The issues listed below may impact Vault functionality for some users. We are actively investigating all known issues and will be providing fixes and updated information in future Vault releases.
| Description |
Issue No. |
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Users may be unable to search for Product records in the Agreement wizard.
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DEV-428403 |
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Sites Evaluated but not Selected are not excluded from TMF Bot model training when training from production data in a sandbox using the CSV upload method.
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DEV-434900 |
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In some rare cases, users are unable to create Clinical tasks from the CRA homepage.
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DEV-438174 |
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Vault fails to populate the Actual Finish Date on a Subject-related milestone when No New Subjects on the Site is not checked.
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DEV-438529 |
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When viewed on a hovercard, Site Activation progress renders on multiple lines rather than one.
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DEV-442979 |
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When a visit is deleted, Vault fails to blank the visit date field.
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DEV-443206 |
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In some cases, a TMF Transfer of over 80,000 documents may take much longer than expected.
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DEV-444380 |
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In some cases, when attempting to click on an Override rule within the eTMF Lifecycle or eTMF Binder Lifecycle, Vault displays a "Server having problems" error.
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DEV-447996 |
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Vault fails to provide an exception message after the Inbound Worker job fails due to Protocol Deviations/Procedures mapping issues.
This issue has been fixed in the current release.
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DEV-448201 |
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When executed from a Document Check record, Site Connects sends a document instead of a document request to SiteVault.
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DEV-448939 |
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Distribution Tasks fail unexpectedly if a recipient's Email Status goes from Sending directly to Opened or Viewed, causing the task to remain in the Sending lifecycle state.
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DEV-449133 |
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Generating a CTN record without a valid Health Authority Code results in a "Server having problems" error.
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DEV-449187 |
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In some cases, the Study Sites selector for a Safety Distribution record may not display all valid sites.
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DEV-450344 |
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Vault fails to create Distribution Task Recipients when there are more than 500 failed Distribution Tasks.
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DEV-451468 |
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Generating a CTN record without a valid Health Authority Code results in a "Server having problems" error.
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DEV-452588 |
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The Trip Report Review Comment modal renders incorrectly.
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DEV-452661 |
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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.
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DEV-452941 |
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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.
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DEV-453599 |
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In cases where the Steady State Count is not set, Vault displays "Server having issues" when a user attempts to update the Requiredness field.
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DEV-455396 |
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With Enhanced Document Update disabled, Vault displays an error when attempting to classify an Unclassified document with a read-only Study and Product into a document type configured for streamlined reuse. The Product remains on the document and cannot be removed, preventing classification.
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DEV-466382 |
| Description |
Issue No. |
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In some cases, merge fields documents with content control content are not formatted as expected.
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DEV-416782 |
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In some cases, the "Position" token value in merged rich text fields is not inherited.
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DEV-416787 |
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In some cases, merged rich text fields incorrectly inherit or fail to inherit certain values.
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DEV-416805 |
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In some cases, Vault adds extra spacing to merge fields documents with content control content.
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DEV-417334 |
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Ordered and unordered list values incorrectly inherit formatting specified in merged rich text fields.
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DEV-417930 |
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In some cases, documents with merged rich text fields include tables of contents that are missing items.
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DEV-418388 |
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Vault does not noticeably display the "Rich Text Fields are not supported to generate barcodes" error.
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DEV-421070 |
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Vault may incorrectly merge paragraphs in documents with merged rich text fields.
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DEV-423305 |
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In some cases, merged text rich fields incorrectly inherit bold formatting when it is not specified.
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DEV-423366 |
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In rare cases, on documents with merged rich text fields, Vault may render a different font family and size from the source document.
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DEV-423390 |
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When the "Retain Bold and Italic styles in Bookmarks" setting is enabled, Vault may not retain font stylings for bookmarks on documents with merged rich text fields.
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DEV-423615 |
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While using Internet Explorer 11, users are unable to upload e-Signature templates.
