The following applications may have different release dates: QualityOne client applications, RegulatoryOne, Safety, and Veeva Claims.
The issues listed below are fixed in the 23R3 release.
| Description |
Issue No. |
|
Vault fails to properly recalculate the ESL when all Subjects are removed from a date-based Study and users initiate the Recalculate Enrollment Metrics action.
|
DEV-485669 |
|
In certain cases, the Safety Information widget is not aligned correctly on the Site User Homepage.
|
DEV-576845 |
|
In certain cases, when you archive a document in your Source Vault, it is not properly moved to the archived state in the Source Vault when it is transferred to the Source Vault.
|
DEV-585922 |
|
In some cases, when attempting to insert Metrics Over Time records via API, users encounter an "Operation Failed" error message and the records are not inserted.
|
DEV-586583 |
|
When an override EDL template applies to a Study, Vault does not properly create new milestone items for EDL items if a milestone item for that EDL item already exists.
|
DEV-591907 |
|
When running Document Reconciliation for a Sites monitoring event, it may delete all related Site Document Check records.
|
DEV-592217 |
|
In some cases, users receive an error message when attempting to test a Study Metadata Extraction model.
|
DEV-592373 |
|
In some cases, when users attempt to download ePro report files, Vault does not download the ZIP file and instead displays a text file in the browser window.
|
DEV-592667 |
|
In some cases, Vault fails to update a Payable Item as Inactive when the Fee Schedule is moved to Draft state and the Visit is moved to a different Fee Schedule.
|
DEV-592775 |
|
In certain cases, Vault fails to correctly generate Payable Items for a Study with a Fee Schedule Template applied.
|
DEV-593106 |
|
In some cases, Clinical Activity records created in CRM fail to transfer to Clinical Operations Vaults and users encounter a Connection Error.
|
DEV-593678 |
|
In some cases, Vault fails to generate Template Tasks associated with a Template Milestone even though the Milestone was generated successfully.
|
DEV-594608 |
|
Users may encounter a CDX issue when attempting to transfer a placeholder document with a simple ruleset.
|
DEV-594619 |
|
In some cases, the Rename Connection action is erroneously available on the Connection (`connection__sys`) object.
|
DEV-594971 |
|
In certain cases, an unexpected error during agreement message processing for TMF transfer can result in duplicate documents.
|
DEV-602647 |
|
When users attempt to complete a Trip Report with unresolved Review Comments, Vault displays an error message without any details about the error.
|
DEV-604364 |
|
In some cases, Vault may incorrectly change inactive lookup fields to active after object changes.
|
DEV-604869 |
|
In some cases, when the Yuzu Global Change Log Job is run, Vault fails to create the expected Join records for CTN and CTN Data Change Log.
|
DEV-605466 |
|
Users may receive an error when trying to add Document Types to Site Packages.
|
DEV-606178 |
|
Users are not able to create more than 5000 EDL Items at once when creating a milestone using milestone template automation.
|
DEV-607076 |
|
In cases where there is no user action configured on a study's country-level lifecycle, the study site lifecycle user action will fail.
|
DEV-607955 |
|
In some cases, Vault fails to update the Milestone Document when users change the EDL Item classification that the Milestone references.
|
DEV-608460 |
|
In some cases, running a report when the primary reporting object is Study Team Role and the related object is Team Roles results in a server error.
|
DEV-612893 |
|
When users attempt to Generate Risk Assessment for a Study using an existing Study as the source, Vault displays an error and does not copy the Study risks.
|
DEV-613793 |
|
In cases where over 250 records are referenced in an object reference field on a document, TMF Transfer may fail to populate the field properly on the target document.
|
DEV-615345 |
|
In some cases, when users attempt to create a Study Risk record, Vault displays a server error.
|
DEV-616808 |
|
In some cases, users may encounter an ambiguous error message regarding the Last Successful Run Date when running the Clinical Operations to CDMS Connection.
|
DEV-617281 |
|
In some cases, certain Distribution Tasks may display that they are still in the Sending state, despite having already been sent.
|
DEV-617489 |
|
The Clinical Operations to CDMS Vault Connection outbound message job may remain in the "Queued" state longer than expected.
|
DEV-618223 |
|
The Study Training to Clinical Operations Vault Connection job errors when the Document Version field in the Study Training Connection Event record (in Clinical Operations) is empty upon processing.
|
DEV-618857 |
|
Users may encounter a server error when attempting to view Trip Report Questions that include a Controlling Question with an empty Answer Set.
|
DEV-619847 |
|
Vault allows users to save a document draft even when there is no value in the required Additional Information field.
|
DEV-625809 |
|
Due to a regulatory requirement change, Dev Termination Notification output from YUZU must be updated.
|
DEV-626729 |
|
In some cases, users encounter an unexpected error when attempting to test a Study Metadata Extraction model.
|
DEV-627769 |
|
In some cases, the Milestone Item Deletion trigger deletes all milestone documents associated with a milestone on a milestone item that is being deleted instead of just deleting the milestone documents associated with the milestone item itself.
|
DEV-629393 |
|
Safety distribution emails that are blocked via Vault suppression list may become stuck as Sending, rather than correctly changed to Failed.
|
DEV-630063 |
|
In some cases, Vault does not populate the Content field on crosslink Documents created through the RIM to Clinical Operations Connection.
|
DEV-630405 |
|
In some cases, when the Expected Action for a document is None, the Expected Action field is blank.
|
DEV-632532 |
|
When users select a Study from the Document Exchange page and then clear the Study field, Vault continues to display the Site name from the previously-selected Study in the document grid.
|
DEV-632632 |
|
In some cases, when users generate a missing Milestone Document, Vault creates the new document, but fails to delete the old one.
