| Description |
Issue No. |
|
In some cases, the Vault incorrectly logs the email address of external users viewing Safety Distributions as external@user.com.
|
DEV-463654 |
|
Vault shows an unneeded period (.) in the radio button cells of the USN selection dialog.
|
DEV-480782 |
|
Vault may double fetch data and incorrectly generate Weekly MOT records.
|
DEV-482704 |
|
Users may receive Unexpected Errors when attempting to perform document reconciliation.
|
DEV-486473 |
|
In some cases involving high volume, CDX uploads fail.
|
DEV-487368 |
|
When users delete a Metric ID on a Study Site and then run the Update Metrics job, Vault does not delete the Metric and instead incorrectly sets the Metric's values to 0.
|
DEV-488288* |
|
In cases where Actual Metrics have a value of Null, the Update Metrics Job fails.
|
DEV-488431 |
|
When users update the First and Last Name fields on the User object, Vault does not apply those changes to the Study Person Name field on the Study person object.
|
DEV-489487 |
|
Vault allows users to run the Distribute to Sites action multiple times consecutively.
|
DEV-491081* |
|
Vault does not transfer Study Countries from CTMS to CDMS when the "Disable Chunking for CTMS Integration" feature flag is selected and when the Country Link is removed from the Country record.
|
DEV-491085* |
|
In some cases, hovering over the Milestone progress icon results in "server having problems."
|
DEV-491305 |
|
When users delete Subject Visit data in CDMS, Vault fails to delete corresponding unblinded Subject Visit data in CTMS despite the "Enable Restricted Transfer Flag" being disabled in CTMS.
|
DEV-492345* |
|
In some cases, Vault incorrectly updates non-Site level expected documents when the reference site workflow action is taken.
|
DEV-492452* |
|
Vault incorrectly limits the number of Distribution Tasks so that no more than 10,000 records can be created.
|
DEV-493623* |
| Description |
Issue No. |
|
After a user approves a manual rendition of a non-renderable source file, the manual rendition no longer appears in the Renditions list.
|
DEV-466681 |
|
In some cases, tokens incorrectly appear on documents.
|
DEV-473831 |
|
The browser may freeze after a user creates a link annotation on a document with over 400 Linked Document relationships.
|
DEV-477122 |
|
In some cases, after a user searches for and selects certain documents in the Library, the "Document Not Found" page displays.
|
DEV-479112 |
|
Field dependency components that begin with "dep" have a Modified Date field value, but audit logs show no changes.
|
DEV-485186 |
|
Running the Create Presentation action on the same document fails if the values of the Lifecycle Stage and Lifecycle State Stage ID fields have changed.
|
DEV-486213 |
|
In some cases, the Review & Approve Monitoring Event workflow generates Trip Reports documents without a viewable rendition.
|
DEV-486224 |
|
In some cases, certain approval workflows that update a document field do not re-render merge fields.
|
DEV-487798 |
|
When navigating to a permalink target in a new window, a "Back to previous page" link may appear unexpectedly. When navigating to a permalink target from the same window, the "Back to previous page" link may return the user to the same page.
|
DEV-488551* |
|
In some cases, some binders may become inaccessible due to corrupted data.
|
DEV-489695* |
|
In some cases, OCR renditions show "There was an error during document processing" until a user refreshes the page.
|
DEV-490188 |
|
When 'Allow Create Draft from existing source content' is disabled, the File section of the Create Draft dialog does not have an 'X' cancel button.
|
DEV-490216* |
|
If users use a doc field containing '#' as an auto name and the auto name exceeds its character limit, the '#' is replaced with @veevaEscapeCharacter.
|
DEV-490554 |
|
After document creation, OCR may update shared fields, which updates the Last Modified By field, even though the shared field values have not changed and there are no audit entries.
|
DEV-490720* |
|
If a retry occurs while updating multiple documents, any documents initially marked as failed are marked as successful during the retry.
|
DEV-491965* |
|
In some cases, users receive internal server errors when attempting to upload documents.
