIM via the RIM-PromoMats Connection, if CPI splitting first fails and later succeeds, the Source for Published Document field may be set incorrectly.
|
DEV-865576 |
|
Users may receive false positives on EU v8.1 rules 16.5 and 16.1 due to an issue with PDF validation.
|
DEV-866322 |
|
Table of Contents documents in report level content plans may be generated incorrectly.
|
DEV-866714 |
|
Submission publishing may fail when a Published Output Location contains special characters.
|
DEV-866981 |
|
The Create and Manage Event Details wizard preview displays Event relationship object DateTime fields as “invalid date” when configured with a default value.
|
DEV-867279 |
|
In some cases, the Calendar drop-down obscrues the error message when the date or date time field is edited in the tabular view.
|
DEV-867339 |
|
Users may receive a false negative for 15.BP3.
|
DEV-867743 |
|
When generating Event Shelf Life records via the CMED wizard, users may create records with invalid field combinations.
|
DEV-869256 |
|
The Approval Type field is not being updated on existing Active Dossier Item Details when loaded in with Active Dossier Loader.
|
DEV-869828 |
|
In some cases, new Active Dossier Templates have the incorrect Reference Model set.
|
DEV-869904 |
|
The Create and Manage Event Details wizard preview does not generate when the intended updates include clearing previously-populated Number or DateTime record fields.
|
DEV-870569 |
|
Under certain circumstances, during UDI Submission Generation, the system fails to include some Market Information.
|
DEV-871381 |
|
When using the Created Related Records wizard and replacing a record with one that has a blank field value, the system uses the value from the old record instead.
|
DEV-871405 |
|
Vault includes the incorrect version in XML for Basic UDI-DI/EUDAMED DI updates.
|
DEV-871526 |
|
Vault includes the incorrect version in XML for UDI-DI update submissions when a UDI includes container packages.
|
DEV-871529 |
|
When generating Event Shelf Life records via the CMED wizard, users may create records with invalid field combinations.
|
DEV-871848 |
|
Users may experience performance issues when running Submissions that include a Table of Contents on-demand from a non-root Content Plan.
|
DEV-873524 |
|
When the Global ID field’s default security setting is Hidden, Vault still displays it in the Content Plan Viewer.
|
DEV-873726 |
|
Create and Manage Event Details wizard users are unable to populate the Manufacturer field on Event Product records when the Product Manufacturer object uses custom instead of standard pharmaceutical product and manufacturer fields.
|
DEV-873795 |
|
Users may receive false positives on CN Rules 3.16, 4.1.31, 3.36 and 5.19.
|
DEV-874551 |
|
Table of Contents documents may be generated successfully even when they contain tokens in incorrect locations that should cause the generation to fail.
|
DEV-874742 |
|
Users may receive a false negative for WHO rule E.05 .
|
DEV-878038 |
|
In some cases, Vault deselects existing Change Items when a Create and Manage Event Details wizard user creates a new Change Item.
|
DEV-878288 |
|
Users receive an error when importing a Japanese eCTD 3.2 submission when a leaf undergoing a Delete operation does not have a Title attribute defined.
|
DEV-878530 |
|
Under certain circumstances, the Content Plan Hierarchy State Change action fails to execute.
|
DEV-878717 |
|
When a Create and Manage Event Details wizard user populates, saves, and then updates a rich text field, the updates do not appear when selecting Show More from the wizard’s main screen.
|
DEV-881663 |
|
Duplicate records are created when the Rich Text, Long Text, Percent, Currency data type fields are populated on the vault loader file.
|
DEV-881887 |
|
Under certain circumstances, unexpected Submission and Regulatory Objective join records may be created for users who are using Created Related Records, Bundle Regulatory Objective, and Bundle Activity.
|
DEV-881907 |
|
If a submission lifecycle is not configured in the vault, archive viewer doesn't show the contents of the submission.
