Description |
Issue No. |
Under certain conditions, the User Role object may allow saving records without required fields.
|
DEV-487722* |
Under certain conditions, a Vault to Vault connection cannot be set to pending. As part of this fix, we renamed the Make Connection Pending action to Reset Connection.
|
DEV-504943* |
Users experience a server error when using the "Save + Create" option to create multiple field rules within an integration rule.
|
DEV-516883* |
If a user changes their name, the username column of new system audit events remains the same.
|
DEV-536105 |
When creating or editing a date-based document or object job definition and adding additional conditions on datetime fields, Vault adds the time zone to the selected date and time, which users must delete in order to save.
|
DEV-536288* |
Vault configuration reports may not correctly display the Password Expiration security policy and other security policy fields with custom values.
|
DEV-536712 |
Vault configuration reports with the Atomic Security component type do not show data for all object lifecycles.
|
DEV-536823* |
When creating or editing a date-based document or object job definition and adding additional conditions on datetime fields using the "is in the range" condition, Vault converts values to date type.
|
DEV-538323* |
Vault fails to execute date-based document or object operation jobs when the trigger date is a datetime type field.
|
DEV-539575* |
In some cases, Vault fails to send notifications for date-based object or document jobs with no operation actions.
|
DEV-539687* |
When delegating access, quickly clicking the "Grant Access" button multiple times will create duplicate access entries.
|
DEV-539731* |
In some cases, users are unable to delegate access to other users.
|
DEV-541346 |
Match EDL Items jobs complete with a status of "Errors Encountered" when run multiple times within a few minutes.
|
DEV-541791* |
Users may experience performance issues when updating User record security profile references and/or performing CRUD operations on User Role records.
|
DEV-541921 |
In some cases, Vault configuration reports with the Atomic Security component type fail with errors.
|
DEV-545144 |
Users are unable to create a new user via the API if the username contains an apostrophe.
|
DEV-549070 |
Description |
Issue No. |
The Domain Admin UI allows editing the 'My Veeva Integration' user.
|
DEV-516274* |
In some cases, Vault generates excessive CTN Data Change Log records for CTN CP/Organization Change Log records.
|
DEV-529286 |
In rare cases, users encounter a server error when attempting to open the TMF Viewer.
|
DEV-530752 |
In some cases, Vault does not correctly log the Study Country and Study Site STAT in CDMS when running the CTMS/CDMS Inbound Job for a new study.
|
DEV-531043* |
When running the Generate Missing Milestone action when no milestone has been recorded, Vault incorrectly displays an error.
|
DEV-534062* |
In some cases, Blinding for High Volume Objects is not working as anticipated, with certain fields being viewable/editable despite the security settings.
|
DEV-536123* |
Vault automatically transfers Study Country and Study Site records for Studies even if users have not taken the Transfer in Scope action.
|
DEV-537963* |
When the Exclude Inactive Document Types from Document Matching setting is enabled, users experience a server error when running the Match Documents action.
|
DEV-538210 |
In some cases, Vault does not correctly apply auto-naming rules on documents.
|
DEV-538270 |
In some cases, when accepting an ePRO Connected study invite and selecting an existing Study to merge to, users may receive an error.
|
DEV-539286 |
When running the Create Related Document from Template action where the Certified Copy field is blank, Vault displays an error message that includes the field's public key (certified_copy__v) instead of the field label (Certified Copy).
|
DEV-539571* |
In some cases, when users search for documents in the TMF Viewer, Vault displays the Title field value incorrectly.
|
DEV-540039 |
Some users are unable to run the Create Subsequent CTN action or job.
|
DEV-540169 |
Users sometimes encounter an error when attempting to open trip reports with multiple sections.
|
DEV-540422* |
When attempting to transfer a document from a RIM Vault to a Clinical Operations Vault with a country that is not present in the Clinical Vault, the resulting User Exception Message contains incorrect information about the error.
|
DEV-541003* |
In some cases, the Monitoring Compliance Summary job does not complete successfully.
|
DEV-541245 |
When using the Generate CTN action, users may be blocked by change logs being created that they are unable to remove.
