The following applications may have different release dates: RegulatoryOne, Safety, and Veeva Claims.
| Description |
Issue No. |
|
In some cases, Vault fails to update the Monitoring Event Review Summary after open review comments are removed from the record.
|
DEV-704416 |
|
When using Study Selector instead of the Study filter, record exports may be blank.
|
DEV-711207* |
|
When linking Milestones and EDL Items, the Milestone may not be correctly applied to the matched documents.
|
DEV-711667 |
|
In some cases, Vault fails to show subsection validation information on Disclosure object records.
|
DEV-715112* |
|
In some cases, when a Safety Distribution includes a Distribution Task in a Cancelled or Rejected state, the entire distribution fails with no notification from Vault.
|
DEV-719107* |
|
Users may receive connection errors when attempting to perform transfers after disconnecting a study.
|
DEV-719606* |
|
CRA users with appropriate permissions cannot edit Study Person Responsibility records.
|
DEV-720106* |
|
When using the Generate CTN action, generated documents may be classified incorrectly.
|
DEV-720888* |
|
In some cases, Vault fails to report system processing when completing Revise and Return workflows.
|
DEV-721181* |
|
In some cases after deleting a document, Vault incorrectly displays "Document Request" for the deleted document in the End-of-Study Media grid.
|
DEV-721217* |
|
Vault incorrectly allows documents marked for recall to be selected for bulk Document Exchange.
|
DEV-721682* |
|
After sending documents to sites, Vault fails to populate the Connected Study Site field in the CSV results file.
|
DEV-722116* |
|
Vault fails to upversion documents uploaded from SiteVault to complete Update and Return tasks.
|
DEV-722806* |
|
In some cases when documents are created by CRA users, Vault fails to generate Site Connect notifications.
|
DEV-722810* |
|
In some circumstances after removing a Study Organization from a CTN, Vault incorrectly displays a Study Organization validation error.
|
DEV-723065* |
|
In some cases, when training a metadata model, Metadata Extraction may time out and fail.
|
DEV-723252 |
|
In some cases, email notifications for the "Resend to new Study personnel" action included already completed tasks.
|
DEV-723448* |
|
The performance metrics for a model evaluation may incorrectly include values for the OTHER UNKNOWN category of results above the Prediction Confidence Threshold.
|
DEV-723629* |
|
In some cases, when unclassified documents are included with a transfer to SiteVault, the entire transfer, including valid documents, fails.
|
DEV-724491* |
|
When 150 documents or more are being transferred to sites, Vault fails to complete the job without displaying an error.
|
DEV-725062* |
|
In some cases, the Add Staff button is incorrectly still enabled when there are five (5) Site Staff already added.
|
DEV-726490* |
|
Under some circumstances, EDLs may not be created properly when running a Create from Template job.
|
DEV-726879* |
|
In cases where the Sponsor/CRO Name setting is off, Vault displays "Server Having Problems" when a user attempts to recall a document.
|
DEV-727123 |
|
In some cases, Vault fails to start the eSignature workflow if another user has previously started but not completed the workflow.
|
DEV-727129 |
|
Vault fails to generate Prediction Metrics when a classification model is the only deployed model.
|
DEV-727680* |
|
Vault incorrectly allows users to repeatedly complete the eSignature workflow on a document in Site Home.
|
DEV-728164 |
|
Vault erroneously hides the Safety Distribution and Document Exchange sections from Site Home when these values are not defined in the Connected Study Type field.
|
DEV-728491* |
|
In cases where the Study Phase field is not populated, Vault fails to display Study Information.
|
DEV-728492 |
| Description |
Issue No. |
|
In some cases, the Audit Trail may incorrectly show System user-actions as performed by a Non-Vault user.
|
DEV-707662* |
|
If Enable Suggested Links is disabled on a document type, users can still create a Claim Link on a document via REST API.
