| Description |
Issue No. |
|
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* |
|
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, the Study Archival job notification # Archived document link directs users to a "No items found" page.
|
DEV-969797* |
|
In some cases, the Comment dialog header remains blank when users navigate between subsections in the Disclosure Form.
|
DEV-969998* |
|
In some cases, users receive a server error when attempting to access Study Personnel records.
|
DEV-970626 |
|
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 |
|
Vault incorrectly allows Sponsor users to create Distribution Tasks using the Sign from the Site Package Grid action.
|
DEV-973206* |
|
In some cases, Vault duplicates the archival audit trail of the original document when creating a Snapshot document of a document with a signature page.
|
DEV-973524* |
|
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* |
|
The Create Expected Documents job notification does not display the corresponding Study, Study Country, or Site values.
|
DEV-973953* |
|
When eCOA End-of-Study Media documents are transferred to the Clinical Operations Vault, the Clinical Operations Vault creates the document in the Draft state instead of the Approved state.
|
DEV-974051* |
|
When users click between subsections in a Disclosure Form with the Comment dialog open, the dialog header updates but the dialog continues to display the comments from the previous section until the new section loads.
|
DEV-974210* |
|
When a user queues two Archive Study jobs and the job for the first Archive Study job fails, Vault fails to queue the second Archival Study job.
|
DEV-975056* |
|
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 |
|
When users are editing a Disclosure record, open dropdown menus display over the Comment dialog.
|
DEV-975721* |
|
Users do not receive the expected error message in the dialog box when removing the Patient Registry from a copied Disclosure record.
|
DEV-975868* |
|
In some cases, users can manually update the Data Change Request field value on OpenData Clinical managed Person or Organization records through the Create Missing Record or Add to Vault actions.
|
DEV-976620* |
|
In some cases, users experience an error when attempting to import US Results Disclosures.
|
DEV-978203 |
|
When users create a missing excluded Investigator or Institution record through the Create Missing Record action on a resolved DCR, some of the OpenData Clinical managed fields do not populate.
|
DEV-978207* |
|
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 |
|
Vault does not enable the Save button when users edit some fields in the ODC section of excluded Investigator or Institution records.
|
DEV-980121* |
|
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 |
|
The text in the Create ODC Institution search and select dialog is too wide, requiring users to scroll horizontally to view the data.
|
DEV-982844* |
|
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 |
|
Vault does not mark Distribution Tasks as Read when users view the document from the PAL Document Viewer.
|
DEV-985558* |
|
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* |
|
In some cases, Monitored Subjects may not be seeded as expected for Date Based Studies.
|
DEV-990179 |
|
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 |
|
Vault creates Milestone Document records for document versions that do not have Milestones.
|
DEV-996303* |
|
An unknown error occurs in some cases when users attempt to enter a USN for a feasibility survey.
|
DEV-998938 |
| Description |
Issue No. |
|
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 |
|
Document Readiness Metrics records are not deleted for documents that are not the latest version.
|
DEV-853800* |
|
Document and binder export fails for failed viewable renditions.
|
DEV-954148* |
|
The binder creation message dialog is be displayed when creating a binder from a template before the binder is validated instead of after.
|
DEV-968342* |
|
The Undo Checkout option is not available for HTML and TXT document formats.
|
DEV-968629* |
|
In some circumstances, barcodes are not generated correctly in viewable renditions, or the rendition fails.
|
DEV-974176 |
|
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* |
|
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 |
|
When creating a new version from the UI, users may receive an unclear error message.
|
DEV-987615* |
|
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.
|
DEV-996748 |
| Description |
Issue No. |
|
When exported to PDF, Object records include invalid links for certain Related Object records.
|
DEV-1002819* |
|
In some cases, document object reference fields do not render correctly in word formatted outputs.
|
DEV-906222* |
|
Under certain circumstances, users are unable to Create Document on Template via user action from an EDL item if the document type for the record has no local templates.
|
DEV-958775 |
|
Users may encounter a Page Not Found error when clicking the Back to previous page link after deleting a related record.
|
DEV-962957 |
|
In some cases, Action Triggers are executed during certain User object operation and causing the operations to fail.
|
DEV-965487* |
|
In some cases, multi-record select fields may add duplicate records to the Recent section in the drop-down if default values are removed from the field. In addition, the drop-down may stop loading records after 100 selections.