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DEV-425485 |
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In Formatted Outputs, referenced records tables with Rich Text formatting display incorrectly and repeat the same record on multiple rows and columns in place of other records.
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DEV-430957 |
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Vault sometimes fails to extract OCR text from documents and displays an unhelpful message in the audit trail.
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DEV-432848 |
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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.
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DEV-433447 |
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The "Download Non-Protected Rendition" action is missing from the document Actions menu when viewing protected renditions.
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DEV-433662 |
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Link annotations may not link to the correct anchors after a document is upversioned.
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DEV-433871 |
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In some cases, opening Vault-generated PDF/A-compliant documents in Adobe® Acrobat® results in errors.
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DEV-435537 |
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In some cases, Vault fails to render videos.
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DEV-438817 |
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When a user creates a new annotation, edits the placemark pattern, then scrolls to another page, the placemark temporarily disappears.
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DEV-439182 |
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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.
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DEV-439587 |
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If a user attempts to move a pending placemark after resizing the browser, Vault may instead draw a new placemark.
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DEV-439708 |
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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.
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DEV-439924 |
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When protected PDF renditions are enabled, Vault displays the error "Vault is unable to display this document" in the document viewer after a user performs the "Make a copy" action.
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DEV-440367 |
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If the PDF file for an XFA EU form contains a dialog, the form fails to render.
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DEV-440696 |
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In rare cases, Vault fails to render Microsoft Excel attachments.
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DEV-441187 |
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Vault may fail to render a file when re-merging a set of fields from a single value to multiple values.
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DEV-441352 |
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In Overlay mode, Vault may draw placemarks in the incorrect location after the user changes the placemark's shape.
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DEV-442150 |
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In some cases, Vault fails to reflect changes to text annotation highlight colors until after the user draws another placemark.
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DEV-442153 |
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In some cases, when users attempt to update their color preferences, Vault does not save their reply color for annotations correctly.
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DEV-443632 |
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When a user attempts to save an annotation that contains invalid characters and then closes the error dialog that appears, another dialog appears that the user can't close.
|
DEV-445164 |
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When a user changes the shape of a pending annotation to or from an arrow and then resizes the browser window, the placemark shifts slightly.
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DEV-445696 |
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Users can remove a Role filter after selecting My Inbox in the Share Inbox dropdown.
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DEV-446963 |
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In some cases, Admins see a server error when attempting to edit the Document Number Format for the Unclassified document type.
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DEV-447711 |
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In some cases, after using collaborative authoring with Microsoft Office and checking in a new version, some links in the document have the wrong URL.
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DEV-448122 |
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In some cases, viewable rendition generation may not complete due to an error during document processing.
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DEV-449146 |
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Search results in the Bookmarks panel display vertically when the bookmark title does not fit the width of the panel.
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DEV-450123 |
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When dragging and dropping a file in a binder, the Upload New Version dialog does not populate the file automatically.
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DEV-451678 |
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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.
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DEV-451728 |
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In some cases, after manually adding a rendition and performing the Make a Copy action, Vault lists an incorrect file size for the copied rendition.
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DEV-452093 |
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In some cases, when a Document Change Control record has three Documents to be Approved, the formatted output may show only two.
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DEV-452724 |
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In some cases, the Export Annotations action fails for certain documents.
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DEV-452895 |
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In some cases, a downloaded viewable PDF rendition may not correctly display images in Adobe Reader.
|
DEV-452987 |
| Description |
Issue No. |
|
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 |
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In some cases, an SDK trigger may attempt to create a record multiple times in a single transaction, resulting in errors.
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DEV-426337 |
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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.
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DEV-436675 |
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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.
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DEV-438252 |
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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 |
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If a record has a controlled field set to a document that is not in a user's Recently Viewed list, and that user updates the controlling field, Vault may clear the controlled field even if it is still valid.
|
DEV-439417 |
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When navigating to a record with a Related Objects section when object reference fields are disabled and the user has Read permission on the parent reference, Vault displays a "Server having problems" error.
|
DEV-441477 |
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In some cases, Vault may display a "Server having problems" error when running the Create Related Records user action.