|
DEV-493991 |
|
In some cases, font processing fails for Type 3 fonts that do not have a font name, and this may result in unexpected validation errors.
|
DEV-495579 |
| Description |
Issue No. |
|
When deploying packages, Vault interprets the "Lifecycle" field as a custom field instead of a standard field.
|
DEV-466448 |
|
Vault will produce a server error when attempting to save a new CAPA Action record that uses linked fields on a Quality Team without object types.
|
DEV-478100* |
|
Vault fails to send to send Complaint notifications to users assigned to the role by DAC records.
|
DEV-480620* |
|
Using certain special characters in a search of Visual Hierarchy records may cause Vault to display an error.
|
DEV-481684* |
|
Using certain special characters in a search of the Explore tab or Curriculums on the Learning homepage may cause Vault to display an error.
|
DEV-481757* |
|
While performing the Generate APQR Binder action on an APQR object record, an inappropriate error message is produced.
|
DEV-488022* |
|
An unexpected error occurs when attempting to Power Delete Training Assignments.
|
DEV-489801 |
|
Vault raises the incorrect error message when workflows are started with External Collaborators that do not have object-level read permissions.
|
DEV-490187 |
|
Vault fails to prevent the creation of duplicate Learner Role-Person records.
|
DEV-490330* |
|
In rare cases, a server error will appear when adding training material to a training requirement.
|
DEV-491298 |
|
Vault fails to freeze header row when Unfreeze Header Row is selected from the Actions menu of a Related Object Comparison.
|
DEV-492073* |
|
Vault incorrectly allows the Direct Assignment action on a Training Requirement with an empty Content Set.
|
DEV-492645* |
|
While performing a Recurrence Check, Vault may return matches that are not the same object type.
|
DEV-493317* |
|
Under certain conditions, Vault fails to update a Training Requirement's content set when a cancelled TRIA exists.
|
DEV-494503* |
|
Vault raises a server error when the Notification Recipients section is added to the page layout of objects that do not have External Notifications enabled.
|
DEV-495043* |
| Description |
Issue No. |
|
In some cases, attempting to open an Audit Checklist task with a QOne Business Administrator security profile returns a server error.
|
DEV-474920* |
|
When attempting to add a Component for an Outbound Package, the filtering for "Object" as the Component Type does not display previously-created Team Member objects.
|
DEV-490351* |
|
When there are a maximum of ten (10) existing Object Sharing Rule records, an error displays when attempting to edit an existing Object Sharing Rule record.
|
DEV-491274* |
|
Vault displays uneven spacing between the Attachments, Action Items, and Hazards sections in MV Checklists.
|
DEV-492562* |
|
In some cases, an unclear server error displays when attempting to save an Inspection Sample Test Result record without selecting an Inspection Sample in the required field.
|
DEV-493314* |
|
In some cases, users receive an error message and cannot remove themselves from a Team Role of a Team configured for an object record.
|
DEV-493785 |
|
For Control Charts, a blank page displays when initially entering special characters in the Supplier Location or Facility filter.
|
DEV-494377* |
| Description |
Issue No. |
|
In some cases, regional XML files fail to render as expected.
|
DEV-461062 |
|
When there is a large load of concurrent content plan creation, users may see a delay between the completion of the creation and viewing of the hierarchy in the content plan viewer.
|
DEV-465554 |
|
In some cases, the submission validation result shows US 1255 CDER and CBER as failed when the submission includes a Lot Distribution Report in XML format.
|
DEV-477532 |
|
When splitting a Content Plan Item and updating tokens in fields, Vault fails to resolve tokens if a Content Plan Item token value is truncated to avoid duplicates.
|
DEV-479949* |
|
Vault does not export files with special characters correctly, resulting in inconsistencies between the contents in the ZIP file and the XML backbone and causing validation errors.
