The following applications may have different release dates: QualityOne client applications, RegulatoryOne, Safety, and Veeva Claims.
The issues listed below are fixed in the 23R2 release.
| Description |
Issue No. |
|
The Response picklist field on Trip Reports is shorter/smaller than other picklist fields on the Trip Report.
|
DEV-507680 |
|
When attempting to upload more than 1,000 milestone documents, Vault only creates the first 1,000 and the rest fail.
|
DEV-536674 |
|
In some cases, when users bulk upload documents, Vault does not correctly default the Product field.
|
DEV-544607 |
|
When users update a draft of a milestone document using the Create Draft action, Vault does not update the milestone document version accordingly.
|
DEV-547992 |
|
In some cases, Vault fails to recalculate the Expected vs Actual field when users upload a new EDL document.
|
DEV-548346 |
|
In certain cases, Vault does not correctly update the Requiredness, # Expected, or Expected Vs Actual fields when users upload a new EDL document.
|
DEV-548350 |
|
In certain cases, Vault does not create a new milestone document when users add an additional milestone to an existing expected document.
|
DEV-548858 |
|
Transfer failure records are not created for the Study Site when the the Study Country does not transfer successfully.
|
DEV-552235 |
|
In some cases, Vault does not correctly update the Missing and Overcount fields when expected documents are added or removed.
|
DEV-552451 |
|
Transfer failure records are not created when referencing a country__v record that only exists in the source Vault but not the target Vault.
|
DEV-552650 |
|
Users with documents that reference deleted milestone records receive an error and are unable to modify those documents.
|
DEV-558603 |
|
In some cases, when Payable Items generated for a single Fee with a Holdback are modified and the Generate Payable Items action is re-run, Vault fails to correctly update the Payable Items and their Related Holdback Items.
|
DEV-560951 |
|
In some cases, when users update the Study Hierarchy Fields on a document with tasks and navigate back to the document's tasks, the filters for Study Hierarchy are not updated accordingly.
|
DEV-561150 |
|
Documents created during email ingestion may fail to render if the TMF Bot is in use.
|
DEV-563719 |
|
In some cases, CTMS to CDMS Inbound jobs get stuck in a running state and do not complete.
|
DEV-565653 |
|
Vault fails to display an error message or other notification when the TMF transfer fails due to a corrupted source file.
|
DEV-566245 |
|
Under certain circumstances, Vault incorrectly allows multiple Study Organization records to be set as the primary payee for a Study Site when there are no existing Study Organizations for the site.
|
DEV-567840 |
|
Vault does not display the expected error message when a user attempts to create a new draft and the product linked to the document's study is no longer valid.
|
DEV-570869 |
|
In some cases, Vault does not create Monitoring Items as expected if there are multiple items of the same type.
|
DEV-573382 |
|
Under certain circumstances, site users may experience server errors after selecting a Study from the Tasks widget on the Site User homepage.
|
DEV-573882 |
|
Vault incorrectly displays the envelope icon in the Notifications section of the Home tab.
|
DEV-574813 |
|
Under certain circumstances, site users may experience server errors after selecting a Study from the Tasks widget on the Site User homepage.
|
DEV-577477 |
|
When creating new Object Types for an Object with Study Migration enabled, the field is provisioned as a Custom field and can therefore be excluded despite being required for Clinical Operations.
|
DEV-578638 |
|
TMF transfer fails if the document being transferred has an attachment with a long file name.
|
DEV-579170 |
|
In some cases in Study Training, users are unable to create Study Site records without licenses even though Study Training is not enabled and licenses should not be required.
|
DEV-579350 |
|
In some cases, the Study Migration field not provisioned on Object Types.
|
DEV-579371 |
|
If a user updates a non-lifecycle field on a CDMS protocol deviation, Vault updates the lifecycle state of the Clinical protocol deviation, triggering any entry actions on the record.
|
DEV-580603 |
|
Users may encounter an error when attempting to create a milestone with an object type of Sponsor Oversight Activity.
|
DEV-580827 |
|
In some cases, the Initiate Study Archival action is unavailable for Studies that are in the Closing lifecycle state.
|
DEV-582336 |
|
When moving a Study to Planning, Vault sometimes fails to create certain EDL items.
|
DEV-582361 |
|
In some cases, the TMF Transfer fails to send any documents and, instead, a CDX Issue is raised.
|
DEV-582550 |
|
At times, users receive an error message when attempting to test a Study Metadata Extraction model.
|
DEV-583923 |
|
In certain cases, the Site Activation Progress report is slow to load.
|
DEV-584371 |
|
At times, the Study Metadata Extraction model fails to populate the Study value on a document.
|
DEV-584908 |
|
Vault does not correctly link Country Override EDL Template items to the applicable Milestones.
|
DEV-585203 |
|
In languages other than English, the label for the 'success_rate__sys' field is translated as "Auto-classification success rate" instead of "Success Rate".
|
DEV-586544 |
|
In some cases, when Vault fails to create Prediction Metrics for one Trained Model, it causes the creation of Prediction Metrics for other Trained Models to fail, as well.
|
DEV-587253 |
|
In some cases, when users attempt to update the Assigned To field on a Quality Issue, Vault displays a server error.
|
DEV-587693 |
|
In some cases, documents fail to transfer and Vault does not display an error message.
|
DEV-587872 |
|
Users are unable to accept agreements for Simple TMF Transfer if the indication_v field in the Source's study record is populated and the Target Vault indication_v picklist is empty.
|
DEV-589707 |
|
Vault displays an error message without any relevant details when users attempt to complete a Trip Report workflow with unresolved Review Comments.
|
DEV-590416 |
|
Users experience a network error when navigating to an expected document from the Review Overcount page.
|
DEV-590449 |
|
In some cases, the CDMS to CTMS Connection fails to send Protocol Deviations, despite the job appearing to run successfully.
|
DEV-591057 |
|
In some non-English Vaults, the Prediction Metrics section of the Trained Model page layout is not translated.
|
DEV-591203 |
|
In some cases, when users move a Visit from one Fee Schedule to another, Vault creates new Payable Items instead of updating existing ones.
|
DEV-592763 |
|
In some cases, Vault applies the Override Teamplate Expected Document instead of the Standard Template Expected Document for some Study-level EDL item records.
|
DEV-594387 |
|
In some cases, Vault does not correctly record a Sent Date for a Signup Request when the request moves from Sending status directly to Signup Started status.
|
DEV-595056 |
|
In some cases, running the Document Reconciliation action does not create a new Site Document Check.
|
DEV-595242 |
|
In some cases, users encounter an error when attempting to test a Metadata Extraction model in production with a large number of studies in the document set.
|
DEV-595584 |
|
In cases where a study is set not to sync with Study Training but the document flag is set to Yes, the document is sent to Study Training with no study in the Study field.
|
DEV-596180 |
|
In some cases, running the Document Reconciliation action clears any closed and open Site Document Check and Document Check records associated with the Study Site.
|
DEV-596228 |
|
In some cases, Vault fails to delete user role setup records when “Grant Access” is changed from yes to No on Study Person records.
|
DEV-599939 |
|
In some cases, Vault fails to update the Milestone Document when users change the EDL Item classification that the Milestone references.
|
DEV-605222 |
| Description |
Issue No. |
|
Vault fails to populate metadata for PDF/A renditions while metadata population is enabled.
|
DEV-451606 |
|
Users may encounter an error when saving records after populating document reference fields configured with steady-state constraints.
|
DEV-495207 |
|
In some cases, Vault reports validation error 5057 (the document contains no text) for documents that do contain text.
|
DEV-496415 |
|
Under certain circumstances, Vault fails to render Microsoft Excel files.
|
DEV-515238 |
|
Annotations become misplaced during export, import, and linking if the pages where the annotations exist are rotated and cropped.
|
DEV-537229 |
|
Vault fails to identify text in documents using Enhanced Suggest Links.
|
DEV-540940 |
|
Under certain circumstances, Vault fails to properly render and merge fields on documents.
|
DEV-542038 |
|
In some cases, user may see false validation results regarding FDA provided forms.