|
DEV-709505* |
|
In rare cases where a document contains a Merge Fields token inside a Merge Fields token, users are unable to generate a viewable rendition of the document.
|
DEV-711713* |
|
In some cases, OCR text detection may overextend and capture text outside of the expected boundary.
|
DEV-713477* |
|
Within the Firefox browser, users may be unable to efficiently select text overlapping an embedded link.
|
DEV-713697* |
|
In some cases, the Workflow Status, Task Status, and Task Queue Group fields on Workflow with Object reports are translated to English in non-English language Vaults.
|
DEV-713702* |
|
In some cases, files with fames longer than a certain length fail to render in Vault.
|
DEV-713836 |
|
Users may receive an Unknown or Unexpected error when attempting to download a viewable rendition with a corrupt trailer.
|
DEV-714355 |
|
Users are unable to generate viewable renditions for documents with includeText or includePicture fields.
|
DEV-714596 |
|
In rare cases, the source file for a Vault document with Merge Fields may become corrupted after being processed for rendering.
|
DEV-715494 |
|
If a Check In entry action is configured to execute after a document moves to the Approved state via Document Change Control, users encounter an error stating the document is no longer in the workflow.
|
DEV-715963 |
|
Under certain circumstances, users may receive errors when attempting to Export Milestone Package Documents.
|
DEV-716363 |
|
Under some circumstances, renditions of documents with form content may fail to render.
|
DEV-718211 |
|
Suggested links created through the Vault Java SDK include references to inactive Link Targets.
|
DEV-718261 |
|
Export Annotations fails when exporting from a document with a comment annotation that has replies.
|
DEV-719305* |
|
In some cases, OCR may fail to detect some of the text in image files that have been rotated.
|
DEV-719645* |
|
Crosslink renditions may fail to update if the user updates a manual rendition of the source document.
|
DEV-719880 |
|
Users encounter error messages when Download Notes and Apply Filters are used on documents with over 200 and 1,000 annotations.
|
DEV-720182* |
|
If a user changes a document's state on the Doc Info page, the All Actions menu does not update with the actions available in the new state.
|
DEV-721425 |
|
In some cases, users may encounter a 'Server having problems' error when loading videos in the document viewer on an application page. Vault then logs the user out of their session.
|
DEV-721758* |
|
Bookmarks that refer to headings on pages with a saved rotation direct users to the incorrect location in the document.
|
DEV-722089* |
|
In some Vaults, link annotations may not be visible in Overlay mode.
|
DEV-722807* |
|
Vault may fail to bring forward reference links when a user lacks the required permissions for the target document.
|
DEV-723837 |
|
In some cases, embedded links do not navigate to the correct location on the target document.
|
DEV-724309 |
|
When a document is downloaded using PDF with Annotations, the annotations in the downloaded PDF do not match the order of annotations in the document viewer.
|
DEV-725308 |
|
Users may receive an error when attempting to generate viewable renditions of SiteVault documents with eSignatures.
|
DEV-725330* |
|
When converting a document to PDF/A, the resulting rendition may be missing some content.
|
DEV-725549 |
|
In some cases, when a Vault is upgraded to 24R1.3, annotations on videos created prior to the upgrade may appear partially or completely outside of the video player, or outside of their original location on the video.
|
DEV-726531* |
|
If a user starts a Comment annotation that uses the Insert style, and then cancels it, the insert placemarks remain on the highlighted text in the document viewer.
|
DEV-727457* |
|
Users without view permissions on the latest version of a document are unable to add that document to a binder.
|
DEV-727643 |
|
In some cases, hyperlinks function normally on source documents, but are broken when clicked in the uploaded viewable rendition.
|
DEV-727805 |
|
PDF with Annotations is disabled for selection on documents with only Anchor annotations.
|
DEV-728032* |
|
When users download an imported rendition, the downloaded file contains saved page rotations intended only for the viewable rendition
|
DEV-728059* |
|
If a user without Edit Sharing Settings permission on the latest document version clicks Send as Link, an irrelevant error message displays.