|
DEV-633509 |
|
When users update the Actual Visit Date on a related Milestone, Vault fails to update the Monitoring Visit Method field on the Monitoring Event.
|
DEV-634336 |
|
If a user without permissions to view a document attempts to view a document exchange page, Vault incorrectly displays "Document Request" instead of "Insufficient Permissions" in the document Name field.
|
DEV-635882 |
|
When users create SiteVault inivitations that contain line breaks, an error occurs and the invites fail.
|
DEV-636290 |
|
If a Trip Report question requires a Monitoring Event if the answer is No and a user initally answers Yes, but later changes the answer to No, Vault does not correctly save the No answer or update the Monitoring Followup Item.
|
DEV-636884 |
|
If a Site Identifier (Name) is longer than 80 characters, Vault displays an error when attempting to run the CRM Connection and the job fails.
|
DEV-637084 |
|
In some cases, updating the Indication Code for a CTN Combination Product results in a server error.
|
DEV-638318 |
|
Under certain circumstances, the Auto-Train Models job fails to run.
|
DEV-644215 |
|
Users are able to edit the Audit data changes for this object field on the Unblinded Subject Visit Data object.
|
DEV-645044 |
|
In some cases, the Milestone workspace becomes populated with an extremely large number of records and the Milestone Document job cannot process them all.
|
DEV-645714 |
| Description |
Issue No. |
|
Following bulk deletion of documents, Vault does not update the total count of documents in the Cart.
|
DEV-502500 |
|
In some cases, annotations are missing from documents downloaded with the Export PDF with Annotations option.
|
DEV-503580 |
|
Re-rendering a document after deleting its viewable rendition may result in annotations from the deleted rendition reappearing.
|
DEV-554360 |
|
If a Rendition Status log with over 65,536 rows of data is exported to CSV, the resulting file will truncate the rows down to 65,536.
|
DEV-555301 |
|
If a secured PDF is re-rendered in PDF/A format, any security on the document is removed.
|
DEV-558124 |
|
Document renditions following Optical Character Recognition and PDF/A conversion may display overlapping text.
|
DEV-559778 |
|
f a user re-renders an encrypted PDF, the I want a rendition in PDF/A format option is available for selection in the Re-render Document dialog.
|
DEV-559831 |
|
In rare cases, Vault fails to apply overlays to all applicable pages in a document.
|
DEV-570298 |
|
When a document with link annotations is re-rendered with the Preserve Annotations setting enabled, the annotation remains visible but the link becomes missing.
|
DEV-574422 |
|
In some cases, users encounter an unexpected error when downloading Formatted Output documents.
|
DEV-578834 |
|
The navigation arrows within the Document Inbox may disappear once the document has reached a steady state.
|
DEV-582734 |
|
If a user re-renders a manual rendition immediately after it's uploaded, Vault overwrites the manual rendition.
|
DEV-584993 |
|
The Title field in the Doc Info panel does not update to the latest title when a merged document is used as the source with an event action.
|
DEV-587162 |
|
In some cases, when creating a Crosslink, the viewable rendition does not display for several hours.Vault creates the Crosslink as a placeholder until the rendition is available.
|
DEV-589285 |
|
In some cases, Vault fails to render PDF source files with PDF/A-1b selected in the File Rendition Settings.
|
DEV-589612 |
|
When the Rendition Profile is set to Generate compliant Viewable Rendition for Source PDFs, any bookmarks in the PDF disappear after the re-rendering process. The Navigation Tab field in the PDF’s properties will still show Bookmarks Panel and Page despite the missing bookmarks
|
DEV-590862 |
|
If a currency formula field on an object record is set to use Local Currency, and the object record is downloaded as a formatted output, the resulting document displays the Corporate Currency instead of the Local Currency.
|
DEV-591916 |
|
In some cases, Vault fails to update the File Created By and File Last Modified By fields in the Document Properties on uploaded PDFs with the user’s current date and timezone.
|
DEV-592464 |
|
The Edit Bookmarks button is available on unlocked Protected PDFs.
|
DEV-592679 |
|
Vault Owners receive a permissions error when attempting to download a Large Size Asset Rendition that is over 4GB.
|
DEV-594832 |
|
When Vault renders a document with table of contents titles longer than one line, text wrapping on the titles is lost in the viewable rendition.
|
DEV-595615 |
|
Under certain circumstances, Vault fails to render large Excel files.
|
DEV-595836 |
|
Merge Field tokens fail to merge if the token includes a special character, such as /, @, [, ], and #.
|
DEV-596823 |
|
PDF/A conversion fails if a document contains multiple fonts with the same names and subtypes.
|
DEV-599882 |
|
In some instances, generating a viewable rendition from a workflow causes a timeout with the error message: "Rendition generation is taking a while. Please refresh your page or try again later" or "Vault is unable to render this file".
|
DEV-602589 |
|
Users may experience a rendering delay when migrating large batches of customs renditions.
|
DEV-602603 |
|
When Vault renders a document with the Blue Link option selected, the sub-headings in the viewable rendition’s table of contents do not render as blue.
|
DEV-605629 |
|
Users are unable to access Link to Content mode directly from View mode on a document in the Library.
|
DEV-607455 |
|
In some cases, if an XML file is submitted for rendering, the render process becomes stuck for an indefinite amount of time and the file is never rendered.
|
DEV-607674 |
|
Vault may fail to regenerate a document's name after document type reclassification.
|
DEV-610078 |
|
Crosslinks may fail to generate a viewable rendition while successfully fetching document metadata from their source.
|
DEV-611017 |
|
Archived documents do not participate in expiry behavior.
|
DEV-611733 |
|
Vault is unable to render documents with a .xlsx file extension.
|
DEV-612125 |
|
Vault may fail to fix link annotations while converting PDF/A viewable renditions.