|
DEV-543097 |
|
In some cases, after applying a basic overlay to a viewable rendition, several pages are missing from the document and users see an error while attempting to open the document in a PDF viewer.
|
DEV-544754 |
|
Users cannot upload a document to the Library from the Google Drive Integration if a “/” exists in the file name.
|
DEV-545307 |
|
In some cases, Vault does not send PDF documents to the standardization queue.
|
DEV-547432 |
|
When viewing a Binder with sections of multiple unbound and bound documents, clicking Expand All displays the incorrect document version. This error also occurs when switching between Bound Documents, Unbound Documents, and All Documents views. This error only occurs if one document is displayed multiple times within the Binder.
|
DEV-547745 |
|
Vault fails to maintain references added to document link annotations before the OCR process is complete.
|
DEV-549298 |
|
When naming binder sections, Vault incorrectly escapes special characters, such as ampersands.
|
DEV-550839 |
|
Vault incorrectly re-renders documents and overwrites manual renditions after users update merged fields on source documents.
|
DEV-552729 |
|
If Prevent Merge Fields on Steady State is enabled, Vault does not update document version number merge tokens when moving a document to the Steady state.
|
DEV-553231 |
|
Vault Loader may fail to extract the document relationships for archived documents.
|
DEV-555766 |
|
In some cases, pdf renditions may appear stretched after downloading.
|
DEV-558470 |
|
In some cases, using the Google Drive integration results in server errors if the Vault's name includes special characters.
|
DEV-560171 |
|
In some cases, Vault fails to display certain document relationship types in the Entry Criteria dropdown menu during Document Lifecycle State configuration.
|
DEV-562022 |
|
In some cases, users are unable to open an embedded link when the URL ends in a comma.
|
DEV-563706 |
|
In some cases, MP3 audio files cause the page to reload continuously, which prevents users from listening to them fully.
|
DEV-566182 |
|
In cases where an unexpected error occurs while saving a Viewable Rendition, users are unable to view their annotations.
|
DEV-571486 |
|
In some cases, Vault may fail to display all annotations after a user re-renders a document.
|
DEV-572356 |
|
When a user creates a new version of a document, Vault does not properly index source file text extracted with Optical Character Recognition.
|
DEV-572551 |
|
Under certain circumstances, Vault fails to render large Adobe InDesign Packages.
|
DEV-572878 |
|
In some cases, users are unable to create a presentation on an uploaded document in the Library.
|
DEV-574298 |
|
When a document is reclassified, Vault sends an automatic rendition request that replaces the viewable rendition of the document with a version that removes electronic signatures through Adobe Sign integration.
|
DEV-574319 |
|
After users sign a document and it moves into the Steady State in which they do not have the View Document permission, Vault intermittently generates the eSignature page while updating the audit trail with the message "Signature page failed to generate." Vault will generate the eSignature Page the next time a user with the appropriate access views it.
|
DEV-576222 |
|
After users sign a document via workflow and it moves into the Steady State, Vault may not automatically generate the eSignature page. Vault will generate the eSignature Page upon the next request.
|
DEV-576718 |
|
Vault incorrectly reports a failure when validating the FDA Form 2253 with RIM Publishing.
|
DEV-577393 |
|
In some cases, as a user attempts to fill out a form in a downloaded PDF viewable rendition, the rendition automatically populates certain table fields and may overwrite user input.
|
DEV-577722 |
|
In cases where the 'model_v' and 'hierarchy_v' fields are the only values in a document approval, users may receive a server error when attempting to approve the document.
|
DEV-578120 |
|
Viewable renditions downloaded from Vault may duplicate table values when fields are populated by a user.
|
DEV-578180 |
|
In some cases, users are unable to download renditions with signature pages.
|
DEV-578772 |
|
In some cases, spaces in table names may appear as " " in bookmarks.
|
DEV-579293 |
|
In previously archived studies, Sharing Settings may not have updated on all documents.
|
DEV-579366 |
|
In some cases, users receive a server error when attempting to delete documents and versions.
|
DEV-579473 |
|
In some cases, after universally applying a legal hold, Vault creates a duplicate Legal Hold record with the same name but a different record ID.
|
DEV-579487 |
|
In some cases, when a user reclassifies a document from a type with the Supporting Documents relationship to a type without the Supporting Documents relationship, Vault displays a "Server having problems" error.
|
DEV-579980 |
|
After a user modifies the object field value referenced by a lookup field on a document, some documents display outdated values.
|
DEV-580994 |
|
If certain characters are present in a document, the Suggest Links functionality is unable to find it.
|
DEV-581274 |
|
Viewable rendition of image files contain unexpected metadata in the PDF’s Title field (File > Properties > Description > Title).
|
DEV-581561 |
|
When attempting to edit labels for system lookup document fields, users may receive a Server having problems error.
|
DEV-581821 |
|
In cases where any documents exist without roles in their sharing settings, documents appear to be missing from users' Libraries after failed reindexing.
|
DEV-582041 |
|
If a bookmark label in a document's table of contents (TOC) contains whitespace before the label name, the bookmark disappears from the TOC.
|
DEV-582612 |
|
In some cases, after sending a PDF for standardization, it may be falsely reported as PDF/A compliant.
|
DEV-582793 |
|
In some cases, when a source document moves to a new steady state, Vault updates the CrossLink document even if the document is bound to a specific version.
|
DEV-583396 |
|
In some cases, Vault does not update controlled document templates to the document's new steady state version.
|
DEV-583411 |
|
In some cases, after sending a PDF for standardization, users may receive a Failed to parse metadata error due to a missing <?xpacket wrapper that should be optional.
|
DEV-584794 |
|
In some cases, large documents with many captions experience timeout errors during the document rendering process.
|
DEV-586093 |
|
Vault fails to render documents with invalid or inactive bookmarks.
|
DEV-586627 |
|
The Title value in the Doc Info pane does not update with changes if a merged document is used as the source.
|
DEV-586820 |
|
In some cases, the resizing process to fit Adobe Illustrator content within a PDF page can cause misalignment of text and images.
|
DEV-587154 |
|
If a PDF contains metadata not written in UTF-8, Vault fails to parse the metadata, which in turns causes the render process to fail.
|
DEV-587300 |
|
When performing the re-render action on a document that contained in-use anchor annotation, users could choose to remove annotations. This sometimes led to invalid inbound references. With this fix, users performing re-render will not have the option to remove annotations.
|
DEV-587388 |
|
Users may experience a connection error while configuring Collaborative Authoring.
|
DEV-588132 |
|
Documents containing invalid XML characters in their metadata fail to convert to PDF/A.
|
DEV-589571 |
|
If a non-Delegate user edits a document annotation created by a Delegate user, the author of the annotation changes from the Delegate user to the Delegator. Refreshing the page does not correct the issue.
|
DEV-590374 |
|
When users attempt to copy and paste a bookmark link with any of the following characters in the bookmark title (\ " ' ( ) * %), they receive the error message: “Error to generate perma link”.
|
DEV-590759 |
|
Vault fails to render PDF documents with XFA encoding.
|
DEV-590809 |
|
In some cases, crosslink documents may incorrectly have their link status set to deleted.
|
DEV-598556 |
|
If an Excel report is exported with over 500 tabular groups and the Collapse report groups option is selected, Vault encounters a server error.
|
DEV-599447 |
| Description |
Issue No. |
|
When adding a user to a role, the audit trail entry for Vault Mobile states the user was added to the "field" rather than the "role".
|
DEV-449090 |
|
If a Tab Collection is deleted while a user is viewing it, Vault displays a "Server having problems" message.
|
DEV-516080 |
|
Signature pages may fail to display signature descriptions.
|
DEV-528080 |
|
In some instances, users may experience a server error when opening user audit trails.
|
DEV-534978 |
|
Under certain conditions, Query Field on an Integration Rule do not display properly.
|
DEV-535988 |
|
Vault may fail to process all rows in a CSV file in the Vault Loader job.
|
DEV-547403 |
|
In rare instances, Vault may add an extra character to the label of components within outbound configuration packages.
|
DEV-549429 |
|
For customers with many users, selection of users for delegation was slow.