|
DEV-882412 |
|
Duplicate Application Join Records may be unintentionally uploaded to Vault via bulk record update and creation processes such as Vault Loader.
|
DEV-882724 |
|
Users may receive false negatives on ZA Rules 6.3.8 and 6.3.9.
|
DEV-883265 |
|
When the "Binder Unbound Document Display Options" setting enabled, users receive "lIfecycle" is null" error when starting a workflow.
|
DEV-884981 |
|
Users may receive a false positive for rule 1736.
|
DEV-886280 |
|
In some cases, users receive a server error when starting a binder workflow with entry actions.
|
DEV-887767 |
|
The Cumulative View grid overlay user interface shows a misleading user-facing message in the scenario where content is imported out-of-sequential order into Veeva RIM Submissions Archive. The user-facing message "An issue occurred while loading. Contact Veeva Support." instead of the Lifecycle History that is able to be displayed with the information available in Vault.
|
DEV-890973 |
|
When a column filter is applied, the Active Dossier region/country filter is not applied.
|
DEV-897065 |
| Description |
Issue No. |
|
When a Validation expression fails while the Void Case action is running, Vault moves the Case to the subsequent lifecycle state without completing all of the expected entry actions.
|
SAF-68736 |
|
During Case promotion through the Inbox Item to Case Compare page, when the Case Compare Followup layout excludes both a field and its Reason Omitted counterpart, Vault displays an error message and prevents follow-up Case creation.
|
SAF-69200 |
|
When running the Upgrade to Latest action to update a Vault's active MedDRA dictionary version, the update sometimes times out, and Vault displays an error message.
|
SAF-69245 |
|
When automated Case promotion fails, Vault does not apply Access Groups to the related Inbox Items.
|
SAF-72212 |
|
If follow-up information adds a new Case Product to a Case that is reportable to the PMDA, when Vault performs the one-time data sync to the Japan Localized Case, it generates duplicate Localized Case Assessments for the original Case Product.
|
SAF-72835 |
|
When an Inbox Item with a Localization value is being merged to an in-flight Case or promoted to a follow-up Case and is matched to a global Case, if two (2) or more Case Products are being deleted, Vault displays an error message and prevents the action.
|
SAF-73127 |
|
When attempting to promote an Inbox Item that has no patient information and is in the Marked for Follow-Up state, if Vault matches to a domestic Case, an error appears when loading the Inbox Item to Case Compare page.
|
SAF-73298 |
|
In some cases in Vaults with the Load Terms for Abstract Highlighting setting enabled, SafetyDocs unexpectedly does not highlight MedDRA Query or MedDRA Synonym terms in the Abstract field of a Literature Article.
|
SAF-73311 |
|
Inbox Items cannot be merged to in-flight Cases or promoted to follow-up Cases if the matched Case has any Localized Cases and the user deletes a Case Product on the Inbox Item to Case Compare page.
|
SAF-73315 |
|
When generating PMDA E2B(R3) files for follow-up Cases initially created by the Safety-Medical Connection, Vault does not format the C.1.4 data element correctly when exporting the Initial Receipt Date from the global Case.
|
SAF-73738 |
|
When conducting automatic literature searches in Vaults with the Literature Article Automatic Search job enabled, SafetyDocs unexpectedly displays an error notification stating that no records were created for Literature Standard Search Terms with Enable Automatic Search turned off or when the Vault contains no Literature Standard Search Terms.
|
SAF-73812 |
|
When creating a follow-up Case through the Inbox Item to Case Compare page, when duplicate Localized Case Assessment Results exist on at least one (1) Localized Case, Vault prevents creation but does not provide a clear error message about the required data correction.
|
SAF-73815 |
|
When generating E2B(R3) files for a Case linked to a Literature Article in a SafetyDocs Vault, Vault encodes multiple articles in a single C.4.r.1 block and concatenates the data with a semicolon, instead of encoding each article in a separate block.
