The following applications may have different release dates: RegulatoryOne, Safety, and Veeva Claims.
| Description |
Issue No. |
|
Transfer failure records are not created for the Study Site when the the Study Country does not transfer successfully.
|
DEV-552235* |
|
When there is a message processing error when running the RIM to Clinical Operations Inbound Worker Job, Vault does not record the error or stop processing, meaning that some job items are lost/not processed.
|
DEV-573125* |
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In some cases, the TMF Transfer fails to send any documents and, instead, a CDX Issue is raised.
|
DEV-582550 |
|
In certain cases, the Site Activation Progress report is slow to load.
|
DEV-584371 |
|
Vault does not correctly link Country Override EDL Template items to the applicable Milestones.
|
DEV-585203* |
|
When users run the Create Milestones from Template action for an Override EDL template, Vault sets the # Expected Field to a value that is not specified on the template.
|
DEV-585282* |
|
In certain cases, archived Study Sites fail to transfer or transfer very slowly.
|
DEV-587065* |
|
When performing the Create Subsequent CTN action, the CTN Data Change Logs for CTN Site IP are not created as expected.
|
DEV-587087 |
|
After navigating to the Milestone workspace from an individual Milestone record, there is no easy way to quickly navigate back to the Milestone record.
|
DEV-588622* |
|
Vault fails to create new Milestones if there are any Milestones that already exist but are not stamped onto a document.
|
DEV-588832* |
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Users are unable to accept agreements for Simple TMF Transfer if the indication_v field in the Source's study record is populated and the Target Vault indication_v picklist is empty.
|
DEV-589707 |
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When users update the "Has Reference Site?" field in the Source Vault, Vault erroneously creates a CDX Issue in the Target Vault.
|
DEV-589850* |
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Users experience a network error when navigating to an expected document from the Review Overcount page.
|
DEV-590449* |
|
In some cases, the CDMS to CTMS Connection fails to send Protocol Deviations, despite the job appearing to run successfully.
|
DEV-591057 |
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In some cases, Vault incorrectly calculates the Correct Predictions Above Threshold metric for metadata extraction models by including documents whose Study fields have not been auto-populated.
|
DEV-591889* |
|
In some cases, Vault incorrectly calculates the Incorrect Prediction Above Threshold metric for metadata extraction models by including documents whose Study fields have not been auto-populated but have been updated manually.
|
DEV-592466* |
| Description |
Issue No. |
|
Annotations become misplaced during export, import, and linking if the pages where the annotations exist are rotated and cropped.
|
DEV-537229* |
|
In some cases, Vault fails to display certain document relationship types in the Entry Criteria dropdown menu during Document Lifecycle State configuration.
|
DEV-562022 |
|
When a document is reclassified, Vault sends an automatic rendition request that replaces the viewable rendition of the document with a version that removes electronic signatures through Adobe Sign integration.
|
DEV-574319 |
|
Vault incorrectly reports a failure when validating the FDA Form 2253 with RIM Publishing.
|
DEV-577393 |
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When users download a viewable rendition of a secure document with an eSignature, the header, footer, and signature page become missing from the document.
|
DEV-578939* |
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In some cases, large documents with many captions experience timeout errors during the document rendering process.
|
DEV-586093 |
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PDFs fail Optical Character Recognition (OCR) in the following scenarios: 1) When a document fails PDF/A-1b rendering but returns OCR results, the PDF/A-1b will show an indefinite load icon. 2) When a file succeeds at PDF/A-1b rendering but fails OCR, the file shows an indefinite load icon instead of a rendition. 3) If the OCR process returns no results, the OCR Requested field is not updated.
|
DEV-586355* |
|
Vault fails to render documents with invalid or inactive bookmarks.
|
DEV-586627 |
|
In some cases, the resizing process to fit Adobe Illustrator content within a PDF page can cause misalignment of text and images.
|
DEV-587154 |
|
If a PDF contains metadata not written in UTF-8, Vault fails to parse the metadata, which in turns causes the render process to fail.
|
DEV-587300 |
|
When performing the re-render action on a document that contained in-use anchor annotation, users could choose to remove annotations. This sometimes led to invalid inbound references. With this fix, users performing re-render will not have the option to remove annotations.
|
DEV-587388 |
|
Users may experience a connection error while configuring Collaborative Authoring.
|
DEV-588132 |
|
Vault fails to render animated GIFs and videos with a duration under one second.