|
DEV-965521* |
|
In some cases, formula fields in Direct Data API export files may return the incorrect value.
|
DEV-966057 |
|
In some cases, users may encounter a server error when attempting to delete a field from a record layout and are prevented from viewing, editing, and creating records using the layout.
|
DEV-972105 |
|
In some cases, Vault may prevent users from deleting default Help Content on standard object fields.
|
DEV-972334 |
|
n some cases, users may encounter an error when attempting to use the Download to PDF action on a raw object.
|
DEV-974792 |
|
In some cases, the Retrieve Available Direct Data Files API may return an Operation Not Allowed error.
|
DEV-975562 |
|
In cases where there are two rowset queries on the same relationship and the first query has a WHERE clause, the second query may not display the expected records.
|
DEV-977089* |
|
In some cases, updates to a Lookup field's source field are not audited and fail to update the Lookup field.
|
DEV-977509 |
|
When users attempt to set an inactive or unavailable picklist value, the error message dialog does not provide info on the specific field.
|
DEV-977628 |
|
In some cases, Vault Comparison reports may show object record components with their public key values.
|
DEV-978574 |
|
In some cases, the blue circle inside a selected radio button in the advanced Search: [Object] dialog may appear misaligned.
|
DEV-978723 |
|
In some cases, the All Related Documents action is not visible for object records with Related Documents sections.
|
DEV-981262 |
|
In some cases, the object reference fields may populate a value when the referenced object is deleted and Set field to blank when related record is deleted is enabled.
|
DEV-982067* |
|
Users with invalid whitespace characters in a record are unable to use Word Formatted Output.
|
DEV-983094 |
|
Users with certain unicode characters in their user names are unable to use Print Record and Word Formatted Ouput.
|
DEV-983229* |
|
In some cases, the screen may start glitching when users view a record detail page in the Safari browser on an iPad.
|
DEV-983284 |
|
In some cases, Show more dialogs may display with a narrow width for Long Text and Rich Text fields, and Lookup fields with a Long Text or Rich Text source.
|
DEV-988213* |
|
In some cases, an object record detail page may error when users select a value from a multi-value picklist field.
|
DEV-988982* |
|
Vault may fail to expand an object record's first Detail section when the page is initially loaded.
|
DEV-990607* |
|
Users may receive an unhelpful error message when attempting to edit standard Formatted Output templates.
|
DEV-999281* |
| Description |
Issue No. |
|
In some cases, filter and conditional fields may not return results for tabular, matrix, and workflow reports.
|
DEV-806831* |
|
The metric legend may be displayed in a randomized order on the Cycle Time Trend graph in a Process View.
|
DEV-953601* |
|
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 |
|
An incorrect error message is displayed in Process Monitor when the selected subprocess exceeds 255 characters.
|
DEV-963289* |
|
When using the Is After or Is Before filter operators on a time field in the Additional Filters section of a Process View, an error is displayed when running the view.
|
DEV-964211* |
|
In some cases, reports containing both an object reference and a document reference with identical names cause timeouts and performance issues.
|
DEV-969923* |
|
Users can view and click Edit and Delete in the Actions menu for system-managed groups in the Report object's custom sharing rules.
|
DEV-971472* |
|
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* |
|
Under some circumstances, an error is displayed when running matrix reports that contain columns for cycle time formula fields.
|
DEV-972532* |
|
In some cases, cycle time functions in report formula fields return blank results for documents where the major version was increased with the Upload new version action.
|
DEV-973433* |
|
Users may encounter a generic error message when attempting to delete a report that references a locked object.
|
DEV-975473 |
|
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* |
|
After updating the name of a picklist value or lifecycle state, the Filter dialog in a Process View displays the previous name.
|
DEV-977897* |
|
An error is displayed when running a Process View with a Quality metric custom chart and no records with a cycle time.
|
DEV-978678* |
|
An error is not displayed as expected when using the MDL RECREATE command on an invalid value in a Process View.
|
DEV-979740* |
|
In some cases, cycle time functions may not appear for selection in Multi-pass Binder with Document and Multi-pass Document Relationship reports.
|
DEV-980218* |
|
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 |
|
In some cases, Vault Owners may encounter a server error when attempting to open a flash report.