|
SAF-74075 |
|
On generated readable renditions of EMA E2B(R3) files, the G.k.2.2.EU.9.r.1 data element does not appear.
|
SAF-74166 |
|
In Vaults configured to isolate blinded clinical trial information, when syncing follow-up information from a global Case to a Japan Localized Case, Vault generates duplicate Localized Case Assessments.
|
SAF-74367 |
|
When a user runs the Void Case action multiple times in quick succession, Vault generates duplicate Transmissions.
|
SAF-74432 |
|
When transferring data through the Medical-Safety Connection, if the data includes an emoji, transfer to the Safety Vault fails, preventing Inbox Item creation.
|
SAF-74456 |
|
In some cases, if SafetyDocs encounters an error when generating reports while running the Schedule Obligation action, Vault does not send an error notification.
|
SAF-74750 |
|
Cases generated from the Copy Case action do not have Case Unique Number values.
|
SAF-74920 |
|
Vault does not generate CIOMS I Distributions for Cases with multiple Case Test Result records when at least one (1) includes a partial date in the Test Date field.
|
SAF-75134 |
|
When a domestic Case is merged to a global in-flight Case or promoted to follow-up for a global initial Case, Vault does not set the Use Domestic State Code field to Yes.
|
SAF-75181 |
|
When generating Transmissions from Transmission Output Templates that include a Reporting Family, Vault considers the Exceptions to PII Masking field of the related reporting rule parameter instead of the Exceptions to Patient Content Protection field on the Transmission Output Template.
|
SAF-75198 |
|
When generating an MFDS E2B(R3) file for a domestic study Case with a value in the Local Assessment Result field on the Localized Case Assessment Result, Vault populates an E2B code in the G.k.9.i.2.r.3.KR.1 data element.
|
SAF-75209 |
|
When promoting an Inbox Item to a follow-up Case through the Inbox Item to Case Compare page, in some cases Vault removes capitalization, punctuation, spacing, and some special characters when comparing WWUIDs and prevents promotion to follow-up.
|
SAF-75313 |
|
When evaluating a Case with custom Validation Criteria, in some cases, the Vault Section field on Validation Results does not contain a hyperlink to the affected record.
|
SAF-75330 |
|
In Vaults configured to isolate blinded clinical trial information, when promoting a domestic Case as a follow-up to an imported, unblinded global Case through the Inbox Item to Case Compare page, Vault generates duplicate blinded records on the Localized Case.
|
SAF-75413 |
|
In Vaults configured to isolate blinded clinical trial information, when a new adverse event is added through a follow-up Case, Vault does not populate the Blinded Reference on Localized Case Assessment Results related to the new Case Adverse Event.
|
SAF-75414 |
|
In Vaults configured to isolate blinded clinical trial information, Vault prevents promoting a localized Inbox Item as a follow-up to a global Case that includes a blinded External Product through the Inbox Item to Case Compare page.
|
SAF-75482 |
|
When an Adverse Event is added to global follow-up Case through the Inbox Item to Case Compare page, Vault syncs the data from both the follow-up global Case and the previous foreign Localized Case to the follow-up foreign Localized Case.
|
SAF-75571 |
|
In rare instances, if a difference between the expectedness on the global Case and the local Japan Case causes the most conservative expectedness and Case Tags to be updated multiple times, Vault displays an error if the changes result in a non-unique Case Name.
|
SAF-75656 |
|
In Vaults configured to isolate blinded clinical trial information, after generating a Transmission with PMDA as the destination for an unblinded global Case, when Vault performs the one-time data sync to the Japan Localized Case, it populates the Blinded Reference field on unblinded Localized Case Assessment and Localized Case Assessment Results records.
|
SAF-75715 |
|
In Vaults with incorrect aggregate report templates, when attempting to generate any type of aggregate report, reports remain in the Generating state instead of moving to the Error state.
