The issues listed below are fixed in the 26R1 release.
| Description |
Issue No. |
|
The Organization field on a Contact Information record does not update after the OpenData ID on a related Organization record is changed.
|
DEV-1001258 |
|
CTN Data Change Logs may be unexpectedly carried over from the Protocol Notification CTN after running the Generate Subsequent CTN action.
|
DEV-1002565 |
|
In some cases, certain CDMS Integration Points may cause data transfers from CDMS to Clinical Operations Vaults to fail.
|
DEV-1002686 |
|
Users experience an unexpected error occurs signing up for a USN when they enter a backslash character "\" in any of the text fields.
|
DEV-1002695 |
|
In some cases, when the Generate Document from Formatted Output action is used to generate a new version of a document for surveys, the survey respondent cannot open the document link in the Completed Survey Notification email.
|
DEV-1004225 |
|
The Vault does not correctly update the Name field on Study Person records to the winning Name value when users run the Merge Persons action.
|
DEV-1004511 |
|
The completion job crashes when users manually execute the Mark Complete workflow, and subsequent milestone state changes cannot be executed.
|
DEV-1005020 |
|
Users are unable to download TMF exports through FileZilla and Vault File Manager if there are leading and trailing spaces in the folder names.
|
DEV-1005258 |
|
Under certain circumstances, CTMS Formatted Output jobs run successfully, but the document is never generated.
|
DEV-1007185 |
|
Users receive an unknown error message when the Auto File To Site job fails due to the Site not having any Site Users with the Manage Unblinded or Manage Essential Documents type Study Person Responsibility.
|
DEV-1008624 |
|
Bulk creating Outreach Survey Person records via Vault Loader allows users to create multiple Outreach Survey Person records with the Sender Type value of From for an Outreach Campaign.
|
DEV-1011521 |
|
The Milestone Planning View automatically changes any updated Planned or Actual Finish Date values to the day prior to the date entered.
|
DEV-1011531 |
|
In some cases, workflows that generate Word Formatted Outputs may unexpectedly fail to run after a successful first run.
|
DEV-1012073 |
|
A server error occurs when users attempt to remove the Tax Rate Total field value while the Tax Rate is in use.
|
DEV-1012306 |
|
Due to a label error in the US Registration disclosure, EU Trial (CTIS) Numbers were not being submitted correctly with the US Registration submission.
|
DEV-1012892 |
|
In some cases, the Log in to Site Connect link in Document Exchange emails redirects users to an empty table.
|
DEV-1013038 |
|
In some cases, long-running TMF Export jobs may block other jobs in the queue from completing.
|
DEV-1013134 |
|
Vault sends site users internal, sponsor-facing notifications stating that the sponsor has received documents.
|
DEV-1014788 |
|
Inconsistent update logic may leave Unblinded Subject Visit Data records in an incomplete state.
|
DEV-1015805 |
|
When a user attempts to create an Update Site Staff Change Request, Vault incorrectly limits the dates users can select in the calendar view.
|
DEV-1019471 |
|
Once a user completes the sign task, Vault does not display the document in the All Documents section but does continue to display the document in the Sent and Received sections.
|
DEV-1019978 |
|
An unexpected error occurs when users attempt to search for USNs with special characters in any of the text fields.
|
DEV-1020194 |
|
The Add Site Staff dialog header does not display when users launch the dialog from the 1572 Form.
|
DEV-1020238 |
|
When a Study Person SHA is in the Scheduled state, users cannot view or select the Study Person's assigned Responsibilities and Vault does not run the email in use validation.
|
DEV-1020964 |
|
The Distribution Task Field Migration job does not validate that Sites are connected to Site Vault prior to running causing the job to fail in some cases.
|
DEV-1021045 |
|
The Apply Template EDL Updates (Bulk) action is provisioned as Active instead of Inactive.
|
DEV-1022505 |
|
Adding a Role with a future Start and End Date value to an existing Site User removes the user's access to the Site.
|
DEV-1022625 |
|
The Archive Study job completes with unexpected errors when users manually execute the Initiate Study Archival action.
|
DEV-1023474 |
|
The browser window closes after users perform the Bulk Copy Issue action.
|
DEV-1029474 |
|
When two Unblinded Monitoring Events with the same Actual Date value exist in the same Vault, Vault may populate a Blinded Monitoring Event in the Previous Unblinded Monitoring Event field for one of the Unblinded Monitoring Event.
|
DEV-1029486 |
|
In some cases, the Autofill Timezone Trigger overrides user entered Site Timezone field values.
|
DEV-1030854 |
|
Vault does not display an error when users enter variations of "n/a" into required string fields on US Registration Disclosure records.
|
DEV-898399 |
|
The Validation Error indicator does not display correctly for subsections with only standard field types in the Study Details section of Disclosure records.
|
DEV-898513 |
|
Some validation messages for the Validate action on US Results appear above the incorrect table.
|
DEV-932323 |
|
Vault does not translate the CTN Attachment Applicant Name label.
|
DEV-934290 |
|
Vault displays a server error when users attempt to deactivate a Transfer Agreement for a deleted Vault.
|
DEV-944886 |
|
In some cases, Vault does not save the values Sites enter for the Last Filed to SiteVault and SiteVault Document Number fields on documents.
|
DEV-950494 |
|
An error occurs in when a Study with recurring Milestones does not have a Milestone Master Set value set.
|
DEV-957253 |
|
In some cases, Vault generates User Exception Items for the Visit Definition Transfer Integration Point when the Event Definitions Help Content field exceeds the character limit.
|
DEV-959551 |
|
In some cases, users receive an unexpected processing error messages related to the DocumentVersionID.
|
DEV-961670 |
|
The Submit Data Change Request API allows userrs to submit fields that should not be changed via a Data Change Request submission.
|
DEV-963944 |
|
Users receive an error message when attempting to remove an inactive Subject Group from a Subject because Vault does not allow the creation of the Subject History record.
|
DEV-965204 |
|
When multiple Expected Documents exist with the same classification but different subartifact, the Push out Expected Document Updates workflow on Reference Sites incorrectly updates the # Expected field.
|
DEV-966897 |
|
In Vaults with the Disclosure application enabled, users experience a server error when they update a Milestone record and remove the Milestone Type value.
|
DEV-968179 |
|
For some documents in eTMF, the Subartifact and Document Type Detail field may be incorrectly populated when a document is updated but not re-classified.
|
DEV-968786 |
|
In some cases, Self-Evident Corrections generates Quality Issue records that incorrectly display updates to fields that have not been updated.
|
DEV-969668 |
|
In some cases, the Check for Updates action incorrectly flags updates for Planned Enrollment when there are none.
|
DEV-970615 |
|
In some cases, users receive a server error when attempting to access Study Personnel records.
|
DEV-970626 |
|
When a Protocol Deviation record is inactivated in the EDC Vault, the Clinical Operations - EDC connection does not update the corresponding Protocol Deviation record's lifecycle state to inactive in the Clinical Operations Vault.
|
DEV-971200 |
|
In some cases, the Action Status on Distribution Task does not update from Pending to Acknowledged even after a the PI views the document.
|
DEV-972804 |
|
In some cases, only Vault Owners can view Site Staff in the Site Profile section of Site Home and when Site Users cannot view the Roles picklist values when trying to add a Site Staff record.
|
DEV-973198 |
|
The Clinical Operations - EDC connection fails to update the Site value for the Protocol Deviation or Procedure records associated with Subject record when a user moves the Subject in the wrong Site to a new Site in the EDC Vault.
|
DEV-973920 |
|
In some cases, Vault may allow a document that is not using the Unclassified Document Type but is using the Unclassified Document Lifecycle into Study Archival.
|
DEV-975069 |
|
In some cases, users experience an error when attempting to import US Results Disclosures.
|
DEV-978203 |
|
In eTMF, the Assigned To field on Quality Issues may not display the defaulted value if more than 100 users have access to the document.
|
DEV-978450 |
|
If the Seed Monitored Enrollment or Proactively Seed Monitored Enrollment actions are configured as Entry Actions on Monitoring Event lifecycle states that are entered after a user is prompted to add dates to the Monitoring Event, the Enable Date-Based Snapshot for Monitored Metrics feature does not work as expected, resulting in incorrect metrics calculations.
|
DEV-979087 |
|
Users may encounter unexpected failures when attempting to generate eCDA documents.
|
DEV-979206 |
|
When the Enable Enhanced Blinding Defaulting feature is enabled, the content field value of documents passed via API is overridden by the unclassified document defaulting logic.
|
DEV-979359 |
|
When the OpenData ID field is not included on the Institution Layout VOF details section, users can't save ODC Institution records created through the Create Missing Record or Add to Vault actions.
|
DEV-979489 |
|
Under certain circumstances, when the Update Monitored Metrics job runs, the calculation may use outdated data.
|
DEV-979902 |
|
In certain cases, users may see amounts in USD rather than the local currency when viewing the Payable item details for Site Home.
|
DEV-979930 |
|
The Job Admin Parameters UI for the Create Word Formatted Output job does not show all configuration options for objects with no object types.
|
DEV-980530 |
|
In some cases, Vault fails to create new Milestones from a template when a deleted Lifecycle State exists in the Prevent Excluded Lifecycle States setting.
|
DEV-981532 |
|
Users who do not have Document Archive permissions may experience an unexpected error when running the TMF Export job.
|
DEV-982162 |
|
When prepopulating the Brief Summary field on a disclosure, the text is cut off if it has more than 250 characters.
|
DEV-985125 |
|
Under certain circumstances, the Seed Metrics action may run successfully but fail to generate the expected Metric records.
|
DEV-985534 |
|
An error occurs when users update an excluded Investigator or Institution record to an non-excluded OpenData ID record when the child Contact Information or Location record doesn't exist.
|
DEV-985953 |
|
In some cases, users may receive errors when attempting to process Milestone documents.
|
DEV-986571 |
|
The Auto-Train Models jobs fail for models with a VQL Criteria field with more than 250 characters.
|
DEV-986868 |
|
In some cases, the Expected vs Actual field displays a negative value.
|
DEV-986870 |
|
Depending upon the validation, Vault displays different error messages when users attempt to clear the OpenData ID field value for OpenData Clinical managed Organization and Person records.
|
DEV-987917 |
|
An unexpected error occurs when users attempt to export the TMF for a study and the documents have a filing level of Site Level or Study Country Level, but the exported study does not have an associated study country or site linked.
|
DEV-988981 |
|
TMF Export fails with unexpected errors when exporting studies that contain signed documents with filenames longer than 100 characters.
|
DEV-989619 |
|
In some cases, Monitored Subjects may not be seeded as expected for Date Based Studies.
|
DEV-990179 |
|
In some cases, Vault Disclosure displays inconsistent validation error messages compared to the PRS validations.
|
DEV-991395 |
|
Users experience an unexpected error when attempting to update the OpenData ID field for a parent Site record to the OpenData ID of a child Site record.
|
DEV-992021 |
|
The Site Connect Study Invitation Cleanup job fails when attempting to proccess more than 1000 records.