|
DEV-549785 |
|
In some cases, Vault Loader does not log errors or display a failure notification when a CSV file is malformed.
|
DEV-553879 |
|
In rare cases, there may be incorrect event actions in an object's audit history.
|
DEV-554070 |
|
Extracting the full list of Vault Domain Users has decreased performance.
|
DEV-554379 |
|
In some cases, the document navigation arrows do not appear for archived documents in the Vault Clinical Archive Library.
|
DEV-555576 |
|
Users are able to input more than the maximum 750 characters into the search bar when adding object references.
|
DEV-556180 |
|
Under certain conditions, the Last Login field for a user does not update.
|
DEV-556776 |
|
Sorting object record audit trails by timestamp may include extra results when including related objects.
|
DEV-558740 |
|
Vault does not display the lock icon next to the names of locked tabs on the tab collection detail page.
|
DEV-559887 |
|
Audit trails may not accurately display delegate actions performed within multi-record workflows.
|
DEV-559983 |
|
Deleting document lifecycles may take longer than expected.
|
DEV-561002 |
|
Certain components present in the target Vault may be displayed as missing when deploying migration packages, resulting in blocked steps.
|
DEV-564567 |
|
Vault may fail to populate document subtype values after a successful VPK deployment.
|
DEV-564589 |
|
On the My Vaults page, if the list of Vaults is on page 2 or greater and a user applies a filter resulting in only one page, Vault shows "No items found."
|
DEV-565083 |
|
In some cases, users may experience performance issues when generating Narrative documents.
|
DEV-566588 |
|
In rare cases, Vault Loader jobs may be delayed or processed for more than 24 hours.
|
DEV-566815 |
|
In some cases, Vault does not display the correct Status and Error Message on the Email Notification Status page for bounced emails.
|
DEV-572150 |
|
Vault prevents users from deleting a nested binder if duplicate documents exist in the binder. The following error message displays: “Server having problems.”
|
DEV-572428 |
|
In some cases, users receive a network issue message when attempting to inline edit a field in the grid view.
|
DEV-573166 |
|
Binders created from a Content Plan are not searchable in the Document Library
|
DEV-574089 |
|
The Business Admin > Picklists drop-down menu does not include a tooltip with the picklist name (e.g., activity_type__c).
|
DEV-574393 |
|
Vault fails to resolve numeric field tokens in notification templates.
|
DEV-576070 |
|
When the Lifecycle Stages banner is displayed on the Doc Info page, users are unable to scroll to the bottom of a document.
|
DEV-577067 |
|
Only users with Full User licenses can see custom tab collections.
|
DEV-577965 |
|
In rare cases, Vault does not display the Business Admin tab collection to users with the External IIs User permission set or some custom permission sets.
|
DEV-580131 |
|
After a user uploads a file with a long filename and hovers over the thumbnail, the "Ready to save" tooltip overlaps the tooltip showing the full filename.
|
DEV-582682 |
|
In rare cases, Vault Owners may receive an "Unknown Client ID" error upon exporting VPK packages.
|
DEV-583903 |
|
Vault may fail to notify users "Your Vault Configuration Report is in the queue".
|
DEV-599235 |
| Description |
Issue No. |
|
In some cases, when navigating from a dynamic tab to an object record detail page, Vault may show a 'Page not found' error.
|
DEV-556917 |
|
When Users select (Undefined) as a search filter, no results are displayed.
|
DEV-557567 |
|
When performing a bulk action from grid view with Study, Study Country, or Site as column, users may receive a server error.
|
DEV-558581 |
|
When deleting a single favorited document on grid layout, users may receive a server error.
|
DEV-560022 |
|
In some cases, users who have Study filters on their Home tab may be unable to remove them.
|
DEV-560194 |
|
If a user exports a saved view that has Study, Study Country, or Site columns, those columns may appear empty.
|
DEV-560228 |
|
Users may receive a server error when changing a Saved View Task Type filter from Document to All, when a sort on document field is saved and Envelope tasks are included.
|
DEV-561400 |
|
In some cases, users are able to create saved views that include outdated study field names.
|
DEV-562239 |
|
In some cases, document placeholder tasks are included in filtered results and result counts when they should not be.
|
DEV-566219 |
|
After navigating to a saved view from a saved or bookmarked URL, users are unable to update or remove Study filters from the view.
|
DEV-566229 |
|
In some cases, users may see highlight symbols in search results on old data grids.
|
DEV-568260 |
|
In cases where Study Hierarchies are broken, saved views with multiple studies applied as filters may incorrectly appear blank.
|
DEV-569147 |
|
Vault displays unexpected characters in the long and rich text fields of objects which are part of an expanded search collection.
|
DEV-574332 |
|
In cases where placeholder tasks are present, Task Type filters on the Home page may display incorrect counts.
|
DEV-576110 |
|
When clicking "Show in Tab" on a related list for a High Volume Object, some filter types will remove all results until the filters are cleared on the Tab.
|
DEV-576387 |
|
Study metadata extraction is case-sensitive, which can cause searches to return fewer results than expected.
|
DEV-577245 |
|
Vault may incorrectly show and hide the advanced search icon in the search bar.
|
DEV-579087 |
|
In some cases, Enhanced Suggest Links may fail to find statements.
|
DEV-581555 |
|
In some cases, users are able to save tabs before loading the filters which may result in bad data.
|
DEV-582666 |
|
In some cases, users are able to save tabs before loading the filters which may result in bad data.
|
DEV-582669 |
|
Searches for "All of these words" may contain unexpected results.
|
DEV-584669 |
|
Users may receive a server error when exporting the related records of an expanded search to Excel.
|
DEV-586580 |
|
Users may observe discrepancies in document count between detail, compact, and thumbnail views.
|
DEV-586593 |
|
Advanced searches using Include Attachments may return unexpected results.
|
DEV-587853 |
|
Custom views are not accessible in Vault Mobile when the Library tab is nested within another tab.
|
DEV-588202 |
|
When using the top search box, multiple wildcard items in the same search criteria do not match as expected.
|
DEV-590593 |
|
In some cases, users can save filters without any selected values.
|
DEV-590859 |
|
In some cases, users are unable to inline edit certain fields.
|
DEV-595213 |
|
In cases where a saved view contains bad data, the view appears completely blank rather than correctly showing an error.
|
DEV-595219 |
|
Enhanced Suggested Links may match single words and return too many/unhelpful results.
|
DEV-596346 |
|
Search results fail to display correctly for search terms that contain a '%.'
|
DEV-598702 |
| Description |
Issue No. |
|
In some cases, an inactive Quality Relationship Automation component may incorrectly continue creating relationships.
|
DEV-508944 |
|
When a user starts or resumes a test in Vault LIMS, the system may not properly display a loading page before displaying the test execution page.
|
DEV-532606 |
|
In certain circumstances in Validation Management, Vault may not display an error message when a user attempts to save a step in the Test Authoring interface without all required fields populated.
|
DEV-534696 |
|
In Vault LIMS, inputs may incorrectly be cleared when adding a sample to a test.
|
DEV-556479 |
|
Some state types may incorrectly be duplicated or share the same label.
|
DEV-556664 |
|
In some cases, the Application Role or Security Profile field may incorrectly display as required but incomplete when attempting to save a QMS User Template.
|
DEV-557037 |
|
Users are unable to manually unenroll from a self-enrolled Classroom Training Requirement due to a missing Unenroll button on the Explore tab.
|
DEV-557175 |
|
Users are able to generate multiple training assignments by clicking the Begin Training button multiple times in quick succession.
|
DEV-557400 |
|
In Vaults using the QMS-RIM connection, in some cases, the system may create duplicate Impacted Country records after performing the Update QMS Details action.
|
DEV-557601 |
|
In some cases, when a Learner attempts to self-register for a class which has already closed, Vault incorrectly creates a Class Roster record.
|
DEV-557769 |
|
In some cases, Vault incorrectly displays the loading animation when no records are present in the Assessment Risk section of an FMEA Risk Assessment Record.
|
DEV-558650 |
|
In some cases in the Risk Builder, navigating to All in the Process Step selector does not correctly switch the interface to View mode.