|
DEV-613374 |
|
When a classified document is reclassified, the Artifacts field updates to the new value in the Doc Info panel, but remains the previous value in other areas of Vault.
|
DEV-614303 |
|
Lifecycle stage colors may not display for old documents that don't have the Lifecycle State Stage ID and Lifecycle Stage fields populated.
|
DEV-617530 |
|
Vault may create an additional record when a crosslinked document is upversioned in the source Vault.
|
DEV-617933 |
|
In some cases, users may see additional characters in some bookmark names within Vault.
|
DEV-618250 |
|
When Create New Version is used on a document with an animated image source file, and new version created is not also an animated image, users encounter an “error transcoding video” error message.
|
DEV-620010 |
|
In some cases, the Export Annotation action does not initiate the download of the generated file.
|
DEV-621263 |
|
In some cases, Vault may fail to ignore superscripts when running Suggest Links on renditions.
|
DEV-623010 |
|
Vault displays unhelpful warning messages when users attempt to delete specific document versions.
|
DEV-623051 |
|
Users may encounter an error when downloading a viewable rendition with an attached signature page.
|
DEV-623523 |
|
Disabling or enabling visibility of one layer on a PDF rendition may disable or enable visibility for other layers as well.
|
DEV-625560 |
|
Vault may fail to display anchor previews in the Select Anchors dialog.
|
DEV-625596 |
|
Vault may fail to update document field security overrides after package deployment.
|
DEV-626893 |
|
In some cases, sandbox Vaults created from snapshots are missing field dependencies.
|
DEV-628284 |
|
Vault fails to identify text in documents using Enhanced Suggest Links when most words in the text contain numbers.
|
DEV-631976 |
|
When a user starts a workflow that validates entry criteria on a document with an invalid field value from a field dependency, Vault incorrectly clears the invalid value.
|
DEV-632227 |
|
Annotations with area placemarks extended to multiple pages if created from the Annotation SDK.
|
DEV-634419 |
|
Users without View Content permission on a specific version can gain access to that version’s content by performing the Send as Link action to send themselves a link to the inaccessible version from the version they have access to. For example, a user with View Content permission on the latest version but not on the latest steady state version can send themselves a link to the latest steady state version via their personal email. This would allow the user to view content that they do not have access to in Vault.
|
DEV-639542 |
|
Vault may return incorrect MD5 checksum values for encrypted files.
|
DEV-639910 |
|
When using non-Latin characters such as Chinese, Japanese, or Korean within a RichText field that is used as a Merge Fields token, the data may be merged into the document as random characters.
|
DEV-640791 |
|
While in View mode, users may be unable to create annotations on video documents via the context menu.
|
DEV-642495 |
|
Vault may incorrectly update Tracked Changes on merge fields documents.
|
DEV-647123 |
| Description |
Issue No. |
|
In Vault LIMS, the system may display inconsistent error messages in cases where the user is updating text result and numeric result fields of a Result record in the Complete state at the same time.
|
DEV-569428 |
|
Certain circumstances may cause Vault to display an error when attempting to execute the Update Periodic Review State action.
|
DEV-570517 |
|
Vault may display an error while transferring data from a Clinical Operations Vault to a Study Training Vault if an object reference field rule is inactive.
|
DEV-579343 |
|
In Vault LIMS, when a user attempts to hierarchical copy a test definition record, the copy may not contain child records as expected.
|
DEV-590345 |
|
In some cases, the Study Training to Clinical Operations Vault Connection job transfers object records which do not fulfill the conditions for transfer.
|
DEV-590630 |
|
In some cases in Vault LIMS, the system may display an error when a user attempts to create a new version of a sample plan or specification record.
|
DEV-591244 |
|
In some cases in Vault LIMS, the system may display a server error when the Generate Lab Tests action executes as a user or event action.
|
DEV-591636 |
|
Vault may display an incomplete error message when the Activate External Collaborators action executes and detects a duplicate external username.
|
DEV-594107 |
|
In some cases in Vault QMS, scrolling within the Risk Builder interface may cause the interface to shift up and down unexpectedly.
|
DEV-594302 |
|
Vault may display an error when attempting to execute the Activate External Collaborators document lifecycle entry action when the Quality External User Template includes certain token combinations including the ${PersonEmailPrefix} token.
|
DEV-594566 |
|
In Validation Management, when a user navigates to a requirement record detail page from the Requirements Burndown View, Vault may not display a navigation breadcrumb in the top left of the detail page.
|
DEV-594833 |
|
For Quality Teams with duplicate team member assignments, the Manage Invalid Team Members dialog may not behave as expected.
|
DEV-601945 |
|
In Vault LIMS test execution, the Actual amount field may be incorrectly required for Consumable inputs which don't specify an amount.
|
DEV-609720 |
|
In some cases in Training, Vault may display an error when a user attempts to click the Filter icon on the Learner homepage.
|
DEV-614904 |
|
Vault Validation Management displays a server error when a user attempts to delete or replace an attachment on a completed Execution Step during the test step change process when both action security is enabled for attachments and atomic security permissions to delete and upload attachments are not configured to execute in the lifecycle state.
|
DEV-615360 |
|
In Validation Management, the Delete Record dialog may display multiple times after repeatedly clicking on the delete icon in a test step in the Test Authoring Interface.
|
DEV-615999 |
|
In Validation Management, the Test Protocol review interface may not properly display the counts of Test Steps.
|
DEV-619621 |
|
In Vaults with the "VPS: Change state of related documents" action configured as an entry action on the "XML Generated" state type, generating multiple XML forms with the same document number may cause the entry action to fail.
|
DEV-620182 |
|
In some cases in Vault LIMS, calculations including datetime values may not resolve as expected.
|
DEV-623792 |
|
In some cases, the Supersede All and Supersede Latest options do not work when running a Recurrence Check.
|
DEV-625996 |
Vault may fail to send Issue Escalation Notifications if recipients are defined by custom-configured application roles populated by Custom Sharing Rules.