|
DEV-993576 |
|
Under certain circumstances, Subject Visits do not correctly inherit the SDR Required value from their parent Subject records.
|
DEV-995414 |
|
An unknown error occurs in some cases when users attempt to enter a USN for a feasibility survey.
|
DEV-998938 |
| Description |
Issue No. |
|
Site Staff | Site staff cannot reassign a participant to a group that has events with anchor dependencies. The system fails and places the participant into an Error state, which prevents the site user from accessing the participant information.
|
MYVC-44798 |
|
Sponsor/CRO Staff | When sponsor/CRO staff perform a data change for an existing repeat section entry in a survey, the Question Completion Time column in the Survey Data Report updates to the time of the change. The report incorrectly replaces the original completion date and time with the date and time of the modification.
|
MYVC-44982 |
|
Site Staff | When site staff populate an end event before a start event for a survey schedule, the system does not create Missed surveys. This occurs for the days between the start and end dates.
|
MYVC-45710 |
|
MyVeeva Users, Site Staff | When a user completes the first part of a multi-part survey containing cross-question validations, the system incorrectly quarantines the survey. This prevents the user from accessing the second part of the survey.
|
MYVC-46217 |
|
Sponsor/CRO Staff | When sponsor/CRO staff configure FTP or SFTP export jobs for Free Draw files, the export always includes drawings from surveys with restricted data, even if the user does not have permission to access restricted data.
|
MYVC-47401 |
|
MyVeeva Users | When a survey rule checks for a Missed status or a specific survey score, the system fails to process the rule. This prevents the system from sending survey notifications to participants.
|
MYVC-47752 |
|
Site Staff | When site staff attempt to move a completed survey to a study event created in a newer study version, the system displays an error. The system fails to complete the move and the survey remains in its original location.
|
MYVC-47804 |
|
Site Staff | The Reinstate Survey option is disabled for surveys that have not reached their due date. Also, when surveys are expired, the Reinstate Survey option is displayed, but an error message is displayed when site staff attempt to select it.
|
MYVC-47869 |
|
Sponsor/CRO Staff | When a user replaces an image URL in a previously approved survey, the new image is not displayed after it is saved. When a user attempts to delete the old image, an error is displayed.
|
MYVC-47989 |
|
Site Staff | When site staff access the history view for a recently transcribed multi-part survey, the system displays the part that was transcribed as Missed.
|
MYVC-48097 |
|
Site Staff | When site staff transcribe a survey part that was previously Missed or Intentionally Left Blank, the past surveys view displays the transcribed responses in Version 1. Version 1 should display the original Missed or Intentionally Left Blank status.
|
MYVC-48245 |
|
Site Staff | When site staff perform a data change on a reinstated survey part, the history view shows the updated values in the previous version of the survey. This system does not display the data as it appeared during that submission.
|
MYVC-48246 |
|
MyVeeva Users, Site Staff | Survey data and compliance reports display different Survey Instance values for parts of the same parent survey. This affects multi-part surveys and composite surveys.
|
MYVC-48248 |
|
Sponsor/CRO Staff | When sites and sponsors are in different regions, the system fails to process survey data and Data Change Requests for site media. This prevents the data from being displayed in reports and Study Home.
|
MYVC-48272 |
|
MyVeeva Users | In diary surveys with exert navigation where a part has been completed and a later part has been Intentionally Left Blank, participants can access the Submit button for the later part.
|
MYVC-48274 |
|
Site Staff | When site staff attempt to open the Data Change Request option for a survey that does not have a language tag, the system displays an error. This also prevents the user from viewing the data change history.
|
MYVC-48315 |
|
Site Staff | When site staff access History of Changes for a composite survey, the system displays the same completion time for all survey parts. Transcribe and Reinstate actions may then overwrite timestamps on previous versions of the survey.
|
MYVC-48323 |
|
Site Staff, Sponsor/CRO Staff | Survey data and compliance reports display different Survey Instance values for parts of the same parent survey. This affects multi-part surveys and composite surveys.
|
MYVC-48365 |
|
Site Staff | When site staff open a composite survey from the event surveys list where all parts are Missed or Intentionally Left Blank, the Transcribe option is not available.
|
MYVC-48458 |
|
Site Staff | When site staff change data for multi-part surveys with conditional questions, they are allowed to proceed if they change an answer and then change it back to the original response.
|
MYVC-48460 |
|
Site Staff | Site staff cannot change the language on the Missed or Intentionally Left Blank screens when all parts of a survey are missed or marked as Intentionally Left Blank.
|
MYVC-48481 |
|
MyVeeva Users | When a participant attempts to submit a survey, the system sometimes failed to validate the data and held the submission in quarantine for additional investigation. This occurs because the system cannot correctly load the survey configuration required to validate the answers.
|
MYVC-48570 |
|
Sponsor/CRO Staff | When sponsor/CRO staff create, update, or delete outbound API credentials, the Studio and Study Home Audit Trail Reports do not display these actions. The system fails to pull these specific records from the audit database.
|
MYVC-48580 |
|
Sponsor/CRO Staff | The system displays 0 for the Previous Value in the audit trail for Data Change Submission Windows setting when changing from no window to a defined window.
|
MYVC-48729 |
|
Sponsor/CRO Staff | When viewing audit logs for data change requests, the system incorrectly displays an internal participant ID instead of the site-entered participant ID.
|
MYVC-48763 |
|
Site Staff | Rarely, site staff cannot access participant records when they are in an error state, even after upversioning the collection.
|
MYVC-48813 |
|
Sponsor/CRO Staff | When sponsor/CRO staff select an event and survey information in Study Preview, the information takes longer to load than expected and can sometimes crash.
|
MYVC-48886 |
|
Site Staff | When site staff submit a survey or perform a data change for a record with a missing device start time, the system displays an error and the user cannot complete the action.
|
MYVC-48902 |
|
MyVeeva Users | On Android devices, participants see survey sections that should be hidden when the block that controls them is also hidden. The system displays these sections even when the controlling block is not answered.
|
MYVC-48907 |
|
Site Staff | When site staff select Surveys to Review to view surveys that need signatures, the Past Surveys page retains filters applied during a previous visit to the page. This prevents the system from displaying only the surveys with a Signature Status of Needs Review.
|
MYVC-49121 |
|
Site Staff | When site staff access the Unscheduled Event list, survey names do not display the correct timepoint labels. The system displays the correct timepoint label in the survey name after site staff create the unscheduled event.
|
MYVC-49311 |
| Description |
Issue No. |
|
When using the Document SDK to get an unprocessed copy of a rendition, the rendition may incorrectly have metadata removal and page rotations applied.
|
DEV-1001386 |
|
In some cases, when uploading a corrupt Excel file, rendering fails without informing the user of the corruption.
|
DEV-1003555 |
|
In some circumstances, when using Download as PDF, related records may be displayed in the PDF as plain text links instead of clickable hyperlinks.
|
DEV-1003999 |
|
When updating the Base document type, the Bring Forward Annotations on Version Create setting incorrectly displays as updated in the System Audit History even if it has not changed.
|
DEV-1004470 |
|
In some cases, a server error may occur when users attempt to complete the Document Change Control Approval workflow task.
|
DEV-1009334 |
|
Tokens for custom document fields do not populate the value as expected on signature pages.
|
DEV-1010464 |
|
In some circumstances, rendition fails when bulk uploading documents with missing version information.
|
DEV-1011709 |
|
When an external user opens a document in the approved viewer, document thumbnails may be displayed even after access to the document has expired or has been cancelled.
|
DEV-1013230 |
|
Under some circumstances, merge fields in Excel files are not populated correctly.
|
DEV-1015573 |
|
After updating a Vault's linked File Staging, rendition reuse jobs may fail, causing users to be unable to import or export files.
|
DEV-1016633 |
|
In rare circumstances, when archiving or unarchiving a document with anchors, an error is displayed.
|
DEV-1016835 |
|
When using Bulk Upload Source Docs to upload protected PDFs, the rendition process hangs or fails.
|
DEV-1020199 |
|
Under some circumstances, OCR-extracted text displayed in the document viewer is different from the extracted text sent to Quick Check Agent.
|
DEV-1021051 |
|
Overlay text applied to PDF/A files is not always transparent as expected.
|
DEV-1022704 |
|
When creating a document, entering an invalid date, clicking Save, and then clicking Today to enter today's date, the Save button is disabled.
|
DEV-1023546 |
|
Under some circumstances, OCR does not extract text well in high resolution files with small text.
|
DEV-1023958 |
|
After OCR processing, some characters may be skipped when selecting or highlighting text in a viewable rendition.
|
DEV-1030486 |
|
When bulk classifying documents with missing required fields, an error is displayed and Classifying Documents loading icon remains displayed in the information panel.
|
DEV-1032842 |
|
In some cases, users may encounter an error when downloading a viewable rendition of a secured PDF with Allow download without Overlay enabled.
|
DEV-554972 |
|
In some cases, viewable renditions with an SVG source file may display with overlapping text.
|
DEV-803166 |
|
When document-level comment annotations are disabled in a document, the document viewer border is not displayed as expected.
|
DEV-816331 |
|
Vault does not populate Doctype components when creating migration packages, Vault Configuration reports, and Vault Comparison reports.
|
DEV-828875 |
|
Under certain circumstances, when generating formatted outputs, they may incorrectly use the System User's Locale rather than Vault Base Locale.
|
DEV-851583 |
|
Document Readiness Metrics records are not deleted for documents that are not the latest version.
|
DEV-853800 |
|
A generic server error is displayed when uploading a new version or checking in a document with a filename that is too long, instead of displaying an error message indicating that the filename is too long.
|
DEV-905327 |
|
Vault does not block referenced document types from deletion.
|
DEV-913230 |
|
Vault improperly renders Thai characters within Word documents set to Thai language.
|
DEV-915498 |
|
In some cases, when a Word document includes a document field token within a deleted version, the merge fields process fails and Vault does not render the document.
|
DEV-920611 |
|
Vault does not generate viewable renditions for .CSV files with ANSI encoding.
|
DEV-924747 |
|
If a user changes the PDF/A setting of a rendition profile after a document was already rendered, the downloaded viewable rendition only matches the new setting if there are overlays or eSignatures to apply, and the doc info panel matches the settings at the time of the last render.
|
DEV-929128 |
|
In some circumstances, controlled document templates are not updated to the latest steady state version of a document when the document enters the steady state.
|
DEV-930277 |
|
In some cases, deleted Document Types are still visible in the Document Check Section Document Type field.
|
DEV-931135 |
|
The page extraction value may be applied incorrectly to viewable renditions of signed and certified PDFs when the Post-Processing Support for PDFs with Security setting is enabled.
|
DEV-931139 |
|
The title text is misaligned on the Where Used view for documents.
|
DEV-933690 |
|
In some circumstances, an error is displayed when rotating an image file in the document viewer.
|
DEV-939149 |
|
When using Retrieve Document APIs, private instead of public keys may be returned for object reference field tokens for document types that use auto-naming.