|
DEV-542190 |
Vault sometimes displays an incorrect error message when users attempt to save Confirmation/Follow-up Letters.
|
DEV-543398 |
Safety Distribution jobs fail if they do not have an email address for every Distribution Task Recipient.
|
DEV-544262 |
In some cases, users encounter a server error when attempting to activate a Person record.
|
DEV-545615* |
In some cases, users encounter an error when attempting to download the EDL Updates from Other Sites CSV.
|
DEV-545620* |
In some cases, users encounter an error when attempting to transfer large files (documents) using CDX.
|
DEV-547212* |
Some users encounter an error when attempting to update Expected Document records.
|
DEV-549270 |
In some cases, Vault may incorrectly change inactive lookup fields to active after object changes.
|
DEV-550264 |
Description |
Issue No. |
In some cases, after manually adding a rendition and performing the Make a Copy action, Vault lists an incorrect file size for the copied rendition.
|
DEV-452093* |
Vault displays an inaccurate error message after users attempt to merge a deleted anchor.
|
DEV-460882* |
In scripts that do not separate words with spaces, such as Chinese, Japanese, Korean, and Thai, Vault treats each character as a separate word, which causes issues with tone markers and vowels (Thai only), searching, and bounding boxes.
|
DEV-507153* |
In some cases, when attempting to perform the Triage workflow action, users may receive a 'Server having problems' error and observe that the workflow action fails to complete.
|
DEV-521362 |
In rare cases, Vault fails to generate a viewable rendition after receiving a Spark message via a Vault connection.
|
DEV-528435 |
Users may receive a 'Server having problems' error when attempting to update a crosslink.
|
DEV-528911 |
In some cases, users may be unable to choose cloned rendition profiles in the document field drop down which may result in rendering documents with incorrect profiles.
|
DEV-530407 |
In rare cases, users are unable to view or download viewable renditions after performing a custom web action.
|
DEV-532349 |
After using Document Migration Mode to create a minor version with a previously used version number, deleting the approved version takes a long time to complete.
|
DEV-534758* |
In rare cases, Vault may display duplicate breadcrumb trails when viewing binder versions.
|
DEV-536175* |
In some cases, PDFs that fail to render may lose manual renditions when re-rendered.
|
DEV-538643* |
Users are unable to click embedded links that contain exclamation marks in the viewable rendition of a document.
|
DEV-539062 |
When a document is reclassified from one lifecycle to another and the two lifecycles have overlapping roles (same name, same application role) Vault will create "duplicate" roles on the document.
|
DEV-540188 |
Users are unable to export document fields from the Library page in grid view.
|
DEV-541562 |
In rare cases, renditions fail to render correctly.
|
DEV-541844 |
Users may experience performance issues when selecting the "Expand All" action on legal holds.
|
DEV-541953 |
When two Vaults are on different PODs, the Source Binding Rule field is not editable on CrossLink documents.
|
DEV-542147* |
After clicking Export Annotations in a Safari browser, users see a blank page.
|
DEV-543039 |
If a document text field is named score__c, it will not correctly display numbers in report and VQL output.
|
DEV-543700 |
When comparing two document versions, Vault may fail to indicate where text was deleted.
|
DEV-545911 |
Vault displays an unhelpful error message after users attempt to import annotations from documents with file names exceeding 218 bytes in length.
|
DEV-546105 |
In some cases, after a user upversions an object attachment to version 5 or greater, Vault fails to generate the viewable rendition for the attachment.
|
DEV-547917 |
In rare cases, manually uploaded viewable renditions may be replaced by a system-generated rendition.
|
DEV-550216 |
In some cases, when attempting to publish and merge a Report Level Content Plan, the documents may fail to merge.
|
DEV-550434 |
Description |
Issue No. |
When attempting to move a Document Change Control's Change Authorization to an Approved state with missing required data, the error message does not correctly display which data is missing.
|
DEV-523546* |
Creating a Quality Team role with a Linked Field value which targets a base object type may result in Vault displaying a server error rather than a helpful error message.
|
DEV-525932 |
In some cases, a date field token used in a Quality External Notification may resolve to an incorrect date.