|
DEV-480887 |
|
In some cases, submission publishing jobs fail when "Set Bookmarks & Hyperlinks to Page & Coordinates - RLCP" is enabled and the submission has an embedded link to a named destination on the target document.
|
DEV-483310* |
|
Under certain cirumstances, continous publishing is able to clear a user's XML Modified File.
|
DEV-483771* |
|
Vault may inaccurately return Rule 1735 failures.
|
DEV-485533 |
|
When navigating back to the SA viewer from a breadcrumb on a document's detail page, documents that should be visible are hidden under a section.
|
DEV-488647 |
|
Continuous tasks fail when a user updates the name of a Clinical Site that impacts multiple active submissions.
|
DEV-490399* |
|
Vault does not display filter suggestions when filtering Submission metadata in the Submissions Archive Viewer
|
DEV-490590* |
|
Users are unable to use Object Type Mapping records to set Object Type when Submissions/RO join records are created through CASRO from Application records with null applicable product type field values.
|
DEV-490600* |
|
In some cases, Vault creates (instead of merges) duplicate study folders in the Submissions Archive Application view.
|
DEV-490603 |
|
The Create Global Content Plan action fails when the Submission Name field is system-managed.
|
DEV-490691* |
|
Vault fails to create Application Clinical Study and Application Inactive Ingredient join records when bundling Regulatory Objectives.
|
DEV-490772* |
|
Vault displays an incorrect error message for Rule 1734.
|
DEV-490921* |
|
Vault displays an incorrect error message when the value for the TSPARMCD field is invalid and Rule 1734 fails.
|
DEV-490959* |
|
Vault displays an incorrect error message when a Submission contains a missing Start Study date.
|
DEV-491069* |
|
Vault Submissions Publishing fails to update Submissions Archive after users update a Clinical Site name.
|
DEV-491319* |
|
Vault may inaccurately return F09 errors.
|
DEV-491818 |
|
In some cases, Vault incorrectly reports PDF rules following on-demand publishing of a Content Plan Item.
|
DEV-492104* |
|
Users receive runtime errors if they have submission join records under inactive applications.
|
DEV-492201 |
|
In some cases, the successful Content Plan Hierarchy State change notification email is sent before the operation is complete.
|
DEV-492968* |
|
When a Submission has two reference leaves with different POLs which ultimately resolve to the same document ID and Version, one reference leaf fails to publish.
|
DEV-494250* |
|
In some cases, a current Japanese Submission fails to publish when a previous Japanese Submission does not have a regional leaf node in the index.xml.
|
DEV-495162 |
The RegulatoryOne release, including all Platform fixed issues, is targeted for tentative availability on July 5, 2022.
| Description |
Issue No. |
|
In some cases, Vault does not filter Multi-Pass reports with advanced logic as expected.
|
DEV-419599* |
|
Under certain conditions, Vault fails to apply filters to Multi-Pass reports.
|
DEV-482113* |
|
Merged cells in Formatted Excel reports have repeated values instead of blanks.
|
DEV-486398* |
|
In some cases, Vault fails to execute reports with aggregate functions.
|
DEV-489137* |
|
In some cases, Vault fails to execute Multi-Pass reports with aggregate functions.
|
DEV-489152* |
|
Report filters return unexpected values when a field label begins with a number.
|
DEV-489810 |
|
In some cases, Vault incorrectly displays conditional fields while users create formula fields.
|
DEV-490785* |
|
Vault may fail to execute reports with multiple groupings.
|
DEV-490864* |
|
In some cases, Vault fails to execute Multi-Pass reports using Std Dev and Std Dev Samp aggregate functions.
|
DEV-491051* |
|
In rare cases, Vault fails to execute reports with aggregate functions and up objects.
|
DEV-492099* |
|
Vault fails to execute grouped Multi-Pass reports that include object views with aggregates.
|
DEV-492287* |
|
Vault incorrectly shows matched document fields on EDL Item with Matched Documents type reports.
|
DEV-493737* |
The Safety release, including all Platform fixed issues, is targeted for tentative availability on June 30, 2022.