|
DEV-728404* |
|
In some cases, users may encounter an error when using Send as Link to send a document link to Vault users assigned a role on the document through group assignment.
|
DEV-728536* |
| Description |
Issue No. |
|
In some cases, the Document Periodic Review job may fail when run for large numbers of documents.
|
DEV-574809* |
|
The Complete button may be disabled even if a user has completed all required fields and prompts on the test step.
|
DEV-692096* |
|
In Validation Management, in Vaults with both Family Validation and Template Requirement functionality configured, performing the Import Template Requirement Set action may fail and result in a job log error.
|
DEV-697598* |
|
Vault may fail to display unsaved changes to the additional prompt of a saved Test Step after a user updates the prompt label, deletes the additional prompt, and restores it.
|
DEV-704487* |
|
Executors may be unable to add a discrepancy to a completed test step within the Test Execution Interface.
|
DEV-707101* |
|
Vault may display incorrect results in the Test Protocol Review Interface if a user applies multiple step filters in quick succession.
|
DEV-713910* |
|
Vault may display a server error when a user without read permissions for QMS User Templates attempts to access the Entry Actions tab in a document lifecycle that has the Activate External Collaborators action configured.
|
DEV-714194 |
|
When using the Test Authoring Interface, Vault may fail to display execution steps in the content panel with the correct pagination after a user clicks the requirement burndown panel.
|
DEV-716959* |
|
Under certain circumstances, users may receive a server error when attempting to remove a course from an unsubscribed Vault.
|
DEV-718779 |
|
Users may encounter an error when attempting to create a new QMS-RIM transaction record in RIM.
|
DEV-718826* |
|
When using the Assign to Learner Action on a Curriculum, the action may fail to create the Individual Learner Role and leave the IAR records stuck in the Requested state.
|
DEV-719682 |
|
When a Classroom training is cancelled, Vault cannot cancel the related Classroom Training Assignments if signatures are enabled on the Class Roster object.
|
DEV-719878 |
|
Users may encounter an error when executing the Create New Version action on a Validation Entity Version.
|
DEV-721636 |
|
Vault may fail to fetch data for reference objects related to an Adverse Event Report.
|
DEV-721995* |
|
Importing a Quality Record Check configuration via a VPK may fail if it contains a configuration with an object type summary field.
|
DEV-723436* |
|
Vault may fail to update the Uniqueness Key field during subsequent naming scheme migrations.
|
DEV-723508* |
|
In cases where a QualityDocs workflow is moved to the Canceled state but is inactive, the expected state change actions do not occur.
|
DEV-723802 |
|
The Insights checkbox may not appear for quality record checks created for the Nonconformance object.
|
DEV-724000* |
|
In the Quality Team management interface, in some cases clicking the Apply button may result in Vault displaying an error.
|
DEV-724180* |
|
Vault may fail to transfer field values from a Template Risk to its resulting Assessment Risks for non-FMEA Risk Assessments.
|
DEV-725334* |
|
Vault may display an error when a user attempts to run a Quality Record Check on a Nonconformance object record.
|
DEV-725463* |
|
Users without Read permission for the Checklist Field Translation and Checklist Design Translation objects receive a Page Not Found error when attempting to access a quiz in Visual Checklist Designer.
|
DEV-727810 |
| Description |
Issue No. |
|
In some cases when users click the Actions menu on a Process Step on the HACCP Flow Diagram, the menu moves slightly to the left before opening.
|
DEV-707422* |
|
If a user attempts to expand a section of the Information panel on the HACCP Flow Diagram while missing Read permission for fields on the relevant join object (for instance, attempting to expand the subsection for a Process Hazard Analysis with associated PRPs while missing Read permission for fields on the PRP/CM Hazard Analysis object), Vault displays an unexpected error message.