Additionally, when the Cascade Document Roles system action is used in the Document Change Control workflow, the Users/Groups in the Document Change Control Roles that are cascaded down to the associated documents are not audited on the Document Change Control records. This occurs if the Users/Groups in the Document Change Control received their roles via Custom Sharing Rules.
|
DEV-626023 |
|
In some cases, Vault fails to delete Related Events that should be deleted when a Recurrence Check is superseded.
|
DEV-627589 |
|
When a user tries to load multiple standalone object records of the same type at once, they may encounter an unexpected error if the records are created in the Cycle Time Start state type.
|
DEV-629557 |
|
In some cases, when the VeevaID Invitation Management job encounters an error after sending an invitation, users receive additional invitations each time the job runs.
|
DEV-630625 |
|
Vault may display an error on the Auditor Profile record detail page after populating the Qualification Completion Date field on a related Role Qualification Criteria Status record.
|
DEV-639960 |
|
In Vault LIMS, in some cases the Reopen icon is not displayed in the test execution interface.
|
DEV-641264 |
|
In some cases in Vault LIMS, complex input and calculated result configurations may result in Vault being unable to resolve all results as expected.
|
DEV-641319 |
|
In some cases in Vault LIMS, a calculated result may fail to calculate as expected if the calculated result relies on the value of another calculated result.
|
DEV-641323 |
|
In Vault LIMS, Vault may display an error when attempting to execute a completion action on a Change Analysis record with duplicate Change Analysis Items.
|
DEV-641464 |
|
In Vault LIMS, the Lab Result History dialog may incorrectly display a change reason for an initial value.
|
DEV-641699 |
|
In Vault LIMS, the Lab Result History dialog may incorrectly display ID values instead of the new and previous values.
|
DEV-641701 |
|
When making a Spec Data effective, Vault incorrectly does not check that the Spec Data Criteria's result to evaluate is a child of the Spec Data Criteria's Test Definition.
|
DEV-641858 |
|
In Validation Management, Vault may not display a warning when users attempt to delete a default prompt.
|
DEV-642380 |
| Description |
Issue No. |
|
When users drag and drop Active Dossier records into the viewer and do not populate the Product field with the Inactive Ingredient field, Vault does not display the created records in the viewer.
|
DEV-544331 |
|
When a matched source document includes Vault annotations to permalinks to multiple targets, on-demand publishing does not up-version source documents and resolve the link if a target document is updated.
|
DEV-552009 |
|
In some cases, Vault does not publish links when the target document does not have a Viewable Rendition.
|
DEV-558009 |
|
Permalinks to named destinations within a target document published as a viewable rendition resolve to the first page of the document rather than the named destination.
|
DEV-577927 |
|
Vault incorrectly reports Rule 5040 as failed if Vault annotation links are added during continuous publishing.
|
DEV-579772 |
|
The Copied From field value is not set on inactive Content Plan records created from the Dispatch/Copy and From/Into Content Plan Actions.
|
DEV-580578 |
|
RIM submissions encounter an error where the output generates a PDF all pages are missing after the first page. The second page includes an error: ERROR: syntaxerror OFFENDING COMMAND: –nostringval–.
|
DEV-589023 |
|
Users cannot lock a Content Plan (perform a hierarchical state change) when the plan contains a Content Plan Item without a published document and its XML Operation field set to “Delete”.
|
DEV-589325 |
|
Vault does not update the Published by Vault field when publishing a reference leaf via continuous publishing.
|
DEV-589751 |
|
When a Submission has multiple Clinical Study or Nonclinical Study relationship records, the Set Leaf Operation dialog does not auto-expand to the section containing both records.
|
DEV-592800 |
|
When a user clicks the Apply button in the Managing Registered Details wizard, the lifecycle state is not applied for the Registration.
|
DEV-593089 |
|
In some cases, filtering for Matched Documents within the Content Plan Viewer may return incomplete data.
|
DEV-593171 |
|
When the “Show inactive Applications and Submissions in Viewer” Submissions Archive Application Setting is disabled, users cannot filter by inactive Submissions, however Vault still displays inactive Submission data in the viewer grid.
|
DEV-594285 |
|
Vault link annotations to multiple lines of target document resolve incorrectly during publishing.
|
DEV-594956 |
|
When managing registered details, the Summary page “Finish” button is disabled when the request exceeds the number of records allowed for creation or update.
|
DEV-595772 |
|
Admins may encounter a deployment failure when migrating Impact Assessment Report records.
|
DEV-595936 |
|
When copying into a Content Plan, the success and failure counts in the resulting notification do not include the total number of matched documents.
|
DEV-596193 |
|
When a user expands a content plan section at the bottom of the tree within the Active Dossier and Content Plan viewers, the view jumps back to the first expanded section in the tree.
|
DEV-598627 |
|
During continuous publishing triggered by updating the Source for Published Document or Published Output Location, Vault up-versions matched documents which are not Ready for Publishing.
|
DEV-598716 |
|
Vault incorrectly reports US Rule 1085 as passed when an Content Plan Item's full source file path is greater than 230 characters.
|
DEV-598738 |
|
In some cases, small submission binders may end up in an inconsistent state where index.xml exists, but the md5 file is left as a placeholder.
|
DEV-599564 |
|
When an Active Dossier Item Detail record references a common country (EU, GCC), users attempting to clear the Active Dossier Status receive an error.
|
DEV-600775 |
|
In some cases, users may see an empty section warning in the Submissions Archive Viewer when it does not apply.
|
DEV-601177 |
|
Vault may fail to populate Acknowledgements on the Product Data Message for Investigational Medicinal Products.