|
DEV-589199* |
|
Documents containing invalid XML characters in their metadata fail to convert to PDF/A.
|
DEV-589571* |
|
If a non-Delegate user edits a document annotation created by a Delegate user, the author of the annotation changes from the Delegate user to the Delegator. Refreshing the page does not correct the issue.
|
DEV-590374 |
|
When users attempt to copy and paste a bookmark link with any of the following characters in the bookmark title (\ " ' ( ) * %), they receive the error message: “Error to generate perma link”.
|
DEV-590759 |
| Description |
Issue No. |
|
In some cases, an inactive Quality Relationship Automation component may incorrectly continue creating relationships.
|
DEV-508944* |
|
In Vaults using the QMS-RIM connection, in some cases, the system may create duplicate Impacted Country records after performing the Update QMS Details action.
|
DEV-557601* |
|
In Validation Management, in some cases an executor may not be able to create a discrepancy when the first attempt has failed.
|
DEV-570032* |
|
In Validation Management, Vault may display an error when a user types "All" or "Not Challenged" into the Filter Requirements dialog.
|
DEV-570708* |
|
In the QMS Risk Builder interface, cells with the number "0" may instead show as blank.
|
DEV-571900* |
|
In some cases, the Study Training to Clinical Operations Vault Connection job encounters unexpected errors when creating a large number of Study Person records (~15K).
|
DEV-572874* |
|
In QualityDocs, the Activate External Collaborators entry action on a document lifecycle may fail if the Person record in the External Collaborators document field does not have an associated User record.
|
DEV-583225* |
|
In the QMS Risk Builder, the Copy function may exclude values not displayed in the grid.
|
DEV-583571* |
|
Vault LIMS always executed the Create Related Batch Records job even if no related Materials were present.
|
DEV-583975* |
|
In Validation Management, the Delete Record dialog in the Test Authoring interface may contain an incorrectly placed question mark.
|
DEV-584249* |
|
Attempting to run a Quality Record Check may fail if the Vault does not have the required label translations for the user's selected language.
|
DEV-584395 |
|
Vault may display an error when a user attempts to start a Duplicate Check on a record of a custom Complaint object type.
|
DEV-586778* |
|
In Vault LIMS, the Lab Test Set object's name field may be provisioned with an incorrect Value Format.
|
DEV-587172* |
|
In Validation Management, Vault may display a server error when a user navigates to their My tasks page when the user has a task but has not had a Validation Team Assignment.
|
DEV-587834* |
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Vault may display an error when attempting to transition the state of a Quality Event (Change Control) from Define Team to Initiated when there is a "Create Record From Template" action on the "Initiated" state with no specified match terms.
|
DEV-587928* |
|
In Validation Management, content in the Actual Results and Expected Results in the Test Execution interface may incorrectly display without line breaks.
|
DEV-588274* |
|
In Validation Management, the Unsaved Changes warning dialog may incorrectly render multiple times, obscuring the rest of the interface.
|
DEV-588506* |
|
Under certain circumstances, attempting to change a Root Cause Analysis record to an Approved state may result in Vault displaying an error.
|
DEV-588530* |
|
In some cases, Vault may display an error when a user attempts to Manage Teams on a standalone Complaint record.
|
DEV-591579 |
|
In some cases, performing the Run Duplicate Check action on a standalone Complaint object record may not create Related Events as expected.
|
DEV-591807* |
| Description |
Issue No. |
|
When generating IDMP elements for products without devices, Vault incorrectly reports errors for device-specific fields.
|
DEV-542227 |
|
When managing registered details, users receive a network issue error on the Summary page when attempting to submit updates to ~17K Registered object records.
|
DEV-553502* |
|
When a STF Content Plan Item’s title is updated, Vault does not update the document title in the STF XML during continuous publishing.
|
DEV-564863* |
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When object lifecycle entry criteria fail, the Quality to RIM Vault Connection does not create a User Exception Item for troubleshooting.
|
DEV-573780* |
|
Vault reports PDF validation errors when Content Plan Items with different Source for Published Document values share the same matched document.
|
DEV-574070* |
|
When the RIM to PromoMats Vault Connection’s RIM Crosslinks Post Processing job encounters errors, the related User Exception Item’s error message is nonspecific and potentially misleading.
|
DEV-575737* |
|
Users without read and execute permission for the Regenerate Comparison action are able to execute the action.
|
DEV-576630* |
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When creating related records in bulk from an Impact Assessment Report containing more than 10K records, Vault creates fewer Activity records than expected for the number of Applications.