|
DEV-943999 |
|
Under some circumstances, CrossLink documents display an error that a viewable rendition does not exist on the source document, even when the viewable rendition exists.
|
DEV-944427 |
|
After adding an attachment on a previous version of a document and viewing the attachment, the audit trail displays that the attachment was viewed on the latest version.
|
DEV-947572 |
|
Admins without permissions to create documents cannot view document classifications when creating field dependencies.
|
DEV-948735 |
|
In some cases, when clicking an annotation info card, the document viewer navigates to the correct location but the info card is not displayed inline with the placemark.
|
DEV-952697 |
|
Document and binder export fails for failed viewable renditions.
|
DEV-954148 |
|
Under certain circumstances, copying and pasting words from viewable renditions generated in Chrome may not work as expected.
|
DEV-954346 |
|
An error is displayed when saving a document and a read-only multivalue field on the document is being updated by another process.
|
DEV-954801 |
|
When a document page has a hidden annotation, users cannot move a visible annotations on that page to a page immediately before or after the hidden annotation.
|
DEV-955965 |
|
For certain Vaults, the File Security setting may not populate.
|
DEV-962972 |
|
A red outline is not displayed around the first blank required object reference field when creating a document.
|
DEV-967560 |
|
The Undo Checkout option is not available for HTML and TXT document formats.
|
DEV-968629 |
|
Vault incorrectly allows documents with invalid characters to be uploaded during document creation.
|
DEV-968853 |
|
After editing bookmarks on a PDF when PDF/A is enabled in the rendition profile, the re-rendered PDF is not PDF/A compliant.
|
DEV-971301 |
|
When the Create new documents as Planned setting is enabled, users are incorrectly able to create CrossLink documents in the Planned status with missing required fields.
|
DEV-971338 |
|
In some circumstances, barcodes are not generated correctly in viewable renditions, or the rendition fails.
|
DEV-974176 |
|
Documents uploaded before 25R3 that have PDFs with security as either the Manual Rendition or Source File may fail to download when overlays or signature pages are needed if Post-processing Support for PDFs with security is enabled on the Rendition Profile.
|
DEV-975800 |
|
Document fields corresponding to standard picklists may not render correctly on generated signature pages or overlays.
|
DEV-975822 |
|
Documents using a Rendition Profile with "Post Processing Support for PDFs with Security" disabled in Vaults that previously had "Allow Viewing and Annotations of Protected PDFs" enabled may not be able to save bookmark edits for manually uploaded renditions.
|
DEV-976365 |
|
Documents of PDFs with security uploaded before 25R3 in Vaults where "Allow Viewing and Annotation of Protected PDF files" was enabled may receive the source file upon download of the viewable rendition if "Post-processing Support for PDFs with security" is disabled on the Rendition Profile.
|
DEV-977959 |
|
Users recieve an unhelpful error message when uploding a PPT file where all slides are hidden.
|
DEV-978395 |
|
Under certain circumstances, PDF custom renditions may be unintentionally modified on download or fail to download entirely.
|
DEV-978589 |
|
Rendition download fails for files with a protected manual rendition uploaded before 21R1 with Allow Viewing and Annotation of Protected disabled and post processing required.
|
DEV-978655 |
|
Viewable renditions may not be generated for Excel files with filenames that start with two hyphens.
|
DEV-979900 |
|
After deleting a text annotation, its text highlight remains displayed in the document viewer.
|
DEV-980446 |
|
In some cases, incorrectly marked manual renditions from before 21R1 may be unintentionally replaced by a re-render when a user views the document or downloads the rendition.
|
DEV-981573 |
|
Users may receive an unexpected error when attempting to migrate documents using Vault loader.
|
DEV-981855 |
|
An extra binder template is incorrectly included in legacy compliance packages.
|
DEV-982888 |
|
In some circumstances, when uploading a document with merge field tokens, the default rendition profile is used instead of the assigned rendition profile.
|
DEV-983251 |
|
Overlapping subimages may cause duplicate or partial OCR results.
|
DEV-984000 |
|
Users are unable to download manual renditions uploaded before 21R1.
|
DEV-985679 |
|
Lifecycle status merge tokens in document headers may not be translated correctly in viewable renditions.
|
DEV-987286 |
|
Merge tokens in viewable renditions are displayed in the user language instead of the document language when multilingual document handling is enabled.
|
DEV-988939 |
|
When using the back breadcrumb from Step 2 to Step 1 while creating a document with a document reference constraint configured on an object field, the Choose Document Type field may become disabled.
|
DEV-993344 |
|
When changing the lifecycle state of a document with merge tokens, the document may be rendered using the default rendition profile instead of the assigned rendition profile.
|
DEV-994792 |
|
In some cases, clickable links may not work on downloaded renditions.
|
DEV-996115 |
|
When Post-Processing Support for PDFs with Security is enabled, some documents with PDF source files are re-rendered when they are first viewed.
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DEV-996748 |
| Description |
Issue No. |
|
In some circumstances, an error is displayed when running a Process View with picklist values selected for the Group By option.
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DEV-1003648 |
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In some circumstances, when exporting reports to Excel using the Data Only option, the Date column is too narrow to display the date results.
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DEV-1008283 |
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An error may be displayed when running a Process View for a document lifecycle that contains a lifecycle state with a name over 30 characters.
|
DEV-1012416 |
|
Object reference fields in Process View additional filters may cause runtime errors.
|
DEV-1014712 |
|
In some cases, filter and conditional fields may not return results for tabular, matrix, and workflow reports.
|
DEV-806831 |
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In some circumstances, when running a report with primary and down objects that uses a formula field with a cycle time calculation, an error is displayed.
|
DEV-828213 |
|
When creating an object with down object report with a formula field column, an error is displayed.
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DEV-920023 |
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The Create Report page is missing some Japanese translations.
|
DEV-927175 |
|
Results are not displayed in reports for formula fields that contain Created By, Last Modified By, and cycle time functions.
|
DEV-927810 |
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Vault displays a server error to users attempting to run a Document with Down Object matrix report that is also grouped by a hidden date field and includes previous document versions.
|
DEV-930668 |
|
The cycle time calculation may be incorrect in Process Monitor when the Start State is set to Last Time Entered and End State is set to First Time In.
|
DEV-930963 |
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An error is displayed when running a report that uses a "contains (insensitive)" operator on an attachment filename.
|
DEV-932092 |
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In some cases, a server error is displayed when viewing a report that uses conditional fields.
|
DEV-933086 |
|
Vault displays a server error to users attempting to run a report grouped by a hidden date field and which also contains a formula field with a cycle time calculation.
|
DEV-937530 |
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In some cases, when running a dashboard with a Multi-Pass report with "name IN" filters, the dashboard prompts you to enter the filter values twice.
|
DEV-937667 |
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After changing your device's timezone to a future timezone, when you select a Timeframe date in a Process View, the date reverts to the previous date.
|
DEV-937827 |
|
For document reports, Vault may display a different number of documents on the Perform Bulk Actions menu and the Refine Selection page when performing a bulk action.
|
DEV-938911 |
|
Reports with hidden fields may be incorrectly filtered when viewed by a Vault Owner.
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DEV-939307 |
|
The page navigation breadcrumb links in Process Monitor are not displayed after changing a Process View, attempting to leave the page without saving changes, and then saving the changes.
|
DEV-942390 |
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Incomplete variants may be displayed in the Variants panel in a Process View when using the Entered End State date.
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DEV-945653 |
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When clicking an unknown grouping on a dashboard component for a Document with Down Object Matrix report grouped on a hidden field, an error is displayed.
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DEV-945924 |
|
In some cases, flash report notifications are not sent to delegate users.
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DEV-952372 |
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An error is displayed when running a report where the primary object and down object have the same document reference fields and outbound relationship name.
|
DEV-952468 |
|
An error is displayed when attempting to delete a report that was referenced by a deleted dashboard.
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DEV-953576 |
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An error is displayed when running a Process View that has an additional filter of Lifecycle State is not equal to Closed.
|
DEV-955399 |
|
In some cases, the Formula Fields, Advanced Options, or Group Rows By sections may not be displayed when creating or editing a document report.
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DEV-956100 |
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The first row in a dashboard bar chart is displayed in a color that does not match the key.
|
DEV-956203 |
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In some circumstances, additional filters may not display as successfully added after changing the process in a Process View.
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DEV-956848 |
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In some cases, if a user's Language is different from their Locale, the Schedule Flash Report dialog may display incorrect translations for field labels.
|
DEV-957355 |
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When running a report that uses a "contains (insensitive)" operator, a generic error message is displayed.
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DEV-957861 |
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When a user without field-level security accesses a flash report ran as a user with field-level security hiding a field on the report, an error is displayed.
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DEV-958638 |
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Users receive a server error when attempting to run a report that includes a formula field with "Concat(PreviousState(documents.status__v), documents.doc_state_type__v)" in the columns.
|
DEV-964831 |
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Using an Object Reference or Attachment field and CycleTime functions in the same formula does not work as expected.
|
DEV-965386 |
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In some cases, when users filter a Document report by multiple document statuses, the filter may return only documents with one of the selected statuses.
|
DEV-967777 |
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In some cases, reports containing both an object reference and a document reference with identical names cause timeouts and performance issues.
|
DEV-969923 |
|
Users may encounter a server error when running a document with up object report that contains a formula field on an attachment field.
|
DEV-972263 |
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Under some circumstances, an error is displayed when running matrix reports that contain columns for cycle time formula fields.
|
DEV-972532 |
|
Users may encounter a generic error message when attempting to delete a report that references a locked object.
|
DEV-975473 |
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An error is displayed when using the MDL RECREATE command on a Process View with an object reference field filter.
|
DEV-976237 |
|
In some cases, the variant frequency for the "Others" variants may appear to be negative in the "Variants by Frequency" panel in Process Monitor. This is a rounding error. The true value will be very close to 0.
|
DEV-977484 |
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In non-English language Vaults, an error is displayed when using "Is in the last" and "Is in the next" timeframe filters in a Process View.
|
DEV-977487 |
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When Vault's base language is set to a non-English language and the user's language does not match Vault's language, state labels are missing from the Process Graph tab in Process Monitor.
|
DEV-977488 |
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After updating the name of a picklist value or lifecycle state, the Filter dialog in a Process View displays the previous name.
|
DEV-977897 |
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An error is not displayed as expected when using the MDL RECREATE command on an invalid value in a Process View.
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DEV-979740 |
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In some cases, users may encounter a server error if they add fields from the down object to the first level of grouping in a report.
|
DEV-980473 |
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In some cases, Vault Owners may encounter a server error when attempting to open a flash report.