|
DEV-601805 |
|
When a user without Read permission for the Submission Metadata object selects Where Used in Archive, the Submissions Archive Viewer does not load. For users with Read permission, the viewer loads but does not automatically expand to the selected location.
|
DEV-601968 |
|
Users without Read permission on the Submission object and object types are able to view them in the Submissions Archive Viewer.
|
DEV-602110 |
|
In some cases, when a Content Plan Item’s XML Operation is set to Delete, the item is not updated accordingly in the Submissions Archive Viewer during publishing.
|
DEV-602154 |
|
Hovercards in the Active Dossier Viewer display an error for Common (GCC) Active Dossier Item Detail records.
|
DEV-602299 |
|
The Active Dossier Viewer does not display the submitted icon and hovercard for Common (EU) Active Dossier Item Detail records.
|
DEV-602304 |
|
In some cases, the Create from Document user action fails to generate a matched document for the related Report-type Content Plan Item.
|
DEV-602341 |
|
Depending on a user’s browser zoom level, longer leaf and section titles overlap and are not readable within the Set Reference Leaf dialog.
|
DEV-603244 |
|
In some cases, when a user attempts to access the Viewer tab, it appears blank.
|
DEV-603271 |
|
When setting a leaf operation for multiple Submissions, users must apply filters for a specific Submission in order to view STF XML files in the dialog.
|
DEV-603493 |
|
Vault does not apply overlays to viewable renditions downloaded from the Submissions Archive Viewer.
|
DEV-604498 |
|
Vault executes (instead of skips) validation checks of FDA Forms against US Rules 5005, 5020, and 5040.
|
DEV-605047 |
|
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-605064 |
|
When transferring Content Plan data from a PromoMats Vault to a connected RIM Vault where the Content Plan does not exist, Vault does not create a corresponding User Exception Message record with the described error.
|
DEV-605288 |
|
For China (CN) eCTD submission records, there are typographical errors in the labels of sections 1.4, 1.4.6, and 1.8.1.
|
DEV-606182 |
|
In some cases, an error occurs and the Update Content Plan job does not complete when Content Plan Item unique name is enabled,
|
DEV-607511 |
|
When a user splitting Activities navigates back from the Summary page to the Define Relationships page and de-selects a record, Vault directs them to a blank Define Relationships page instead of the Summary page.
|
DEV-608164 |
|
Under certain circumstances, users receive a Page Not Found error when accessing the Viewer tab.
|
DEV-608234 |
|
In some cases, Vault incorrectly reports US Rule 7 as failed.
|
DEV-608930 |
|
In some cases, the RIM to Promomats Vault Connection creates and deletes Submission records without generating a User Exception Message.
|
DEV-609026 |
|
Users without Read permission for the Application object are able to view but not execute the Create Registrations action.
|
DEV-610772 |
|
Vault incorrectly reports Rule 5202 as failed if a merged document contains Vault annotation or embedded links.
|
DEV-610882 |
|
Vault incorrectly reports Rule 5205 as failed if a merged document contains Vault annotation or embedded links.
|
DEV-611099 |
|
Vault does not report Rule 2002 as failed when STF XML includes errors which should fail.
|
DEV-611754 |
|
The Submissions Archive Viewer displays inactive Content Plan Items where a document was previously matched.
|
DEV-612982 |
|
Vault converts STF XML with HF tags to lowercase and does not execute Rule 2002.
|
DEV-613257 |
|
During continuous publishing, Vault does not report Rule 1323 as failed when there is a published placeholder.
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DEV-613342 |
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Vault incorrectly reports GCC Rule 12.9 as passed when a Labeling or Cover Letter Content Plan Item contains an incorrect xlink:href value.
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DEV-613762 |
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Vault incorrectly reports US Rule 1255 as failed for ANDA submissions when items in sections M1-14 and M1-16 are Microsoft Word documents, reflected in the Published Output Location as .doc.
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DEV-613765 |
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Vault exports Application-level Correspondence documents when they are hidden from the Export view and the Dossier Status is Publishing Active.
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DEV-614082 |
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Vault does not report Rule 11.12 as failed when a leaf is deleted or replaced by more than one node.
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DEV-614169 |
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Vault does not update the Published by Vault field when publishing a reference leaf via continuous publishing.
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DEV-614526 |
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The Learn More link from the Training Summary Results field within Trained Model records incorrectly resolves to the Clinical Vault Help page for the TMF Bot (page ID: 72739). The link should resolve to the Regulatory Vault Help page, Evaluating RIM Bot Auto-Classification Models (ID: 518092).
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DEV-615638 |
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The Active Dossier Viewer and Editor do not respect field-level atomic security configured for the Active Dossier Item and Active Dossier Item Detail objects.
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DEV-615808 |
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Users cannot edit bookmarks in merged Report Level Content Plans when an overlay is applied.
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DEV-618251 |
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In some cases, the the incorrect submission folder name displays in the email notification users receive after importing using Vault File Manager drag and drop functionality.
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DEV-618380 |
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In some cases, Vault displays a server error when users initiate the Direct Approval Workflow for Binder VV-SUB-00007.
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DEV-618557 |
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When a user navigates to another Application from the Submissions Archive Viewer, the viewer does not respect applied column filters.
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DEV-619062 |
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In some cases, the page may appear blank when a user attempts to scroll through a document within the Submissions Archive Viewer.
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DEV-620245 |
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When Vault creates a Validation Result for an invalid backslash (\) character, the Detailed Publishing Results do not include the character.
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DEV-620247 |
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In some cases, previously matched documents that should be filtered out are incorrectly auto-matched to EDL items.
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DEV-620646 |
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When users select Update Administrative Information on an EU Submission, Vault does not display all Related Submissions.
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DEV-620748 |
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In some cases, Vault does not execute Rule 1737.