| Description |
Issue No. |
|
Fixed an issue with sending email transmissions where the distribution record was still in "Ready" state instead of "Sent" state.
|
SAF-27630 |
|
Fixed an issue where adding more than ten Dosage records to a Case Product was prevented by the system.
|
SAF-28074 |
|
Fixed an issue where, when the Evaluate Regulatory Conformance action was run, the system determined where the Case was reportable and which validations to run based on the Product or Study Registration countries. As a result, regional validation rules may have caused unnecessary validation failures on the Case.
|
SAF-28392* |
|
Fixed an issue with promoting an Inbox Item to multiple cases where, if the Patient Initials field was set to a Reason Omitted, the system overrode the value with “PLACEHOLDER” during promotion.
|
SAF-28523 |
|
Fixed an issue with imported Cases where the Case Assessment Record ID was exported to the Assessment Name field on CIOMS I forms. Now, the field will be populated with the Case Adverse Event Name and Product Name.
|
SAF-28784 |
|
Fixed an issue by displaying open-label products as unmasked on blinded forms.
|
SAF-28785 |
|
Fixed an issue with Cases containing a custom child record without a lifecycle state where, when the Create Revision or Create Follow-Up action was selected for the Case, a non-descriptive error message appeared.
|
SAF-28809 |
|
Fixed an issue with validating E2B(R3) files where the D.9.2.R.2 Reported Cause(s) of Death (free text) was required if D.9.2.R.1 Reported Cause(s) of Death was populated. Now, in accordance with EMA Business Rules, the field is always optional.
|
SAF-28917 |
|
Fixed an issue where, when an Inbox Item was created from a non-E2B source file, the Origin field was blank after Case promotion.
|
SAF-28973 |
|
Fixed an issue where the Validation Results could not be processed and saved.
|
SAF-28979 |
|
Fixed an issue where the most conservative product selection was not limited to products defined within the Product Parameter.
|
SAF-29045 |
|
Fixed an issue where the Auto-Calculate checkboxes were unselected upon creating Follow-Up Cases.
|
SAF-29094* |
|
Fixed an issue with E2B import to Inbox Item where, a Product in the Drug History record was getting created as a Case Product when there is a Product in the library with the same name.
|
SAF-29125 |
|
Fixed an issue where, when the Deep Duplicate Search feature was enabled, the system excluded Preferred Terms (PT) when comparing the Event (MedDRA) field during duplicate case detection. The system compared using only Lowest Level Terms (LLT), which may have resulted in missing potential matches.
|
SAF-29296* |
|
Fixed an issue with CIOMS I generation by displaying the earliest onset date for the 4-6 Reaction Onset field instead of the onset date for the primary Adverse Event.
|
SAF-29299 |
|
Fixed an issue where an error message appeared upon trying to save a Validation Criteria after editing the Rule Formula Format field.
|
SAF-29346* |
|
Fixed an issue where an auto-calculation warning message was incorrectly displayed on the second and subsequent Case Product Dosage records.
|
SAF-29420* |
|
Fixed an issue where, when importing an E2B file through a System Gateway, the system did not create Inbox Items, and instead created AERs.
|
SAF-29432 |
|
Fixed an issue where B.4.k.19 (Additional Information on Drug (free text)) was not being exported to E2B(R2) files.
|
SAF-29496* |
|
Fixed an issue with the List of Death Cases for PADER reports where the age unit was missing if the Case only contained an Age (normalized) value and no Age at Onset.
|
SAF-29520* |
|
Fixed an issue where, when the Patient and/or Parent Age at Vaccination field was auto-calculated by the system, unselecting the Auto-Calculate checkbox and clearing the Age at Vaccination value and unit fields still resulted in the system retaining the auto-calculated value upon saving the Case.
|
SAF-29535* |
Fixed the following issues with global (ICH) Validation Criteria objects:
Changes to editable fields were prevented by the system.