|
SAF-75862 |
|
If the version number of an initial Case is updated to a previously existing version number on the related follow-up Case and the follow-up includes a Validation Result Summary, after running Evaluate Regulatory Conformance on the initial Case an error message appears and indicates Vault cannot generate the Validation Summary Result record due to a duplicate name issue.
|
SAF-75888 |
|
When a user runs the Generate Local Reporting Details action on a follow-up Case reportable to the PMDA and the Destination Case ID of the Local Reporting Details record contains a value, Vault sets the Reason on the Transmission to Initial instead of Follow-up.
|
SAF-75915 |
|
When a user copies a Case with a value in the Initial Case field, Vault copies the Initial Case value to the new Case.
|
SAF-76026 |
|
If a Study Product Group is selected during Study Arm creation, Vault does not apply the Study Product Group selection upon Save.
|
SAF-76035 |
|
If any Inbox Item or Case that generates email correspondence is missing a Reporter-type Case Contact, Vault cannot send any scheduled email correspondence.
|
SAF-76060 |
|
When attempting to generate Health Canada E2B(R2) files that use custom SDK, Vault does not generate the file and provides an unclear description of the issue in the error message.
|
SAF-76062 |
|
When attempting automatic Case promotion using the Override merge method for an imported E2B file, if the matching Case is in a prohibited state based on the Allow Mark Follow-up application settings, Vault does not promote the Inbox Item to a follow-up Case.
|
SAF-76065 |
|
FDA E2B(R3) generation fails for Cases with attachments in the .docx format.
|
SAF-76205 |
|
On generated FDA E2B(R3) files, the FDA.E.i.3.2h data element tag appears as E.i.3.2h and the FDA.G.k.10.1 tag appears as FDA.G.k.10.r.1.
|
SAF-76262 |
|
For exported NMPA E2B(R3) files, Vault does not populate the C.1.CN.3 data element as expected.
|
SAF-76291 |
|
Vault populates the C.2.r.3 Reporter's Country Code data element on PMDA E2B(R3) files for non-primary reporter Reporter-type Case Contacts.
|
SAF-76439 |
|
In Vaults configured to isolate blinded clinical trial information and with the Exclude reporting rule parameter set to Placebo, for a double-blinded study Case with an unblinded Case Product record for the Placebo, the reporting rule engine evaluates the blinded record instead of the unblinded record.
|
SAF-76457 |
|
For JSON-imported Cases created using tabular data format import, if a Case includes a Parent Information Case, after import the Inbox Item is blank.
|
SAF-76513 |
|
When generating E2B files for a Case in the Superseded state, Vault exports the date of report generation instead of the Approval Date on the Case to the N.2.r.4 and C.1.2 data elements of E2B(R3) formats and to the A.1.3b data element of E2B(R2) formats.
|
SAF-76676 |
|
In some cases in Vaults with the Literature Article Automatic Search job enabled, SafetyDocs encounters an error when searching the PubMed database and does not generate the expected Literature Review and Literature Article records.
|
SAF-76734 |
|
On readable renditions of FDA E2B(R3) files, Vault displays nullFlavors outside of tables.
|
SAF-76781 |
|
When generating FDA E2B(R3) and FDA VAERS E2B(R3) forms for Cases with Combination Products that have multiple devices, Vault does not populate the FDA.G.k.12.r.6 Device Product Code data element.
|
SAF-76816 |
|
For Inbox Items imported through a multi-Case tabular CSV file or multi-CSV ZIP file, after Case promotion Vault duplicates Case Assessments.
|
SAF-76819 |
|
In some cases, when updating the Indication (Reported) field on a Case Product record from a nullFlavor to a coded term, Vault fails to update the Product Indication card header to the coded MedDRA term.
|
SAF-76828 |
|
When attempting to promote an Inbox Item created through tabular data import, if Parent age number and unit values exist but Patient age number and unit values are blank, Vault prevents Case promotion.
|
SAF-76901 |
|
When generating E2B readable renditions, Vault does not display the G.k.5a and G.k.9.i.3.2b data element codes correctly and does not include all Case Assessment Results.