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DEV-980521 |
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In some cases, when users click Add field to group by (optional), Vault directs them to the Home page.
|
DEV-987305 |
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An error is displayed when running a Process View that includes records missing a new lifecycle state value.
|
DEV-988832 |
|
Some dates may be incorrect on the Cycle Time Trend chart in a Process View when using "is after" or "is in the last" Timeframe filters.
|
DEV-990600 |
|
Some translations are missing from Process Monitor, including Fit in the zoom dropdown, filters in list view, and months in charts.
|
DEV-994950 |
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Under certain circumstances, dashboard drilldowns may not function as expected.
|
DEV-998911 |
|
When adding a chart to a Process View using MDL, the chart name is blank in the UI.
|
DEV-999189 |
| Description |
Issue No. |
|
Training automation does not populate the Creation Context field, resulting in workflow errors that use field conditions to automatically close TRIA records.
|
DEV-1000296 |
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In some cases, Learners cannot view a Classroom Training Assignment with a substitute. Instead, Vault displays a server error.
|
DEV-1000301 |
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In some cases, Field Corrective Action jobs do not complete, potentially causing performance issues and failing to create the expected records.
|
DEV-1000616 |
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Users may encounter inconsistency between the formatting of different Date and DateTime values on the Document Control Homepage.
|
DEV-1003411 |
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In some cases, an unexpected error occurs when users transition a document to an Effective or In Review state.
|
DEV-1007590 |
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A server error occurs when users attempt to transition a Document Change Control to the Training Requirement Impact Assessment state when multiple versions of a document are a referenced by the same Document Change Control.
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DEV-1010417 |
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Object reference fields configured to display in the Record History section show the referenced record's ID instead of its Name.
|
DEV-1010738 |
|
Vault may fail to correctly show documents with system-managed relationships in the Quality Relationships panel.
|
DEV-1013414 |
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In some cases, Learners cannot scroll the full list of Referenced Materials (Supplemental Materials) on the Training Assignment task page.
|
DEV-1014670 |
|
Vault fails to generate a document from a workflow job step when a field on the originating object record has the same name but different data type as a required field on the target document.
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DEV-1015877 |
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Frequently used actions display above the HACCP Flow Diagram, including actions that should not be visible from the diagram.
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DEV-1017104 |
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In some cases, users experience an error when adding columns to sections on the Document Control Homepage.
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DEV-1018150 |
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Under certain circumstances, users may experience a server error after moving a Document Change Control record to the In Document Impact Assessment state.
|
DEV-1020633 |
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In rare cases, Vault displays a server error after users perform the Reassign External Collaborators action.
|
DEV-1021580 |
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Vault incorrectly displays system-managed document relationships to users in the Quality Relationships panel.
|
DEV-1022499 |
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While creating document association criteria for a Quality Process, users cannot select values for the Document Package field.
|
DEV-1029523 |
|
In some cases, users may experience degraded performance after applying filters to the Document Control Homepage.
|
DEV-1029750 |
|
Vault produces an unexpected error and does not load the Curriculum Sequencing Rule Builder page for some users.
|
DEV-1029945 |
|
Vault may fail to display translated text in the Quality Relationships panel.
|
DEV-793799 |
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Process Navigator may fail to display a steady state document that was dynamically associated if the document was up-versioned to a non-steady state.
|
DEV-870047 |
|
In Veeva Batch Release, the Add Disposition job may incorrectly fail if the triggering user does not have view permissions to the affected document.
|
DEV-871132 |
|
When an existing Related Record Configuration includes an inactive object for included reference records, users receive a generic unexpected error when attempting to update and save the configuration.
|
DEV-886429 |
|
In some cases, Vault generates validation errors for EU MIR 1.3.4d-l but does not display the validation error icon for that field.
|
DEV-887382 |
|
When returning quiz results for a large quiz (e.g., three sections with 50 questions each), Vault displays a server error and does not present the Results section.
|
DEV-900713 |
|
Vault displays a server error when users search using the "and," "with," or "or" keywords in the Validation Reference Instruction Prompts section or the Requirements Burndown View.
|
DEV-928417 |
|
After you upgrade Vault Product Surveillance to use EU MIR 7.3.1, text in Adverse Event Reports may appear distorted or squished.
|
DEV-928890 |
|
Under certain circumstances, Vault displays a server error when the "Start checklist" action runs.
|
DEV-931245 |
|
In some cases, Inspection Requests in the Audit Room display in the incorrect lifecycle state.
|
DEV-932078 |
|
The Copy FMEA Risk Assessment user action fails when the obsolete Mitigation Action Set field on the Assessment Risk object has the "Do not copy this field in Copy Record" attribute enabled.
|
DEV-934599 |
|
Vault may fail to remove links to a Document Change Control record from a document after users delete the related Change Authorization record.
|
DEV-934647 |
|
Under certain circumstances, users experience an error when changing the state of a Change Authorization record to Rejected if they deleted the target document.
|
DEV-935147 |
|
When deploying a configuration migration VPK package, in some cases an unexpected Object Type Field error displays in the deployment log.
|
DEV-936623 |
|
Users are able to scan and select more than 100 records on the Controlled Copies for Reconciliation page. The system only supports selection of less than 100 records on this page.
|
DEV-939291 |
|
In some cases, users are unable to start workflows from the Controlled Copies for Reconciliation page if they select 100 records.
|
DEV-939299 |
|
When a user attempts to change the state of a record that does not meet the entry criteria for Quality Team membership, the resulting error message displays the incorrect state.
|
DEV-939699 |
|
In some cases, fields removed from the Target section of the Fields for Document Association Criteria on Visual Hierarchy Configurations are still visible.
|
DEV-940712 |
|
Vault may fail to correctly apply datetime filters on the Controlled Copies for Reconciliation page.
|
DEV-941238 |
|
Users cannot delete records from the Related Events section of a record if they do not have Read permission for the Reciprocal Link Id field on the Related Event object.
|
DEV-950465 |
|
Vault fails to display the Generate Record Suggestions user action lightbulb icon on Quality Event and Noncomformance objects.
|
DEV-950763 |
|
When the Promote to Complaint action executes, in some cases, Vault does not copy custom fields from the Complaint Intake to the Complaint.
|
DEV-951216 |
|
When using the Root Cause Analysis Tool, if multiple Why cards with the Root Cause field set to Yes are in edit mode, Rich Text fields may display as a text box.
|
DEV-954548 |
|
Users may experience an error after attempting to save a Visual Hierarchy Configuration with missing required fields.
|
DEV-961130 |
|
Vault displays an error when users attempt to add a filter that includes a decimal number to the Document Control Homepage.
|
DEV-965752 |
|
In some cases, the Document Control Homepage displays unrelated workflow envelopes after users apply the Period Review Workflow filter.
|
DEV-965760 |
|
In some cases, the Associated Documents panel in Process Navigator is cut off.
|
DEV-966105 |
|
Learners without permission to view custom Session object fields receive an Unexpected Error when attempting to add the session to their calendar.
|
DEV-966592 |
|
After executing the Promote to Complaint action, .msg attachments on the Complaint that were copied from the Complaint Intake do not render when opened.
|
DEV-968100 |
|
In some cases, when removing Quality Team assignments via the Manage Invalid Team Members dialog, Vault displays a server error.
|
DEV-970314 |
|
After you upgrade Vault Product Surveillance to use EU MIR 7.3.1, Adverse Event Reports may fail with an XSD validation error.
|
DEV-971378 |
|
Quality Record Checks may return incorrect record matches if their configuration's related object match criteria use VQL Criteria.
|
DEV-971431 |
|
In some cases, Vault displays a server error when users attempt to navigate to a Reason for Change record.
|
DEV-972831 |
|
When using the Document Change Control -Training Requirement Impact Assessment feature, users are unable to complete Document Change Control upversions that are linked to Training Requirement Impact Assessment referencing older minor versions of documents.
|
DEV-976615 |
|
When users attempt to create a Recognized Contact record, the Create Contact dialog is blank.
|
DEV-977500 |
|
Vault may display a blank page after users edit or remove filter criteria in the Document Association Criteria dialog.
|
DEV-977599 |
|
When opening a Dry Run Test Script on the Test Execution app page, the app page may crash in cases where the Post-Approval Comment object type is inactive.
|
DEV-977904 |
|
Training Admins may be unable to publish classes where there are learners that are not Vault users.
|
DEV-978144 |
|
Vault fails to display an error when users create criteria rules on hidden document fields.
|
DEV-978389 |
|
Under certain circumstances, users are unable to use barcode scanners to add Batches into Quality.
|
DEV-979115 |
|
In some cases, the system may store incorrect data in the Matching Search Terms field of Record Check Result object records, leading usersto believe their overrides were not applied to the executed Record Check.
|
DEV-979571 |
|
Users may receive an error when attempting to open a Root Cause Analysis.
|
DEV-981314 |
|
Users are unable to see Record Check Result record detail pages in specific cases where they have added the match criteria control to the page's layout and have changed the Quality Record Check's date comparison field from Date to DateTime or vice versa.
|
DEV-981361 |
|
In some cases, the Recurrences tab on the Recurrence Check Insights page not only shows confirmed recurring records, but any similar record shown in the Recurrence Check that was not given an Unrelated verdict.
|
DEV-982897 |
|
Vault does not correctly filter Assessment Risks in the Risk Builder when filtering by a Risk Response (risk_response__v) value of Mitigate.
|
DEV-983051 |
|
Dates on the Document Control Homepage are displayed in inconsistent formats and do not follow Vault locale.
|
DEV-983754 |
|
Users receive an error when attempting to filter the My Learning page by a custom Training Assignment picklist field.
|
DEV-987394 |
|
In Vaults with TRIA Creation Setting: Always Implement Latest Trainable State enabled, users may encounter an error when running the Issue Training Assignments entry action on a Document that is part of two different TRIA records' Reviewed Content Sets with a different version on each.
|
DEV-988124 |
|
When performing a recurrence check for a record with an inactive picklist value selected, in some cases, the Run Record Check dialog does not load.
|
DEV-990330 |
|
When using keyboard shortcuts to navigate the Risk Builder, users cannot scroll a selected cell out of view.
|
DEV-990776 |
|
Under certain rare circumstances, Change Control records using an Action Path may cycle continuously between lifecycle states, resulting in a high volume of audit trail entries.
|
DEV-994688 |
|
Users with a long Justification field value for a Batch Disposition Check are unable to see the full text when viewing the Batch Release App Page. Additionally, if the value is multiline, the lines are formatted incorrectly.
|
DEV-996040 |
|
In some Vaults, the APQR object unexpectedly has a proposed_apqr__qdm field. This can result in blocked deployment of Vault migration packages (VPKs).
|
DEV-999154 |
| Description |
Issue No. |
|
Rule JP-eCTD4-100 fails when suspending Context of Use in 4.0 Submission.
|
DEV-1001262 |
|
When submissions are imported out of order and the latter submission has a suspended Context of Use, the Submissions Archive Harmonization job is able to resolve the suspension however the Application Hierarchy Path under the new parent does not follow its new parent's path.
|
DEV-1001332 |
|
WHO Rule F.19 generates errors related to the folder path and file names when users attempt to generate a submission.
|
DEV-1002816 |
|
In certain circumstances, Extended Metadata records are created when the Related Change Type value is blank.
|
DEV-1003253 |
|
Users may receive a 1255 validation error when the file extension is .json.