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DEV-623708 |
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In some cases, the IDMP Data Viewer shows obsolete data.
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DEV-624240 |
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Vault incorrectly reports Rule US 1850 as failed when the Published Output Location includes uppercase letters.
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DEV-624719 |
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Vault does not populate IDMP Manufacturing Site records with the Finished Product Manufacturer referenced on the related Registered Packaging record.
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DEV-624875 |
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When Global to Local Submission Type Mapping is enabled, users are able to navigate to the bulk creation wizard’s Additional Details page without selecting a Submission Type.
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DEV-625069 |
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The filter UI in the Submissions Archive Viewer may become unstable and difficult to use when there is a large number of selections.
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DEV-625079 |
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Vault incorrectly reports Rule 1738 as failed.
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DEV-626996 |
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Vault does not report Rule US 1850 as failed when a non-STF leaf is appended to an STF leaf.
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DEV-627280 |
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When the Quality to RIM Vault Connection encounters a state change error in RIM, the connection creates and immediately inactivates the related User Exception Message.
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DEV-627296 |
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On-demand publishing fails when an embedded relative path link resolves to an active Content Plan Item which shares a matched document with an Inactive Content Plan Item.
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DEV-627977 |
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When bundling Activities or Regulatory Objectives, users without Read or Create permission for the Submission Authorization object receive a nonspecific error message.
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DEV-629479 |
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Users may be unable to update fields for a Registration/Registered join object through the Edit and Verify page when there are populated specific version Document fields included in that object's page layout.
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DEV-630692 |
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Users are incorrectly able to modify or delete Active Dossier Template records, which can cause issues.
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DEV-632849 |
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Users may be unable to apply filters to the Related Manufacturer fields on the Registered Active Substance and Registered Inactive Ingredient grids in the Manage Registered Details wizard.
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DEV-633075 |
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When a given Content Plan Item has more than 2,000 potential documents for auto-matching, Vault matches only 1,000 documents via the daily job, and does not match the remaining documents when the Match Documents action is run.
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DEV-633836 |
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Bulk imports fail when users import four (4) or more submissions via UI.
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DEV-634626 |
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When a given binder section contains documents with the same name, Submissions Archive creates duplicate subsections upon import.
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DEV-635884 |
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In some cases, the Submission wizard does not create Submission Authorization records when users select only Regulatory Authorization relationships.
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DEV-641402 |
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Custom (__c) picklist values do not display for selection in Health Authority object picklist fields.
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DEV-641499 |
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When creating registrations in bulk, the “Create separate Registrations for any selected Complex Products and their selected component Products” checkbox does not appear if the “Use regulatory objective data as object source when bulk creating registrations” Application Setting is enabled.
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DEV-642387 |
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When a source document using the PDF Compliance rendition profile contains a broken page link, publishing jobs fail instead of reporting a validation error.
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DEV-645080 |
| Description |
Issue No. |
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After submitting a report to the PMDA and receiving an ACK message, the Destination Case ID field on the Transmission and Local Reporting Details objects is not updated to include the PMDA receipt number.
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SAF-26962 |
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In some instances, merging Inbox Items to domestic Follow-up Cases through the Case Compare page fails.
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SAF-34349 |
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When values in an E2B file map to inactive records, E2B import fails.
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SAF-36203 |
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When Follow-Up Cases are created from blinded studies with open-label or unblinded Standard of Care products, the Blinded field on Case Products is incorrectly set to Yes.
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SAF-39149 |
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When creating Follow-Up Cases, Expectedness values from initial Cases are changed on the Assessments and Case Assessment Expectedness sections of Follow-Up Cases.
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SAF-40548 |
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After merging a Localized Inbox Item to an In-flight Localized Case, the updated Case includes two (2) Narrative documents.
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SAF-41971 |
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When an Inbox Item is saved immediately after updating its New Info Date, the date does not appear in the New Info Date column of the Inbox Item Inbox, although the date has been saved.
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SAF-42184 |
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The audit trail on inbox items created from E2B files displays picklist names instead of labels.
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SAF-42631 |
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For unblinded Cases, changing the Study Report Type to a custom value breaks the blind on Product Names.
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SAF-42695 |
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Users with the Case Processing security profile are unable to view data in the Medical Review Timeline of an inbox item that has been promoted to a Case.
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SAF-42713 |
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After E2B import, when multiple countries in Vault Safety match the country code on the file, the system maps the code on the Case inconsistently instead of mapping to the first code in alphabetical order.
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SAF-42855 |
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Inbox items cannot be created from JSON files if the values entered in Controlled Vocabulary fields are invalid.
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SAF-42899 |
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When Case Access Group Security is turned on, if Case Assessment Result records do not have a value in the Case field, users may receive a 'Server having problems' error when attempting to run a report.
|
SAF-43033 |
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When creating a Follow-up Case or merging to an In-flight Case, the Case-level Reporter Country field is not updated.
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SAF-43369 |
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During External Product coding, if the Country Obtained field is populated with "United Kindom (Northern Ireland)" or "United Kingdom (Great Britain)", when the WHODrug Browser is opened the country filter is set incorrectly.
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SAF-43648 |
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When Study Cases have postmarketing PMDA Reporting Categories, Localized Study Names are not exported to the C.5.2 Study Name data element on PMDA E2B(R3) reports.
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SAF-43653 |
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In rare instances during E2B Import, when notification messages about successful E2B imports are not sent, the successfully imported Inbox Items remain stuck in the "Import Error" state.
|
SAF-43737 |
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In some instances, the system times out when running Multi-Pass Reports for Non-Vault Owners.
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SAF-44044 |
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For E2B-imported Inbox Items, the primary Case Product is not included in Case names.
|
SAF-44090 |
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When an E2B file does not include both values and units for First Dose Latency and Last Dose Latency, none of the data elements are imported and the related Case Assessments are not generated.