|
SAF-76920 |
|
In Vaults configured to always use the CBER Study Transmission Profile when the Study Product Type is Biologic and the CDER Study Transmission Profile for any other Study Product Type for clinical trial study Case submissions with no Transmission Profile specified on the Study Registration, Vault does not evaluate Inv. to Marketing (same agency) cross reporting when generating FDA E2B(R3) files.
|
SAF-76982 |
|
When merging an Inbox Item with a non-Japan Case Product Registration into an in-flight Japan Domestic Case with a Japan Case Product Registration that is not linked to a Local Reporting Details record, Vault displays an error message and prevents the merge.
|
SAF-77047 |
|
In Vaults configured to isolate blinded clinical trial information, after generating a Transmission with PMDA as the destination for an unblinded global Case, when Vault performs the one-time data sync to the Japan Localized Case, it populates the Blinded Reference field on unblinded Localized Case Assessment and Localized Case Assessment Results records, which prevents follow-up creation.
|
SAF-77141 |
|
On FDA E2B(R3) files, for non-clinical trial study Cases, Vault incorrectly exports values to the FDA.C.5.5a IND Number where AE Occurred, FDA.C.5.6.r IND number of cross reported IND, and G.k.1.a FDA Other Characterisation of Drug Role data elements.
|
SAF-77145 |
|
SafetyDocs cannot save a Product Alias with an Alias value longer than 128 characters.
|
SAF-77174 |
|
When editing a Product on a domestic Case, the Indication (Reported) fields display unexpectedly, with labels misaligned with input fields, the Auto-code button enabled when no input has been made, and confirmation and failure messages displaying in an unexpected font.
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SAF-77205 |
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After importing a multi-Case tabular CSV file or a multi-CSV ZIP file to Inbox Item, Vault does not map values for the Study Type of the Case or the Reaction Recurrence of Case Assessments.
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SAF-77216 |
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After importing a multi-Case tabular CSV file or a multi-CSV ZIP file to Inbox Item, Vault does not map the Gestation (Unit) value.
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SAF-77217 |
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After auto-coding an Adverse Event on an Inbox Item, if the user collapses and re-expands the Adverse Event section, Vault clears the MedDRA code.
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SAF-77245 |
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For imported Inbox Items, the Source Data pane for Patient information displays labels with "Gender" instead of "Sex".
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SAF-77263 |
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For manually created Transmissions with blank Transmission Reason values, Vault does not generate Distribution documents and does not send a notification with the reason to the user.
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SAF-77297 |
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For exported NMPA E2B(R3) files, Vault does not populate the G.k.CN.3 element as expected.
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SAF-77509 |
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When generating EU Convention E2B(R2) files with Patient Content Protection set to Mask PII, Vault does not apply masking correctly, which sometimes results in NACKs.
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SAF-77512 |
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When the A.2.2 or C.4.r.1 Literature Reference(s) data element exceeds 500 characters, Vault does not truncate the value, resulting in NACKs from agencies.
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SAF-77604 |
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When attempting to merge an Inbox Item to an in-flight Case, if a user selects Ignore on any Product or Adverse Event on the Inbox Item to Case Compare page, Vault displays an error message and prevents the merge.
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SAF-77677 |
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After running the Retrieve Reportable Case Product Registrations action on a blinded Japan Localized Case, Vault incorrectly generates investigational registrations on the Case Product.
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SAF-77682 |
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In Signal, running the Calculate action for the EBGM Signal Calculation Run results in an error when the expected or actual counts return a value of zero (0).
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SAF-77749 |
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For Rule Engine-created Transmissions to the FDA, Vault considers all Transmission Profiles, instead of the Registration Type of Transmission Profiles (Investigational or Marketing), when finding and inactivating duplicate Transmissions, resulting in incorrect inactivation and creation of Transmissions.