|
DEV-559177 |
|
Choosing certain items from the Risk Response dropdown in the Risk Builder may result in Vault displaying an error.
|
DEV-559790 |
|
The Risk Builder may display an incorrect Process Step under certain circumstances.
|
DEV-560217 |
|
When errors occur while attempting to save an Assessment Risk in the Risk Builder, the user may incorrectly be navigated out of editing mode.
|
DEV-560244 |
|
In the Risk Builder, an input box may incorrectly remain after switching to View mode.
|
DEV-560698 |
|
When using the QRM Risk Builder, Vault may incorrectly display an error when a user without Admin permissions attempts to copy or save a Risk.
|
DEV-561968 |
|
Notifications sent using the External Notifications feature using large Text or Long text fields may be formatted incorrectly.
|
DEV-563459 |
|
The Related Root Cause Analysis Item field may incorrectly be editable on manually-created Root Cause records.
|
DEV-564495 |
|
Vault may incorrectly display errors when a user without permissions to update the Risk Matrix field attempts to make changes in the RIsk Builder.
|
DEV-564662 |
|
In cases where a Learner has failed a class, then been added to a new class, the Learner Homepage may fail to display properly.
|
DEV-566744 |
|
In Validation Management, Vault may display an error when a user types "All" or "Not Challenged" into the Filter Requirements dialog.
|
DEV-570708 |
|
In Vaults using the QMS to RIM connection, transactions may be marked with an incorrect status when certain combinations of failures and successes are processed together.
|
DEV-570715 |
|
In some cases, the Study Training to Clinical Operations Vault Connection job encounters unexpected errors when creating a large number of Study Person records (~15K).
|
DEV-572874 |
|
In some cases, lab tests are completed without corresponding Result Evaluations, which causes the Specification Criteria Evaluation Section to display a label of "0-NaN of undefined" and become stuck in a loading loop.
|
DEV-575811 |
|
Under certain configurations on custom Risk object types, Vault may incorrectly display an error when a user populates the Severity, Occurrence, and Detectability values.
|
DEV-576377 |
|
In some cases, curricula on the Learner Role Details page may have an incorrectly-applied overdue alert icon.
|
DEV-578190 |
|
In Surveillance, selecting multiple values on certain fields in EU MIR or eMDR forms may incorrectly result in a data validation error.
|
DEV-579094 |
|
In some cases, a Class page may incorrectly display the 'Submit Result' button after the Class has been completed.
|
DEV-580413 |
|
When using the QRM Risk Builder, Vault may incorrectly display an error when a user without Admin permissions attempts to copy or save a Risk.
|
DEV-580691 |
|
In Surveillance, if multiple values are selected for classification of incident or gender, the resulting eMDR or EU MIR may not correctly resolve to the correct values.
|
DEV-581851 |
|
Vault LIMS always executed the Create Related Batch Records job even if no related Materials were present.
|
DEV-583975 |
|
In Validation Management, the Delete Record dialog in the Test Authoring interface may contain an incorrectly placed question mark.
|
DEV-584249 |
|
Attempting to run a Quality Record Check may fail if the Vault does not have the required label translations for the user's selected language.
|
DEV-584395 |
|
Attempting to evaluate Vault LIMS test results which depend on results from other tests may cause Vault to display an error.
|
DEV-585868 |
|
In Validation Management, content in the Actual Results and Expected Results in the Test Execution interface may incorrectly display without line breaks.
|
DEV-588274 |
|
In Validation Management, the Unsaved Changes warning dialog may incorrectly render multiple times, obscuring the rest of the interface.
|
DEV-588506 |
|
In Vault LIMS, the Review button incorrectly remains available while editing a field in a Lab Test.
|
DEV-594821 |
|
In Vault LIMS, the system may incorrectly set the Additions field value on the Batch record to "False" after a Sample has been added to the Batch.
|
DEV-594949 |
|
In some cases in Vault LIMS, the Intermediate Batch Job may fail when multiple related materials are found for a Material in the Batch.
|
DEV-595278 |
|
If adding a Test to a Sample in Vault LIMS, but that Test is not part of the Batch's Protocol, in some cases there is an error that prevents the Test from being successfully added.
|
DEV-598515 |
|
In cases where the ClinOps < > Study Training connection performs consecutive operations on CrossLink documents that result in Vault attempting to create a new document rendition, CrossLink documents may not properly display a viewable rendition.
|
DEV-598763 |
|
In some cases attachment downloads for test steps shall appear in the audit trail although users do not actually download them. If a test step contains at least 1 attachment and the test step is edited from the Test Execution UI (e.g. actual results modified, verdict selected, completed), an audit trail entry will be added to download the attachment even though the user did not actually download the test step file attachment.
|
DEV-599912 |
|
In some cases in Vault LIMS, the Results Grid may not resize correctly with multiple Inputs displayed.
|
DEV-601129 |
| Description |
Issue No. |
|
During continuous publishing, Vault incorrectly reports Rule B35 as failed on source documents when a target document linked within is up-versioned.
|
DEV-264058 |
|
In some cases, Vault is unable to resolve links in STF XML during initial and continuous publishing.
|
DEV-481557 |
|
When a user sets a reference leaf and clicks Save, they must refresh the page in order to view the updated Published Output Location and Node Type.
|
DEV-515323 |
|
Vault incorrectly reports JO Rule 12.9 as passed when a Labeling or Cover Letter Content Plan Item contains an incorrect xlink:href value.
|
DEV-518135 |
|
When users quickly expand and collapse (double-click) a node in the Content Plan Hierarchy Viewer, the node enters inline editing mode.
|
DEV-530789 |
|
In some cases, the notifications for the Update Content Plan and Update Global Content Plan actions do not specify the constraints excluded during the update.
|
DEV-538745 |
|
When generating IDMP elements for products without devices, Vault incorrectly reports errors for device-specific fields.
|
DEV-542227 |
|
When a user selects a cross-application Reference Leaf, Vault does not include the Application folder name in the Published Output Location.
|
DEV-548109 |
|
Permalinks are not published if the link target’s Published Output Location is shared by other Content Plan Items with a DELETE operation.
|
DEV-549868 |
|
Embedded permalinks with broken links may cause publishing to fail.
|
DEV-550569 |
|
When a leaf fails validation for EU Rules 11.9 and 11.BP1 and a user subsequently updates its XML Operation field to New, Vault does not clear the previous validation results and incorrectly fails the rules again.
|
DEV-550873 |
|
The Submission Archive Viewer displays leaves and empty section styling for sections which should be empty.
|
DEV-552778 |
|
Vault incorrectly orders Content Plan Items in the new Submissions Archive Viewer after on-demand or continuous publishing.
|
DEV-553061 |
|
When managing registered details, users receive a network issue error on the Summary page when attempting to submit updates to ~17K Registered object records.
|
DEV-553502 |
|
Some RIM Submissions Application Settings appear in RIM Vaults where the Submissions application is not enabled.
|
DEV-554190 |
|
Users with incomplete permissions receive a nonspecific error message when setting a Reference Leaf.
|
DEV-554282 |
|
In some cases, RIM Admins receive a nonspecific job error message when a connected Clinical Operations Vault is not responsive.
|
DEV-555139 |
|
When transferring a document from a RIM Vault to a Clinical Vault, the User Exception Message does not show all document transfer errors when the RIM to Clinops Connection: Transfer steady and superseded state document versions Application Setting is enabled.
|
DEV-555305 |
|
When users apply a saved view in the Active Dossier viewer, Vault does not populate the Product Family filter, and the Product Family picklist is blank.
|
DEV-555308 |
|
Publishing jobs fail when a published placeholder contains a source reference.
|
DEV-556461 |
|
When users expand a section in the new Submissions Archive Viewer, Vault does not display the loading icon.
|
DEV-556946 |
|
Vault may report false validation results against US Rule 1519.
|
DEV-558050 |
|
In Vaults with the QMS to RIM connection, under certain conditions the data update action may fail to create Impacted Countries as expected.
|
DEV-559004 |
|
When a Submission Metadata record references a document that does not exist, Rule 1697 fails with a nonspecific error message.
