The issues listed below are fixed in the 22R1 release.
| Description |
Issue No. |
|
In some cases, notifications list an inaccurate number of EDL Item records created from the Create Expected Documents job and the downloaded file includes an error message.
|
DEV-320940 |
|
In some cases, notifications list an inaccurate number of Milestone Item records created from the Create Milestones from Template job.
|
DEV-321078 |
|
When attempting to add a non-associated Study Product to a new document being merged with an existing placeholder, Vault displays "Server having problems."
|
DEV-342524 |
|
The legacy TMF Viewer allows selecting a Study Site without a Study Country selected.
|
DEV-391692 |
|
In cases with missing remote files or directories, the Clinical Network FTP Clear job fails in both SiteVault and Clinical Operations Vaults.
|
DEV-398145 |
|
Vault displays unhelpful errors when either a supporting document or a safety document reference in the parent Safety Distribution is missing a Study value.
|
DEV-399737 |
|
Users may be unable to search for Product records in the Agreement wizard.
|
DEV-428403 |
|
In some cases when attempting to deactivate a Study Site, Vault displays "Server having problems."
|
DEV-433375 |
|
Vault displays an unhelpful error when an admin can not create a Study Person due to configuration issues.
|
DEV-436781 |
|
In some cases, Vault does not save radio button responses on Trip Reports.
|
DEV-436937 |
|
In some rare cases, users are unable to create Clinical tasks from the CRA homepage.
|
DEV-438174 |
|
Vault fails to populate the Actual Finish Date on a Subject-related milestone when No New Subjects on the Site is not checked.
|
DEV-438529 |
|
In some cases, auto-classified documents are missing renditions.
|
DEV-438686 |
|
In some cases, Vault provides unhelpful messages for TMF Transfer errors.
|
DEV-439464 |
|
In some cases, CTMS Vaults create duplicate Event Definitions after receiving multiple versions from CDMS.
|
DEV-440251 |
|
When creating a CTN, Vault fails to include the Study and Study Country for the Study Person and Study Organization records.
|
DEV-440623 |
|
TMF Transfer fails if document attachments contain a leading space.
|
DEV-441646 |
|
Vault displays an incorrect error message when a user executes the Distribute to Sites action from a Safety Distribution record and the related Study record does not have any Study Products.
|
DEV-442031 |
|
When a visit is deleted, Vault fails to blank the visit date field.
|
DEV-443206 |
|
Vault continues to display the TMF Reference Model 3.0 modal in the TMF Viewer after disabling the modal.
|
DEV-443635 |
|
In cases where workflows create new documents from previous versions, Vault may incorrectly clear the Language field on the previous version.
|
DEV-445402 |
|
Vault may not show all related events after a user performs the Apply Milestone Template action.
|
DEV-446748 |
|
When executed from a Document Check record, Site Connects sends a document instead of a document request to SiteVault.
|
DEV-448939 |
|
In cases with more than 200 Sites, Safety Distributions fail to create more than 200 Distribution Task records.
|
DEV-449096 |
|
Generating a CTN record without a valid Health Authority Code results in a "Server having problems" error.
|
DEV-449187 |
|
In some cases, changing document lifecycle configuration causes TMF Transfer to display errors when attempting to transfer in-scope documents.
|
DEV-449201 |
|
Vault displays an unhelpful error when a user with incorrect permissions attempts to drag and drop a document to an EDL.
|
DEV-450415 |
|
Vault fails to create Distribution Task Recipients when there are more than 500 failed Distribution Tasks.
|
DEV-451326 |
|
Using the Make a Copy action to create Study Person records results in those records causing issues with URS Sync.
|
DEV-451498 |
|
In some cases with large numbers of resulting binders (300 +), Vault fails to create binders from Study documents.
|
DEV-451613 |
|
In cases with very large numbers of Subject Visit records, Vault displays "Server having problems" when running the Proactively Seed Monitored Enrollment action.
|
DEV-451796 |
|
In some cases, the document list will not populate in TMF Viewer.
|
DEV-452073 |
|
The Trip Report Review Comment modal renders incorrectly.
|
DEV-452661 |
|
In some cases, when filtering on Study Site States, the Distribute to Sites action may include Study Sites that are not in the desired state.
|
DEV-452941 |
|
Vault fails to send email Safety Distributions after adding a supporting document to the distribution.
|
DEV-452969 |
|
When a user in a sandbox Vault attempts to archive a Study, Vault will fail to archive the Study if there is an insufficient number of Archived Site Licenses.
|
DEV-453599 |
|
In some cases where very large numbers of documents are available for TMF Bot training, Vault fails to complete Trained Model auto-training.
|
DEV-454072 |
|
In some cases where duplicate Subject records exist in a CTMS Vault, connected CDMS Vaults do not show all Subject Visits.
|
DEV-454292 |
|
Vault incorrectly attributes the Copy Field to Related Object action to "System on behalf of" instead of "System" in Subject Visit audit trails.
|
DEV-454434 |
|
In cases where the Steady State Count is not set, Vault displays "Server having issues" when a user attempts to update the Requiredness field.
|
DEV-455396 |
|
Site Connect incorrectly sends External IDs from the Clinical Operations Vault when creating or updating Products in SiteVault.
|
DEV-456904 |
|
In some cases, Vault incorrectly displays an insufficient license error when attempting to archive sites when there are available licenses.
|
DEV-457487 |
|
In cases where multiple Recalculate jobs are run concurrently, Vault creates duplicate Enrollment Status logs.
|
DEV-457618 |
|
Users are not able to create more than 500 EDL Items at once when creating a milestone using milestone template automation.
|
DEV-458952 |
|
In cases where a user with limited permissions adds a USN to an Organization, Vault fails to establish a Site Connect connection.
|
DEV-460451 |
|
If a user attempts to update the status of a Site Fee record and the Payee Override field is blank, Vault fails to save the update and gives a server error.
|
DEV-460962 |
|
In cases where a Study only has two (2) types of Enrollment Metrics Over Time, Vault displays an error when attempting to load the Study from the Study Management Homepage.
|
DEV-461068 |
|
Updates to the Metrics Over Time planned__v field fail to roll up to the Study.
|
DEV-463668 |
|
Vaults that were cloned after 21R3 are missing Global Subject Metric Enablement records.
|
DEV-464402 |
|
In some cases of high traffic, the Send Safety Distributions job may leave some Distribution Task Recipient records in Sending rather than updating them to Sent.
|
DEV-464569 |
|
In some cases, Vault creates duplicate Safety Distribution Tasks and displays multiple copies of documents in the external viewer.
|
DEV-464594 |
|
When a user attempts to run the Create Milestone from Template job and there are more than 200 expected document types for the milestone, Vault fails to create milestone items for the expected document types after the first 200.
|
DEV-467154 |
|
In some cases, TMF transfers fail and show a server error.
|
DEV-467308 |
|
Model training that takes longer than 30 minutes times out and fails.
|
DEV-467593 |
|
When a user adds Response Follow Up items or Issues to Trip Report Question section rows via the lookup dialog or adds an item to one dropdown and removes an item from another, duplicate records may appear.
|
DEV-467636 |
|
Vault fails to process Tracked Email events with event IDs longer than 32 characters.
|
DEV-468349 |
|
With Enhanced Document Update enabled, Vault fails to change content from Unblinded to Blinded via User Action.
|
DEV-469251 |
|
In some cases, inbound documents integration with a RIM Vault will fail and users will be unable to receive inbound documents in the RIM Vault.
|
DEV-470630 |
|
In cases where the Last Distribution Date field is empty, Safety Distribution and Safety Distribution Support record Lifecycle State and Initial/Latest Distribution Dates do not update correctly.
|
DEV-471688 |
|
Creating a Monitoring Schedule Template Item results in an error.