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SAF-77911 |
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When generating E2B(R2) formats, Vault exports more than five (5) characters to the B.4.k.13.1a and B.4.k.13.2a data elements, resulting in NACKs.
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SAF-78049 |
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When generating Transmissions from a Transmission Output Template for a destination with a previous Transmission, Vault populates some fields based on the Transmission Profile instead of the previous Transmission.
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SAF-78066 |
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When generating FDA E2B(R3) files, validation fails when the FDA.C.5.5a IND Number where AE Occurred data element is populated and the associated Transmission Profile is a postmarket CDER or CBER.
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SAF-78067 |
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When importing custom E2B formats with many Case Assessment updates, in some instances, Vault displays a memory usage error.
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SAF-78087 |
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Vault prevents copying Workbench Views that include SQL-restricted terms anywhere in the View.
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SAF-78100 |
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On adverse event terms coded using the multilingual MedDRA Browser, Vault displays the Non-Primary tag for terms with Yes in the Primary SOC field.
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SAF-78149 |
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In some instances, E2B-imported Cases do not include all expected Case Assessment Results.
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SAF-78168 |
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In some instances, Vault does not create any Correspondence records due an exceedingly large number of MedDRA Criteria object records with the Include Lower Level field set to Yes.
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SAF-78204 |
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When adding a Base Case Product to the Case Products section of a domestic Case for Korea or Japan, the expected Launch Korea Drug or Launch JDrug button does not appear in the Product Coding Browser.
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SAF-78215 |
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In Vaults configured with both the "Suppress File Generation for Auto-Submit Transmissions" and "Regenerate Email Transmissions When Submitting to Gateway" application settings enabled, after generating Transmission documents for Auto-Submit Email Transmissions and running the Submit to Gateway action on a Case, Vault does not send documents and Transmissions remain in the Ready state.
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SAF-78216 |
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In Vaults with the "Suppress File Generation for Auto-Submit Transmissions" application setting enabled, for Email Profile-type Transmission Profiles with Auto-Submit set to "Yes", after running the Case-level "Async Submit to Gateway" action, the Transmission remains in the "Queued for Submission" state and no Submission document is generated.
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SAF-78218 |
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When generating NMPA E2B(R3) files, for External Products Vault exports the Generic Name from other Case Products to the G.k.CN.1 data element, although External Products should be excluded.
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SAF-78250 |
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For Product Registrations with a Registration Applicant/Holder value that exceeds 60 characters, Vault prevents saving the related Case Product on a domestic Case because the number of characters cannot be mapped to the same field on the Localized Case.
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SAF-78265 |
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When migrating study data through the Safety-Clinical Operations Connection, Vault creates Study and Study Registration records in Safety Vaults for Study and Study Country records in Clinical Operations Vaults with "M" in the Study Migration field.
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SAF-78309 |
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When uploading new and changed custom Units of Measurements, for CSV file rows with multiple Group values, Vault creates Unit of Measurement records with a single Group value.
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SAF-78359 |
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When coding adverse events through the MedDRA Browser, if a user selects a term that is not in the MedDRA Dictionary and selects the Confirm button twice, Vault creates duplicate MedDRA Term records.
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SAF-78364 |
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For users with the Windows operating system, the MedDRA Browser includes two (2) scroll bars.
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SAF-78365 |
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In Vaults with the Change Localized Case State on Creation application setting enabled, when the Localization value of a domestic Case is a country under the EMA's jurisdiction, after Submission generation the Localized Case lifecycle state does not move from "Active" to "Ready for Localized Processing".
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SAF-78396 |
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On Cases created from E2B(R2) files, if the B.1.9.3 data element value is "3", Vault populates "No" in the Autopsy field on the Case Patient record.
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SAF-78417 |
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When the Reason field on a Transmission is blank, Vault does not generate PMDA MHLW Paper Forms.
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SAF-78452 |
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In some instances, the number of Closed Cases included in Case Volume Metric reports is lower than those counted based on the Process Completion Date field on the Case object.