|
DEV-559259 |
|
Vault does not revalidate the STF XML when the index XML is published after continuous publishing is enabled.
|
DEV-559866 |
|
In some cases, Vault incorrectly reports Rules 16.BP2, 16.BP3, 20.BP2, 20.BP3, and 19.1 as failed.
|
DEV-560135 |
|
When a user with insufficient permissions generates a Table of Contents, the related job encounters errors but does not notify the user or include error details in the log.
|
DEV-560456 |
|
Users are unable to view some older submissions in the new Submission Archive viewer.
|
DEV-562151 |
|
When an Admin re-labels any field appearing in the Submissions Archive Viewer, the Submission column disappears from the grid, and users cannot select it to display in the viewer.
|
DEV-562317 |
|
Vault incorrectly reports validation results for Rule AP.APFs.BR.2 (for the Authorised Pharmaceutical Form) when a submission includes a co-packaged medicinal product.
|
DEV-562372 |
|
Vault incorrectly reports Rule 1323 as failed when a previously-published Reference Leaf Content Plan Item’s Enable Continuous Publishing field is disabled and re-enabled.
|
DEV-562945 |
|
The Global Version ID is inconsistent between the document field and the value populated on the Viewable Rendition of merged documents with overlays.
|
DEV-563241 |
|
Vault inconsistently displays section labels in the Submissions Archive Viewer.
|
DEV-564494 |
|
When splitting Activities, Vault does not Regulatory Objective Product Characteristic and Regulatory Objective Packaging Characteristic records if the Enable Application Relationships and Exclude Submission Lifecycle States application settings are enabled.
|
DEV-564870 |
|
After creating an Application record with the Medicinal Application type, users may see a notification that Vault failed to create an Application Country join record, even though the record was created successfully.
|
DEV-565359 |
|
When the Active Dossier Viewer grid is not displaying any records, users cannot export the Excel tree.
|
DEV-565509 |
|
When Vault is processing a large volume of transactions, updates to the Published Document Reference field can be delayed, resulting in Rule 1425 validation failure.
|
DEV-565590 |
|
When pulling Regulatory Objective data to a Submission, Vault does not create Product Characteristic join records.
|
DEV-566421 |
|
Within the M5 STF section, running On-Demand Publishing can result in binder leafs in a different order than the Content Plan Items are displayed.
|
DEV-566749 |
|
After selecting and clearing an application in the Submissions Archive Viewer and then opening and closing the advanced search dialog, the previously selected application appears in the selector.
|
DEV-566787 |
|
Users without read access to the Submission Metadata object are unable to apply filters in the new Submissions Archive Viewer, and the viewer displays but does not allow users to select Submission related objects in the Submission filter.
|
DEV-567129 |
|
When the Published Output Location is updated on a linked target document, continuous publishing fails to properly update inbound permalinks to named destinations when locking the target document.
|
DEV-567588 |
|
Vault displays lists of related objects to users without Read permission on the object.
|
DEV-568273 |
|
Users cannot drag and drop to match documents from a document tab within a Tab Collection into the Content Plan Hierarchy Viewer.
|
DEV-568477 |
|
When creating Submission records in bulk from an Event, Vault does not create records if there are Constraints configured for the selected Submission Type.
|
DEV-568536 |
|
In some cases, Submissions loaded via Vault File Manager cannot move past the Transmission Initiated lifecycle state.
|
DEV-570171 |
|
In some cases, duplicate Submission Contact Records can be created with the RIM-PromoMats Connector.
|
DEV-570323 |
|
Users cannot navigate the UDI Submission Viewer using the Next button.
|
DEV-572142 |
|
On-demand publishing fails with a nonspecific error when a Table of Contents is edited after publishing and merging.
|
DEV-572311 |
|
Users are able to unmatch documents from inactive Content Plan Items in the Content Plan viewer, resulting in inaccurate document counts.
|
DEV-572503 |
|
When managing registered details, Vault does not include all updated fields in the CSV results file.
|
DEV-572969 |
|
In some cases, Vault does not provide details in the User Exception Message and the job log when a RIM to PromoMats Vault Connection remote query fails.
|
DEV-573109 |
|
For AU submissions with a blank ARTG Number, Vault generates the ARTG Number in the XML.
|
DEV-573588 |
|
If a user sets a Global Content Plan to an unrelated event, the Global Content Plan becomes invalid and the user will need to re-create the Global Content Plan.
|
DEV-573768 |
|
When object lifecycle entry criteria fail, the Quality to RIM Vault Connection does not create a User Exception Item for troubleshooting.
|
DEV-573780 |
|
Document and leaf hovercards may show incorrect results when users scroll up and down in the new Submissions Archive Viewer.
|
DEV-573866 |
|
The Submission Wizard is unable to load the Application Relationship page when there is at least one relationship with a populated number field.
|
DEV-574489 |
|
In some cases, Vault cannot execute the Content Plan Hierarchy State Change job when other non-conflicting jobs are in progress.
|
DEV-574705 |
|
Vault does not execute Rule 1734 on content plans missing the ts.xpt file.
|
DEV-574973 |
|
When dragging and dropping documents to the Active Dossier Editor, the Add to Active Dossier dialog’s Save button is disabled if the user selects a different Section from the drop-down.
|
DEV-575350 |
|
Users cannot create Registered Regulatory Text records using the Manage Registered Details wizard.
|
DEV-575732 |
|
When the RIM to PromoMats Vault Connection’s RIM Crosslinks Post Processing job encounters errors, the related User Exception Item’s error message is nonspecific and potentially misleading.
|
DEV-575737 |
|
In some cases, the RIM to PromoMats Vault Connection job errors when attempting to update the Related Submission record's object_type__v field.
|
DEV-575954 |
|
The Generate UDI Submission job confirmation CSV file incorrectly counts the number of UDI Submission DI records Vault created during the job run.
|
DEV-575981 |
|
UDI Submission XSD validation results are not logged correctly when the UDI Submission Viewer setting is disabled.
|
DEV-575988 |
|
Under certain circumstances, users may experience errors while migrating Activity Registration records.
|
DEV-575990 |
|
When dragging and dropping a document with a Source Reference to the Active Dossier Editor, Vault does not populate it as the Submissions Archive Document in the resulting Active Dossier Item and Active Dossier Item Detail records.
|
DEV-575993 |
|
The Submissions Archive Viewer incorrectly displays the XML Element Name as the folder name.
|
DEV-576216 |
|
Users receive a Page Not Found error when attempting to view FHIR messages in the IDMP Viewer if the XML does not include an <id value="mpid"/> tag under <MedicinalProductDefinition>.
|
DEV-576250 |
|
When users bulk update STF Content Plan Item file tags and continuous publishing is enabled, Vault intermittently does not maintain their ordering in the Submissions Archive Viewer.
|
DEV-576363 |
|
Vault incorrectly reports Rule 14.BP3 as failed if the file name begins with “specifications-”.
|
DEV-576693 |
|
New users created without the old Submission Archive Viewer tab permission cannot view or export submissions even if the new Submission Archive Viewer is enabled.
|
DEV-576710 |
|
Vault fails to show more than 100 users or groups when sharing a view in the Submissions Archive Viewer.
|
DEV-577877 |
|
In the cases of some large Applications, the Submissions Archive Viewer may fail to load Correspondence Documents.
|
DEV-578241 |
|
In some cases, users may incorrectly see 'No Items Found' when attempting to view Applications with orphaned Correspondence sections or documents.
|
DEV-578271 |
|
Users may experience performance issues with Crosslink Postmatch jobs.
|
DEV-578353 |
|
Users experience slow performance in the Content Plan Hierarchy Viewer when document reference columns are included.
|
DEV-578396 |
|
When bundling Regulatory Objectives using the Safari browser, the bundling wizard skips the Define Regulatory Objectives page.
|
DEV-578867 |
|
When the href is updated after initial publishing, Vault does not update the Published Output Location during continuous publishing.
|
DEV-578909 |
|
In some cases, users may receive a server error when attempting to load a checklist.
|
DEV-579074 |
|
When creating related records in bulk from an Impact Assessment Report containing more than 10K records, Vault creates fewer Activity records than expected for the number of Applications.