|
DEV-474549 |
|
During a Review and Approve Monitoring Event workflow, users are sometimes unable to complete tasks due to an error with blank required fields.
|
DEV-477280 |
|
In some rare cases Vault lists duplicate records in the Conditional Actions dropdown.
|
DEV-478819 |
| Description |
Issue No. |
|
Vault Loader for documents allows unsupported date formats.
|
DEV-211940 |
|
When attempting to reclassify a crosslink to a document type that does not support crosslink renditions, users receive an unhelpful generic error message.
|
DEV-248248 |
|
When two users cancel checkout on a document at the same time, Vault adds 2 entries to the audit trail.
|
DEV-274341 |
|
Despite allowing page breaks within content, text in Formatted Outputs flows into the footer of the page. Any remaining text is truncated.
|
DEV-334710 |
|
In some cases where binders are nested three levels deep, Vault may generate incorrect binder reports.
|
DEV-361266 |
|
After on-demand publishing, some Expected Document List (EDL) documents are displayed as placeholders in the viewer.
|
DEV-400031 |
|
When dynamic linking is enabled, Vault fails to render Microsoft Word documents with markup in the Table of Contents.
|
DEV-402307 |
|
Vault fails to render PDF/A compliant documents due to missing fonts.
|
DEV-406529 |
|
In rare cases, when downloading multiple controlled copies at once, one controlled copy failing to download due to an eSignature error causes the remaining downloads to fail.
|
DEV-412405 |
|
Vault incorrectly renders footer content in documents with both landscape and portrait pages is incorrect.
|
DEV-412925 |
|
Under certain conditions where document subtypes and classifications inherit their active status from their parent, users cannot create new document subtypes on that specific document type.
|
DEV-418689 |
|
In certain circumstances, users cannot perform the "Export Document" action on a Crosslink.
|
DEV-420738 |
|
In some cases, the Library's Tabular Vew shows a smaller document total than the Detail, Tile, and Compact View.
|
DEV-424007 |
|
Renditions with a PDF source file lose destinations after Vault completes the OCR process.
|
DEV-428149 |
|
The message on the Rendition Status page when users attempt to merge a barcode on a document with rich text fields and WHERE clauses is incorrect.
|
DEV-433447 |
|
In some cases, Vault fails to validate viewable renditions.
|
DEV-433713 |
|
Link annotations may not link to the correct anchors after a document is upversioned.
|
DEV-433871 |
|
In some cases, Vault fails to render Follow Up letters with merge fields.
|
DEV-434231 |
|
In some cases, opening Vault-generated PDF/A-compliant documents in Adobe® Acrobat® results in errors.
|
DEV-435537 |
|
In some cases, Vault does not populate Rich Text fields in downloaded Formatted Outputs.
|
DEV-436483 |
|
Vault fails to render documents due to missing fonts.
|
DEV-436517 |
|
When a user enters fullscreen mode, the annotate toolbar may disappear, rendering them unable to exit fullscreen mode.
|
DEV-436628 |
|
When dynamic linking is enabled, Vault incorrectly renders bookmarks if the document contains hidden fields and the “Show all formatting marks” option in Word is disabled.
|
DEV-436639 |
|
In some cases, users are unable to check in documents that were checked out using Collaborative Authoring.
|
DEV-437033 |
|
In View Links mode, if a user views one page and then returns to another with area link annotations, Vault may draw a second placemark over an existing one, rendering the text beneath unreadable.
|
DEV-437062 |
|
When there are more than nine entries, the document list in the "Filter Anchors by Referring Document" dialog is partially cut off.
|
DEV-437158 |
|
In some cases, Vault fails to render merge fields documents with tables.
|
DEV-437208 |
|
If a user selects an existing placemark after cancelling a text-selected pending placemark, Vault still displays the cancelled placemark.
|
DEV-437457 |
|
When a user attempts to select the placemark of a newly created text annotation, Vault may create a new pending annotation instead.
|
DEV-437458 |
|
In some cases, Vault fails to render merge fields documents due to unmerged tokens.
|
DEV-437774 |
|
When a user attempts to use "Send as link" to send a document to an email address that is longer than 50 characters, Vault fails to send the email or log it in the audit trail.
|
DEV-437845 |
|
When users attempt to move an arrow placemark, the placemark may revert to its previous shape and appear in the wrong place.
|
DEV-438430 |
|
In some rare cases, line placemarks move to the wrong page in a document.
|
DEV-438439 |
|
In some cases, Vault fails to render videos.
|
DEV-438817 |
|
When a user creates a new annotation, edits the placemark pattern, then scrolls to another page, the placemark temporarily disappears.
|
DEV-439182 |
|
In some cases, Vault continues to display deleted documents in the Document Inbox.
|
DEV-439252 |
|
When a user creates a new annotation with an arrow placemark, scrolls to another page, then returns and changes the placemark shape, the arrow may persist in the UI.
|
DEV-439587 |
|
If a user attempts to move a pending placemark after resizing the browser, Vault may instead draw a new placemark.
|
DEV-439708 |
|
In some rare cases, after a user cancels a reply to an annotation due to an error in saving it, Vault may still display the reply.
|
DEV-439924 |
|
In some cases, Vault fails to reflect changes to text annotation highlight colors until after the user draws another placemark.
|
DEV-442153 |
|
Users are unable to view embedded docviewers within iframes in Firefox or Internet Explorer 11.
|
DEV-442809 |
|
In some cases, Vault duplicates values of merge fields repeaters in tables.
|
DEV-442903 |
|
In some cases, when users attempt to update their color preferences, Vault does not save their reply color for annotations correctly.
|
DEV-443632 |
|
In rare cases, when users with a sepcific combination of permissions attempt to delete an anchor, Vault deletes the anchor but not the related note, resulting in an anchor in an invalid state.
|
DEV-444256 |
|
In some cases, a password-protected document may incorrectly have a value for the Pages field.
|
DEV-444453 |
|
In cases where users attempt to change a document name by adding a "#" character, Vault fails to capture the change.
|
DEV-444498 |
|
In cases where a document formula field was edited or created in Vault and then exported using a configuration package, the Package Component Comparison may not show a difference between the source and target Vault.
|
DEV-445131 |
|
Users can create invalid documents by creating a document from a template and then selecting a document type that does not match the template type.
|
DEV-445372 |
|
In some cases, Vault fails to render videos.
|
DEV-445733 |
|
Vault fails to correctly save users' text mark style preference after they copy text.
|
DEV-446379 |
|
Users can remove a Role filter after selecting My Inbox in the Share Inbox dropdown.
|
DEV-446963 |
|
In some cases, users may receive a server error when attempting to create a new draft of a document with Approved/Auto Links to permalink references within the same document.
|
DEV-447307 |
|
In some cases, Admins see a server error when attempting to edit the Document Number Format for the Unclassified document type.
|
DEV-447711 |
|
In Vaults where Action UI is enabled, Vault displays the Attachments document section with the "Attachments" Label in lieu of any custom Labels applied during field layout confuguration.
|
DEV-447821 |
|
When using the grid view of the Document Inbox, if a user tries to remove the Role filter, Vault fails to remove it.
|
DEV-447986 |
|
In some cases, Vault fails to validate viewable renditions.
|
DEV-449485 |
|
Search results in the Bookmarks panel display vertically when the bookmark title does not fit the width of the panel.
|
DEV-450123 |
|
In some cases where Excel spreadsheets include empty cells, Vault fails to merge fields on those spreadsheets.
|
DEV-450668 |
|
If the PDF file for an XFA EU form contains a dialog, the form fails to render.
|
DEV-450955 |
|
When dragging and dropping a file in a binder, the Upload New Version dialog does not populate the file automatically.