|
DEV-579295 |
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Vault incorrectly reports validation failures in section 3.2.P.5.6 for certain regions if a file name begins with “specifications-”.
|
DEV-580572* |
|
Vault incorrectly reports CA Rule A03a as failed when a file is smaller than 150MB.
|
DEV-581290* |
|
Vault incorrectly reports CA Rule A03a as passed when a file is larger than 200MB.
|
DEV-581291* |
|
Vault incorrectly reports Rule 1734 in section M5 when the Submission’s Application Type is IND.
|
DEV-582593 |
|
In some cases, users are unable to select a Reference Leaf if the target leaf has already been replaced in the Content Plan Item.
|
DEV-582721 |
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Vault cannot create a Submission when the XML STF DTD/XSD Version and Create Note Extension fields are both populated for certain lead markets and regions.
|
DEV-583129 |
|
Active Dossier records are not created for documents with special characters in their Type.
|
DEV-583951 |
|
Vault does not render regional XML when the XML file does not have a stylesheet attribute.
|
DEV-584420* |
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The Enable machine-to-machine UDI submissions to EUDAMED setting is not visible on the Application Settings page.
|
DEV-584462* |
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Publishing fails when Vault detects an inconsistent number of source documents and bookmarks found for a published document.
|
DEV-584944 |
|
Vault sends the notification and link to download exported Submissions before updating the export job status, resulting in an error when a user clicks the download link.
|
DEV-584945 |
|
When Rule G08 fails, the detailed validation results file does not specify which section is missing an attribute.
|
DEV-585090 |
|
The Activity splitting wizard does not load for users without read and edit permissions for the Related Application and Regulatory Objective fields.
|
DEV-586213* |
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When a user opens the comparison viewer from a notification and completes the comparison, the confirmation dialog remains open and the user is not redirected to the previous page.
|
DEV-586365* |
|
When a Submission has multiple Active Substance relationship records, the Set Leaf Operation dialog does not auto-expand to the section containing both records.
|
DEV-586619* |
|
In some cases, the Submissions Archive Viewer does not load when the Submissions Archive application is enabled in an existing RIM Vault.
|
DEV-586715* |
|
When a dispatched source global content plan section is deleted, Vault allows users to generate a comparison and does not display the appropriate error message.
|
DEV-586851* |
|
When creating new target content plans during dispatching, Vault orders documents alphanumerically instead of aligning with the source content plan order.
|
DEV-586874* |
|
When a user removes an auto-matched document from a comparison, Vault incorrectly displays an error and includes the document in the target content plan.
|
DEV-586886* |
|
When a source Content Plan Item is deleted immediately after dispatching, the dispatching job fails to run and Vault does not provide the expected error message.
|
DEV-586980* |
|
Vault displays the incorrect error message when a dispatched source Content Plan Item does not have a corresponding record in the target content plan.
|
DEV-587041* |
|
When a user accepts changes in a comparison and does not have Read permission for the Application record, the related job fails without the expected error message and dispatch summary file.
|
DEV-587074* |
|
When a user removes a source Content Plan Item from a dispatch, the dispatch summary file includes the incorrect message for excluded changes.
|
DEV-587090* |
|
Users with a saved view and no Submissions Metadata permissions may be unable to see anything in the Viewer tab.
|
DEV-587134 |
|
In some cases, Vault receives XEVMPD acknowledgements but does not update the Product Data Message record accordingly.
|
DEV-587575 |
|
When the “Use regulatory objective data as source when bulk creating registrations” setting is enabled, users cannot select a Regulatory Objective when launching the bulk creation wizard from the Affiliate Home page.
|
DEV-587598* |
|
When a user selects Where Used in Archive for Index XML, the Submissions Archive viewer does not load and displays a console error.
|
DEV-587629* |
|
Content plan records are not created for a Global Content Plan when Lead Market or Region are populated on the Content Plan Template.
|
DEV-587946* |
|
Users are unable to access the Archive Viewer from any application if they do not have Submissions Metadata permissions.
|
DEV-588339 |
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The Submissions Archive Viewer does not display country metadata for Ukraine (UA) submission sections M1.0 and M1.2.
|
DEV-588486 |
|
In some cases, Vault allows users to regenerate comparisons and does not display the appropriate error message.
|
DEV-588731* |
|
Object page layouts do not display configured Help Text for the Publishing Status field.