|
DEV-579295 |
|
If a user does not have permissions to certain fields, Vault prevents navigation to some steps in the UDI viewer.
|
DEV-580221 |
|
Vault incorrectly reports validation failures in section 3.2.P.5.6 for certain regions if a file name begins with “specifications-”.
|
DEV-580572 |
|
The Submissions Archive Viewer displays Correspondence documents tagged with only an Application at the top of the Correspondence section instead of the bottom.
|
DEV-580835 |
|
Vault incorrectly reports CA Rule A03a as failed when a file is smaller than 150MB.
|
DEV-581290 |
|
Vault incorrectly reports CA Rule A03a as passed when a file is larger than 200MB.
|
DEV-581291 |
|
Permalinks on approved documents are not properly embedded on PDFs in archives.
|
DEV-581388 |
|
Vault incorrectly reports Rule 1734 in section M5 when the Submission’s Application Type is IND.
|
DEV-582593 |
|
In some cases, users are unable to select a Reference Leaf if the target leaf has already been replaced in the Content Plan Item.
|
DEV-582721 |
|
Vault cannot create a Submission when the XML STF DTD/XSD Version and Create Note Extension fields are both populated for certain lead markets and regions.
|
DEV-583129 |
|
Active Dossier records are not created for documents with special characters in their Type.
|
DEV-583951 |
|
Vault does not render regional XML when the XML file does not have a stylesheet attribute.
|
DEV-584420 |
|
Publishing fails when Vault detects an inconsistent number of source documents and bookmarks found for a published document.
|
DEV-584944 |
|
Vault sends the notification and link to download exported Submissions before updating the export job status, resulting in an error when a user clicks the download link.
|
DEV-584945 |
|
When Rule G08 fails, the detailed validation results file does not specify which section is missing an attribute.
|
DEV-585090 |
|
In some cases, users may see a max row limit warning in the new Submissions Archive Viewer when it does not apply.
|
DEV-585283 |
|
The Activity splitting wizard does not load for users without read and edit permissions for the Related Application and Regulatory Objective fields.
|
DEV-586213 |
|
When a Submission has multiple Active Substance relationship records, the Set Leaf Operation dialog does not auto-expand to the section containing both records.
|
DEV-586619 |
|
In some cases, the Submissions Archive Viewer does not load when the Submissions Archive application is enabled in an existing RIM Vault.
|
DEV-586715 |
|
Users with a saved view and no Submissions Metadata permissions may be unable to see anything in the Viewer tab.
|
DEV-587134 |
|
In some cases, Vault receives XEVMPD acknowledgements but does not update the Product Data Message record accordingly.
|
DEV-587575 |
|
When a user selects Where Used in Archive for Index XML, the Submissions Archive viewer does not load and displays a console error.
|
DEV-587629 |
|
Content plan records are not created for a Global Content Plan when Lead Market or Region are populated on the Content Plan Template.
|
DEV-587946 |
|
In some cases, Vault does not allow users to lock Report Level Content Plans.
|
DEV-588096 |
|
Users are unable to access the Archive Viewer from any application if they do not have Submissions Metadata permissions.
|
DEV-588339 |
|
US 5040 executes on FDA forms when it should skip them.
|
DEV-588477 |
|
Object page layouts do not display configured Help Text for the Publishing Status field.
|
DEV-588756 |
|
When bundling Activities, the wizard’s summary page incorrectly displays Regulatory Objective records the wizard does not eventually create.
|
DEV-589511 |
|
When creating Active Dossier Item Detail records during publishing, Vault incorrectly sets the “Is eCTD” field to Yes for non-eCTD dossier formats with blank UUIDs.
|
DEV-589613 |
|
The Submissions Archive Viewer displays duplicate Correspondence document sections for some imported Submissions.
|
DEV-589959 |
|
When bundling Activities, the wizard's summary page does not show information for Regulatory Objectives that will be set to Inactive.
|
DEV-590754 |
|
Users experience slow performance in the Content Plan Hierarchy Viewer when document reference columns are included.
|
DEV-592284 |
|
For published Ukraine (UA) submissions, the Submissions Archive Viewer displays binder nodes as “specific” (rather than with the country information), and leaf hovercards do not include the Country field.
|
DEV-593465 |
|
When the Enable Dispatch Comparison Application Setting is disabled, Vault attaches content plan dispatch failure files to the Submission record and success files to the Dispatch Message record, rather than adding both to the Dispatch Message only.
|
DEV-595214 |
|
In rare cases, users cannot filter matched documents by Lifecycle State in the Content Plan Hierarchy Viewer.
|
DEV-596692 |
|
During content plan dispatch, Vault does not populate the Dispatch Date when the Last Dispatch Date is not configured on the Submission object type.
|
DEV-597523 |
|
Vault incorrectly reports EU Rule 15.6 and CA C05 as passed when the Published Output Location includes invalid characters.
|
DEV-598614 |
|
When synchronizing content plans with more than 500 new Content Plan and Content Plan Item records, the related job encounters errors.
|
DEV-599128 |
|
Some submission validation rules are not reported as they should be.
|
DEV-599655 |
|
When a user opens a Submission from an Application via Show in Tab, the View Content Plan button opens to the root Content Plan record detail page.
|
DEV-600312 |
|
Vault executes (instead of skips) validation checks of FDA Forms against US Rules 5005, 5020, and 5040.
|
DEV-601911 |
|
Users without Read permission on the Submission object and object types are able to view them in the Submissions Archive Viewer.
|
DEV-606427 |
| Description |
Issue No. |
|
Fixed an issue where an Inbox Item could be promoted by multiple users at the same time, which resulted in duplicate Cases.
|
SAF-34840 |
|
Fixed an issue where Follow-up Case creation for Inbox Items created from E2B-imported files failed if the Inbox Item had Assessments without an Adverse Event.
|
SAF-35437 |
|
Fixed an issue with generating Transmissions for Combination Products where Partner Distributions were generated for constituent Products.
|
SAF-38036 |
Fixed an issue with E2B export where nullFlavors for Case Product Dosage Batch/Lot Number Reason Omitted field values were incorrectly populated in the G.k.4.r.7 - Batch / Lot Number data element. Now, Reason Omitted field nullFlavors are exported as follows:- EMA E2B(R3): Blank or Unknown = UNK, Masked = MSK, Asked But Unknown = ASKU
- ICH E2B(R3), FDA VAERS E2B(R3), and PMDA E2B(R3): Blank, Masked, Asked But Unknown = no nullFlavor exported
Validation Criteria updates are as follows:- FDA.G.k.4.r.7 Batch/Lot Number is no longer mandatory.
- PMDA.G.k.4.r.7 Batch/Lot Number is now mandatory only if PMDA Reporting Category (J2.1a) is 'AA' or 'DA'.
|
SAF-38644 |
|
Fixed an issue where EDQM terms were not included for some Dose Forms and Routes of Administration.
|
SAF-38698 |
|
Fixed an issue with E2B import where, if Inbox Items were opened while in the Importing state, some fields were not imported.
|
SAF-39092 |
|
Fixed an issue with Cases that included constituent Products of a Combination Product where, when the Combination Product field was set on one constituent, the Combination Product and Drug Role fields were not updated on any related remaining Case Product constituents.
|
SAF-39344 |
|
Fixed an issue with E2B import where, when the two-letter ISO country code in the source file matched multiple Country records, the system mapped the country code inconsistently. Now, the system matches the country code to the first Country record in alphabetical order based on country name.
|
SAF-39400 |
|
Fixed an issue where, in some cases, performance issues occurred when generating Narrative documents.
|
SAF-39515 |
|
Fixed an issue where, when Inbox Items were promoted to Follow-up Cases or merged to In-flight Cases, Case-level Seriousness was not updated.
|
SAF-39584 |
|
Fixed an issue with the Intake API where an error occurred when E2B files included a Transmission Profile parameter.
|
SAF-39625 |
|
Fixed an issue where it was possible to set up the Case Validation Status field so it was copied from the original Case when creating a Follow-up Case.