|
DEV-980521 |
|
Some dates may be incorrect on the Cycle Time Trend chart in a Process View when the chart data is grouped by week.
|
DEV-985653* |
|
In some cases, when users click Add field to group by (optional), Vault directs them to the Home page.
|
DEV-987305 |
|
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* |
|
In some circumstances, when adding a chart to a Process View, a default Sort By value is not automatically selected, and an error is displayed when running the Process View.
|
DEV-997007* |
|
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* |
|
In some cases, Learners cannot view a Classroom Training Assignment with a substitute. Instead, Vault displays a server error.
|
DEV-1000301* |
|
Vault may fail to display translated text in the Quality Relationships panel.
|
DEV-793799* |
|
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* |
|
Users are able to assign more than 100 documents to a Document Change Control record via Change Authorization records in Business Admin and do not see an error.
|
DEV-961653* |
|
Users are unable to add a document to a Document Change Control record if an older version of the document was previously added.
|
DEV-961655* |
|
Vault may fail to display an error when users attempt to add documents with missing required fields to Document Change Control records.
|
DEV-961660* |
|
Vault displays a server error when the Risk Factor Score on a Risk Factor Scoring record exceeds the maximum allowed Assessment Score.
|
DEV-965483* |
|
Vault displays an error when users attempt to add a filter that includes a decimal number to the Document Control Homepage.
|
DEV-965752* |
|
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 |
|
When a user views the Training Dashboard while the Veeva AI Chat window is pinned, some dashboard panels overflow or are cut off, such as the filter panel.
|
DEV-970601* |
|
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 |
|
In some cases, the Generate Document from Formatted Output action fails for records that have related Reason for Change records.
|
DEV-973144* |
|
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* |
|
In some cases, Learners cannot submit incorrect Quiz answers.
|
DEV-978693* |
|
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 using keyboard shortcuts to navigate the Risk Builder, users cannot scroll a selected cell out of view.
|
DEV-990776* |
|
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 |
|
When a user does not have Read permission for the related_event_type__v field of the Related Event object and navigates to a Change Control that has a Related Events section, Vault displays a server error.
|
DEV-999321* |
| Description |
Issue No. |
|
Rule JP-eCTD4-100 fails when suspending Context of Use in 4.0 Submission.
|
DEV-1001262* |
|
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* |
|
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* |
|
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* |
|
Users receive a console error when navigating to the record detail page from Content Plan Viewer when there is one breadcrumb.
|
DEV-934284* |
|
In some cases, CrossLinks are not matched to Content Plan Items after being recreated using the Revise and Resubmit action.
|
DEV-935609* |
|
In some cases, the Create Related Records wizard does not replace records with defaulted fields.
|
DEV-936922* |
|
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* |
|
Page numbers are not resolved after updating the Publishing Output Location of the Table of Contents continuously.
|
DEV-939259* |
|
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* |
|
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* |
|
Under certain circumstances, users may encounter false negatives for AU 6.6.
|
DEV-963676 |
|
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 |
|
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 |
|
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 |
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Users may receive a false positive for AU rule 4.3.2.
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DEV-979118 |
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The priority number on the 4.0 leaf is set as 0 on suspending a 3.2 submission.
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DEV-979163* |
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The Context of Use block for CPI2 is missing in SU XML but the document is published and displayed in Binder.
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DEV-979630* |
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In RIM Publishing, the Download Certificates button in a gateway profile may not function as expected.
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DEV-980854* |
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When a user runs the Export Excel Tree with All Descendants, and part of it is incomplete on the Content Plan.
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DEV-981290 |
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Users may receive a false positive for EU 11.10.
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DEV-981600 |
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After dragging and dropping to an inactive Content Plan Item, the user interface fails to refresh and a grey overlay persists.
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DEV-982000* |
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Document grid columns are not loaded based on default columns when navigating between Content Plan Items having different default filters in Match Document Mode.
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DEV-982004* |
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When continuous publishing is not enabled and on-demand publishing is triggered, Vault publishes reference leaf matched documents.
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DEV-982012 |
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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.
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DEV-982720 |
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In some cases, XML species keywords are chosen randomly when multiple species exist.
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DEV-983410* |
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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.
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DEV-983758* |
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The data grid action menu does not auto-close after running the "Excel Tree with All Descendants" action.
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DEV-984620* |
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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.