|
DEV-530398 |
When the Document Change Requests or Periodic Review auto-link action runs at the same time that a Change Authorization is approved, the DCR or PR may not automatically link corresponding to the documents that were added via Change Authorization.
|
DEV-535391 |
Vault displays API names instead of labels in error messages if it fails to transition a record's state type.
|
DEV-535913* |
The Vault LIMS test step selector contains a misaligned arrow icon.
|
DEV-537926* |
The Vault LIMS test step selector may not display the correct alert icon for a step.
|
DEV-538324* |
Under certain circumstances, it is not possible to make new Specification versions effective without first removing the Specification Mappings on the prior version.
|
DEV-539281* |
In some cases when using a Quality Document Generation action, roles are not populated as expected on the generated document.
|
DEV-539377* |
Certain configurations may cause Vault to display an error when attempting to view a Quality Team Configuration.
|
DEV-542262 |
Some users with the All Objects - Create permission in their production Vaults may incorrectly see a new Select Person Type dialog appear whenever attempting to create new person records.
|
DEV-542349 |
When editing reopened test results in Vault LIMS, the Out of Specification and Out of Control icons may not appear as expected.
|
DEV-542606* |
In some cases when editing reopened test results in Vault LIMS, calculated results may not update as expected after edits.
|
DEV-542607* |
Vault may display an error when the Issue Training Assignments entry action attempts to calculate document revision training due dates based an empty date field.
|
DEV-543022 |
Station Manager users may incorrectly see a user permission error message.
|
DEV-543126 |
In some cases, Push to Register may fail when an Assessment Risk is pushed to multiple Risk Registers.
|
DEV-543936 |
Under certain circumstances, the QMS to RIM connection may incorrectly generate User Exception Messages for each unconnected Activity when it enters an applicable lifecycle state.
|
DEV-544566 |
Documents on training assignment cards may display with additional document numbers.
|
DEV-546313 |
Vault LIMS may not display the correct value when hovering over alerts for values in the Specification Criteria Evaluation section.
|
DEV-553219* |
Description |
Issue No. |
During continuous publishing, Vault does not publish links to published target documents correctly.
|
DEV-372269* |
When continuous publishing is enabled, if a user unmatches a document, Vault creates a placeholder document but doesn't populate the Application and Submission document fields.
|
DEV-421083* |
When a user matches and then immediately un-matches a target document linked to a published source document, Vault does not remove the link to the target document from the source document during continuous publishing.
|
DEV-445829* |
Publishing fails during the validation phase for any files containing unresolved embedded links.
|
DEV-462336* |
When a user sets a reference leaf from a Content Plan Item containing documents matched to multiple Content Plan Items, Vault selects the first document in the hierarchy instead of the one selected in the UI.
|
DEV-527263 |
In Vaults with multiple gateway profiles, Admins cannot set each profile with a separate corresponding message sender for attachment-only XEVMPD submissions.
|
DEV-530762 |
Users without Application field Read permission on the Submission Active Substance and Submission Drug Product objects cannot filter the new Submissions Archive Viewer by the Submission Manufacturer object.
|
DEV-534262* |
While the Source for Published Document field is set to a custom rendition, Vault incorrectly uses the viewable rendition as the source for published outputs.
|
DEV-535985 |
In some cases, users may receive errors when attempting to create Submission/Regulatory Objective joins via the Submission Wizard.
|
DEV-536996 |
In some cases, users are unable to remove duplicate Submission Modes or experience missing Submission Modes within the Submission Administrative Information for EU worksharing submissions.
|
DEV-537733 |
Vault does not create IDMP Pack Size records when the Registration or Registered Packaging fields are not populated on a related Pack Size record.
|
DEV-537749 |
When a source document is linked to a matched target document and the source document is matched during continuous publishing, Vault does not execute some PDF validation rules.
|
DEV-537808* |
Vault does not display the default view in the grid when a user deletes a saved view from the new Submissions Archive Viewer.
|
DEV-537945* |
When the Content Plan Hierarchy State Change asynchronous system action is executed, Vault notifies the last user to complete the workflow task instead of the workflow initiator.