|
DEV-1003262 |
|
With WHO eCTD v3.2, the validation criteria for Rule F.06 checks that the prefix is separated from the substance name with a hyphen instead of a space.
|
DEV-1003369 |
|
When creating FHIR messages in bulk, the confirmation page indicates that Vault will update the Provenance reason (instead of the Operation Type) on the related IDMP PDS records.
|
DEV-1004088 |
|
In Set document metadata update dialog, the Content Plan that contains Content Plan Items has additional options that are not needed.
|
DEV-1004504 |
|
When a Content Plan Viewer user updates the Expected Document Count inline or in match document mode, Vault does not respect atomic security for the Split CPI and Change State to Draft suggested actions.
|
DEV-1005994 |
|
In certain cases, the Create Related Records wizard incorrectly skips Inactive Ingredient records with related Inactive Ingredient records that do not have the Special Record Classification field populated.
|
DEV-1007869 |
|
In some cases invalid tokens are displayed on Active Dossier Templates.
|
DEV-1008030 |
|
Users may receive false positives on validation rules CA B22, AU 6.13, CN 6.11, and ECOWAS 6.3.3.
|
DEV-1008728 |
|
When a user clicks the Where Used in Archive link on a Submissions Archive document associated with an eCTD 4.0 Group Title Keyword, the Submissions Archive Viewer may enter a continuous loading state and fail to expand the corresponding section in the Submissions Archive hierarchical structure.
|
DEV-1009450 |
|
When a Content Plan Viewer user updates a Content Plan Item's Expected Steady State Count to be less than or equal to the All Document Count, then launches match document mode, the match document mode user interface skips the Content Plan Item.
|
DEV-1010476 |
|
Users cannot use the existing action to launch Match Document Mode when the enhanced action for this feature is not configured on the Content Plan Item lifecycle.
|
DEV-1011194 |
|
Manage Registered Details wizard users can experience extremely slow UI response times when working with a large number of records.
|
DEV-1011350 |
|
When generating UDI-DI Container Package submissions, Vault sets the <e:version> XML element as 1 (instead of 0) for initial submissions.
|
DEV-1011662 |
|
The Referenced Document ID is not updated when inactivating the Content Plan Item continuously.
|
DEV-1012678 |
|
The CN regional XML received validation criteria version 1.1 instead of 1.0 after inactivating 1.1.
|
DEV-1013022 |
|
The Submissions Archive Viewer displays raw Japan PMDA Health Authority code values (e.g., jp_adam_20250328) instead of user-friendly labels in the Grid and Keyword hovercards.
|
DEV-1013547 |
|
In some cases, the source file path fails for Japan eCTD 4.0 submissions.
|
DEV-1016140 |
|
Due to a translation error in the validation criteria, Rule 4.3.11 may report false positives.
|
DEV-1017062 |
|
The Content Plan Viewer's match document mode does not display filters for custom text fields configured within the Content Plan Matching Field picklist.
|
DEV-1017308 |
|
In some cases, the Harmonization Job incorrectly deletes documents.
|
DEV-1017665 |
|
Content Plan Viewer users cannot load match document mode when a Content Plan Item's name includes special characters.
|
DEV-1023517 |
|
Under certain circumstances, Rule 4.2.1 may report false positives for valid Drug Substance Applications.
|
DEV-1024582 |
|
When the Organization object's Organization Type contains multiple values, Vault incorrectly flags this as an invalid source data configuration during IDMP record generation. ("The organization referenced on the medicinal product must be type pharmacovigilance master file location.")
|
DEV-1024715 |
|
In some cases, the Submissions Archive Harmonization job does not resolve eCTD placeholder files.
|
DEV-1026493 |
|
In some cases, Vault displays a "This content plan is being processed by the system" error to users attempting to access the Content Plan hierarchy viewer.
|
DEV-1027743 |
|
The previous user exception message remains active even after a new user exception message is created.
|
DEV-711715 |
|
When the document has a required field set on RIM vault, crosslinks are not created on RIM and get UEM "Missing required parameter" as expected but the crosslink post processing job shows success and the submission stuck in Planned state.
|
DEV-729013 |
|
When the root Content Plan is deleted or the user has permissions revoked from another tab, a server error banner occurs when an action refreshes the grid.
|
DEV-853269 |
|
When Content Plan Viewer users in-line edit a rich text field and attempt to change or remove a hyperlink, the rich text editor closes and does not change or remove the link.
|
DEV-856125 |
|
In some caes, Asynce MDN is not sent to the Health Authority or partner.
|
DEV-907761 |
|
The Hierarchy Lifecycle state change is blocked by failed Report Level Content Plan tasks.
|
DEV-912845 |
|
Vault displays a Server having problems error when a user populates and then clears the Lifecycle State field within a Registered Product.
|
DEV-914241 |
|
The Show in Tab button in the Activities dialog opens a standalone page without an event filter.
|
DEV-919035 |
|
Page numbers are not resolved after runing on-demand publishing on Content Plan Item merge.
|
DEV-927270 |
|
The generate Table of Contents job may fail because the missing Page Numbering configuration doesn't have the failure notification.
|
DEV-928226 |
|
Duplicate Health Authority Commitment records display in the panel.
|
DEV-928227 |
|
In some cases the Latest for Authoring lookbehind logic does not match PD metadata.
|
DEV-928393 |
|
PDF Merge requests for PDF/A documents may fail if the filename contains special characters.
|
DEV-928463 |
|
Publishing fails with an internal error when the regional XML Published Output Location is empty for EU region.
|
DEV-928656 |
|
Users receive an error when running the bulk edit document action but no permission to root content plan.
|
DEV-928846 |
|
Using tab button to shift focus between column filters causes misalignment of Content Plan Viewer columns.
|
DEV-929920 |
|
When a mandatory field is missing, the Content Plan Preparation/Creation Job shows success but the content plan is not created.
|
DEV-930030 |
|
The data grid is not refreshed upon closing the error dialog due to no primary submission populated on the root Global Content Plan.
|
DEV-930886 |
|
In some casesm the JP eCTD3.2 Set Leaf Auto-Expand does not expand to a Content Plan Item after the leaf has been set and saved.
|
DEV-931184 |
|
In some cases the Health Authority Response document is not created if the originating and response applications are different.
|
DEV-931549 |
|
In some cases, eCTD 4.0 JP 1.6 Validation takes longer than expected.
|
DEV-933101 |
|
Rules CN6.26, 5005, and 5020 incorrectly change from "Fail" to "Not Executed" after continuous publishing.
|
DEV-933663 |
|
Users receive a console error when navigating to the record detail page from Content Plan Viewer when there is one breadcrumb.
|
DEV-934284 |
|
The leaf hovercard is missing the key icon for Non-Clinical study and missing label and display name for Container code, group title, facility, component, and descriptor.
|
DEV-934346 |
|
In some cases, CrossLinks are not matched to Content Plan Items after being recreated using the Revise and Resubmit action.
|
DEV-935609 |
|
Content Plan Items may not display auto-matched documents in the correct order.
|
DEV-936661 |
|
In some cases, the Create Related Records wizard does not replace records with defaulted fields.
|
DEV-936922 |
|
When running on demand publishing and validation, the submission level rules are run twice.
|
DEV-937341 |
|
Return bookmarks were not created in non-merged Content Plan Items after the 1st time running Section Level Merge.
|
DEV-937883 |
|
RIM Publishing dependency on Submissions and Submissions Archive is broken in Vault Management Console.
|
DEV-938360 |
|
The Set Leaf Operation menu does not expand when performing the action from a Content Plan Item with replace Operation.
|
DEV-938633 |
|
Vault fails to create return bookmarks when users continuously baseline TOC Content Plan Items.
|
DEV-939256 |
|
Page numbers are not resolved after updating the Publishing Output Location of the Table of Contents continuously.
|
DEV-939259 |
|
When hovering over a keyword icon, the hovercard displays the correct keyword display name and keyword code, but it displays incorrect submission and sequence ID.
|
DEV-939349 |
|
When a Submissions Archive Viewer user edits or rearranges columns then reloads the page, the Submission ID no longer appears in the leaf operation.
|
DEV-939991 |
|
When committing updates without a preview, the results files for the Create Related Records and Update Local Regulatory Information wizards display "Not Applicable" for the Parent Record ID of Labeling Concepts.
|
DEV-942725 |
|
The breadcrumb should not be displayed on the Health Authority Response guided flow.
|
DEV-944255 |
|
For some Applications, the Application UUID field is not populated with any value.
|
DEV-945137 |
|
Auto Return Bookmarks are created for the root table of contents even if the root table of contents was published as placeholder.
|
DEV-946756 |
|
The RIM-Clinical Operations Connection queries inactive field rules, generating false UEMs.
|
DEV-952521 |
|
In some cases, when a Submission Viewer user adds Clinical Site columns for Module 4 in the application view, the viewer does not populate the column values as expected.
|
DEV-952593 |
|
The Submissions Archive Viewer inconsistently displays updated document titles across the Submission structure and hovercard.
|
DEV-958592 |
|
Scheduled Data Export jobs may fail when they are interrupted by maintenance releases.
|
DEV-959330 |
|
When using the Extract Active Dossier Relationships bulk action on an application(s) that has over 5,000 records, extraction may take longer than expected to complete.
|
DEV-959894 |
|
Document cell selections are lost when a user encounters a non editable cell during page scroll.
|
DEV-962474 |
|
Under certain circumstances, users may encounter false negatives for AU 6.6.
|
DEV-963676 |
|
The Registration Verification, Create and Manage Event Details, Assess Local Activities, and Split Activities Registrations wizards do not apply updates to Yes/No fields configured as a checkbox.
|
DEV-964005 |
|
Manage Registered Details wizard users without Edit permission for the Registration object are able to update the Lifecycle State field via inline editing.
|
DEV-965954 |
|
The Create Related Record wizard does not create Activity Dependency records when multiple values are selected for the Event's Applicable Product Type field.
|
DEV-966018 |
|
In some cases, Vault extracts inactive Active Dossier Item Detail records via the Extract Active Dossier Relationships action.
|
DEV-966316 |
|
Clicking the Hide Inactive button causes a server error banner when the inactive Content Plan has an active child record.
|
DEV-966546 |
|
When an import includes multiple index.xml files at different levels of submission, Vault does not recognize regional XML and imports fail at pre-validation.
|
DEV-967238 |
|
In some cases, the Source relationship is not created within a document after a submission is imported.
|
DEV-967318 |
|
In some cases, users receive a 4.8.1 False Positive for Singapore eCTD 1.0.
|
DEV-967658 |
|
5200 errors are showing as broken hyperlinks, but when viewed in Archive Viewer the document is opening up.
|
DEV-970426 |
|
In some cases, dispatch Global Content Plan fails without sending a notification when the user does not have read permission to the target Country record.
|
DEV-970429 |
|
Users may receive a false positive for AU 6.19.
|
DEV-971206 |
|
Users without the necessary permissions to edit the lifecycle states of Registrations and related Registration Details can update the state through the Manage Registered Details Wizard.