|
DEV-451678 |
|
When users have the Edit Relationship permission on an older version of a document but not the latest, they cannot delete version-specific relationships on the older version of the document.
|
DEV-451728 |
|
If a user clicks a reply link for an annotation that has been deleted, the link directs them to the first page of the document instead of the annotation's former location and lists the current page as 0.
|
DEV-451785 |
|
In some cases, when a user is mentioned in an annotation and clicks the reply link, Vault navigates to an incorrect location in the document.
|
DEV-451788 |
|
In some cases, Vault fails to render Microsoft Word documents with mail merge data.
|
DEV-452688 |
|
In some cases, the Export Annotations action fails for certain documents.
|
DEV-452895 |
|
In some cases, users may encounter a server error when attempting to create a classification under the Reference Document document type.
|
DEV-452901 |
|
The "Download Notes" action fails on documents with only resolved annotations.
|
DEV-453125 |
|
When a document has less than 100 but more than 0 characters, Vault is unable to automatically detect the document language and defaults to English rather than the creating user's language according to their user profile.
|
DEV-453431 |
|
Users cannot create page-level permalink links to a single-page target document.
|
DEV-453958 |
|
Users of Internet Explorer 11 cannot create text annotations.
|
DEV-454040 |
|
In some rare cases, documents fail to resolve the correct matching rules when they are created.
|
DEV-454200 |
|
In cases where actions share an icon, the Frequently Used Actions Bar fails to display all actions.
|
DEV-454375 |
|
In cases with merge fields using VQL tokens referring to multiple object levels, Vault fails to merge correctly.
|
DEV-454490 |
|
In some cases, Vault fails to create renditions for US V3 regional XML files.
|
DEV-455260 |
|
In some cases, Vault fails to apply generate a Formatted Output report.
|
DEV-455439 |
|
The "Export Annotations" action fails if an annotation contains bad color formatting.
|
DEV-455692 |
|
Annotations in Notes view used a different color palette than in Document view.
|
DEV-456219 |
|
The "Export Annotations" action fails if an annotation contains invalid formatting.
|
DEV-458720 |
|
When a collaborator is removed from Collaborative Authoring while making changes to the document, Vault fails to display the correct error message when they attempt to save their changes.
|
DEV-458991 |
|
In rare cases, the Export Annotation action fails due to invalid area border colors.
|
DEV-460667 |
|
After Vault fails to save an edited annotation in Notes view, users can see the unsaved edits in Documents view.
|
DEV-460982 |
|
When a document version with invalid Linked Document relationship data is copied, Vault preserves the invalid data on the new document.
|
DEV-461813 |
|
In Firefox, the annotation color menu does not appear correctly.
|
DEV-464683 |
|
Users are unable to export archived documents using the document export bulk action.
|
DEV-464752 |
|
In the Notes view, users are unable to expand or collapse the containers of relationships within link or anchor annotations.
|
DEV-465387 |
|
In the Notes view, users are unable to access the relationship's target document by selecting it within the relationship's container in a link or anchor annotation.
|
DEV-465467 |
|
In the Show all attachments view on a document, users can delete attachments in the Attachment Version History dialog.
|
DEV-465854 |
|
When trying to check in a .docx, .pptx, or .xlsx document that is checked out to Google Drive, users may receive a Google Drive error.
|
DEV-467483 |
|
When users use Download Notes to CSV for a document with anchor names that have been updated, the CSV uses the old anchor names instead of the new ones.
|
DEV-467690 |
|
After failing to apply overlays and generate a rendition, Vault does not add an entry to the audit trail.
|
DEV-467727 |
|
When uploading new unclassified documents from Google Drive with duplicate detection on, Vault fails to complete the upload.
|
DEV-469547 |
|
When creating a draft with a description that is too long, users may receive a server error instead of the correct error informing them that the description is too long.
|
DEV-469592 |
|
In some cases, while in fullscreen mode, Vault draws the placemark for a pending annotation in the wrong spot.
|
DEV-471477 |
|
In some cases, users cannot view documents and see a "Document not found" error due to a missing signature template.
|
DEV-472733 |
|
Vault returns incorrect MD5 checksum values after Merge Fields updates.
|
DEV-475259 |
|
In some cases, the Bookmarks Edited field appears at the top of the General section of the document fields panel
|
DEV-478074 |
| Description |
Issue No. |
|
When the user is a System Administrator, the ban icon does not appear for hidden checkbox fields in list views.
|
DEV-342882 |
|
The "Equals" operator for advanced picklist filters in single value picklists on HVO objects do not return correct values when two picklist values are selected.
|
DEV-426080 |
|
In some rare cases, Vault fails to save Lookup Field content after saving.
|
DEV-435967 |
|
When a document reference field is read-only and a user changes the controlling field in a way that invalidates the document, the expected error dialog may not appear for the Latest document reference field.
|
DEV-436675 |
|
When the user language is set to Portuguese (Brazil), Vault does not translate the object state label in Grid View.
|
DEV-437479 |
|
If a user's profile language is set to Japanese, the status change notification for a favorite document shows 'null' instead of the correct status.
|
DEV-437526 |
|
If a user updates a record's document reference field to match criteria and then copies the record, the document reference field value for the record is not copied.
|
DEV-438252 |
|
If a user adds Criteria VQL that invalidates a record, and the user then copies that record, Vault clears the Specific field value but may retain the Latest field value and display a validation error.
|
DEV-438454 |
|
In some cases, the Match EDL Items to Documents job sometimes fails unexpectedly.
|
DEV-440889 |
|
Vault displays a server error when a user attempts to create a Related Object from a Related Object Section with a boolean Criteria VQL and the Apply on Create option if there is also a formula expression that checks the boolean field.
|
DEV-441723 |
|
In some cases, the Match EDL Items to Documents job fails when match fields are inactivated.
|
DEV-442987 |
|
In some scenarios, when a layout rule results in a field being hidden, the field value is not deleted, and saving the record results in an error.
|
DEV-443638 |
|
Component relationships for objects have missing entries when the object is recreated again after it was deleted.
|
DEV-448126 |
|
In cases where objects have document reference fields and lifecycle stages, Vault may prevent the creation of new records.
|
DEV-448267 |
|
In the Advanced Search dialog for an object record, users are able to filter on formula fields. This does not return the correct records since Vault does not support it.
|
DEV-449519 |
|
In some cases, if changing a page layout results in a warning that the controlled and controlling fields are in different sections, the changes may be saved after the user clicks Cancel.
|
DEV-450414 |
|
In some cases, after starting a workflow on a Content Plan, a user may receive a notification with an error that the hierarchical state change did not complete.
|
DEV-451519 |
|
When a user updates an object record field that references the latest version of a document, Vault generates a "Record saved with no changes" audit entry in addition to the expected entry.
|
DEV-451657 |
|
In some cases, after removing a field from an object type, deploying the object's page layout configuration fails because the VPK includes the removed field.
|
DEV-451799 |
|
When two fields have the same name but one is the grandparent of the other, users are able to filter the grandparent field.
|
DEV-451985 |
|
When a user attempts to send a Direct Assignment to more than 1,000 Learners, Vault displays a network error instead of a warning that the number of Learners is more than the allowed number.
|
DEV-454225 |
|
The Type and Subtype fields in the object record Advanced Search dialog may display the Base Document type and inactive document types.
|
DEV-454731 |
|
When the 251st character in a rich text field is the newline character or has formatting such as font color, the Show More ellipses do not appear upon saving the field.
|
DEV-455082 |
|
In some cases, Vault may add a "Record saved with no changes" event after initializing a Lookup field.
|
DEV-455226 |
|
When a user's profile Language is not set to English, the object page layout Edit Columns dialog does not open.
|
DEV-455680 |
|
Email to Vault fails to process emails containing multiple HTML or text bodies.