|
DEV-708430* |
|
If users attempt to open the Actions menu on a Process Step on the HACCP Flow Diagram while also editing the Process Step in the Information panel, the Actions menu opens and displays the text "No actions available".
|
DEV-718792* |
|
When Admins attempt to save a configuration of the Generate Document from Report user action without entering values for either the User Field or Team and Team Role fields, the error message that displays does not specify the correct missing field values.
|
DEV-719987* |
|
If a user attempts to run the Create Proposed Audits action without having Read permission on the configured Source Object Optional Fields, the action does not run and no error message displays.
|
DEV-720931* |
|
If a user loses Read permission on fields in the Risk Assessment subsection of the Information panel while editing the subsection, the HACCP Flow Diagram disappears and a blank page displays when the user attempts to save their edits.
|
DEV-720955* |
|
Clicking the binoculars icon next to the HACCP Plan Ingredients section's header in the Information panel of the HACCP Flow Diagram expands the section if minimized, and minimizes the section if already expanded.
|
DEV-721684* |
|
When running a migration job to prepare a Vault for HACCP Plan localization, the number of translation records created that displays in the job log is incorrect when the number of records created exceeds 500.
|
DEV-722180* |
|
When users clear the Risk Category (risk_matrix__v) field in the Hazard Assessment subsection of the Information panel on the HACCP Flow Diagram, the Justification (justification__v) field resets instead of the Justification Q1 (justification_q1__v) field.
|
DEV-722595* |
|
When users attempt to expand the subsection for a deleted Process Hazard Analysis in the Hazard Analyses section of the Information panel on the HACCP Flow Diagram, Vault displays a server error.
|
DEV-723182* |
|
In some cases when a loading progress indicator displays on Process Steps on the HACCP Flow Diagram, it does not display in the center of the Process Step.
|
DEV-723199* |
|
When users run the Create Proposed Audits action on an Audit Program with a group assigned to the owner role, Vault assigns only the user who ran the action to the owner role of the new Proposed Audits.
|
DEV-724063* |
|
If the object reference field specified in the Outbound Reference Field is inactivated while an Admin is creating a Related Record Setup, Vault displays a server error when the Admin attempts to save the new Related Record Setup.
|
DEV-725214* |
|
When an Admin exports a translation file for field labels using the bulk translation tool, the translations for the Title (title__v) field on the Audit and Proposed Audit objects are not included.
|
DEV-725600* |
|
Translations are not available for the notification users receive when the Create Proposed Audits user action completes.
|
DEV-725710* |
|
When creating Process Hazard Analysis records in batches for the same HACCP Plan Process Step Group, Vault automatically sets the HACCP Plan field only on the last record created in the batch.
|
DEV-726009* |
|
If the object reference field specified in the Outbound Reference Field on a Related Record Setup is inactivated on the Source Object or Source Object Type while an Admin is editing the Related Record Setup, Vault displays a server error when the Admin attempts to save their edits.
|
DEV-726139* |
|
When users hover over a selected Material Step while the HACCP Flow Diagram is in Edit mode, a list of ingredients associated with the Material Step does not display.
|
DEV-726419* |
|
When users run the Create Related Record action on an object with a Related Record Setup that references an inactivated field in the Outbound Reference Field, users see an unexpected error message and no failure notification.
|
DEV-726915* |
| Description |
Issue No. |
|
In some cases the order of Active Dossier Items and Active Dossier Item Details changes after collapsing or expanding the section.
|
DEV-604580* |
|
When continuous publishing is not enabled for a Content Plan Item and the item is re-published, Vault does not republish the corresponding XML.
|
DEV-608804* |
|
Users are able to save Application and Submission records with special characters (including forward slashes) in their respective folder names (application__v.folder_name__v and submission__v.xml_submission_id__v).
|
DEV-652227* |
|
When creating and managing Event details in bulk, Vault does not create an Event relationship record if the user does not have Edit permission for a field with a default value.