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SAF-44214 |
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Reporting Rules are not evaluated correctly for Reporting Families with Product Registrations.
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SAF-44332 |
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When the primary Product is changed on a Study Case for an open-label Study with Unspecified Products, the Case name is not updated.
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SAF-44392 |
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In some instances, a server error occurs when Non-Vault Owner users try to view the Medical Review Timeline section of Cases.
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SAF-44404 |
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The system automatically voids Cases when they have no Primary Products or the "Generate Assessments for both Serious and Non-Serious Adverse Events" setting is turned off.
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SAF-44406 |
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In some instances, WHODrug-coded Substance Names for External Products are missing parentheses, leading to incorrect population in the B.4.k.2.2 Substance / Specified Substance Name data element of E2B(R2) reports.
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SAF-44531 |
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When a PMDA Case has multiple LRDs, the values entered in some J2 fields and Localized Case Comments are mapped from the wrong LRD upon export.
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SAF-44906 |
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After promoting a Domestic Case created from an E2B(R3) file, some Localized Assessment Result records are not created.
|
SAF-45007 |
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Warnings don't appear when the Case Product Dosage Frequency field is missing either a unit or number value.
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SAF-45081 |
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The system does not correctly identify whether Company-Product Combination Products have Device-type Product Constituents or other types of Product Constituents when generating FDA MedWatch 3500A, FDA E2B (R2) and E2B (R3), and EMA E2B (R3) files.
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SAF-45308 |
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When generating E2B files, Dose Forms from the Controlled Vocabulary are not truncated to 50 characters.
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SAF-45515 |
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When the Generate Assessments user action completes, system notifications do not appear.
|
SAF-45796 |
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When a foreign Localized Study Case includes Substance records but no Transmissions, changing the Case Study Product on Follow-up Cases is prevented.
|
SAF-45867 |
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Case Access Group security rules are not applied to the Local Reporting Details and Local Reporting Details/Product Join objects.
|
SAF-45868 |
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When Pregnancy Cases are locked, the lock is not extended to related Child Information or Parent Information Cases.
|
SAF-45870 |
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When using Case Access Group security, manually created Parent Cases do not inherit Access Groups from Child Cases.
|
SAF-46052 |
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When using Case Access Group security, Case role assignment does not consider the Localization set on the User Access Group Assignment record.
|
SAF-46088 |
|
When a case narrative is updated, the narrative preview and generated XML file do not reflect these changes.
|
SAF-46100 |
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The "Product" Reporting Rule Parameter does not evaluate whether Cases contain Company Products.
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SAF-46175 |
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When generating E2B(R2) files for Cases with multiple indications, B.4 Drug(s) Information blocks can now be generated for each indication. Previously, indications other than the first one on the Case were exported to the B.4.k.19 Additional Information on Drug (free text) data element. For more information or to enable this behavior in your Vault, contact Veeva Support.
|
SAF-46205 |
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The system automatically voids Cases when there are no Primary Products or Assessments in their source E2B files, and the resulting error message does not reflect the real issue.
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SAF-46260 |
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When generating Individual Case Safety Reports (ICSRs), exporting multiple Device Follow-Up Type values for a single device is supported. On FDA MedWatch 3500A reports, multiple checkboxes can be selected in the H2 If Follow Up, What Type? field. On VAERS E2B(R3) reports, the FDA.G.k.12.r.2.r If follow-up, what type? data element repeats for each selected follow-up type. On FDA E2B(R2) reports, multiple B.4.k.20.FDA.18.1 data elements can be set to 1. Support for this feature requires configuring the new Device Follow-Up Type field. For more information, contact Veeva Support.
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SAF-46262 |
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The Due Date field on Localized Cases is not set to the earliest due date from their Localized Case Assessments.
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SAF-46301 |
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When generating PMDA E2B(R3) reports, if the Case Product Dosage Route of Administration field is set to Unknown, the G.k.4.r.10.1 Route of Administration data element tag is incomplete and the G.k.4.r.10.2a Route of Administration TermID Version Date / Number and G.k.4.r.10.2b Route of Administration TermID data elements are exported although they should not be.
|
SAF-46318 |
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When using Case Access Group security, users with access to a Pregnancy Case cannot see the Case Child Information and do not have the expected assigned roles based on their Case Access Group Assignment roles.
|
SAF-46385 |
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When creating CIOMS II reports, if a Study in the Reporting Family includes a Case where the primary Product has a Drug Role other than Suspect or Interacting, an error occurs and the report does not generate.
|
SAF-46498 |
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Entering multiple values in the Device Follow-Up Type field is now supported. For more information, contact Veeva Support.
|
SAF-46546 |
|
When voiding a migrated Case and submitting one last time, if the Case includes a completed Transmission that references an inactive Transmission Profile, the Case does not move into the Voided state.
|
SAF-46625 |
|
In some instances, there is no break between paragraphs when viewing Company Comments and Reporter's Comments in the Show More Text window.
|
SAF-46699 |
|
During Case promotion, merging to an In-flight Case does not complete when there are more than 500 Case Assessment Expectedness records, and the Inbox Item remains unprocessed in the system.
|
SAF-46707 |
|
PMDA.J2.2.2 fails and causes a validation error even in Follow-up Cases.
|
SAF-46710 |
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When a non-Admin user clears the Country field on an Inbox Item, the field is not automatically cleared in the Case Validity and Source section.
|
SAF-46737 |
|
Submissions are prevented when a single Reporting Rule is overridden by multiple Rules within another Rule Set.
|
SAF-46771 |
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Values entered in the Source field are mapped to the Localized Source field upon Case promotion even when the "Enable Localization-based Mapping on Import" setting is turned off.