|
DEV-455865 |
|
The Show More dialog for Rich Text and Long Text field is too small and is not resizable.
|
DEV-456040 |
|
After an Admin locks an EDL Item match and a user updates the document to a new major version, the document is no longer locked to the EDL Item.
|
DEV-456403 |
|
Inbound email addresses are case-sensitive.
|
DEV-461536 |
|
Exporting to Excel may not export all formula fields.
|
DEV-467726 |
|
When entering formulas, users are able to select object reference fields from the Fields list, which is not supported and causes a validation error.
|
DEV-471458 |
| Description |
Issue No. |
|
After a submission is initially published, when a user performs updates in bulk, continuous publishing does not publish all matched documents.
|
DEV-327020 |
|
Users cannot update Efficacy and Description values when managing Submission Administrative Information for a South African application and submission if a Submission Country record exists for South Africa.
|
DEV-335018 |
|
When the Content Plans tab is unavailable, the Content Plans breadcrumb link navigates the user to the Submissions tab.
|
DEV-379696 |
|
Submission object page layout validation rules can fail when an associated PDF rendition contains unexpected values.
|
DEV-388902 |
|
When running on-demand publishing and validation jobs, Publishing Status is not updated on some Content Plan Items.
|
DEV-404508 |
|
Vault fails to validate Submissions if Content Plan Items or Validation Criteria are made inactive during the publishing process.
|
DEV-408070 |
|
After a user sets the Enable Continuous Publishing field to No on the primary Submission record of a grouped submission, Vault sets the non-primary Submission's Dossier Status to Publishing Active.
|
DEV-411825 |
|
In some cases, Vault falsely reports outstanding items to publish when selecting a submission to submit via the Gateway.
|
DEV-414264 |
|
In some cases, Vault incorrectly reports US 1714 as failed for grouped submissions.
|
DEV-415664 |
|
In some instances when there are many Content Plan Items, some records have an incorrect lineage value, causing them to not display in the Hierarchy Viewer.
|
DEV-425637 |
|
Vault incorrectly reports validation rule US 1153 when the Submission for the modified file does not have a Dossier Status value.
|
DEV-426173 |
|
In some cases when related records are created by another process, Vault creates a duplicate record.
|
DEV-428331 |
|
The content plan creation job fails when a related Submission Language record’s Country field is blank.
|
DEV-432100 |
|
In some cases, when a user up-versions a document that is matched to multiple Content Plan Item records, Vault may publish each Content Plan Item several times.
|
DEV-432216 |
|
In some cases, on-demand and continuous publishing jobs can fail during validation when linking to Submission Archive documents.
|
DEV-432448 |
|
When a user rearranges columns in the Content Plan viewer, Content Plan data appears under incorrect column headers in Excel exports.
|
DEV-433503 |
|
When submitting XEVMPD messages via the EMA gateway, Vault fails to log performance statistics.
|
DEV-434739 |
|
When the Submission Contains Files field is set to "No" in a Submissions Publishing Vault and a user attempts to delete a Submission, Vault displays an unexpected error.
|
DEV-435554 |
|
The "Import files not referenced in the eCTD XML" option does not apply to EAEU submissions.
|
DEV-436975 |
|
During validation, Vault incompletely reports Rule C03 failures in some cases.
|
DEV-438170 |
|
When an EU Submission Type is "Variation" or "Extension", Submission Mode appears as blank on the Update Administrative Information page.
|
DEV-438223 |
|
When an EU Submission Type is "Variation" or "Extension", Submission Mode appears as blank on the Update Administrative Information page.
|
DEV-438227 |
|
When a Report Level Content Plan publishing job fails, the notification does not specify the reason for the error.
|
DEV-438586 |
|
When submitting to the EU EMA Gateway, Submission Publishing fails to add Submission and Application IDs to the delivery XML file, preventing any Dynamic Access Control rules from applying and preventing successful transmission.
|
DEV-438591 |
|
In some cases, Vault incorrectly reports Rule 5040 when submission source documents contain permalinks, Vault links, or embedded links.
|
DEV-438693 |
|
When multiple submissions are being published simultaneously, Vault intermittently fails to publish XML files.
|
DEV-439006 |
|
Certain fields are unavailable within IDMP output objects:
-IDMP Manufactured Item Ingredient: Quantity Operator, Quantity Operator Code, Quantity Operator Code Text, Quantity Operator Term, Quantity Operator Term Text
-IDMP AP Reference Strength: Reference Code, Reference Substance, Reference Substance Term
|
DEV-439049 |
|
When the "Import files not referenced in the eCTD XML" option is enabled and a user imports an attached submission, Vault displays an unexpected warning.
|
DEV-439426 |
|
When the "Enable Dynamic Ordering" option is enabled and a user imports an attached 0000 submission, r022 XML appears above the list of sections in the Submissions Archive Viewer instead of below.
|
DEV-439740 |
|
XEVMPD business rule validation does not match the EMA's updated controlled vocabularies.
|
DEV-440237 |
|
When "Automatic creation of Product Family join records" is enabled in RIM Vaults utilizing the TMF-RIM Connector, duplicate Product Family records are created in some cases.
|
DEV-440553 |
|
Users without Read access to the Submission Metadata object are unable to view Submission Administrative Information.
|
DEV-440951 |
|
When an Admin runs the RMS Integration and Synchronization job with certain filter values, the SPOR List Name shows Document Type instead of Product Information Document Type.
|
DEV-441659 |
|
In some cases, documents in section 5.3.6 of an eCTD Submission have blank Product fields after on-demand publishing.
|
DEV-442052 |
|
When a user initiates the "Generate FHIR Message" user action, the PMP.42 value in the generated XML is incorrect.
|
DEV-443184 |
|
Vault incorrectly reports Rule 1697 for some submissions.
|
DEV-443801 |
|
When creating child or sibling Content Plans from the viewer, Vault fails to populate the Related Grouped Submission field.
|
DEV-444157 |
|
When a user creates an Active Dossier through a Submission Content Plan and the lifecycle operation is delete, the Active Dossier Status is Pending Current instead of null.
|
DEV-444344 |
|
When a Vault link targets a Submissions Archive document with the Ready for Publishing field set explicitly to No, Vault does not resolve the links during publishing.
|
DEV-445253 |
|
When a ZIP file contains an unreferenced file and an eCTD submission folder at the root but no application folder, Vault imports the submission as non-eCTD.
|
DEV-445703 |
|
When "Set Bookmarks & Hyperlinks to Page & Coordinates" is enabled, permalinks in published Submission Content Plans are incorrectly converted to use coordinates.
|
DEV-445725 |
|
The Generate IDMP Elements job results in errors when the data contains only Medicinal Product and IDMP Product Data Submission records.
|
DEV-446486 |
|
When submitting to the EMA Gateway, the Submission may fail if the generated ZIP filename contains more than 60 characters.
|
DEV-446491 |
|
In some cases, Submissions Archive creates placeholder documents in the Starting lifecycle state.
|
DEV-447929 |
|
In cases where the same document is matched multiple times within a Content Plan for a large submission, Vault incorrectly publishes reference leafs, resulting in Vault using an incorrect checksum.
|
DEV-448259 |
|
In some cases, the number of submissions that will be created is incorrect in the splitting wizard summary.
|
DEV-449057 |
|
Published documents can disappear from the Submission Archive Viewer when a content plan is locked before publishing has completed.
|
DEV-449496 |
|
The selected Submission value is not displayed in Submissions Archive Viewer filters when users apply a Submission join filter that does not relate to the selected Submission.
|
DEV-449915 |
|
The Content Plan Hierarchy viewer displays the incorrect number of matched documents when a filter related to a matched document is applied.
|
DEV-451047 |
|
The publishing progress indicator shows a failure when the Enable Continuous Publishing field is changed from blank to ‘No’.