|
DEV-538017 |
Active Dossier Viewer may show rows that do not reflect the user's selected region filters.
|
DEV-538228 |
If a user runs on-demand on an item in an ad promo section with inactive promotional material sections in the same content plan, they receive an error and the item fails to publish.
|
DEV-538667* |
In some cases, while using the Manage Registered Details wizard, Vault fails to display registrations on the "Add New Details" page.
|
DEV-538706 |
Publishing jobs may fail if the application folder name or document name in POL contains the "%" character.
|
DEV-539059 |
When managing registered details, the Edit and Verify page does not display an error on the Regulatory Objective and Lifecycle State required fields if blank.
|
DEV-539110* |
Under certain circumstances, Vault fails to publish the source document during continuous publishing after users inactivate then reactivate the source EDL item.
|
DEV-539133* |
When creating related submission records, the Submission Type drop-down does not include the Global Submission Type.
|
DEV-539356* |
When defining Clinical Study relationships in the Submission Wizard, users without appropriate permissions cannot select specific Clinical Study relationship records.
|
DEV-539481 |
In some cases, hovering and clicking on documents in the New Submissions Archive Viewer results in an error.
|
DEV-539626* |
Under certain circumstances, Vault fails to publish US AdPromo Submissions if there are inactive EDLs.
|
DEV-539688* |
The new Submissions Archive Viewer displays nodes expanded (instead of collapsed) if the Submission join filter returns multiple submissions.
|
DEV-539692* |
If a document is open in the new Submissions Archive Viewer, users receive a network issue error message when applying a filter to the Name column.
|
DEV-539753* |
Users may receive a server having problems error when editing an application record.
|
DEV-539791 |
In some cases, Vault fails to correctly display Japanese Submissions in the New Submissions Archive Viewer.
|
DEV-539835* |
If a user does not have access to view an application record, they may see an unhelpful error message rather than the empty viewer.
|
DEV-540744* |
Vault incorrectly reports Rules 16.BP2 and 16.BP3 as failed when a link begins with a “mailto:” prefix.
|
DEV-541079 |
Users cannot export EAEU submissions imported into Submissions Archive.
|
DEV-541345* |
Vault incorrectly reports AU, CA, TH, JP, and CN rules related to regional XML as failed.
|
DEV-541379* |
In some cases, users are unable to complete checklists due to issues with dependent question behavior.
|
DEV-541611 |
In some cases, Vault fails to save and load user preferences in the Submissions Archive Viewer.
|
DEV-542031* |
In some cases, Vault fails to discard unsaved changes after users modify and refresh the Active Dossier viewer.
|
DEV-542167* |
In rare cases where it is necessary, users are unable to have duplicate Application UUIDs in the same Lead Market.
|
DEV-543291 |
In the new Submissions Archive Viewer cumulative view, leaf title text exceeding 512 characters overlaps other leaf cards in the view.
|
DEV-544257* |
The new Submissions Archive Viewer displays STF XML in the current view.
|
DEV-544259* |
Under certain circumstances, Vault displays an incorrect error message when users attempt to dispatch a Global Content Plan with missing records.
|
DEV-544344* |
Vault incorrectly reports Rule 14.BP3 as failed if the file name begins with “specifications-”.
|
DEV-544364 |
The new Submissions Archive Viewer grid does not load when a text filter includes a blank space at the end of the alphanumeric search term.
|
DEV-544856* |
In some cases, Vault incorrectly creates duplicate Activity Dependency records.
|
DEV-545064 |
In some cases, when the Registration lifecycle includes entry criteria fields to which a user does not have edit permission, Vault does not display the Save and Verify button when managing registered details.
|
DEV-545640* |
Vault incorrectly reports Rule G32 as failed when two submissions within the same CA application have different published XML language values.
|
DEV-546087 |
Vault incorrectly reports Rule 1154 as failed when the target submission has a previous Regional XML version (2.01).
|
DEV-549242 |
Users are unable to view the Submission Wizard's result CSV files on any Regulatory Vault that does not have the RIM Submissions app enabled.
|
DEV-551963 |
Users are unable to add more than 12 Regions to the 'Automatically generate medicinal product records' setting.
|
DEV-553932 |
When a Correspondence document is associated with at least one Null-status submission record, any subsequent Correspondence documents are not picked up by the Correspondence feature.
|
DEV-553956* |
The RegulatoryOne release, including all Platform fixed issues, is targeted for tentative availability on February 21, 2023.