|
SAF-46772 |
|
When generating E2B(R2) files, the Case Product Expiration Date is not exported to the B.4.k.19 data element.
|
SAF-46894 |
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When processing a Pregnancy Case, if the Gestation field includes a zero (0) in the numeric field and a unit of measurement is selected, clicking Save does not save the Case details.
|
SAF-46962 |
|
When generating PMDA E2B(R3) files for a Study Case where there is no Localized Study child record for Japan, the C.5.2 data element is not included in the file.
|
SAF-47001 |
|
Safety Rule Configuration Reports do not correctly apply more than two levels of inheritance.
|
SAF-47048 |
|
During Domestic Case promotion, when merging Inbox Item data into an existing Case, global Case data is not displayed on the Case Compare page.
|
SAF-47061 |
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When generating FDA 3500A files for Cases with Devices or Combination Products with Devices, multiple checkboxes are not selected in the H.1 Type of Reportable Event field when they should be.
|
SAF-47066 |
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When generating PMDA E2B(R3) reports, the N.1.5, N.2.R.4, C.1.2, C.1.4, and C.1.5 data elements are not converted to Japanese Standard Time (JST) and do not use the 24-hour format.
|
SAF-47077 |
|
After importing Cases received through version 23.2 of the Intake JSON API to Inbox Items, the Reasons Omitted fields are not populated.
|
SAF-47079 |
|
Safety Rule Set Configuration Reports do not include Rule Set Parameters for inherited Rules.
|
SAF-47082 |
|
When importing E2B files through an AS2 gateway, ACK2 messages are not sent.
|
SAF-47099 |
|
When Case Access Group security is enabled, a server error occurs when attempting to view Cases if the user does not have Read permission on hidden fields in the Drug History section.
|
SAF-47130 |
|
Localized Reason Omitted records are not included in cloned Vaults.
|
SAF-47184 |
|
In some cases, users may experience performance issues when viewing Cases.
|
SAF-47205 |
|
In some instances, system performance is slower than expected when loading individual Inbox Items.
|
SAF-47239 |
|
One Last Time (OLT) reporting is prevented if a previous Case version includes an inactive Transmission Profile or Organization.
|
SAF-47329 |
|
After successful import of a multi-Case CSV file, automated Case promotion fails.
|
SAF-47330 |
|
When generating Transmissions for Company Product Case Products, the Transmission Product Type set up on the Product Registration is not used to match to the Product Types set up on the Transmission Profile Scope.
|
SAF-47443 |
|
When Narrative document templates have merge tokens formatted in a table, after updating the Narrative on a blinded Case using that template, in some instances the Narrative preview and generated XML files do not reflect the changes.
|
SAF-47546 |
|
For imported Inbox Items, in some instances, the Source Data panel overlaps with Inbox Item fields when in Edit mode.
|
SAF-47609 |
|
In Vaults cloned from a Vault with a link to the gateway service, the Sync the Connection to Gateway action is prevented for AS2 Gateways.
|
SAF-47634 |
|
Errors occur when refreshing a sandbox from a snapshot of a Vault with AS2 Connections.
|
SAF-47803 |
|
When importing an E2B file received through API transmission, if the Inbound Transmission specifies an Origin Organization where the PV Agreement field is set to Agent, the New Info Date field on the Inbox Item is set to the Transmission Generated date.
|
SAF-47959 |
|
In some instances, although a Case passes Validation, unexpected Validation Result issues appear on the Submission and result in a Validation Error state.
|
SAF-47971 |
|
When opening a Study Case for the Open Label arm of a Study with both Blinded and Open Label arms, the system generates the Case Product record name with the Study Product Placeholder name instead of the Product (Coded) or Product (Reported) name.
|
SAF-47973 |
|
Headers from Narrative documents are appearing in generated ICSRs, resulting in non-compliant Transmissions.
|
SAF-48093 |
|
One Last Time reports are generated for destinations that do not have back reporting configured on the Transmission Profile.
|
SAF-48204 |
|
When voiding a Case with a Transmission in the E2B ACK Accepted lifecycle state, the Case does not move to the Nullified state.
|
SAF-48225 |
|
When generating Transmissions for imported Cases, validation failures related to MedDRA version and dates occur when the data is valid.
|
SAF-48339 |
|
The system-managed Route of Administration record for "Occlusive dressing technique" does not include the E2B Version.
|
SAF-48487 |
|
After importing a high volume of Cases, if indexing of migrated cases for duplicate search is initiated, in some instances the process fails.
|
SAF-48974 |
|
On Inbox Items created from imported E2B(R2) files, the Patient RoA TermID Version is always set to 2.0 regardless of the version in the Route of Administration record.
|
SAF-49006 |
|
During cross reporting, expected back reporting Transmissions are not generated when back reporting is configured on related agency Transmission Profiles.
|
SAF-49061 |
|
When creating AERs from E2B-import through Vault AS2 Gateway, ACK2 messages are not sent.
|
SAF-49159 |
|
When Inbox Item Medical Events or Product Indications include trailing white spaces, after Case promotion the system creates duplicate MedDRA records.
|
SAF-49850 |
|
When generating FDA 3500A forms for Cases with Company Product-type products with a Product Registration record set to the Transmission Product Type of Device, sections D and H of the form are not populated.
|
SAF-49931 |
|
When generating FDA E2B(R2) Combination Product reports for Cases where the Device Report Type field includes Public Health Risk, the A.1.9 data element is not populated with code 4 unless the Case Product is a Device.
|
SAF-49959 |
|
When using Case Access Group Security, Access Group assignment does not consider the Origin field correctly.
|
SAF-50070 |
|
When generating PSMF Logbooks, text that exceeds the maximum Excel row height is truncated instead of split across two rows.
|
SAF-50546 |