|
DEV-451154 |
|
In some cases, Vault may not correctly up-version an imported Japanese Submission document.
|
DEV-451581 |
|
On the first import of a new Submission record with a content plan, Vault initiates the reimport process instead of the import process.
|
DEV-451854 |
|
When multiple Submissions are being imported simultaneously, the Submissions Archive Import job fails if the Submissions share sections in the same Application.
|
DEV-451878 |
|
Submissions Publishing fails when active Content Plan Items are contained within inactive Content Plans
|
DEV-451885 |
|
In cases when updating or creating applications using Common (GCC) or Common (EU) as the lead market, Vault incorrectly reports that all records were not created.
|
DEV-451982 |
|
In some cases when using record triggers, Vault fails to complete xEVMPD Submission transmission.
|
DEV-454058 |
|
After a user imports a Submission to Vault via FTP, Vault may not import certain documents if they do not already exist in the Vault.
|
DEV-454363 |
|
Vault Report-Level Content Plan Publishing jobs can become stuck when the Report-Level Content Plan is not referenced on the Report-Level Content Plan object.
|
DEV-454494 |
|
In some cases, Submissions with very large numbers of links may fail to publish.
|
DEV-455155 |
|
In some cases, Vault incorrectly reports Rule CN 6.26 as Pass when matched documents contain unembedded non-standard fonts.
|
DEV-455334 |
|
Vault fails to show the "Create separate Registrations for any selected Complex Products and their selected component" checkbox in the Create Bulk Registrations wizard.
|
DEV-455460 |
|
When creating a GCC Submission, the Agency value fails to populate for countries with multiple Health Authorities.
|
DEV-456452 |
|
In some cases, Vault displays "Server having problems" when a user attempts to view an Application.
|
DEV-456678 |
|
During publishing, Vault reports validation Rule 1636 as failed when referencing a previous Submission with a Dossier Status of 'Publishing Inactive'.
|
DEV-457231 |
|
Published Study Tagging File XML does not render in eCTD submission modules 4 and 5.
|
DEV-457441 |
|
In some cases, Vault fails to display a selected relationship within the Define Relationships step of creating related records.
|
DEV-457525 |
|
Vault fails to update the Most Recent Submitted indicator on Product Data Submission records after reaching the XEVMPD Submitted lifecycle state.
|
DEV-457529 |
|
In some cases, when creating related records, Vault fails to apply validation rules to fields in the Submission/Regulatory Objective Organization and Submission/Regulatory Objective Site Role objects.
|
DEV-457771 |
|
Content plan sections containing a token for the Submission Pharmaceutical Form object fail to copy.
|
DEV-457834 |
|
In some cases where Vault Renditions jobs are taking longer than expected to complete, links do not appear on published documents.
|
DEV-458083 |
|
In cases where Submission Archives contain both links and Content Plan items linked to the same document, Vault displays an error when attempting to import the Submission Archive.
|
DEV-458356 |
|
When a non-primary Submission record field is updated, Vault fails to trigger continuous publishing for the primary Submission and update Regional XML.
|
DEV-458517 |
|
In some cases, initial, on-demand, and continuous publishing tasks may sometimes fail unexpectedly.
|
DEV-462331 |
|
The content plan viewer UI freezes when a user drags and drops an unlocked matched document to which they do not have access.
|
DEV-462371 |
|
The RIM Submission Publishing job fails in some cases when the Content Plan field XML Element Name is blank on the Content Plan root node.
|
DEV-463373 |
|
Vault Link Annotations to Permalinks are not resolved when the target document is not the most recent version.
|
DEV-464327 |
|
For on-demand publishing, the downloaded publishing progress indicator can show fewer errors than displayed in the user interface.
|
DEV-464579 |
|
Vault incorrectly reports Rule 2025 for some submissions.
|
DEV-465006 |
|
Links to Report Level Content Plan module Tables of Contents (TOC) are not clickable within resulting merged PDFs.
|
DEV-465391 |
|
In some cases, when there is a large number of content plan items to be published, and multiple actions performed on those content plan items, some documents may not be published.
|
DEV-465402 |
|
When publishing a Report Level Content Plan, a new document is published rather than upversioning the existing published document when the matched document is changed.
|
DEV-465608 |
|
In some cases, the Submissions Archive Empty Section Indicator job fails to process all existing Submission Archive binders upon feature enablement.
|
DEV-466630 |
|
Activity records for Cambodia, Laos, and Myanmar do not appear on the affiliate homepage.
|
DEV-467666 |
|
In some cases, auto-naming and 'Relate multiple records' configurations for the Application Country and Application Indication objects are overwritten by the Submission Wizard feature upgrade task in Limited Release Vaults.
|
DEV-467894 |
|
In some cases, reference leafs are not published when the target was imported out of order.
|
DEV-468254 |
|
In cases where there is an imported submissions archive with a cross-application reference leaf, the reference leaf is not published.
|
DEV-468731 |
|
In some cases, Vault performance is degraded when creating related records from an Event.
|
DEV-469026 |
|
In some cases, Vault fails to pull Regulatory Objective data due to irrelevant Object Type Mapping records.
|
DEV-469072 |
|
Vault reports a runtime error when a user loads Application relationships by ID.
|
DEV-469436 |
|
When viewing both New and Replace documents in the viewer, if a user navigates into a document and then selects "Back to viewer," the Replace documents disappear from the viewer.
|
DEV-471045 |
|
Vault displays fewer records in the Global Content Plan dispatch notification than were created during the operation.
|
DEV-471403 |
|
The FDA async gateway relies on certificates being loaded into the sync gateway profile.
|
DEV-472265 |
|
When creating related records and pulling Regulatory Objective data, Vault omits the Manufacturer name from the names of Submission Inactive Ingredient and Regulatory Objective Inactive Ingredient records.
|
DEV-472632 |
|
In some browsers, the "Back to Previous Page" link is missing from pages displaying Regulatory Objectives.
|
DEV-472648 |
|
In some cases, the Create Content Plan job fails for previously-published Report Level Content Plans if the plan’s object type is changed.
|
DEV-472959 |
|
When creating related records and pulling Regulatory Objective data, Vault fails to create target Submission Inactive Ingredient and Submission Clinical Study records when source Event record fields Event Product and Event Indication fields are populated.
|
DEV-473307 |
|
When active and inactive Content Plan Items share a matched document, Vault updates the active item’s Published Output Location to match the inactive item.
|
DEV-474010 |
|
In some cases, Vault fails to join records while creating registrations in bulk.
|
DEV-474240 |
|
In some cases, Vault creates new related join records based upon inactive join records when creating related records from an Impact Assessment Report.
|
DEV-474683 |
|
Users may see an error when loading an Application relationship with more than 2,000 records.
|
DEV-476261 |
|
Users that do not have the registration application are unable to use the Pull Objective Data wizard.
|
DEV-481822 |
| Description |
Issue No. |
|
Fixed an issue where, when promoting an E2B imported AER or Inbox Item with a narrative document to a Case, the merge fields used information from the Case as well as the AER/Inbox Item and the narrative document was linked to both the Case and the AER/Inbox Item.
|
SAF-11415 |
|
Fixed an issue where the Primary Product was unable to be changed on an E2B imported Case.
|
SAF-16345 |
|
Fixed an issue where, after the Evaluate Regulatory Obligations action was run on a Case with Localization set to a non-global value and a distribution was created, the Substance Name was not copied to the Localized Case Product Substance.
|
SAF-18894 |
|
Fixed an issue with ICH E2B(R2) reports where the DOCTYPE DTD (document type definition) could not be modified.
|
SAF-19096 |
|
Fixed an issue where, when upgrading a Follow-Up Case to a SUSAR, an incorrect Due Date was populated on the Transmision record (15-day instead of 7-day SUSAR).