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SAF-78503 |
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In Vaults with the Change Localized Case State on Creation application setting enabled, when users manually create Transmissions, Vault moves the lifecycle state of related Localized Cases in the "Approved" or "Closed" state to the "Ready" state type.
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SAF-78508 |
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In some instances, when Auto-Submission is generating a high volume of Transmissions, Vault attempts to submit Transmissions before initial document generation completes, resulting in no response from the partner or health authority.
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SAF-78554 |
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When generating FDA E2B(R3) files, Vault maps FDA Concept Codes (NCI Concept Identifiers) to the C.2.r.4 Qualification data element, instead of E2B codes.
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SAF-78755 |
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On generated Workbench Serious Adverse Reaction (SAR) Line Listings, if the active date of the selected Datasheet does not match Case expectedness evaluations based on date range, Vault leaves the Listedness column blank instead of populating "Unlisted".
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SAF-79089 |
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In Vaults with the One Last Time Reporting for all Destinations application setting enabled, for Cases with the Transmission Reason set to Amendment or Nullification, Vault does not copy the Transmission Reason value from the Case to the Reason field of One Last Time (OLT) report Transmissions.
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SAF-79100 |
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When searching for a product code in the Korea Drug Browser window, Vault returns no results for search terms that start with uppercase English alphabet characters.
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SAF-79315 |
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When transferring PQCs from a Safety Vault to a Quality Vault through the Quality-Safety Connection and an error exists, Vault does not create the correct User Exception Message for Cases with more than 500 Case Assessments.
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SAF-79503 |
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When users run the Copy Case action on a global Case or a non-Japan domestic Case, Vault duplicates Case Product Registration records on related foreign Japan Localized Cases and displays an error message when users run the Evaluate Reporting Obligations action.
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SAF-79693 |
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When generating MFDS E2B(R3) files for E2B-imported Cases with Parent Information, Vault exports the local Study Number instead of the global Study Number to the C.5.3 data element.
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SAF-79710 |
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After coding a term from the Korea Drug Dictionary, Vault adds the MFDS Standard Drug code, instead of the Local MPID, to the Korea Drug field.
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SAF-79718 |
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When mapping online questionnaire responses to follow-up Inbox Items, Vault does not map picklist field values, including Seriousness on Case Adverse Events and Race, Pregnancy Outcome, and Delivery Method on Cases.
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SAF-79780 |
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When transferring Adverse Events through the Medical-Safety Vault Connection, where Rich Text fields in Medical Vaults are mapped to Long Text fields in Safety Vaults, Vault truncates values above 250 characters.
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SAF-79790 |
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The Submission Rule Log includes Passing Assessment IDs for failed custom Reporting Rule Parameters.
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SAF-79829 |
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SafetyDocs fails to generate Local RMPs when running the Create Local RMPs action on a Core RMP with multiple Product Registrations for the same Country.
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SAF-79872 |
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After updating the Narrative on a Case created through the Copy Case action, the Narrative Preview on the new Case continues to display the Narrative of the copied Case.
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SAF-79975 |
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In some cases when running the Create Local Implementations action on a Core Implementation Strategy, SafetyDocs fails to generate Local Implementation Strategies.
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SAF-80064 |
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In Vaults configured to isolate blinded clinical trial information and with the Re-generate Domestic Case entry action configured on the Medical Review lifecycle state, when the action runs on a follow-up domestic Case with a Parent Information Case, Vault does not generate the domestic Localized Parent Information Case.
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SAF-80066 |
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Users experience AS2 Connection issues after uploading a partner certificate with certificate chains.
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SAF-80128 |
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When the Re-generate Domestic Case action runs as an entry action on the Medical Review lifecycle state, Vault clears the existing narrative document on the Localized Case and then generates and links a new, blank localized narrative.
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SAF-80310 |
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On Cases created through tabular data import, Vault does not map Weight and Weight (unit) codes correctly.