|
DEV-588756 |
|
When bundling Activities, the wizard’s summary page incorrectly displays Regulatory Objective records the wizard does not eventually create.
|
DEV-589511 |
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When creating Active Dossier Item Detail records during publishing, Vault incorrectly sets the “Is eCTD” field to Yes for non-eCTD dossier formats with blank UUIDs.
|
DEV-589613 |
|
The Submissions Archive Viewer displays duplicate Correspondence document sections for some imported Submissions.
|
DEV-589959 |
|
When a user does not have View permission on a document, the Active Dossier Viewer displays a blank hovercard without the expected error message.
|
DEV-590567* |
|
When bundling Activities, the wizard's summary page does not show information for Regulatory Objectives that will be set to Inactive.
|
DEV-590754* |
|
Vault does not update Active Dossier Item Detail records’ Active Dossier Status field when a user initiates the related workflow from a Regulatory Objective.
|
DEV-592254 |
|
When a user accepts or rejects a comparison, Vault does not populate the user's name in the Dispatch Message record's Reviewed By field.
|
DEV-592304* |
|
The Publishing Progress Indicator CSV file provides insufficient error details when a Content Plan contains STF leafs without the XML STF DTD/XSD Version specified on the Submission.
|
DEV-592683* |
The RegulatoryOne release, including all Platform fixed issues, is targeted for tentative availability on July 11, 2023.
The Safety release, including all Platform fixed issues, is targeted for tentative availability on July 6, 2023.
| Description |
Issue No. |
|
Fixed an issue where an Inbox Item could be promoted by multiple users at the same time, which resulted in duplicate Cases.
|
SAF-34840 |
|
Fixed an issue where email questionnaires were not generated for Blinded Study Cases although questionnaire templates without specified Products existed.
|
SAF-41139 |
|
Fixed an issue where, when a Case contained no eligible Products for a specific agency, custom SDK Reporting Rule Parameters for that agency’s Rule Set resulted in an error.
|
SAF-41144 |
|
Fixed an issue where, when adding Product records through Vault Loader, import was prevented if the file included multiple Products with the same generic name.
|
SAF-41433 |
|
Fixed an issue with E2B import where, after the import acknowledgement was received, the Body and Code fields on the Transmission Message of the Inbound Transmission record were not updated.
|
SAF-42016 |
|
Fixed an issue with E2B import where, when the New Info Date was in the future, the Inbox Item Details section did not display a validation error and the Case could be promoted.
|
SAF-42240 |
|
Fixed an issue where promoting Pregnancy Inbox Items to Cases was prevented when Organization was set to required on the Child Information object type.
|
SAF-42299 |
|
Fixed an issue with adding Case Identifiers to Inbox Items where using the keyboard shortcut (TAB, Enter) on the Add Identifier button did not result in Case Identifier fields being added.
|
SAF-42439 |
|
Fixed an issue where, in some instances, editing Case Products caused a system error to occur.
|
SAF-42495 |
|
Fixed an issue where, when an Inbox Item was created from an E2B file with invalid patient data, invalid data error messages were not displayed until the Verify button for that section was selected.
|
SAF-42514 |
|
Fixed an issue on Inbox Items where, if Case Access Group Security was enabled, custom-type Action Item records could not be displayed.
|
SAF-42567 |
|
Fixed an issue where the Anatomical Site field did not appear in the Case Product Dosage section for Company Product product types.
|
SAF-42569 |
|
Fixed an issue with merging Inbox Items to In-flight Cases where, if the primary Adverse Event was not the same on the Inbox Item and Case, the Assessment Ranks were not updated to reflect the new Adverse Event Ranking.
|
SAF-42578 |
|
Fixed an issue where, when an Inbox Item was edited to add a Study with unspecified Products, previously auto-coded Products were removed.
|
SAF-42680 |
|
Fixed an issue where, after adding a Study Product using the Specify Study Products action, if the user selected Cancel on the Inbox Item the pagination of the Product section was not updated.
|
SAF-42684 |
|
Fixed an issue with downloading the latest MedDRA version where, when there were duplicate Localized MedDRA records, the Update to Latest Version action could not complete.
|
SAF-42686 |
|
Fixed an issue where, when the Inbox Item Medical Events section was not configured to display the Cessation date, after entering a date in the Onset date field an error message was displayed.
|
SAF-42711 |
|
Fixed an issue where, when an Inbox Item with a Localization value was promoted to a Case, each Localized Case Assessment appeared on the Localized Case twice.