|
SAF-20131 |
|
Fixed an issue where a cleanup operation of duplicate MedDRA records failed when the vault contained Product Datasheets which referenced a duplicate MedDRA record but was not referenced by a watchlist.
|
SAF-21516 |
|
Fixed an issue where, when a Study with a name that exceeds 1500 characters but is less than 2000 characters was selected on a Case, the Case could not be saved.
|
SAF-22283 |
|
Fixed an issue where Case Product Substances were not snapshotted upon promoting an Inbox Item.
|
SAF-22484 |
|
Fixed an issue where, when the Evaluate Submission Obligations action was run on a Case created from an E2B imported Inbox Item with a registration in a foreign country, the system created a new English narrative document on the generated localized Case instead of using the existing narrative document in the local language.
|
SAF-22746 |
|
Fixed an issue where some Japanese terms used in Controlled Vocabularies were incorrect or not aligned with the Health Authority.
|
SAF-22748 |
|
Fixed an issue where AS2 connectivity between two Safety vaults could not be established and the Distribution record was moved to Error state due to port 4080 not being open for outbound transmission.
|
SAF-22759 |
|
Fixed an issue where, when promoting an Inbox Item with Localization set to a non-global value, the English translation on the Case Medical History was overwritten by the reported term in the native MedDRA language.
|
SAF-22821 |
|
Fixed an issue where, upon importing an Inbox Item from an Intake API or E2B file, the record ID for multiple fields were displayed in the Inbox Item audit log.
|
SAF-22865 |
|
Fixed an issue where, when the Re-evaluate Submission/Distribution action was run on a Case, a NullPointerException (NPE) error appeared if the country on the Expectedness record did not match the registration country.
|
SAF-22897 |
|
Fixed an issue with the PADER Summary of ADR from Postmarketing Sources report where, if the Case Assessment Expectedness was overridden, the adverse event was detected as both labeled and unlabeled in the generated report.
|
SAF-22903 |
|
Fixed an issue where, when a Vault Owner tried to update the Distribution Rules field on the EMA ICSR Reporting Rule Set, an error appeared stating the field can not be updated.
|
SAF-23053 |
|
Fixed an issue where a submission record could not generate if the agency was missing the API name.
|
SAF-23053 |
|
Fixed an issue with domestic Case processing where the localized Patient Contact was not generated for the Case after Case promotion.
|
SAF-23134 |
|
Fixed an issue where Cases with more than two blank fields used in duplicate detection were not considered as potential matches when promoting an AER or Inbox Item.
|
SAF-23428 |
|
Fixed an issue where, when Indicate Unexpected Terms was enabled, the DSUR log sheet for Cumulative Summary Tabulation of Serious Adverse Reactions included unrelated Cases. The total number of events was not impacted in the tabulation.
|
SAF-23459 |
|
Fixed an issue where, when creating a Case from an E2B imported Inbox Item, a duplicate Case Product Substance was created.
|
SAF-23617 |
|
Fixed an issue with localized Cases where, when the Case narrative document was updated with text in the local language, the localized Case narrative preview was not updated to display the text in the local language and instead displayed it in English.
|
SAF-23668 |
|
Fixed an issue where an error message did not appear when a user exceeded the maximum character limit for the Reporting Summary app control field.
|
SAF-23684 |
|
Fixed an issue with E2B(R3) export where the Dosage Text (G.k.4.r.8) field was not truncated to 2000 characters upon export.
|
SAF-23775 |
|
Fixed an issue where, when an AER was promoted to a Follow-Up Case, the Study Registration was not downloaded from the Study library and was not added to the Case.
|
SAF-23799 |
|
Fixed an issue where the Study-type Case Product Registration and Product fields were not populated on the Case upon promoting an E2B imported Inbox Item.
|
SAF-23974 |
|
Fixed an issue where, when a Study Case was promoted, the Case Product name was not included in the name of the Case if there was no Study Product name. Now, if there is no Study Product name, the system includes the Primary Product name in the name of the Case, if it exists.
|
SAF-24312 |
|
Fixed an issue where each time the Inbox Item Details section was saved with no changes, the audit trail logged "Record saved with no changes". In addition, if the Study field was populated when saving the Details section, the audit trail logged changes from the Product section when there were none.
|
SAF-24327 |
|
Fixed an issue where, when a user tried to verify the Awareness Details, a server error appeared due to duplicate entries existing for one field.
|
SAF-24406 |
|
Fixed an issue with E2B imported Inbox Items where, after promoting to an Initial Case and, subsequently, to a Follow-Up Case, Case Assessment records were created for all concomitant medications.
|
SAF-24430 |
|
Fixed an issue where, when some Inbox Item sections were verified and saved, certain fields were logged in the Old Value and New Value columns on the audit trail.
|
SAF-24452 |
|
Fixed an issue where a submission to the FDA containing Northern Ireland country code "XI" was rejected. Now, submissions to the FDA will use the country code "GB" for Northern Ireland whereas submissions to all other destinations will use the 2-character country code in Vault.
|
SAF-24493 |
|
Fixed an issue where, when a user tried to verify the Awareness Details, a server error appeared due to duplicate entries existing for one field. This is a previous fixed issue (SAF-24406) from 21R3.0.3 with a newly implemented solution. Now, if a field is updated more than once, the value reflects the most recently entered data.
|
SAF-24535 |
|
Fixed an issue where, when an ICH E2B(R2) regulatory report was generated, the header contained "FDA".
|
SAF-24548 |
|
Fixed an issue with FDA MedWatch 3500A form generation where if Patient Initials was blank, Section A.1 on the form (Patient Identifier) was not populated with Investigation MRN.
|
SAF-24549 |
Fixed an issue where, when loading a MedDRA .zip file into different vaults, an inconsistent number of records between vaults were displayed. The MedDRA Hierarchy for CMQ and Vault Reporting feature addresses this issue with a new user action to download the full active MedDRA version from the central dictionary to a vault.
|
SAF-24576 |
|
Fixed an issue with a Localized Case translated from a Global Case where, when an ICH E2B(R3) report was generated, Event (Reported) used data from the Localized Case instead of the Global Case.
|
SAF-24588 |
|
Fixed an issue where the Age (normalized) field was rounded up instead of being truncated.
|
SAF-24609 |
|
Fixed an issue where, when the ISO character "Z" was included in the date field value, this resulted in an incorrect field value.
|
SAF-24625 |
|
Fixed an issue for FDA E2B(R2) combination product reports by supporting partial dates for the Case Product Expiration Date field.
|
SAF-24626 |
|
Fixed an issue where, an additional blank Product record was created for a Localized Case upon Case promotion.
|
SAF-24628 |
|
Fixed an issue where the Race Reason Omitted field value on the Inbox Item was not copied over to the Case upon Case promotion.
|
SAF-24660 |
|
Fixed an issue where the CIOMS I file failed to generate due to a missing delimiter in the Case Assessment name.
|
SAF-24669 |
|
Fixed an issue where an error message appeared and a Follow-Up Case was unable to be created after deleting the Product Indication and Dosage record on the Case Compare page from an initial domestic Case.
|
SAF-24724 |
|
Fixed an issue where duplicate detection did not return any potential matches if Matching Contents contained special characters and operators, such as " ' ( ) *. Now, special characters and operators are treated as normal characters and do not impact duplicate detection.
|
SAF-24737 |
|
Fixed an issue with ICH Case-level validations where multiple records were created for the validation criteria (one record for each agency it was run for) in the summary file.
|
SAF-24742 |
|
Fixed an issue for Inbox Items created from an imported document where, when only the "Other medically important condition (specify)" checkbox was selected and extracted, an incorrect P3 Priority was suggested and a "Seriousness was not found" rationale was provided.