|
DEV-679522* |
|
When editing the last cell visible on the Content Plan Viewer, the user is not able to the entire inline editing box.
|
DEV-680867* |
|
Users receive an error when empty spaces are added to the dropdown filters in Content Plan Viewer.
|
DEV-692404* |
|
In some cases, users are still able to edit cells in the Content Plan Viewer when an error message is displayed.
|
DEV-695659* |
|
The Active Dossier template has a token for inactive ingredient, which forces users to enter a product & inactive ingredient to create records in this section and leads to wrong/incorrect data.
|
DEV-699187* |
|
In some cases, Rule VRSP0024 is broken if section merge is set to yes.
|
DEV-704123* |
|
In some cases, the subtitle text on define relationship pages for special joins is missing object labels for referenced join records.
|
DEV-704404* |
|
Following a section level merge, embedded links may resolve to the incorrect page in the target merged document.
|
DEV-709491* |
|
In some cases, the vertical scroll bar is missing in the global filters header.
|
DEV-711381* |
|
In some cases, when a document is matched to two Content Plan Items with the same Source for Published Document field value, Vault does not synchronize document versions during continuous publishing.
|
DEV-712562 |
|
In some cases, the application and submission fields on published Archive document types may not be consistently populated when using Continuous Publishing.
|
DEV-712965 |
|
Users may receive incorrect results for ZA 14.BP3 and related filename validation rules.
|
DEV-713302 |
|
When a user clicks the cancel button, the text in the dialog is incorrect.
|
DEV-715982* |
|
When a user adds or reorders columns, the grid is not loaded and users receive an error.
|
DEV-716622* |
|
When a user attempts to save a view, the global header collapses and expands.
|
DEV-716966* |
|
In some cases, the Submissions Archive Viewer displays certain Microsoft Word files with the PDF icon.
|
DEV-717804 |
|
Under certain conditions, users receive an error that they are unable create a Health Authority Question due to incorrect values on constraining fields, even when the values are correct.
|
DEV-719997* |
|
When extracting a Health Authority Question, the hovercard is missing when hovering over the remove icon.
|
DEV-720058* |
|
When a user refreshes the page, Filter by Transaction is reset to the default settings instead of the current value.
|
DEV-720187* |
|
In some cases, continuous publishing is triggered unexpectedly for Submissions without a Content Plan.
|
DEV-720279 |
|
When extracting a Health Authority Question, users may receive an error message that "The record could not be created" rather than a helpful error message which explains why Vault could not create the record.
|
DEV-720537* |
|
The submissions viewer may fail to display all documents published and matched to the same Content Plan Item.
|
DEV-720645 |
|
When a user adds columns in grid, the grid is not loaded and users receive an error.
|
DEV-720946* |
|
When using the global filter By Regulatory Objectives, Active Dossier Item rows are displayed that are irrelevant or have blank or no Active Dossier Item Details displayed.
|
DEV-721370* |
|
When using By Region filter, the Active Dossier viewer displays non-relevant country columns & Active Dossier Item Details.
|
DEV-721382* |
|
Vault may display all fields in the list layout within the IDMP Viewer instead of the first ten (10) fields.
|
DEV-721482* |
|
The limit reached banner is missing from the Active Dossier Viewer and Editor where records are more than 500
|
DEV-721509* |
|
Arrows are incorrectly displayed for updates of Content Plans and Content Plan Items.
Internal issue published in error
|
DEV-721515* |
|
When merging a Report Level Content Plan containing password-protected or corrupt matched documents, the job fails and users receive the incorrect notifications.
|
DEV-721525* |
|
When deselecting the document and Content Plan/Content Plan Item rows from the comparison grid, both rows are removed from the comparison grid. In addition, the Load 2000 more documents button is displayed and unknown icons are added to the Unmapped Documents Tray.
Internal issue published in error
|
DEV-721557* |
|
The version of unlocked document in the Unmapped Document Tray is displaying incorrectly.