An incorrect error message appeared when a user tried to edit protected fields.
|
SAF-29580 |
|
Fixed an issue with EMA Submissions where the Transmission Lifecycle reverted to the "MDN Received" state after the "ACK Accepted", "ACK Rejected", or "ACK Warning" state.
|
SAF-29634 |
|
Fixed an issue where, when the number of characters on the Inbox Item Dose Text field exceeded the maximum character limit, the error message appeared inside the text box instead of below it.
|
SAF-29705* |
|
Fixed an issue where, when merging an Inbox Item to a Follow-Up Case, Assessment Tags were not correct on the Case name, though they were correct on the Case.
|
SAF-29723 |
|
Fixed an issue with global Cases with multilingual MedDRA enabled where the English label for dual input fields overlapped with the field label.
|
SAF-29742* |
|
Fixed an issue where, if a manual Inbox Item was saved and then edited to add a Source document, the Save button had to be selected twice to save the Inbox Item.
|
SAF-29772 |
|
Fixed an issue where transmission documents were not generated when there Transmission Profile details were not added.
|
SAF-29839* |
|
Fixed an issue where the Event (Reported) - English field for the primary Adverse Event record was not being compared in duplicate detection.
|
SAF-29913 |
Fixed an issue where, if a previous Transmission to a destination was Downgraded, the system did not correctly evaluate the One Last Time Reporting Rule.
Enablement: This fix requires support enablement in 22R1.0.8 but will be auto-on in 22R2.
|
SAF-29919 |
|
Fixed an issue where, when EDQM was enabled in vault and the Submit to Gateway action was triggered for an EMA submission, the EMA sent ACK warnings regarding the Patient / Parent ROA TermID and ROA TermID Version being null even when these fields were populated.
|
SAF-29925* |
| Description |
Issue No. |
|
When users search on Data Grid, Vault fails to populate the user fields.
|
DEV-479281* |
|
Icons do not appear in the Document Action Menu in the Library Tabular Layout.
|
DEV-481072* |
|
In the tabular view of the Library or Expanded Search page, only the Name column follows the grid truncation/wrap rules.
|
DEV-484201* |
|
When performing a search on an object tab after sorting by a column, the results are not sorted by relevance as they should be.
|
DEV-489461* |
|
Saved views fail to save the document section of expanded search results.
|
DEV-490641* |
|
Vault fails to highlight non-name fields for document sections in expanded search results.
|
DEV-490759* |
|
When creating a new record via the Copy Record functionality, users remain on the Record Detail page rather than being returned to the Object List page.
|
DEV-490932* |
|
When creating object records from a custom tab pop up dialog, the record does not appear in the table until the user refreshes the page.
|
DEV-490943* |
|
When a user begins the process of copying a report but cancels the action, the report title may appear as "Copy of ReportName" rather than simply "ReportName."
|
DEV-490980* |
|
Vault fails to display the "This object is currently inactive. Contact your system administrator for more information" notification for inactive objects on the object list page.
|
DEV-491230* |
|
Vault fails to display hovercards on the Library page after users make changes to the grid.
|
DEV-491250* |
|
When exporting to Excel/CSV, Vault limits long text field values to 250 characters rather than 500.
|
DEV-491343* |
|
In the Library tabular layout, some icons do not display in the Document grid.
|
DEV-491364* |
|
When a user navigates from a saved view to the standard "ALL" view and back, Vault still displays the data grid for the "ALL" view.
|
DEV-491757* |
|
In the Library tabular layout, the Checked Out icon does not display beside the document name in the Document grid.
|
DEV-492112* |
|
When a user attempts a row-level edit or copy record action on an object section of expanded search results while on a document tab, Vault redirects the user to the 'All' view of the tab rather than performing the action.
|
DEV-492440* |
|
In some cases, users with a specific security profile cannot load Vault pages.
|
DEV-494746 |
|
When a user adds Type, Subtype, and Classification columns to a view, the columns appear blank until the user refreshes the page.
|
DEV-495353* |