|
SAF-24862 |
|
Fixed an issue where, when a case processing user attempted to mark an Inbox Item as Mark as Follow-Up on the Potential Matches page, an error appeared stating the user does not have permission.
|
SAF-24866 |
|
Fixed an issue where the Inbox Item audit trail logged the unverified Product section as "Verified" instead of "Edited" when the Study was changed in the Details section.
|
SAF-24913 |
|
Fixed an issue where, when promoting an Inbox Item to Follow-Up from the Case Compare page, the Source MedDRA Version was not set on the Follow-Up Case.
|
SAF-24917 |
|
Fixed an issue where Suspect = Yes was configured at the rule set level and could not be overridden for a Case with a Drug Role that was updated to "Drug Not Administered". As part of this fix, the Suspect = Yes rule set-level parameter was removed from the EMA, FDA, and PMDA rule sets.
|
SAF-24953 |
|
Fixed an issue with PSUR reports where, when multiple Core Datasheets contained the same MedDRA term, the Expectedness was set using an incorrect or unrelated Core Datasheet.
|
SAF-24991 |
|
Fixed an issue where using Vault Loader to update Study Persons was unsuccessful if the First Name and Email fields were left blank. This is due to system-managed validation rules for the Person object which limit the number of characters and does not accept null fields. Now, First Name Length and Email Address Length validation rules can be edited.
|
SAF-24993 |
|
Fixed an issue with E2B(R2) and E2B(R3) imported Inbox Items and AERs where, after promoting to Case, the unknown Case Assessment records from the E2B file were not created on the Case.
|
SAF-25006 |
|
Fixed an issue where an error appeared when a Vault Owner tried to update the Default Seriousness field on the system-provided DME watchlist (dme__v). Now, fields such as Default Seriousness and Watchlist Exclusions can be configured for the DME watchlist.
|
SAF-25022 |
|
Fixed an issue where an Index Out of Bounds error appeared and the CIOMS I report failed to generate for a distribution.
|
SAF-25024 |
|
Fixed an issue where, when any Inbox Item section or record was verified with no changes made, the old and new values on the audit trail still displayed all the fields.
|
SAF-25025 |
|
Fixed an issue where the Result (qualifier) picklist field in the Case Test Result object contained invalid values.
|
SAF-25032 |
|
Fixed an issue where the EMA validation rule for G.k.9.i.2.r.1.EU.1 (EU Source of Assessment) was missing.
|
SAF-25066 |
|
Fixed an issue with the Cumulative Tabulation of Serious Adverse Reactions from Clinical Trials report generation where the Expectedness calculation was not consistent.
|
SAF-25071 |
|
Fixed an issue where Localized Cases were moved to Closed state upon promoting them to a Follow-Up Case.
|
SAF-25154 |
|
Fixed an issue where, after creating a Case Product Registration record for a Japanese Domestic Case and promoting the Case to Follow-Up, the Follow-Up Case did not contain the Case Product Registration record.
|
SAF-25180 |
|
Fixed an issue where, when a PADER Non-Primary Suspect Product Report was generated, an older Case version with a non-primary suspect product was included.
|
SAF-25207 |
|
Fixed a limitation where the Most Conservative Product reporting rules evaluation method was not evaluating for Distributions through a Partner or MAH Distribution List.
|
SAF-25223 |
|
Fixed an issue where Reason Omitted (nullFlavor) values were incorrectly displayed for some FDA VAERS Regional fields.
|
SAF-25237 |
|
Fixed an issue where, when the Upgrade rule was configured for custom rule sets, the rule did not pass for an upgraded Case.
|
SAF-25243 |
|
Fixed an issue where the Meddra Version was not populated with "-" when importing an E2B file to AER with a blank MedDRA Version. This resulted in the E2B Import field being set to No.
|
SAF-25245 |
|
Fixed an issue where inconsistent timezones were used to determine the date in generated forms. Now, CIOMS I and FDA 3500A reports will use Vault's default timezone. For E2B exports, users can convert the date to use the appropriate timezone.
|
SAF-25344 |
|
Fixed an issue where, when the bulk unblind operation was run, the Case was still included in the blue category (closed Cases that have not been unblinded) and a follow-up version was created.
|
SAF-25368 |
|
Fixed an issue where the user was not notified when D.2.2a (Age at Time of Onset of Reaction / Event (number)) was truncated from an imported E2B file.
|
SAF-25411 |
|
Fixed an issue with the local MedDRA dictionary where, when the Terms Hierarchy was applied, no results were shown.
|
SAF-25416 |
|
Fixed an issue where, when the Terms Hierarchy was applied and a term is entered in any MedDRA language except English and Japanese, the LLT term under the hierarchy could not be found.
|
SAF-25419 |
|
Fixed an issue where, when the Void Case user action was triggered, the pop-up message to indicate the user does not have permission was displayed as an error.
|
SAF-25446 |
|
Fixed an issue with system-generated AERs and Inbox Items where, if the field value for Case Contact Rank is not 1, the Primary Source in the Case Contact record was left blank upon Case promotion.
|
SAF-25447 |
|
Fixed an issue where an incorrect error message was displayed when the New Info Date was blank during Inbox Item promotion to Case.
|
SAF-25454 |
|
Fixed an issue with E2B(R2) export where, when a distribution with Study Content Protection set to Mask Unblinded Content was created, the masked file contained susbtance information.
|
SAF-25502 |
|
Fixed an issue with Date Received by Manufacturer (24c) field mapping when generating the CIOMS I form. Now, the New Info Date field will be used to populate Date Received by Manufacturer on the form for both Initial and Follow-Up Cases.
|
SAF-25679 |
|
Fixed an issue where, when a Case Product or Case Adverse Event was deleted, the Matching Contents record was not updated and these records were still being considered in duplicate detection.
|
SAF-25711 |
|
Fixed an issue with E2B(R3) export where, when the Mask Reporter for Postmarket Non-Literature Case setting was enabled, the nullFlavor values were not masked upon generating the report.
|
SAF-25725 |
|
Fixed an issue with E2B(R2) export where, when the Patient Content Protection was set to Mask PII, the Date of Birth field was not exported when it should have been exported as PRIVACY.
|
SAF-25753 |
|
Fixed an issue where, after deleting an Inbox Item subsection or editing a Product Dosage record, these changes were not saved on the Inbox Item upon selecting the global save button.
|
SAF-25762 |
|
Fixed an issue where, after importing an open Study to Inbox Item and promoting to Case, the Product and Product Registration fields were blank.
|
SAF-25765 |
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Fixed an issue where, when importing an E2B(R2) file to AER or Inbox Item, the test Result (B.3.1d) and Test Result (unit) (B.3.1e) were mapped to Normal Low Value (B.3.1.1) and Normal High Value (B.3.1.2) fields.
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SAF-25802 |
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Fixed an issue where the FDA MedWatch 3500A form failed to generate when a narrative document was uploaded to the Case.
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SAF-25832 |
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Fixed an issue with E2B(R2 and R3) form generation where validations were not triggered and the transmission document was successfully generated with an error notification stating the document was not generated.
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SAF-25912 |
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Fixed an issue where, when importing an E2B(R2) file to AER, Inbox Item, or Case, the Case Seriousness (A.1.5) was mapped to all Adverse Events instead of considering the Term highlighted by the reporter (B.2.i.3) field value for each Adverse Event.
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SAF-25996 |
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Fixed an issue where an error appeared when a user tried to load more than 250 Case Assessment records in one batch using Vault Loader.
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SAF-26073 |
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Fixed an issue where vaults provisioned after the 20R1 release contained at least one controlled vocabulary API name that did not match that of vaults provisioned before the 20R1 release.