|
DEV-971679 |
|
In some cases, continuous publishing does not update published documents.
|
DEV-972115 |
|
Users receive a server error when trying to perform a bulk action on the Content Plan Viewer when a static filter with no value is applied.
|
DEV-972148 |
|
In some cases the messaging in the Dispatch Summary/notification is inconsistent with the Dispatch Status.
|
DEV-973573 |
|
In some cases, users may be unable to generate IDMP Pack Size Elements automatically.
|
DEV-973637 |
|
In some cases, Vault falsely reports a configuration error for Authorised Pharmaceutical Forms when generating IDMP elements.
|
DEV-975052 |
|
When executing the Drag and Drop action to copy M5 section into the target content plan, users receive a record limit error.
|
DEV-976603 |
|
In some cases, users receive a false negative for US rule 1362.
|
DEV-978635 |
|
Users receive a Network Error when attempting to use the Test Connection button on the EUDAMED Gateway Profile.
|
DEV-978904 |
|
Users may receive false positives on CA Rule G06 in cases where the Manufacturer Code is not present for 2.3.p and 3.2.p
|
DEV-978977 |
|
When using the Review and Refine Related Records feature, the system may not correctly save changes that are confirmed, which may lead to the creation of records that were actually deselected.
|
DEV-979080 |
|
Users may receive a false positive for AU rule 4.3.2.
|
DEV-979118 |
|
The priority number on the 4.0 leaf is set as 0 on suspending a 3.2 submission.
|
DEV-979163 |
|
The Context of Use block for CPI2 is missing in SU XML but the document is published and displayed in Binder.
|
DEV-979630 |
|
In RIM Publishing, the Download Certificates button in a gateway profile may not function as expected.
|
DEV-980854 |
|
When a user runs the Export Excel Tree with All Descendants, and part of it is incomplete on the Content Plan.
|
DEV-981290 |
|
Users may receive a false positive for EU 11.10.
|
DEV-981600 |
|
After dragging and dropping to an inactive Content Plan Item, the user interface fails to refresh and a grey overlay persists.
|
DEV-982000 |
|
Document grid columns are not loaded based on default columns when navigating between Content Plan Items having different default filters in Match Document Mode.
|
DEV-982004 |
|
When continuous publishing is not enabled and on-demand publishing is triggered, Vault publishes reference leaf matched documents.
|
DEV-982012 |
|
In cases where there are multiple Content Plan Items with the same matched document locked to different versions with a merge Content Plan Item and a Table of Contents present, publication may fail.
|
DEV-982720 |
|
In some cases, XML species keywords are chosen randomly when multiple species exist.
|
DEV-983410 |
|
In some cases, when creating two or more Event details in advanced mode with different primary field values, the Create and Manage Event Details wizard adds the second record's primary field value to the first.
|
DEV-983758 |
|
The document field filter shows in Match Document Mode after refreshing the browser tab when the user no longer has permission to the document field.
|
DEV-984820 |
|
Vault does not populate previously-selected leafs in the Set Leaf dialog when the dialog is closed then re-opened for eCTD 4.0 Content Plan Items.
|
DEV-984983 |
|
Users may encounter a blank page when attempting to navigate to another CPI in the navigation pane after selecting a link in the linking pane.
|
DEV-985012 |
|
Vault does not update Priority Numbers during continuous publishing of eCTD submissions.
|
DEV-985057 |
|
The XML Operation incorrectly changes from 'REPLACE' to 'NEW' On Submission Metadata object, when the eCTD4 modified files is empty.
|
DEV-986767 |
|
In some cases, Active Dossier tasks may become stuck and expire without informing the user.
|
DEV-987123 |
|
When testing against the EUDAMED playground server, users may observe that related UDI Submission Errors objects cannot be created and there are warnings in their notifications.
|
DEV-987143 |
|
Submission Publishing may fail in Publishing Progress Indicator during prevalidation due to missing XML Element Name.
|
DEV-987338 |
|
When the eCTD4 Modified File path is empty for delete Content Plan Item and other Content Plan Items have a valid target for replace then the rule fails with an Internal Error.
|
DEV-990164 |
|
In the Select Leaf Operation the Content Plan that contains CPI has extra options "Cumulative view" and "Sorts options" which are not needed.
|
DEV-990655 |
|
The Submissions Archive Harmonization Job fails with errors encountered status when importing submissions with all keywords out of order.
|
DEV-992201 |
|
An extra attribute for the stylesheet element in the regional.xml header displays for Taiwan submissions.
|
DEV-992257 |
|
When dispatching a Global Content Plan to an an activity that doesn't have the Related Submission populated, Vault displays a server error.
|
DEV-992606 |
|
When creating a Document Set from a template, the Create from Template dialog footer displays outside the dialog window.
|
DEV-993124 |
|
Vault launches the Manage Registered Details wizard with empty rows on the Update Registered Drug Product Details page when a Registration or Regulatory Objective relationship object does not include RIM Object Configurations.
|
DEV-995251 |
|
When importing an eCTD 4.0 submission via FTP, the resulting confirmation email does not include XML leaf checksum warnings.
|
DEV-996244 |
|
Under certain circumstances, when publishing eCTD submissions, the XML Species field value on a Submission Nonclinical Study does not match its value on an Application Nonclinical Study.
|
DEV-998914 |
|
When eCTD 4.0 submissions are imported out of order, the Submissions Archive Viewer mini-browser displays incorrect values for the Archive Sections and Submissions Archive Document Sections fields.
|
DEV-999864 |
| Description |
Issue No. |
|
During follow-up promotion for a domestic Case for Japan, if the combined names of a Product Registration and Case Adverse Event exceeds 128 characters, an error occurs when Vault attempts to generate the name of the related Localized Case Assessment.
|
SAF-100556 |
|
In Vaults configured to isolate blinded clinical trial information, after adding an unblinded Case Product to an unblinded Case, Vault does not populate the Blinded Reference on the associated Localized Case Product or Localized Case Product Indication.
|
SAF-64696 |
|
After promoting an Inbox Item with an Adverse Event with Onset and Cessation field values, the Inbox Item to Case Compare page incorrectly indicates the event was modified if the Duration (Status) field is not included on the page's layout.
|
SAF-70044 |
|
When bulk unblinding or running the Create Follow Up Case action, for unblinded Case Products, the audit trail shows that Vault runs entry actions twice to set the lifecycle state on the new Case.
|
SAF-76832 |
|
After auto-promoting Inbox Items to follow-up Cases using the Override merge method, the Follow-Up Summary on narratives generated using rules based narratives includes unnecessary statements about data on the previous Case version.
|
SAF-79322 |
|
In some cases, Signal encounters an error when executing a Signal Calculation Run with an Empirical Bayes Geometric Mean (EBGM) calculation and fails to run the calculation.
|
SAF-79543 |
|
After running the Calculate Japan Reportability action on a Japan Localized Case with a nullified Transmission, Vault changes the Reason on the Transmission from Nullification to Follow-Up.
|
SAF-84452 |
|
In some cases when running the Create Statistical Data action on a Signal Calculation Run, Signal fails to complete the action.
|
SAF-84763 |
|
If users run the Create Follow Up Case action to create a follow-up to a Case with blind protection, Vault does not apply blind protection nor append [Blind Protected] to domestic localized narratives.
|
SAF-85759 |
|
The Do not copy this field in Copy Record option on the Alias Type field of the Product Alias object is set to false.
|
SAF-85854 |
|
When users run the Generate Assessments action to regenerate previously deleted Case Assessment Results on a global Case, Vault does not regenerate Localized Case Assessment Results on the related Localized Case, and then during the one-time sync from the global Case to the Localized Case after follow-up Transmission generation, Vault displays an error and prevents Case approval.
|
SAF-86108 |
|
In some cases when running a DSUR or PBRER Workbench Report that contains a Case without a Study Type field value, Workbench includes unexpected Cases in the report.
|
SAF-86647 |
|
Case Processing users without Read permissions for Inbox Items can promote to Inbox Items to Cases through the Vault API.
|
SAF-86825 |
|
When processing domestic Cases for Spain or Italy, users without Edit access to the State/Province field on Localized Case Contact records cannot edit the equivalent global Case field.
|
SAF-86875 |
|
In some cases, Online Safety Forms throw an error when a respondent inputs a value containing multiple comma-separated items in the Previously Reported Reference Number(s) field.
|
SAF-86906 |
|
If a user resizes component columns widths on a Workbench Dashboard, after switching dashboard tabs, column widths reset.
|
SAF-87064 |
|
In some cases when validating FDA E2B(R3) files, Validation Criteria pass for the FDA.G.k.9.i.2.r.3 and FDA.G.k.12.r.11.r data elements when they should fail.
|
SAF-87123 |
|
On localized Inbox Items, if users page forward in the Medical Events section and then page backwards, Medical Events headers appear in English instead of the local language.
|
SAF-87290 |
|
In some cases, upon creating a Submission reportable to the MFDS on a global follow-up Case that contains an External Product coded using the WHODrug Search browser, Vault clears the Local MPID field on the corresponding Localized Case Product and/or Localized Case Drug History.
|
SAF-87309 |
|
When Admins add custom Long Text fields to the Case Compare Followup page, users may experience an error when loading the page.
|
SAF-87385 |
|
If the Generate Local Reporting Details action cannot run due to duplicate Destination Case IDs on existing Local Reporting Details records, Vault does not display a clear message about how to fix the issue.
|
SAF-87921 |
|
If Vault cannot generate Transmission documents due to unsupported characters in the narrative, Vault does not display a clear error message about how to fix the issue.
|
SAF-88253 |
|
When promoting an Inbox Item to a Case, the Receipt Date field label does not appear in the comparison table on the enhanced Potential Matches page.
|
SAF-88377 |
|
On viewable renditions of E2B(R2) files, the tag for the B.5 section does not appear.
|
SAF-88412 |
|
In Vaults configured for strict Case locking, if a lifecycle state change fails during promotion, Vault does not populate the System Alerts field in the Details section of the Case.
|
SAF-88413 |
|
When sorting on a Workbench Dashboard Component does not change the data displayed, the dashboard remains in a loading state.
|
SAF-88418 |
|
For Workbench Dashboards, after triggering the Export to CSV or Generate and Run Report action, Vault times out and fails to create a CSV file or to create a CSV and Excel file, respectively.
|
SAF-88422 |
|
After running the Create Follow Up Case action on a global Case, Vault does not map region-specific field values from the previous Localized Case version to the follow-up foreign Localized Case.
|
SAF-88767 |
|
When a user runs the Submit to Gateway action immediately after the Generate Transmission Document action, in some instances, Transmissions remain in the Sending ICSR state.
|
SAF-88891 |
|
EMA E2B(R3) files generated through the Async Submit to Gateway action do not include the H.5.r section.
|
SAF-88902 |
|
When a user creates a follow-up Case, if they don't have permissions for the Localization on a related Localized Case, Vault does not generate that localized narrative and leaves the Case Narrative field blank on the Localized Case.