The Safety release, including all Platform fixed issues, is targeted for tentative availability on February 16, 2023.
Description |
Issue No. |
Fixed an issue with FDA E2B(R2) files where, when there was no patient death or parent information, blank tags were exported for the B.1.9 Patient Death and B.1.10 Parent data elements.
|
SAF-13587 |
Fixed an issue where page layout rules with field-level conditions were not immediately executed in the same edit session when a field was part of a control. For example, when a case was promoted for a male patient, and then the Gender field was subsequently changed to Female, the gender-specific fields such as pregnancy information did not appear immediately.
|
SAF-29964 |
Fixed an issue where, when user actions were prevented while the system generated Case Narratives, error messages did not describe the cause of the issue.
|
SAF-33377 |
Fixed an issue with E2B(R3) validation where the ICH.C.5.1.r.1 data element always required that the Study Registration Number was populated with a valid unique EU trial number or EudraCT number. Now, this validation criteria applies only to Transmissions to the EudraVigilance Clinical Trial Module (EVCTM).
|
SAF-34818 |
Fixed an issue with E2B import through API transmission where, in some instances, the Retrieve Job Status API call did not return acknowledgements after successful imports.
|
SAF-34985 |
Fixed an issue with CIOMS I and FDA 3500A preview generation for Study Cases without Case blinding, when a blinded Study included open Study Arms, the report data was masked. Now, when a Study Case is not set to be blinded and the blinded Studies included open Study Arms, Vault Safety includes the option to generate unmasked report previews. Enablement: Support
|
SAF-35118 |
Fixed an issue with copying patient information from an existing Case to a new Case where, when Narratives were copied, additional Narrative documents were generated and prevented Case processing.
|
SAF-35553 |
Fixed an issue with generating FDA E2B(R2) files with device-specific adverse events where International Medical Device Regulators Forum (IMDRF) codes for Medical Device Problems and Investigation Conclusions were not exported correctly.
|
SAF-35844 |
Fixed an issue where, when an Inbox Item was merged to an in-flight Case and the Adverse Event was changed, after the merge the Case Assessment name was not updated, although the Case name and Adverse Event record were updated correctly.
|
SAF-35938 |
Fixed an issue with E2B import where, when the Auto-select Inbox Item Localization by Reporter Country feature was enabled and an Inbox Item had a Localization Type of Local, the system mapped the Name (Reported) field to the localized field instead of the global field (English).
|
SAF-35958 |
Fixed an issue with E2B file export where, when a Case with a Combination Product also included a non-Combination Product with a Drug Role of "Similar Device", the Product with the Drug Role of "Similar Device" was exported to all E2B Transmission formats. Now, those Products are exported only to FDA E2B(R2) and FDA VAERS E2B(R3) formats.
|
SAF-35963 |
Fixed an issue with generating FDA 3500A forms where the Due in Days calculation was not updated to reflect the Due Date calculation.
|
SAF-35964 |
Fixed an issue where, when the value in the Case Test Result (Unit) field did not comply with the EMA Unified Code of Units of Measure (UCUM) list, the Submit to Gateway action was not prevented, resulting in Negative Acknowledgement (NACK) messages.
|
SAF-36122 |
Fixed an issue with E2B export where values in the Study Name (Continued) field were not populated in the C.5.2 Study Name data element of E2B(R3) files.
|
SAF-36184 |
Fixed an issue with E2B(R3) import where, when the C.5.2 Study Name data element included more than 1,500 characters, import failed instead of populating the additional characters in the Study Name (Continued) field, as expected.
|
SAF-36218 |
Fixed an issue where, when a PSMF PDF was generated from a global PSMF Binder, in some cases the Table of Contents displayed template text instead of text from the binder documents.