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SAF-80360 |
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Vault does not include codes from the 2025 IMDRF dictionary version that have the new IMDRF status "Not selectable, Modified (editorial)".
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SAF-80370 |
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When coding External Products using the WHODrug Search browser on Cases, Vault does not truncate Registration values that exceed 60 characters.
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SAF-80376 |
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On imported Inbox Items, the Source Data pane does not include the Show More link on custom text fields with values longer than 500 characters.
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SAF-80418 |
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When generating FDA E2B(R3) files for study Cases that have a Case Adverse Event with a Seriousness that includes Death or Life Threatening, during postmarket cross-reporting for Investigational to Marketing submissions, Vault exports code 6 to the FDA.C.1.7.1 data element, resulting in rejections.
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SAF-80446 |
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During duplicate detection, Vault does not display follow-up Cases created from end of study bulk unblinding.
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SAF-80498 |
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After a user selects the Copy Record action on a Case, Vault displays a blank screen and does not create a copy.
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SAF-80551 |
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For Study Countries that fail the transfer through the Safety-Clinical Operations Connection, on subsequent data migration that includes those Study Countries, Vault does not reattempt to transfer the previously failed records.
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SAF-80553 |
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During domestic Case and Localized Case processing for Japan, when Vault populates a JDrug code on an External Product through WHODrug Cross Reference Tool (CRT) Japan mapping, Vault maps values of fewer than four (4) characters to the Local MPID field, preventing Case approval.
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SAF-80727 |
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When generating MFDS E2B(R3) files for domestic Cases, Vault populates the codeSystemVersion in the G.k.2.1.KR.1a and G.k.2.1.KR.1b data elements, resulting in rejections.
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SAF-80728 |
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When unblinding a Study Product with a value in the Country Obtained field, Vault fails to update its lifecycle state to Unblinded.
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SAF-80907 |
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When generating MFDS E2B(R3) files, if the Qualification on a Reporter-type Case Contact is Unknown, Vault does not include the codeSystemVersion and codeSystem values in the C.2.r.4 data element.
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SAF-80909 |
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When generating FDA E2B(R3) files, Vault does not include codeSystem values in the G.k.4.r.10.1 and G.k.4.r.11.1 data elements, resulting in rejections.
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SAF-80949 |
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When generating MFDS E2B(R3) files with Personal Identifiable Information (PII) masking, Vault exports values to the D.2.2 data elements when the D.2.1 data element includes the value "MSK".
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SAF-81044 |
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When users select PMDA MHLW Paper Form in the Addiitonal Transmission Document Type field on Submissions, Vault does not generate the form and the Submission moves into the Error state.
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SAF-81125 |
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Non-Vault Owner users cannot access PVA Obligations, PVA Activities, or PVA Reconciliations from PV Agreement records.
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SAF-81588 |
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The transfer of Product Quality Complaints (PQCs) through the Quality-Safety Connection fails when the Product Received value is blank.
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SAF-81636 |
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When transferring the Product Nomenclature Code from a Product in a RIM Vault to the FDA Product Code field on a Product in a Safety Vault fails due to character length, Vault does not provide an error message.
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SAF-81862 |
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When generating FDA E2B(R3) files, Vault populates the FDA.C.5.5a data element only for clinical trial study Cases.
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SAF-82611 |
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An error occurs when Vault attempts to generate follow-up correspondence for a Case that matches a Follow-up Rule Criteria with a formula expression that has more than 250 characters in the rule_expression_v field.
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SAF-82794 |
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Vault prevents associating an Alert Rule Set with more than ten (10) Signal Product Profiles.
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SAF-82811 |
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After Vault completes an Admin-initiated indexing of migrated Cases for duplicate detection, Vault clears the "Index Migrated Cases" application setting checkbox as expected, but also clears the value in the "Auto code min Product Confidence level" application setting.
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SAF-83017 |