|
SAF-88965 |
|
When generating PMDA E2B(R3) files, if the Worldwide UID includes spaces, a validation error occurs for the C.1.8.1 Worldwide Unique Case Identification Number data element.
|
SAF-89133 |
|
On imported Inbox Items with multiple Product, Medical Event, and Reporter sections, if users manually add Products without Ranks, Vault changes the Product sorting order.
|
SAF-89203 |
|
When generating a CIOMS I (Chinese) form, Vault does not map the complete narrative from the Localized Case or the MedDRA Preferred Term (PT) Chinese name into the CIOMS I (Chinese) field 7 + 13 Describe Reaction(s) or the CIOMS I (Chinese) field 23 Other Relevant History.
|
SAF-89253 |
|
In some cases, Signal encounters an error and does not display a preview when running the Preview action on a Signal Calculation Run that contains an advanced Signal Calculation with any Signal Calculation Mappings.
|
SAF-89669 |
|
In some cases, Workbench encounters an error when attempting to generate a Workbench View that is dependent on the Workbench DSUR / PBRER Principal Workbench View.
|
SAF-89683 |
|
After populating and saving the State/Province on a Case Contact record, Vault does not save subsequent attempts to clear the State/Province.
|
SAF-89828 |
|
When creating a Workbench Report, changing the Workbench View field value from DSUR / PBRER Principal View to any other value in the same aggregate report results in missing filters in the Filters section.
|
SAF-89986 |
|
On E2B-imported Cases, deprecated Assessment Results values display in the Assessment Results grid view, but not the detail view.
|
SAF-90032 |
|
In some cases when coding an External Product using the WHODrug Search browser, Safety does not populate the TermID Version field on the generated Substance records, triggering a validation error.
|
SAF-90116 |
|
When Vault generates a narrative from an outline for a Case with an existing narrative, if a Case Product has been deleted, the summary on the upversioned narrative includes a statement indicating that the deleted product's drug role changed.
|
SAF-90545 |
|
In the Workbench Report object lifecycle, Vault included the Change State to Review, Change State to Published, and Change State to Archived as standard actions, preventing Admins from deleting them. Now, the standard actions are removed, and Admins can add them to the applicable states as custom actions if needed.
|
SAF-90690 |
|
When the Re-evaluate Submissions and Distributions action runs, Vault updates previously completed Transmissions in the E2B ACK Accepted, Completed, and E2B ACK Warning states to Deleted.
|
SAF-90708 |
|
When using the Document Intake Highlighter, after running the Extract Company Products action, products added to the panel based on matching Study Name include non-product annotations.
|
SAF-90771 |
|
In Vaults with the Load Terms for Auto-Extraction setting enabled, after running the Extract Company Products action from the Document Intake Highlighter panel, Vault does not auto-code the extracted Products.
|
SAF-90785 |
|
In some cases upon removing a Yes/No filter from a Workbench Dashboard, Workbench encounters an error and displays a blank dashboard.
|
SAF-90836 |
|
In rare cases, Workbench encounters an error when running a Workbench Report generated from a Workbench Report Set or a Workbench Dashboard Component.
|
SAF-90888 |
|
When running the Generate Document Collection action would result in a binder name with more than 100 characters, Vault does not generate the Case Collection.
|
SAF-90967 |
|
In some cases after running a Generate CIOMS I Collection action on a Workbench Report, Workbench encounters an error and fails to generate the Case Collection.
|
SAF-90991 |
|
In some cases when generating a Workbench Report with a specified Case series, the downloaded report file contains no data.
|
SAF-91011 |
|
On an E2B-imported Inbox Item with a missing Dose Unit value, after a user adds a Dose Unit, Vault continues to display a validation error.
|
SAF-91043 |
|
When generating MFDS E2B(R3) files, Vault exports the H.5.r Case Summary and Reporter's Comments in Native Language section for foreign, instead of domestic, Korea cases.
|
SAF-91111 |
|
When running a PADER Workbench Report for the 15-Day and Non-15 Day Summary Report, the Summary of ADR from Postmarketing Sources, or the Interval Line Listings tabulation, Workbench does not check that the Transmission reportable product registration matches the selected Aggregate Reporting Group.
|
SAF-91235 |
|
In some instances, during promotion of an Inbox Item with a high number of Products, an error occurs during duplicate detection, which prevents case processing.
|
SAF-91274 |
|
After nullifying a Case, in some instances, Vault does not link related Localized Cases with the associated nullification Transmission.
|
SAF-91319 |
|
Case Collection binders exclude generated E2B files with warnings.
|
SAF-91325 |
|
If running the Evaluate Local Reporting Details or Calculate Japan Reportability action on a follow-up Localized Case for Japan results in multiple submissions with the same Destination Case ID, Vault populates the Follow-up Number on only the first submission.
|
SAF-91339 |
|
After linking an Adverse Event Report classified document to a JSON-imported Inbox Item, Safety populates an incorrect parent identifier on the Drug History record and prevents the Doc Info pane from opening.
|
SAF-91425 |
|
In Vaults without the Enable Isolation of Blinded Product Information setting enabled, after populating the Combination Product field on an unblinded Study Product within a Case that already contains one or more of the Study Product constituents as Case Products, Vault creates duplicative Case Products for those constituents.
|
SAF-91437 |
|
When generating FDA E2B(R3) files, Vault does not consider the Report Type of a Case or the Study Type of a Case Study to determine when to populate the 7-day E2B code (6) in the FDA.C.1.7.1 data element, resulting in rejections when cross reporting spontaneous foreign Cases to the FDA.
|
SAF-91565 |
|
When a Case has multiple Transmissions that use the EMA E2B(R3) format to report to different agencies, Vault does not consistently run the EMA.F.r.3.3.validation criteria at the Case level.
|
SAF-91612 |
|
When generating FDA E2B(R3) files for Cases with no First Admin Date in the Dosages section for a combination product, Vault does not populate the FDA.G.k.10.1 FDA Specialized Product Category data element.
|
SAF-91624 |
|
In some instances, when running the Create Statistical Data action users may experience slow performance.
|
SAF-91725 |
|
When generating MFDS E2B(R3) files, Vault does not export a code to the G.k.9.i.2.r.3.KR.1 WHO-UMC Result of Assessment data element if the Assessment Result on the Case Assessment Result is Reasonable Possibility.
|
SAF-91730 |
|
Following a change to a product name in an EDC Vault that is transferred to a Safety Vault through the Safety-EDC Connection, if the product matches a Product of a different Product Type in the Safety Vault, Safety creates duplicate Product records with the same Link field value.
|
SAF-91762 |
|
For Inbox Items generated by imported JSON files with a linked source document, Vault displays an error when users navigate to the document's Doc Info panel.
|
SAF-91778 |
|
The Promote to Multiple Cases action is not available for Inbox Items imported from a JSON or CSV file that contain a Parent Information Case.
|
SAF-91839 |
|
When duplicate Localized Case Assessment Results exist on a PMDA foreign Localized Case, the one-time data sync on follow-up does not complete.
|
SAF-92040 |
|
On generated E2B(R3) formats with the G.k.4.r.11.1 data element populated with a nullFlavor, Vault exports the codeSystemVersion to the G.k.4.11.r.2a data element.
|
SAF-92054 |
|
In some cases when accessing a Case with failed Validation Results, Vault displays a record count of 0 for Validation Results (Failures & Warnings) in the sidebar.
|
SAF-92139 |
|
After running the Evaluate Reporting Obligation action, for some Cases where the Agency is missing Submission Rules, Vault does not display an error message and can still generate Transmissions.
|
SAF-92175 |
|
When a user copies a Workbench Report Set with one or more Workbench Report Definitions with safety view parameters, if the reports within the set have not been generated, users can't enter parameter values, preventing them from saving the set.
|
SAF-92192 |
|
If the WHODrug Browser is launched from the Product Browser with a Country filter, the WHODrug Browser does not reflect the Country filter.
|
SAF-92215 |
|
When generating a Transmission to the NMPA for a foreign follow-up Localized Case for China, if multiple Case Assessment Results have the same Relatedness value, an error occurs during the one-time sync from the global Case to the Localized Case, and Vault prevents Case processing.
|
SAF-92319 |
|
After linking an existing Inbox Item to a PDF with the Case > Source > Adverse Event document type, an error occurs when opening the Doc Info pane or editing the Report Type on the Doc Info pane.
|
SAF-92461 |
|
For E2B-imported Inbox Items that include a narrative document, when promoting to follow-up through the Inbox Item to Case Compare page and choosing to ignore Narrative Preview changes, Vault sets the previous Case version's narrative to v0.1 and the E2B narrative to v0.2.
|
SAF-92526 |
|
Upon specifying a Signal Case Series on a Workbench Report, Workbench continually refreshes the page, preventing the user from selecting a different Signal Case Series.
|
SAF-92599 |
|
Signal displays an error when running the Create Statistical Data action and signal alert rule engine for the same Product Family.
|
SAF-92819 |
|
When generating MFDS E2B(R3) files, Vault detects an error for the C.5.4.KR.1 data element and moves Submissions into the Validation Error state, instead of the Ready state.
|
SAF-92893 |
|
When Vault performs the one-time data sync from a global follow-up Case to a foreign follow-up Localized Case for the NMPA, users experience significant performance issues when Vault syncs Case Assessment Results.
|
SAF-92920 |
|
When processing a Case that includes some, but not all, constituents of a Combination Product, users experience significant performance issues when Vault maps and creates Case Product records for the remaining constituents.
|
SAF-92961 |
|
Vault displays an error when users attempt to run a preview using the "PV Filter View - Interval Product-Events for a Product Family" or "PV Filter View - Cumulative Product-Events for a Product Family" dependent views.
|
SAF-92975 |
|
When generating E2B(R3) files, Vault does not convert the TermID Version to YYYYMMDD format when populating the G.k.2.3.r.2a data element, resulting in NACKs. This issue does not impact MFDS E2B(R3) files.
|
SAF-92983 |
|
For cases with a high volume of data, users experience performance issues when promoting Inbox Items to Cases through the Inbox Item to Case Compare page.
|
SAF-93006 |
|
When generating Vigiflow E2B(R3) files, the "Non-Always Evaluate" ICH validation criteria does not run at the Case or Submission levels.
|
SAF-93032 |
|
Users cannot void follow-up Case versions if a previous version relates to a foreign Localized Case with unsubmitted Transmissions, such as a Transmission in the Withdrawn state.
|
SAF-93054 |
|
During approval of a global follow-up Case with a related foreign follow-up Localized Case for the NMPA, users experience performance issues while Vault performs the one-time data sync from the global to the Localized Case.
|
SAF-93122 |
|
On migrated Cases with no adverse event onset date, if the Receipt Date is before the Date of Birth, Vault populates a negative Age (normalized) value.
|
SAF-93129 |
|
When mapping a Literature Reference value that contains over 500 characters from an EVDAS Line Listing record to the C.4.r.1 Literature Reference(s) data element in an E2B file, Signal maps only the first 500 characters.