|
SAF-36220 |
Fixed an issue with evaluating the Downgrade reporting rule parameter for Clinical Trial Cases where, when the Safety Rule Set had Product Selection set to "Most Conservative Product", the most conservative product on the original Case was not considered. Now, the most conservative product on both the original and Follow-up Case is evaluated to determine if the Clinical Trial Case's seriousness, expectedness, and relatedness have been downgraded or upgraded.
|
SAF-36440 |
Fixed an issue with E2B(R2) file export where, when only a non-primary Case Adverse Event was Serious, the A.1.5.1 Serious data element was set to "No" although the A.1.5.2 Seriousness Criteria was set to "Yes" for the applicable Seriousness Criteria. Now, when any Case Adverse Event includes Seriousness Criteria, the A.1.5.1 data element is set to "Yes".
|
SAF-36441 |
Fixed an issue where, when creating binders with custom document types, after selecting Save the system displayed an error message although the binder was saved. This issue did not prevent merging binder documents into a PDF.
|
SAF-36450 |
Fixed an issue where, when voiding localized Follow-up Cases, generated Transmission records linked to the original Localized Case, instead of the Follow-up Case.
|
SAF-36554 |
Fixed an issue with Localized Cases where values in the English Event (Reported) field were overridden with MedDRA terms when adverse events were coded through the MedDRA browser.
|
SAF-36617 |
Fixed an issue where, when Inbox Items were created through email intake, the Receipt Date field was populated with the date the email was sent. Now, when Inbox Items are created through email intake, the Receipt Date field is left blank.
|
SAF-36707 |
Fixed an issue where global Case data was not synchronized to follow-up foreign Localized Cases when the associated Transmission records were created by rules evaluation.
|
SAF-36713 |
Fixed an issue with manual Submission and Distribution creation where, when a Transmission Profile was selected, the system did not apply some settings to the Submission or Distribution record. Now, the following Transmission Profile settings are applied to the record:- Outbound Format
- Additional Output Formats
- Sender User
- Message Subject (including tokens)
- Message Body (including tokens)
- Cover Letter Template
Enablement: Support
|
SAF-36734 |
Fixed an issue with E2B(R3) file generation where, when a patient's height was less than 10 cm and included decimals, the value exported to the D.4 Height (cm) data element was not rounded.
|
SAF-36764 |
Fixed an issue where Read access permission for localized objects was required to view Inbox Items without localization.
|
SAF-36824 |
Fixed an issue where, when a Transmission was created manually and then the Transmission Document Type was later changed to E2B, the E2B Message ID was not generated.
|
SAF-36831 |
Fixed an issue where, when a Case Product had a Drug Role of Concomitant and the related Dosage record had partial dates (for example, YYYY-MM) in the First Admin Date or Last Admin Date fields, the New Case - Copy Patient Information action was prevented.
|
SAF-36913 |
Fixed an issue where, when the Cumulative Dose field on the Case Product was missing a unit value, E2B(R2) export failed.
|
SAF-36989 |
Fixed an issue where, when a Case with an External Product had a Localized Case Submission, changing the External Product and its Substance on a Follow-up Case was prevented by the system.
|
SAF-37129 |
Fixed an issue where, when errors occurred when adding Study Registrations, system error messages did not describe the cause of the issue.
|
SAF-37267 |
Fixed an issue with merging Inbox Items into in-flight Cases where Case identifiers doubled with each merge. This led to a high number of duplicate records with the potential to impact system performance.
|
SAF-37300 |
Fixed an issue where, when atomic security was configured to hide fields with protected health information (PHI) and personally identifiable information (PII), some values still appeared on the Potential Matches page during Case promotion. Now, Vault Safety includes the option to hide all Reporter, Patient, and Adverse Event Onset field values on the Potential Matches page. Enablement: Support
|
SAF-37499 |
Fixed an issue where, when promoting an Inbox Item and merging it into an in-flight Case or creating a Follow-up Case, if a Case child object on either the Inbox Item or the matched Case exceeded the system limit of 300 records, none of the Inbox Item records for that object were applied to the new Case version. Now, the system limit for Case child objects is 500 records.
|
SAF-37528 |
The Veeva Claims release, including all Platform fixed issues, is targeted for tentative availability on February 21, 2023.