Internal issue published in error
|
DEV-721727* |
|
Users receive a server error when applying a custom region filter or a country filter without a valid country code.
|
DEV-721741* |
|
When Vault creating Event details, Vault considers number fields with whole decimals (.0) and treats text fields as case-sensitive, resulting in duplicate records.
|
DEV-721765* |
|
Active target CP/CPI records are shown as status "Update" after D+D to the CPI row.
|
DEV-721888* |
|
Documents that were mapped based on CPITM and D+D in the target structure in comparison viewer are not synced to target SCP. With this fix, documents are matched to the corresponding target CPIs in the SCP.
|
DEV-721899* |
|
The favorite icon is not spaced properly on the Expected Document List item in the EDL hierarchical viewer.
|
DEV-722192* |
|
In some cases, the Archive Sections document field shows as null on a Submissions Archive document even though the audit trail shows the import was successful.
|
DEV-722249 |
|
Vault may incorrectly remove links from a table of contents following a section level merge for a Report Level Content Plan.
|
DEV-722297* |
|
The Unmapped Document Tray in the comparison viewer is expanded by deafult instead of collapsed.
Internal issue published in error
|
DEV-722365* |
|
Vault may fail to display results when a user removes a filter within the IDMP Viewer.
|
DEV-722373* |
|
Document rows are not displayed under the expected Content Plan Item and documents do not display correctly in the Unmapped Document Tray.
Internal issue published in error
|
DEV-722648* |
|
Users receive an error message in document only dispatch when they accept changes to activate records.
Internal issue published in error
|
DEV-722755* |
|
All records are displayed when there are no joins added in the transaction object.
|
DEV-722808* |
|
When a user selects the Registrations checkbox, the Select All checkbox is selected automatically.
|
DEV-722861* |
|
When checking limit prevalidation, users receive a failure notification that the target Submission Content Plan exceeds the limit.
Internal issue published in error
|
DEV-722983* |
|
When the target Submission Content Plan Template field is blank, dispatch succeeds and a new comparison is created.
Internal issue published in error
|
DEV-722987* |
|
In some cases, documents that are matched to inactive Content Plan Items on the source are traversed/dispatched when there is no matching document ID on the target.
Internal issue published in error
|
DEV-723068* |
|
Under certain conditions, xEVMPD submissions incorrectly receive a Validation error.
|
DEV-723077 |
|
The results shown in an IDMP comparison may not match the records selected in the grid view.
|
DEV-723399* |
|
The IDMP Viewer may fail to display picklist values.
|
DEV-723522* |
|
Document set filtering does not function properly on document only dispatch.
Internal issue published in error
|
DEV-723525* |
|
Region and lead market country filtering does not function properly on document only dispatch.
Internal issue published in error
|
DEV-723542* |
|
Target document is not unlocked when syncing over the source document that is unlocked.
|
DEV-723589* |
|
Users are unable to add, remove, or change the position of country columns.
|
DEV-723835* |
|
The Data View Selection window may not display any users if the Prompt for IDMP Viewer User setting is enabled.
|
DEV-723850* |
|
Vault publishes study tagging files as placeholders when its related Content Plan Item is inactive.
|
DEV-723899 |
|
The Clear Selection button on the Submissions Archive Views dialog is styled as a link instead of a button.
|
DEV-723930* |
|
The Submissions Archive Views dialog shows the Clear Selection button when no views are selected.
|
DEV-724064* |
|
When Domibus sends a response for a UDI Submission, Vault does not receive it and the Accept or Reject UDI Submission job fails.
|
DEV-724364* |
|
The job to publish a submission may fail when the Health Authority Code is blank for a particular Submission type.
|
DEV-724875* |
|
The Summary Page may fail to load when format masks are configured on fields on the Regulatory Objective object.
|
DEV-724993* |
|
In some cases, records are missing when the root section filter or view current is applied in view mode.