This issue has been fixed in the current release.
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DEV-446945 |
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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 |
| Description |
Issue No. |
|
Linked Quality Team role fields may fail to synchronize in cases with large numbers of records.
|
DEV-437119 |
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In some cases, after editing a record's Quality Team's role membership while a record is in an active workflow, the Workflow Timeline view section arrows may not behave as expected.
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DEV-440042 |
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In cases where a learner's User record is in the Pending state, the Update Training Assignments job may assign a Training Assignment to the learner in a Created state instead of the correct Assigned state."
|
DEV-441038 |
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When a user manually sets an Adverse Event Report record to a complete state, Vault does not send a notification.
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DEV-443442 |
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In Vault Training, the Issue Training Assignments entry action may incorrectly update a Training Requirement's content set after a "Changes do not affect Training Req." verdict was given during the Training Requirement Impact Assessment workflow.
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DEV-444391 |
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The Quality Events tab may experience performance issues.
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DEV-445265 |
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Executing the Submit to Gateway action on a manually created Adverse Event Report results in an error that the Country field cannot be null (null pointer exception).
|
DEV-445895 |
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In some cases, a Facilitated Training job may fail to change a Facilitated Training Request record to the Completed state if the record contains a validation rule that references today('user').
This issue has been fixed in the current release.
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DEV-450545 |
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Users who lack Edit permission to the Release Change Control object may be unable to add Periodic Reviews to a Document Change Control record.
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DEV-451231 |
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Vault may incorrectly display an inadequate permissions error when triggering a Change State of Related Record entry action on a Change Authorization record.
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DEV-451364 |
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Vault may display an incorrect error message when a user adds a non-latest version of a document to a Documents to be Released section on a Multi-Document Change Control record.
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DEV-451616 |
| Description |
Issue No. |
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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 |
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When submitting XEVMPD messages via the EMA gateway, Vault fails to log performance statistics.
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DEV-434739 |
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The RIM Submission Plan job intermittently fails to create Content Plan sections and resolve tokens.
|
DEV-435165 |
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The "Import files not referenced in the eCTD XML" option does not apply to EAEU submissions.
|
DEV-436975 |
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When an EU Submission Type is "Variation" or "Extension", Submission Mode appears as blank on the Update Administrative Information page.
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DEV-438223 |
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When an EU Submission Type is "Single" via the Update Administration Information page, Vault does not populate the corresponding Submission Mode value in the submission XML.
|
DEV-438227 |
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When a Report Level Content Plan publishing job fails, the notification does not specify the reason for the error.
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DEV-438586 |
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 |
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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 |
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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 |
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XEVMPD business rule validation does not match the EMA's updated controlled vocabularies.
|
DEV-440237 |
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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.
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DEV-441659 |
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In some cases, when a user navigates to a document in the Submissions Archive Viewer, some permalinks in the document may not work.
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DEV-442996 |
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When a user initiates the "Generate FHIR Message" user action, the PMP.42 value in the generated XML is incorrect.
|
DEV-443184 |
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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.
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DEV-444344 |
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When a source file contains Vault links and permalink annotations to a Submissions Archive document, Vault does not publish the Vault links during continuous publishing.
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DEV-445253 |
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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.
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DEV-445703 |
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When copying a custom Rich Text matching field, the Create Related Records wizard copies the text but not the formatting.
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DEV-445993 |
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When "Allow user to select multiple values" is enabled for the language_for_submission__v field, the notification sent after IDMP element generation may report errors in IDMP Attachment elements.
This issue has been fixed in the current release.
|
DEV-446178 |
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The Generate IDMP Elements job results in errors when the data contains only Medicinal Product and IDMP Product Data Submission records.