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SAF-26091 |
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Fixed an issue with CIOMS I and FDA MedWatch 3500A report generation where, when the Study Product dosage was blinded, the Frequency on the report was blank instead of displaying *****.
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SAF-26092 |
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Fixed an issue with CIOMS I form generation for Cases with Combination Products where assessment results were generated for device constituents. Assessment results should only be generated for products listed in Section 14 (drug constituents).
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SAF-26125 |
Fixed an issue affecting clinical trial study cases where, in both evaluating the Expected reporting rules parameter and determining the Most Conservative Product, the system was using Local Datasheets for regional expectedness.
Now, the system will only explicitly evaluate regional expectedness for non-study and postmarket study cases.
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SAF-26144 |
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Fixed an issue with creating a Follow-Up Case from an Inbox Item where, if the blank option on the Adverse Event section dropdown was selected on the Case Compare page, a blank Adverse Event record was promoted along with the other Adverse Events.
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SAF-26179 |
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Fixed an issue where validation did not run when the Evaluate Regulatory Conformance action was triggered on a global Case with only E2B format submissions for localized Cases.
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SAF-26189 |
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Fixed an issue where the Due in Days Override parameter was overriden when being used in a rule set that inherits a Base Rule Set.
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SAF-26273 |
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Fixed an issue where, when exporting to E2B(R2 and R3), G.k.4.r.6a (Duration of Drug Administration (number)) did not truncate to 5 characters.
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SAF-26277 |
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Fixed an issue where, when a manual Inbox Item with a Study (and Study Arms) was promoted to Case, the Study Product field on the Case was blank.
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SAF-26306 |
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Fixed an issue where, when searching for certain MedDRA terms, the MedDRA browser search was not prioritizing exact matches when returning search results.
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SAF-26331 |
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Fixed an issue where, when an Inbox Item with Localization set to a non-English value was promoted to Case, the narrative document was not created for the local Case.
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SAF-26415 |
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Fixed an issue where, when an FDA MedWatch 3500A form was generated, the UID/MFR Report # was not completely printed on the form for some cases.
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SAF-26416 |
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Fixed an issue with manual Inbox Item intake from emails where the Study Arm field was hidden on the Inbox Item.
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SAF-26462 |
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Vault Safety will now generate Distributions for Cases containing a Case Product or Product Registrations which were members of a Reporting Family for a Partner or MAH Distribution List when the Case has a "Report Type" of Study. Previously, Study Case could only trigger partner Distributions through matching on the Study or Study Registration.
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SAF-26512 |
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Fixed an issue where, duplicate Transmission records were generated for the same destination if multiple Transmission Profiles exist for the origin and destination pair.
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SAF-26518 |
Fixed an issue with the E2B SDK extension for E2B(R2) where the literaturereference element was not being generated.
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SAF-26571 |
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Fixed an issue where some emails to vault were not creating Inbox Items due to the email subjects exceeding 100 characters.
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SAF-26595 |
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Fixed an issue with E2B imported Inbox Items with Parent Information. When the Study field was set on the Inbox tab in list view, this resulted in only the Parent Case Study being updated upon Case promotion and not the Patient Case Study.
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SAF-26661 |
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Fixed an issue where, when the Localization field was selected or updated on an Inbox Item, the localized text fields were not updated on the Inbox Item page.
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SAF-26684 |
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Fixed an issue where, when exporting an XML file with a blank F.r.3.2 (Test Result value / qualifier) and F.r.3.3 (Test Result unit), an empty tag was included in the XML file, which led to a failed import.
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SAF-26754 |
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Fixed an issue where, when an FDA MedWatch 3500A form was generated, section B2 (Outcome Attributed to Adverse Event) only contained the primary Case Adverse Event Seriousness values and did not contain those for the non-primary Case Adverse Event.
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SAF-26762 |
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Fixed an issue with UID matching (UID, WWUID, External System UID, Case Identifier) where duplicate search was case sensitive. Thus, if an Inbox Item and Case UID matched but were not in the same Case sensivity, duplicate search did not detect this field as a match.
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SAF-26804 |
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Fixed an issue where any additional updates after Case promotion made to the Follow-Up global case were not synched to the localized Case(s).
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SAF-26807 |
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Fixed an issue where the Study Number on the Case was unable to be updated after being renamed.
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SAF-26817 |
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Fixed an issue where, if a serious Case Adverse Event was added to an existing Case, the system-generated Case Assessment Result for the reporter was not automatically assigned the "Source Type".
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SAF-26839 |
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Fixed an issue where, when a transmission document was generated on a submission with Reason set to Amendement and Reason Text containing more than 200 characters, the Reason Text was still exported to B.5.1 (Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information) in the E2B(R2) files.
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SAF-26881 |
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Fixed an issue with E2B(R2) export where certain MedDRA data elements contained the term name in addition to the MedDRA LLT code. The system will now export the data elements with only the MedDRA LLT code.
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SAF-26938 |
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Fixed an issue where, when the Patient RoA was selected on the Inbox Item, the Patient RoA TermID and Patient RoA TermID Version were not set, which led to G.k.4.r.10.2a (Route of Administration TermID Version Date / Number) and G.k.4.r.10.2b (Route of Administration TermID) not being exported to E2B(R2 and R3).
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SAF-26966 |
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Fixed an issue where, when an Inbox Item containing two Combination Products was promoted, only one Combination Product was included on the Case.
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SAF-27004 |
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Fixed an issue where Case Assessments and Assessment Results imported from E2B(R2) to Inbox Item were not copied to the Case upon Case promotion.
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SAF-27080 |
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Fixed an issue with E2B(R2) import where the Reaction Recurrence (B.4.k.17.1) was not imported to Inbox Item or AER.
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SAF-27110 |
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Fixed an issue with E2B(R2) import, where if data element B.1.9.4b Autopsy-determined Cause(s) of Death did not match to a MedDRA term, the value was not imported. Now, the system will import the text value if it does not match to a MedDRA term.
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SAF-27112 |
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Fixed an issue with E2B import to Inbox Item, where if the dose frequency unit was "Cyclical," "As Necessary," or "Total", the value was not imported to the Frequency field. This issue did not impact AERs.
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SAF-27141 |
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Fixed an issue where, when an Inbox Item with Localization set to a non-global value contains an Indication and references a combination product with multiple product constituents, a Domestic Case failed to create upon Case Promotion.
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SAF-27196 |
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Fixed an issue with E2B(R3) import, where an error appeared indicating the result_text__v value exceeded the 2000 character limit in certain scenarios when the limit was not exceeded.
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SAF-27287 |
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Fixed an issue where the most conservative product selection method was generating Submissions with a mismatched Transmission Profile in Cases with Combination Products.
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SAF-27292 |
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Fixed an issue where the most conservative product selection method was not evaluating correctly in Cases with Combination Products.
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SAF-27293 |
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Fixed an issue with EMA E2B(R3) export where if a Study contained a Registration Number from any EU country, the Country was updated to "EU" on the generated EMA E2B(R3) XML file. This led to submission rejections and E2B ACK warnings.
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SAF-27454 |
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Fixed an issue in a sandbox environment where if a Reporter Qualification value was selected, a server error appeared and the Identifiable Reporter field was set to No.
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SAF-27489 |
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Fixed an issue where, when importing an EMA E2B(R3) file to Inbox Item, the Inbox Item was not created and the document went to Error state.
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SAF-27553 |
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Fixed an issue where, when an Inbox Item was promoted to a Follow-Up Case, custom fields were not copied from the previous Case version. If using the Create Follow-Up Case user action, custom fields were copied as expected.
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SAF-27559 |
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Fixed an issue where, when the Evaluate Reporting Obligations action was run on a Case containing an Investigational Study Product and a Placebo Study Product set as unexpected and related (SUSAR), submissions were still generated with the SUSAR rule.
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SAF-27796 |