|
SAF-39685 |
|
Fixed an issue where, when merging an Inbox Item into an In-flight Case with no changes on the Case Compare page, duplicate Expectedness records were created.
|
SAF-39709 |
|
Fixed an issue with Transmission generation for unblinded Study Cases where, when a Partner Distribution Rule had Study Content Protection set to "Mask Unblinded Content", blinded Transmission documents were generated with the Blind Protection set to "On", instead of "Null".
|
SAF-39741 |
|
Fixed an issue with creating AERs from E2B files where document import failed if the "Always: Set new major version" entry action was added to the Imported state for AERs.
|
SAF-39796 |
|
Fixed an issue where Submissions were generated for inactive FDA Product Registrations.
|
SAF-39985 |
|
Fixed an issue with PBRER generation where, if a Case had multiple versions with different Report Types within a reporting interval, the Case was overcounted on the Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources.
|
SAF-40009 |
|
Fixed an issue where, when Inbox Items were created from ZIP or E2B files with multiple cases, values entered in the Origin field of the Case Information section were not imported.
|
SAF-40033 |
|
Fixed an issue with E2B import where, when Cases included some parent information but did not include Parent Medical History or Parent Drug History information, parent Cases were not created.
|
SAF-40063 |
|
Fixed an issue with general reporting and Investigational –> X cross reporting where reporting rules generated Transmissions for Non-Study Case Products instead of just for Study Case Products with Suspect or Interacting drug roles in Clinical Trial Study Cases.
|
SAF-40180 |
|
Fixed an issue with setting a Product or Study Registration to Inactive where, when the registration included a MAH/Reporting Organization, the registration was not removed from the corresponding Reporting Family.
|
SAF-40229 |
|
Fixed an issue with E2B(R3) import of a single Case where, when the Study in the source file did not match a Study in the Business Admin library, the system incorrectly populated the ACK.A.4 Transmission Acknowledgement Code with "AE—E2B Import with Warnings" instead of "AA—E2B Import Success".
|
SAF-40258 |
|
Fixed an issue with Cases that included one constituent Product of a Combination Product where, when the Combination Product field was set, Combination Product constituents of the Company Product type were added with the Base Product type.
|
SAF-40303 |
|
Fixed an issue with Case promotion where the Potential Matches page did not include Cases with different Report Types. Now, the Potential Matches page matches across Report Types with the exception of Clinical Trial Study Cases, which will match only to other Clinical Trial Study Cases.
|
SAF-40328 |
|
Fixed an issue with E2B(R2) import where the system performed a case-sensitive search for matching Study names, resulting in missed matches.
|
SAF-40330 |
|
Fixed an issue with conducting deep duplicate detection on Inbox Items with custom lifecycle states where the Potential Matches page did not display the lifecycle states of the matching Inbox Items.
|
SAF-40594 |
|
Fixed an issue where, when a user's language was set to French, the Event Reported field on Cases and Adverse Events displayed the French translation of the LLT code.
|
SAF-40656 |
|
Fixed an issue where, when Localization-based Mapping on Import was enabled for Domestic Cases, populating the English values for the Patient RoA and Dose Form fields caused the local text values for these fields to disappear.
|
SAF-40710 |
|
Fixed an issue where users with the Case Processing security profile received a job error notification when they performed actions such as "Create New Case" or "Promote to Follow-Up" on the Case Compare page.
|
SAF-40827 |
|
Fixed an issue with deep duplicate detection where, on the Potential Matches page, some cases with matching Gender and Country fields were ranked higher than expected, while some with matching Patient Initials were ranked lower than expected.
|
SAF-40847 |
|
Fixed an issue with the system-provided FDA ICSR Reporting Rule Set where the Rule Parameter for the Reporting Scenario "General Reporting, Investigational to Marketing (same agency)" was not included in the One Last Time rules.
|
SAF-41008 |
|
Fixed an issue where, when a suspected and unexpected assessment was added to a Case created from a Clinical Trial study, the Assessment Tag did not change from SAE to SUSAR.
|
SAF-41079 |
|
Fixed an issue where, when voiding a Case and submitting one last time, the Previously Submitted Reporting Rule Parameter specified that Transmissions in only the "E2B ACK Accepted" or "Completed" states were evaluated. Now, a new option, All Transmission States, supports evaluating Transmissions in any lifecycle state, unless the Transmission is inactive or deleted.
|
SAF-41082 |
|
Fixed an issue where email questionnaires were not generated for Blinded Study Cases although questionnaire templates without specified Products existed.
|
SAF-41139 |
|
Fixed an issue where, when a Case contained no eligible Products for a specific agency, custom SDK Reporting Rule Parameters for that agency’s Rule Set resulted in an error.
|
SAF-41144 |
|
Fixed an issue with cross reporting for Follow-up Cases created from Imported Study Cases where, when the Eligible Products Based on Cross Reporting feature was turned on, all expected Submissions were not generated.
|
SAF-41145 |
|
Fixed an issue with E2B import where, in some instances, an error occurred on the Inbound Transmission due to the EMA DTD being unavailable.
|
SAF-41210 |
|
Fixed an issue where, when users did not have Read permission for Product Dose Form, a system error occurred and Inbox Items would not load.
|
SAF-41292 |
|
Fixed an issue where, during deep duplicate detection, Study and Study Number matching was completed within Reporter matching and was also assigned the same priority as Reporter matching.
|
SAF-41329 |
|
Fixed an issue with creating Follow-up Cases from the Case Compare page for Japan Localized Cases where, when Primary Case Product Registration records and Local Reporting Details were included, a system error occurred.
|
SAF-41372 & SAF-46207 |
|
Fixed an issue with Case Access Group Security where, in some instances, roles with access to personally identifiable information (PII) received system errors when processing Cases.
|
SAF-41423 |
|
Fixed an issue where, when adding Product records through Vault Loader, import was prevented if the file included multiple Products with the same generic name.
|
SAF-41433 |
|
Fixed an issue where the information entered in the Parent Medical History Text field was incorrectly mapped to the Patient Medical History Text field on Cases imported from E2B files with the Localization Type set to "Local".
|
SAF-41540 |
|
Fixed an issue with coding Japanese MedDRA terms where terms with English characters were not auto-coded.
|
SAF-41665 |
|
Fixed an issue where the Translation Connection Languages and Translation Settings records were not included in the Vault Safety template.
|
SAF-41671 |
|
Fixed an issue where, when the Enable Smart MedDRA Autocoding and Enable Smart MedDRA Coding Predictions settings were not turned on, the Coding Method fields for Indication and Event were populated on Inbox Items.
|
SAF-41674 |
|
Fixed an issue with local language intake for Russian (Russia) where, when a local language value was entered in the Inbox Item Product Indication field, the local value appeared in the English Indication field upon saving.
|
SAF-41726 |
|
Fixed an issue with calculating Age Groups for Infants and Children where the definition was out of date. Now, to align with the latest EMA and FDA definitions, Infant is defined as "1 month to less than 24 months" and Child is defined as "2 years to less than 12 years".
|
SAF-41781 |
|
Fixed an issue with Pregnancy Cases imported from E2B files where, when Follow-up Cases were created, Child records were not created.
|
SAF-41789 |
|
Fixed an issue where, in some instances, Case Adverse Events were not displayed and a system error occurred when the event included a MedDRA term that had undergone a hierarchy change and was in a Closed state.
|
SAF-41825 |
|
Fixed an issue with promoting manually created Inbox Items to Follow-up Study Cases where, when the Study Product was open-label, an additional blinded instance of the same Study Product appeared on the Follow-up Case and had to be manually deleted.
|
SAF-41860 |
|
Fixed an issue with Case Access Group Security where, in some instances, roles with access to personally identifiable information (PII) received system errors when expanding the Products section on Cases.
|
SAF-41871 |
|
Fixed an issue with promoting AERs to Cases where, if the AER included special characters, during duplicate detection the system displayed error messages and prevented promotion.
|
SAF-41888 |
|
Fixed an issue where PSMF Logbook comments did not upgrade to the latest document version, making the comment unavailable on the latest PSMF Logbook.