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DEV-446486 |
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In some cases when importing a Submission, Vault fails to show the prevalidation warning for unreferenced files.
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DEV-446526 |
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In some cases, the number of submissions that will be created is incorrect in the splitting wizard summary.
|
DEV-449057 |
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If there are unreferenced files at the root of the ZIP file for import at the submission level, Vault may import the submissions as non-eCTD instead of eCTD.
This issue has been fixed in the current release.
|
DEV-450185 |
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On the first import of a new Submission record with a content plan, Vault initiates the reimport process instead of the import process.
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DEV-450431 |
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If the PDF file for an XFA EU form contains a dialog, the form fails to render.
|
DEV-450955 |
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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 |
| Description |
Issue No. |
|
When submitting an E2B XML file through an AS2 gateway to CDMS, there are intermittent failures where the AER is not imported and an error ACK is returned.
|
SAF-15573 |
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When searching in the WHODrug or MedDRA browser with a single letter, no results are returned.
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SAF-21706 |
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When importing an E2B file to Inbox Item, if there is a Study and a Company Product in the library, only the Study is mapped whereas the Company Product is not.
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SAF-22402 |
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When you run the Evaluate Submission Obligations action on a Case created from an E2B imported Inbox Item with a registration in a foreign country, the system creates a new English narrative document on the generated localized Case instead of using the existing narrative document in the local language.
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SAF-22746 |
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When promoting an Inbox Item with Localization set to a non-global value, the English translation on the Case Medical History is overwritten by the reported term in the native MedDRA language.
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SAF-22821 |
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When promoting an Inbox Item to Case, an incorrect Seriousness was being populated on the Case.
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SAF-22841 |
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Vault Safety is missing EMA E2B(R3) business validation rule G.k.9.i.2.r.1.EU.1 (EU Source of Assessment).
|
SAF-23136 |
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The DSUR log sheet for Cumulative Summary Tabulation of Serious Adverse Reactions includes unrelated Cases when the Indicate Unexpected Terms is enabled. The total number of events is not impacted in the tabulation.
|
SAF-23459 |
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Some dynamic labels, such as field labels and picklist values, are not being translated during domestic Case processing.
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SAF-23539 |
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When creating a Case from an E2B imported Inbox Item, a duplicate Case Product Substance is being created.
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SAF-23617 |
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On a localized Case, when updating the Case narrative document with text in the local language, the localized Case narrative preview is not being updated to display the text in the local language and instead displays it in English.
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SAF-23668 |
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For an Inbox Item with a non-global localization, newly added localized text field values are not copied over to the follow-up domestic Case during promotion. The record is still created on both Global and Localized Cases, but the user will need to re-enter the localized text field values on the follow-up domestic Case.
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SAF-23714 |
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In PSUR, when the Product Family contains an odd number of drug products, some terms in the generated PSUR report for the Product Family are incorrectly marked as Expected.
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SAF-23736 |
When running the Fetch Dictionary Releases action on the MedDRA dictionary, the dictionary is stuck at Importing status when multiple languages are selected.
Workaround: Remove the languages in the Languages field and run Fetch Dictionary Releases. You can set the languages in the field again after the action runs.
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SAF-23812 |
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When removing Edit permissions for standard roles on the Case Lifecycle, users are unable to save the updated permissions.
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SAF-23823 |
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When saving the Details or Products section on an Inbox Item but with no new changes, the audit trail is still logging passthrough objects into the Old Value and New Value columns.
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SAF-24451 |
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When verifying the Details section on an Inbox Item for the first time, the audit trail is displaying a blank New Value.
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SAF-24452 |
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When trying to complete the QC task and send the Case to Approved state, users are receiving an error message stating the operation could not be completed successfully.
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SAF-24525 |
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When generating an ICH E2B(R2) regulatory report, the header in the generated report contains “FDA”.
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SAF-24548 |
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When verifying the Awareness Details, a server error appears if there are duplicate entries for one field.
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SAF-24564 |