|
SAF-93134 |
|
In Vaults with the "Related Case Identifier source (On Edit)" application setting enabled, users may experience performance issues following changes to the Related Case on a Case Relationship record.
|
SAF-93138 |
|
When a user creates a second Case Contact with Patient qualification on an Inbox Item, a validation error correctly occurs, however, Vault still takes the second Patient Case Contact into consideration during duplicate detection.
|
SAF-93183 |
|
In Vaults configured to isolate blinded clinical trial information, during bulk unblinding Vault does not map Substance Names from the Product library to Case Products.
|
SAF-93224 |
|
If a Case Assessment is created without a Case Product or a user manually clears a Case Product on a Case Assessment, users may experience performance issues.
|
SAF-93318 |
|
When running Signal Calculations, in some instances queries do not complete and Vault does not generate Workbench Logs.
|
SAF-93402 |
|
On E2B readable renditions, the value, instead of the unit, appears in the F.r.3.3 Test Result (unit) field.
|
SAF-93409 |
|
When validating domestic postmarket Cases, if Term ID is blank on the Localized Case Product Substance, Vault does not consider the CAS Number of the Substance related to the Case Product, causing validations to fail.
|
SAF-93532 |
|
In some cases, selecting Clear Selection on the WHODrug field fails to hide the WHODrug and JDrug fields or re-enable the Product Browser (binoculars icon), preventing the user from returning to the initial product coding view.
|
SAF-93541 |
|
When users select Ignore All on the Inbox Item to Case Compare page, Vault does not ignore information in Case-level fields.
|
SAF-93660 |
|
In rare instances, when generating Inbox Items from emails, Vault displays an error and does not create the Inbox Item.
|
SAF-93667 |
|
When generating Transmissions with Patient Content Protection set to Mask PII (EU Guidance), Vault does not add the prefix "PII_Protected_" to the document name.
|
SAF-93858 |
|
When copying the Post-Market Serious Sample Outline used to configure rules based narratives, Vault displays an error message that Narrative Statement Options with the same Name exist.
|
SAF-93938 |
|
On Workbench PBRERs, migrated Cases for Studies with blank Study Types appear in the Cumulative Tabulation of Serious Adverse Events from Clinical Trials tab instead of the Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources.
|
SAF-93990 |
|
Vault calculates the Data Period End date on next aggregate reports using the Data Period End date from the previous report instead of the Data Period Start date.
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SAF-93995 |
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When generating Transmission documents, if a Transmission has an XSD schema error, Vault moves the document to the Validation Error state.
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SAF-94010 |
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After clearing the "Contact is also reporter" checkbox on a Case Contact on an Inbox Item, during duplicate detection Vault continues to evaluate the contact as a reporter.
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SAF-94035 |
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On EMA E2B(R3) files, the xml comment for D.10.7.1.r.1ab appears as D.7.1.r.1ab.
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SAF-94114 |
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When generating the August 2024 version of the FDA MedWatch 3500A for Cases with Combination Products that have more than one device constituent, Vault exports information for only one constituent to the form.
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SAF-94181 |
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When transferring data through the Safety-EDC Connection, values in custom fields do not map to the Safety Case.
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SAF-94192 |
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In Vaults configured with strict Case locking, when a Case is locked to a user, Vault does not prevent other users from editing Case Product Dosage or Case Product Indication records.
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SAF-94200 |
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In some instances, an error occurs when validating a MedDRA dictionary license.
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SAF-94239 |
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After a non-EDC Inbox Item with a Link value is promoted to a follow-up Case or merged to an in-flight Case, Vault populates "Veeva EDC" as the Case Identifier type.
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SAF-94243 |
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When PVA Obligations are scheduled to run weekly and include a Days to Run value, Vault does not calculate dates using the Activity Creation Days Prior value.
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SAF-94273 |
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When generating CIOMS I (Chinese) forms, Vault cannot export more than two characters to Field 1a. Country.
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SAF-94298 |
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In Vaults configured to isolate blinded clinical trial information, Vault prevents users from deleting unblinded study Products with associated blinded records.
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SAF-94336 |
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If the Datasheet field on Case Assessment Expectedness records is blank, the Reporting Rules Engine cannot run.
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SAF-94348 |
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When generating MFDS E2B(R3) and NMPA E2B(R3) files for a Localized Case with a Localized Parent Information Case, in some instances Vault attempts to populate the H.5.r block with data from the Localized Parent Information Case instead of the Localized Case, resulting in an error.
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SAF-94381 |
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Vault creates a new MedDRA Synonym if a reported term includes leading or trailing spaces but would otherwise match an existing MedDRA Synonym.
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SAF-94481 |
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When generating CIOMS I, FDA MedWatch 3500A, and FDA E2B(R3) file in Vaults configured to isolate blinded clinical trial information, when evaluating the order of unblinded Case Products, Vault considers the Rank of the unblinded record, instead of the blinded record.
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SAF-95079 |
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When generating a One Last Time Distribution for a Case with multiple previous Transmissions, Vault does not always use the most recent Transmission to calculate the Due In Days value.
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SAF-95083 |
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When generating Transmissions with Patient Content Protection set to Mask PII (EU Guidance), Vault does not apply masking logic to formats other than EMA E2B(R3) and does not mask Parent Identification fields for parent-child cases. In addition, Vault removes the Sender data elements.
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SAF-95178 |
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In Vaults with the Mask Reporter For PM Non-Literature Case application setting enabled, when generating the FDA MedWatch 3500A form (August 2024 version) for postmarket non-literature Cases, Reporter Qualification and Reporter Country values are masked.
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SAF-95217 |
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If the Organization of the Sender on a Transmission is blank, Vault does not use the Sender Type from the Organization on the Case to populate the C.3.1 Sender Type data element on PMDA MHLW Paper Forms.
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SAF-95241 |
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When creating a follow-up Case for a closed Case with Parent Information, after promotion Vault sets the follow-up Parent Information records to the Closed state, instead of the Initial state.
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SAF-95252 |
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When recoding a MedDRA Term on a MedDRA Query Criteria record, Vault displays the term being recoded in the MedDRA Browser. In addition, the RECODE tag continues to appear when the MedDRA Term is updated to match the MedDRA version.
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SAF-95281 |
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In some cases after merging an Inbox Item to an in-flight Case, the Inbox Item's audit trail displays the incorrect number of potential matches.
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SAF-95320 |
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When exporting Dictionary page layouts through an API, Vault displays an error.
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SAF-95462 |
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Vault creates corrupted or duplicate MedDRA records when users select the pinned term from the browser on records with an active RECODE tag.
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SAF-95491 |
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When a user updates a MedDRA term to a version that matches the parent object's active MedDRA version, Vault does not clear the RECODE tag.
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SAF-95510 |
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The ICH.D.9.2.r.2 validation criteria fails when a Localized Case does not exist.
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SAF-95588 |
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Vault creates duplicates of local-only Local Risk Measures as a result of re-running the Create Local Implementations action on a Core Implementation Strategy.
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SAF-95661 |
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An error occurs when filtering a Workbench Report or Workbench Dashboard by a MedDRA Query that includes a Building Block.
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SAF-95896 |
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In some instances, Admins may experience slow performance when creating or updating a Workbench Principal View.
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SAF-95928 |
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In Vaults configured for MedDRA Suggestions, when auto-coding a MedDRA Term, if Vault does not find a match and opens the MedDRA Browser, attempting to navigate through pages on the browser does not update the displayed results.
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SAF-95953 |
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Certain fields, including the New Info Date, do not always display for Imported Follow-Up Information types of Cases.
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SAF-96259 |
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Device Code Type values on JSON-imported cases created using tabular data format import do not appear in Inbox Items.
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SAF-96329 |
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When generating E2B files for NMPA Cases, if the Case Product is a Combination Product and the NMPA Center on the related Transmission Profile is CDR, Vault does not populate the G.k.CN.4 data element, resulting in a Transmission-level validation error.
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SAF-96532 |
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Vault sets Public Access Link Expiration Dates to 30 days from the date on which Vault sends a follow-up questionnaire, regardless of the configured Follow-up Questionnaire Rules.
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SAF-96575 |
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When a user clears the Report Type or New Info Date values of an Inbox Item on the Inbox tab records grid, the record's detail page does not reflect the change.
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SAF-96575 |
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When the Excel output of Workbench Reports is configured to display fields as links, Vault allows more than 65,530 links per worksheet, resulting in errors and non-functional links.
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SAF-96653 |
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In Vaults with the Load Terms for Abstract Highlighting setting enabled, Vault prevents deletion of Product Aliases with an Alias value that contains more than 128 characters.
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SAF-96659 |
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For the Submit to Gateway and Send Email actions when Strict Transmission Version Enforcement is enabled, Vault does not consider Transmissions in the Logically Deleted state when identifying the most recent Transmission.
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SAF-96684 |
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On NMPA E2B(R3) files, Vault populates the H.5.r data elements for foreign Localized Cases.
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SAF-96779 |
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On FDA VAERS E2B(R3) files, Vault populates the wrong codeSystem value in the G.k.1.a data element.
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SAF-96931 |
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On NMPA E2B(R3) files, Vault populates the G.k.9.i.CN.2 data element only for Case Assessments related to the primary Case Adverse Event.
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SAF-97407 |
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When performing Inbox Item to Case compare, Vault does not consider Start Date and End Date values in the Drug History section as tie-breakers when identifying the best possible match.
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SAF-97585 |
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In view mode on a safety view, Cmd + f opens the browser's search instead of the SQL Editor search panel.
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SAF-97797 |
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When Workbench Dashboards include a MedDRA Query filter, if a MedDRA Query expands to more than 5,000 MedDRA LLTs Vault displays an error and the dashboard does not load.
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SAF-97932 |
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During the daily transfer of safety data from Veeva Safety to Veeva Safety Workbench, in some instances Vault displays an error message although the transfer completed successfully.
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SAF-97933 |
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When running MedDRA Queries, Vault does not exclude inactive MedDRA Criteria.
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SAF-98062 |
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When Workbench Dashboards include a MedDRA Query filter, if a MedDRA Query expands to more than 15,000 MedDRA LLTs Vault displays an error and the dashboard does not load.
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SAF-98107 |
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When generating FDA eMDR files, when the organization used to populate the D.3.7 Manufacturer Country data element matches the Transmission Origin or Destination organization, Vault displays an error message and does not generate the file.
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SAF-98315 |
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When a study product Datasheet inherits expected adverse events from a core Datasheet, Vault does not populate the Listedness (Core) or Listedness (status) values on Case Assessments for the Study Product.
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SAF-98320 |
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In some instances, users may experience slow performance when running the Download CSV action on an exported Workbench Dashboard Component.
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SAF-98323 |
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When generating EMA E2B(R3) Submissions with Patient Content Protection set to Mask PII (EU Guidance), Vault populates the Sender's Country Code, Sender's Telephone, and Sender's Fax with invalid data, even when these fields are blank on the Case, resulting in rejected Submissions.
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SAF-98454 |