|
DEV-725262* |
|
When a CH Submission results in a 11.10 failure, Vault displays insufficient detailed publishing results.
|
DEV-725532 |
|
Vault incorrectly reports Rule A09 as failed during continuous publishing when a Content Plan Item’s Published Output Location’s file extension is .docx and the matched document’s is .doc.
|
DEV-725612 |
|
Under certain conditions, atomic security may not be respected in the submission wizard with Sub RO and Reg RO objects.
|
DEV-725629* |
|
If a user creates a Submission with a Sequence ID, publishes, wipes the Sequence ID, and creates another Submission with the same Sequence ID, they may encounter duplicate CDNs.
|
DEV-726466 |
|
In some cases, users receive a server error when attempting to remove the Application Source from the Submission Drug Product record.
|
DEV-728511 |
| Description |
Issue No. |
|
When a double-blinded Study Case has multiple products with dose information populated, upon unblinding, blind-protected values are only populated for the Primary Case Product.
|
SAF-51202* |
|
When Inbox Items with unblinded Study Products are promoted to Cases, the Case-level Product field is set to the primary Study Product.
|
SAF-53993* |
|
When incorrect data is entered in the Gestation Exposure (unit) or Child Indication Data fields, Vault displays an error message that does not describe the cause of the issue.
|
SAF-54150* |
|
When a new Adverse Event is added to a Japan Domestic Case through the Promote to Follow-Up Case or Merge to Current actions, Vault does not name the newly generated Localized Case Assessment based on the name of the associated Case Product Registration.
|
SAF-55645* |
|
When Case Access Group security is turned off and then a Case is locked to a specific user, Vault updates the number of Cases assigned to that user.
|
SAF-57152 |
|
Users can run the Promote to Multiple Cases action multiple times on the same Inbox Item.
|
SAF-57241 |
|
Case Product Registrations added to a Case are not copied over to subsequent Follow-up Cases.
|
SAF-57328* |
|
Vault prevents Inbox Item promotion when the Case Contact First Name field includes "And".
|
SAF-57723 |
|
When the Base Language is set to Japanese, some values in the Message Catalog for the Sender Based Inbound Validations group are not translated.
|
SAF-58258* |
|
Vault prevents Follow-up Case creation when the previous Case version includes an Adverse Event linked to a Diagnosis.
|
SAF-58266 |
|
When exporting custom E2B formats with ICH as the base document type, if a Case is also reportable to another agency with a regional E2B, Case-level validations for the ICH base document type for the custom E2B may not run if regional superseding validation criteria are configured for the regional E2B.
|
SAF-58606 |
|
When a global Case includes a Product (Coded) value with more than 250 characters, if there is an associated Localized Case, Vault displays an error message and cannot sync the data.
|
SAF-58607 |
|
If auto-set Inbox Item Localization by Reporter Country is enabled, when importing an Inbox Item with no match for Primary Reporter Country and Report Type, Vault sets the Inbox Item Localization field based on the Reporter Language instead of leaving it blank.
|
SAF-58807 |
|
When the Assessment Generation field is blank on the Japanese (Japan) Localization record, Vault does not populate the Case Product field on Localized Case Assessments for domestic and foreign Japan Localized Cases.
|
SAF-58854* |
|
Vault cannot save Case Drug History records if the Drug (Coded) value exceeds 250 characters.
|
SAF-58856 |
|
Vault prevents creating a Follow-up Case from an Inbox Item if an associated Localized Case has a Localized Case Document record with a value in the Case field.
|
SAF-58926 |
|
Combination Product device constituents are exported to the Suspect Product(s) Information section of CIOMS I forms.
|
SAF-59065 |
|
When generating a PMDA E2B(R3) report for a Japan Study Case with no Parent Information, the ICH.D.10.6-1 validation criterion fails at both the Case and Submission levels.