|
SAF-41942 |
|
Fixed an issue with manual Inbox Item creation where, when Enable Auto-Set Inbox Item Localization by Reporter Country was turned on, the system allowed selecting inactive Localizations, which caused Inbox Item creation to fail.
|
SAF-41949 |
|
Fixed a caching issue that, in some instances, prevented users with the Case Processing security profile from viewing the Drug page on Study Cases.
|
SAF-42003 |
|
Fixed an issue with E2B import where, after the import acknowledgement was received, the Body and Code fields on the Transmission Message of the Inbound Transmission record were not updated.
|
SAF-42016 |
|
Fixed an issue where, in some cases, users may have experienced performance issues when processing Cases.
|
SAF-42023 |
|
Fixed an issue with limits on the number of users allowed in a single role within a Case Access Group. This fix affects only POD VV1-1150.
|
SAF-42068 |
|
Fixed an issue with importing E2B files with blank Localization where, when the Enable Localization-based Mapping on Import feature was turned on, Product (Reported) and Patient RoA were mapped incorrectly on the Inbox Item and then did not appear on Cases after promotion.
|
SAF-42198 |
|
Fixed an issue where promoting Pregnancy Inbox Items to Cases was prevented when the Organization field was set to Required on the Child Information object type.
|
SAF-42299 |
|
Fixed an issue with the Products section on Inbox Items for Studies where an Unsaved Changes error message was displayed when viewing Products, and the Add button was disabled.
|
SAF-42303 |
|
Fixed an issue where, when Case Processors did not have Read permission for the Dose Unit of the Case Product Dosage field, a server error occurred when trying to view the Medical Review Timeline.
|
SAF-42415 |
|
Fixed an issue where, when some E2B XML files encoded as UTF-16 were received through an AS2 gateway, the Transmissions were not imported as Inbox Items.
|
SAF-42519 |
|
Fixed an issue where, when the MedDRA dictionary language was set to two languages and the Update to Latest Version action was run, an error appeared. This was due to duplicate Localized MedDRA records being created.
|
SAF-42520 |
|
Fixed an issue on Inbox Items where, if Case Access Group Security was enabled, custom-type Action Item records could not be displayed.
|
SAF-42567 |
|
Fixed an issue where the Anatomical Site field did not appear in the Case Product Dosage section for Company Product product types.
|
SAF-42569 |
|
Fixed an issue with merging Inbox Items to In-flight Cases where, if the primary Adverse Event was not the same on the Inbox Item and Case, the Assessment Ranks were not updated to reflect the new Adverse Event Ranking.
|
SAF-42578 |
|
Fixed an issue with Pregnancy Cases where, when the Linked Cases section included a Non-Child information Case, Follow-up Case creation was prevented.
|
SAF-42579 |
|
Fixed an issue with downloading the latest MedDRA version where, when there were duplicate Localized MedDRA records, the Update to Latest Version action could not be completed.
|
SAF-42686 |
|
Currently, sharing rules and user roles are used to send notifications and emails. If using Case Access Group Security instead, sharing rules must be deleted for the object. Fixed an issue where, when Case Access Group Security was enabled, notifications were not received by the respective users. Now, if Case Access Group Security is enabled, user IDs can be obtained through User Access Group Assignments.
|
SAF-42788 |
|
Fixed an issue with Vaults cloned from the 23R1 template where EDQM mappings were not created.
|
SAF-42937 |
|
Fixed an issue where, when the Async Submit to Gateway action was used, Submissions with a Transmission Profile Type of Manual that were created on a Case moved to the Queued state.
|
SAF-42997 |
|
Fixed an issue with Inbox Items for Domestic Cases where the Case Contact State/Province field allowed entry of more than 40 characters, which caused errors after Case promotion.
|
SAF-43000 |
Fixed an issue with PMDA E2B(R3) export where, when Localized Cases for Japan included PMDA Rank 1 Product Registrations for both the INV and PMK Registration Categories, the following data elements were not exported to the Investigational report:- J2.12 Clinical Compound Number (CCN)
- All data elements in section J2.13.r
- C.5.2 Study Name
|
SAF-43104 |
|
Fixed an issue with indexing newly migrated Cases where, if Cases were created and then deleted from the Vault, the system considered the deleted Cases to be missing and indexing was not turned off.
|
SAF-43136 |
|
Fixed an issue with evaluating the Transmission Reason reporting rule parameter for Imported Cases where, when the previous imported Case version did not have Transmissions to same reporting destination, Transmission Reason was set to Follow-up.
|
SAF-43146 |
|
Fixed an issue where, when evaluating Distributions for a destination, only the first-created Partner Distribution List was evaluated.
|
SAF-43182 |
|
Fixed an issue with creating Inbox Items received through the Intake API where, when Case Access Group Security was enabled, the Intake user was not given access to source documents they imported.
|
SAF-43360 |
|
Fixed an issue where the Case Access Group assigned to an Inbox Item or Case was not applied to generated Correspondence records, resulting in users in that Case Access Group not being able to view the correspondence.
|
SAF-43519 |
|
Fixed an issue where a system error occurred when manually creating an Inbox Item.
|
SAF-43709 |
|
Fixed an issue with voiding a Case and submitting one last time where, when any previous Case version had a Transmission in an incomplete state, the Case entered the Voiding state and never entered the Voided state. Now, the Case moves to the Voided state when all Transmissions on the latest Case version move to a completed state.
|
SAF-43739 |
|
Fixed an issue with attaching documents to Transmissions where, if an attachment had no text in the Description field but had text in the Description(continue) field, the word "null" appeared before the text in the Documents Held by Sender data element—C.1.6.1.r.1 on E2B(R3) reports and A.1.8.2 on E2B(R2) reports.
|
SAF-43760 |
|
Fixed an issue with creating a Follow-up of an Inbox Item with Study Arms where, although the Study Products were manually specified, the system added all of the configured Study Products from the Study.
|
SAF-43775 |
|
Fixed an issue with PMDA E2B(R3) export where, when a Japan Localized Case included multiple Local Reporting Details records with unique Report UIDs, the Report UID from the first-created Local Reporting Details record was populated in the N.2.r.1 Message Identifier and C.1.1 Sender's (case) Safety Report Unique Identifier data elements of all Submissions.
|
SAF-43866 |
|
Fixed an issue where, when Strict Case Locking was enabled, a system error occurred when non-Vault Owners tried to promote a Pregnancy Inbox Item.
|
SAF-43955 |
|
Fixed an issue with Gateway E2B import where Case details were stored in the Body field of the Inbound Transmission record. This created the potential for personally identifiable information (PII) to appear in the log.
|
SAF-44032 |
|
Fixed an issue where generated Transmissions were not correctly identified as initial or follow-up due to previous Transmissions to the same destination.
|
SAF-44063 |
|
Fixed an issue with device-type Cases where the Lot Number field supported only 25 characters, although the B.4.k.20.FDA.16 Device Lot Number data element on FDA E2B(R2) reports supports 35 characters. Now, the Lot Number field supports 35 characters.
|
SAF-44064 |
|
Fixed an issue with generating FDA VAERS E2B(R3) reports where the FDA.D.1a Patient Name Prefix data element was not exported when nullFlavours were selected and the ICH E2B(R3) D.1 Patient (name or initials) data element was included.
|
SAF-44317 |
|
Fixed an issue with sending follow-up questionnaires to Case Reporters where, when an invalid email address was entered on the Inbox Item and an error occurred during send, after fixing the email address the questionnaire still could not be sent.
|
SAF-44451 |
|
Fixed an issue where, during cross reporting for Marketing to Marketing scenarios, reporting obligations for Cases with multiple products with different cross-reporting eligibility were not evaluated correctly.
|
SAF-44943 |
|
Fixed an issue where, when a Case Product Dosage record included a Parent RoA value but no Patient RoA value, custom E2B files failed to generate.
|
SAF-45777 |
|
Fixed an issue where, when a user was assigned to the All Access Case Access Group, they could not see Case tasks.
|
SAF-45911 |
|
Fixed an issue with E2B import where the ACK.A.4 Transmission Acknowledgement Code in the Body did not match the code in the E2B file.
|
SAF-46604 |