|
SAF-42715 |
|
Fixed an issue with E2B import where rows with invalid data were not displayed in the CSV rendition of the file.
|
SAF-42718 |
|
Fixed an issue where, when entering a value in the Case Identifier(s) field, a validation message appeared before the user completed data entry.
|
SAF-42761 |
|
Fixed an issue where Inbox Items could be saved when Case Identifiers were added without a value in the Type field.
|
SAF-42763 |
|
Fixed an issue where, when the Language field on the User Profile was set to a non-English value, the Specify Study Products action was not available.
|
SAF-42769 |
|
Currently, sharing rules and user roles are used to send notifications and emails. If using Case Access Group Security instead, sharing rules must be deleted for the object. Fixed an issue where, when Case Access Group Security was enabled, notifications were not received by the respective users. Now, if Case Access Group Security is enabled, user IDs can be obtained through User Access Group Assignments.
|
SAF-42788 |
|
Fixed an issue where, when importing a multi-Case E2B file, system performance was slow if one of the E2B files was invalid.
|
SAF-42808 |
|
Fixed an issue where, when reporting on Combination Products with an FDA registration and the Transmission Profile Type set to Drug, Device-type Constituent Products were included on FDA 3500A files even when neither of the Drug or Device Constituents had an FDA registration.
|
SAF-42812 |
|
Fixed an issue where, when reporting on Combination Products without an FDA registration, Device Constituent Products were excluded from FDA 3500A files even when the selected Transmission Profile was not set to exclude Device Constituents by default.
|
SAF-42814 |
|
Fixed an issue where, when using an API version prior to 22.3, E2B(R3) files could not be imported.
|
SAF-42816 |
|
Fixed an issue with the Specify Study Products window where the horizontal scroll bar was hidden.
|
SAF-42825 |
|
Fixed an issue where Case Processors with Read-only permission could select or deselect the Pregnancy Case checkbox on Inbox Items. After selecting Save, their edited checkbox setting was not saved.
|
SAF-42881 |
|
Fixed an issue with E2B import where, when a unit value was invalid in section D Patient Characteristics or E.I Reaction(s) / Event(s), the CSV file did not include a warning.
|
SAF-42890 |
|
Fixed an issue where, when the Async Submit to Gateway action was used, Submissions with a Transmission Profile Type of Manual that were created on a Case moved to the Queued state.
|
SAF-42997 |
|
Fixed an issue where, when adding multiple Study Products through the Specify Study Products window, Rank 1 was assigned to a Product other than the first Product selected.
|
SAF-43030 |
|
Fixed an issue where system performance was slow when importing large E2B files to create Inbox Items.
|
SAF-43032 |
Fixed an issue with PMDA E2B(R3) export where, when Localized Cases for Japan included PMDA Rank 1 Product Registrations for both the INV and PMK Registration Categories, the following data elements were not exported to the Investigational report:- J2.12 Clinical Compound Number (CCN)
- All data elements in section J2.13.r
- C.5.2 Study Name
|
SAF-43104 |
|
Fixed an issue with indexing newly migrated Cases where, if Cases were created and then deleted from the Vault, the system considered the deleted Cases to be missing and indexing was not turned off.
|
SAF-43136 |
|
Fixed an issue with creating Follow-up Cases where, when the Case included more than 500 Product records, Case Assessments and Assessment Results were not displayed on the Case Compare page.
|
SAF-43228 |
|
Fixed an issue with creating Inbox Items received through the Intake API where, when Case Access Group Security was enabled, the Intake user was not given access to source documents they imported.
|
SAF-43360 |
|
Fixed an issue where, when adding multiple Products to an Inbox Item at once, changing a column width on the Specify Study Products window caused a system error to be displayed.
|
SAF-43494 |
|
Fixed an issue with sending AS2 transmissions through the Safety Gateway where, when the AS2 Message ID exceeded 128 characters, Submissions could not be sent. Now, the field supports up to 256 characters.
|
SAF-43706 |
|
Fixed an issue with PMDA E2B(R3) export where, when a Japan Localized Case included multiple Local Reporting Details records with unique Report UIDs, the Report UID from the first-created Local Reporting Details record was populated in the N.2.r.1 Message Identifier and C.1.1 Sender's (case) Safety Report Unique Identifier data elements of all Submissions.
|
SAF-43866 |
The Veeva Claims release, including all Platform fixed issues, is targeted for tentative availability on July 11, 2023.