|
SAF-59067 |
|
During Transmission generation, in some instances, Vault generates a new report instead of up-versioning an existing report.
|
SAF-59096 |
|
When generating PMDA E2B(R3) reports for Cases with multiple Localized Case Identifiers, Vault exports the C.1.9.1.r.1 Source(s) of the Case Identifier data element only once.
|
SAF-59144* |
|
In some Vaults, the Case object's Device Follow-Up Type (device_multi_followup_type__v) field does not appear.
|
SAF-59156 |
|
When Automated Case Promotion is configured with the Smart or Override merge method, Vault promotes Inbox Items to Follow-ups for Cases in prohibited states.
|
SAF-59162 |
|
After generating a Follow-up Questionnaire, Vault populates the Case Identifier field on the Questionnaire record with the Case Name instead of the Case Number.
|
SAF-59173* |
|
When a Vault has the Only Include Investigational Products for SAR application setting enabled, Vault counts all adverse events as expected when deciding if a Case should be included in the DSUR and PBRER Serious Adverse Reaction listings and tabulations.
|
SAF-59177* |
|
For Vaults with strict case locking enabled, when a user tries to edit a Case or Case-related record that is not locked to them, in some instances, a system error occurs instead of Vault displaying the expected error message.
|
SAF-59202* |
|
After sending a gateway transmission and receiving a Message Delivery Notification (MDN) or an Acknowledgment (ACK), Vault does not populate the Attachments section of the Transmission Message record with a TXT file (for MDNs) or XML file (for ACKs).
|
SAF-59221 |
|
When transferring Product Registrations through the Safety-RIM Connection, if the Product Registration Holder field on the Registration record in RIM is blank, the Registration record is not created in Vault Safety.
|
SAF-59282* |
|
When generating PMDA E2B(R3) reports and exporting values to the G.k.2.3.r.1 Substance / Specified Substance Name data element, if the Localized Case Product Substance Name (Reported) field is blank, Vault does not map the value in the Name (Reported) field of the corresponding global record.
|
SAF-59289* |
|
During validations for PMDA E2B(R3) reports, Vault does not fail the ICH.F.r.3.1-1 and ICH.F.r.3.2-1 Validation Criteria at the Case level.
|
SAF-59290 |
|
During Inbox Item import, Vault does not match Product Aliases to Study Products.
|
SAF-59292* |
|
When regenerating FDA MedWatch 3500A and CIOMS I forms, if the Patient Content Protection field is populated, Vault generates new documents instead of upversioning existing ones.
|
SAF-59426* |
|
When creating Inbox Items through the Medical-Safety Connection, Vault does not map custom fields correctly, and record creation fails.
|
SAF-59488 |
|
For users with Read permission on Reason Omitted fields, those fields appear editable when in edit mode on Cases, although Vault does not save entered changes.
|
SAF-59527* |
|
When the Case Assessment control section is configured on the Case layout, when using the record navigation arrows on a Case Assessment detail page, Vault displays Case Assessments across all Cases in the Vault instead of just for the open Case.
|
SAF-59658* |
|
During Transmission evaluation, when a regional superseding validation criteria applies to all Transmission document types, Vault runs "Always Evaluate" ICH validation criteria at the Submission level and sets EMA Submissions to the Validation Error state with no failures.
|
SAF-59676 |
|
Draft PSMF logbook entries associated with minor versions associated with a previous major version of documents are not automatically updated to the most recent minor version.
|
SAF-59686 |
|
Vault does not evaluate the Product Family reporting rule parameter for Product records that include the Product Family field.
|
SAF-59788* |
|
When generating E2B(R3) reports, Vault incorrectly populates "nullFlavour" instead of "nullFlavor" in the C.5.3 Sponsor Study Number data element.
|
SAF-59857 |
|
When a User Access Group Assignment record for a Case Access Group has a blank Localization field, Vault allows users to view all Localized Cases, instead of only Global Cases.
|
SAF-60685 |