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DEV-984820* |
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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.
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DEV-984983* |
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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.
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DEV-985012* |
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Vault does not update Priority Numbers during continuous publishing of eCTD submissions.
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DEV-985057* |
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The XML Operation incorrectly changes from 'REPLACE' to 'NEW' On Submission Metadata object, when the eCTD4 modified files is empty.
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DEV-986767* |
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In some cases, Active Dossier tasks may become stuck and expire without informing the user.
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DEV-987123* |
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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.
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DEV-987143* |
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Submission Publishing may fail in Publishing Progress Indicator during prevalidation due to missing XML Element Name.
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DEV-987338 |
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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.
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DEV-990164* |
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The Submissions Archive Harmonization Job fails with errors encountered status when importing submissions with all keywords out of order.
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DEV-992201* |
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An extra attribute for the stylesheet element in the regional.xml header displays for Taiwan submissions.
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DEV-992257 |
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When dispatching a Global Content Plan to an an activity that doesn't have the Related Submission populated, Vault displays a server error.
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DEV-992606* |
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When creating a Document Set from a template, the Create from Template dialog footer displays outside the dialog window.
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DEV-993124 |
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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.
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DEV-995251* |
| Description |
Issue No. |
|
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.
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SAF-76832* |
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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.
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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* |
|
In some cases when running the Create Statistical Data action on a Signal Calculation Run, Signal fails to complete the action.
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SAF-84763* |
|
Case Processing users without Read permissions for Inbox Items can promote to Inbox Items to Cases through the Vault API.
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SAF-86825* |
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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 |
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EMA E2B(R3) files generated through the Async Submit to Gateway action do not include the H.5.r section.
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SAF-88902* |
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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 |
|
On E2B-imported Cases, deprecated Assessment Results values display in the Assessment Results grid view, but not the detail view.
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SAF-90032 |
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In Vaults with the Enable Duplicate Search Potential Matches Safety App Page setting enabled, the breadcrumb trail on the Potential Matches page is not visible for non-Vault Owner users.
|
SAF-90615* |
|
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.
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SAF-90771 |
|
After running a Principal View preview of a Workbench Report, the meddra_hlt column displays the record ID instead of the MedDRA term.
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SAF-90924* |
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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 |
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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 |
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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 |
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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.
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SAF-91725 |
|
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.
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SAF-91762* |
|
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 |
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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 |
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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 |
|
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* |
|
During follow-up processing for a global Case with a Japan Localized Case, after accepting a Product Registration deletion on the Inbox Item to Case Compare page, Vault deletes the Product Registration on the Case Product of the global Case, but does not delete the Case Product Registration on the Japan Localized Case.
|
SAF-92511* |
|
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 |
|
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* |
|
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 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 rare instances, when generating Inbox Items from emails, Vault displays an error and does not create the Inbox Item.
|
SAF-93667 |
|
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 displays an error and prevents moving a Case into a lifecycle state configured with "Create Correspondence and Questionnaires" as an entry action.
|
SAF-93994 |
|
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.
|
SAF-93995 |
|
When generating Transmission documents, if a Transmission has an XSD schema error, Vault moves the document to the Validation Error state.
|
SAF-94010 |
|
On EMA E2B(R3) files, the xml comment for D.10.7.1.r.1ab appears as D.7.1.r.1ab.
|
SAF-94114 |
|
When transferring data through the Safety-EDC Connection, values in custom fields do not map to the Safety Case.
|
SAF-94192 |
|
In some instances, an error occurs when validating a MedDRA dictionary license.
|
SAF-94239 |
|
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.
|
SAF-94243 |
|
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.
|
SAF-94273* |
|
When generating CIOMS I (Chinese) forms, Vault cannot export more than two characters to Field 1a. Country.
|
SAF-94298 |
|
If the Datasheet field on Case Assessment Expectedness records is blank, the Reporting Rules Engine cannot run.
|
SAF-94348 |
|
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.
|
SAF-94381* |
|
Vault creates a new MedDRA Synonym if a reported term includes leading or trailing spaces but would otherwise match an existing MedDRA Synonym.
|
SAF-94481* |
|
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.
|
SAF-95083 |
|
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.
|
SAF-95217* |
|
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.
|
SAF-95241 |
|
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.
|
SAF-95281 |