Beginning with 25R1.3 and for all subsequent releases, Safety, RegulatoryOne, and Veeva Claims release on the same date as the Veeva Vault Platform.
| Description |
Issue No. |
|
In some cases, site users receive Document Exchange and Safety Distribution notifications for recalled documents.
|
DEV-848149* |
|
When the RIM-Clinical connection attempts to transfer many documents to Clinical, the process can run for over 30 minutes before raising an error.
|
DEV-848716* |
|
In Vaults with active CTMS or TMF transfer agreements, the Source Subartifact field does not update on the target document when users update the Subartifact field on the source document.
|
DEV-851219* |
|
Users with the System Admin security profile cannot save changes to the Category field on Subcategory records.
|
DEV-852883* |
|
Vault does not automatically update the Process Name field value during document reclassification when the field is editable.
|
DEV-853454 |
|
Users cannot add the Confidentiality Recipient value to a Study Person record for a Study Site with an existing inactive Study Person record with the Confidentiality Recipient value.
|
DEV-854520* |
|
An error occurs when users attempt to change the End Date value to a future date on an inactive Study Person record with the Confidentiality Recipient value when an active Study Person record with the Confidentiality Recipient value and an End Date value of today already exists for the same Study Site.
|
DEV-855765* |
|
The Global CTN Data Change Logs job may fail for any Organization used in more than 500 CTNs.
|
DEV-857076* |
|
An unexpected server error occurs when only one document exists in the Vault and users create a Quality Issue from the Business Admin tab.
|
DEV-857529* |
|
In some cases, users cannot update the visit_status__v field of custom object type Visit records to the In Progress value.
|
DEV-858011 |
|
The Document Type field drop-down menu does not group the values by document type and document subtype.
|
DEV-858745* |
|
An unexpected error occurs when users populate the Actual Finish Date field on Milestones where the Milestone Type is blank.
|
DEV-858793* |
|
When the Create Metrics Over Time action runs, the Planned value of a Metric Over Time record with Subject Group is unexpectedly rolled up to the Planned Rollup field on a Metric record with no Subject Group.
|
DEV-858947 |
|
When a failed Distribution Task causes the Distribution Task Recipient for a user to fail, all Distribution Task Recipients for that user across other Sites and Distribution Tasks also fail.
|
DEV-859216* |
|
An unexpected server error occurs when users attempt to resend Document Exchange Distribution Tasks by selecting the Resend to New Personnel action on Distribution Tasks or the Resend action on Distribution Task Recipients.
|
DEV-859330* |
|
The Seed Issues and Create Metrics Over Time actions will not fail at all levels if a Metrics or Metrics Over Time Object Type is inactivated at only one level.
|
DEV-860574 |
|
An error occurs in Vaults configured to send respondents an email containing a PAL link to the PDF version of their survey answers, causing the Vault to fail to send the email to the respondents.
|
DEV-864497* |
|
The Create Milestone from Template job encounters an error when users select all records for the Ad Hoc user action and have a Template Milestone Master Set with both active and inactive template milestones sets at the same level.
|
DEV-868275* |
|
Vault cannot create new Study Person records for users who have duplicate User records but one of them is inactive.
|
DEV-870896* |
| Description |
Issue No. |
|
In some cases, word documents with annotations time out during rendition creation.
|
DEV-830151 |
|
An incorrect error message is displayed when Vault cannot connect to the collaborative authoring SharePoint drive.
|
DEV-833972* |
|
When moving a document to a Steady State while viewing the Document Readiness panel, the Doc Info pane may become blank.
|
DEV-836322* |
|
In some cases, when rendering an .msg file with a default hyperlink color set to white, the email links are not visible.
|
DEV-836424 |
|
Some collaborative authoring notifications are displayed in English only instead of the configured language.
|
DEV-841533* |
|
There are failures in Powerpoint files where an extra tag/text is added during Powerpoint Rendering.
|
DEV-852536* |
|
In some cases, the warning field on HVO objects do not reset to 0 when re-rendering is in progress.
|
DEV-853666* |
|
In some cases, OCR is not requested for .docx and .pptx files when it is created in a binder.
|
DEV-854611* |
|
In some cases, when a document is in the steady state, users do not receive an error message for non-existent documents.
|
DEV-854750* |
|
In some cases, check sections without check items don’t get deleted through check section deletion internal API endpoint.
|
DEV-854823* |
|
When post processing a document that underwent OCR, if PDF/A is enabled, the "Viewable" and "Ready to Annotate" content process statuses temporarily show a Failure status despite a successful rendering.
|
DEV-855362* |
|
When async OCR runs on a .docx or .pptx file, the content process has to be re-completed once OCR finishes. However, the OCR response doesn't have any warning details so the warnings get wiped out.
|
DEV-856878* |
|
Thumbnails may appear in the incorrect sections of linearized document renditions.
|
DEV-858292* |
|
In some cases, merge fields excel files fail to render with a chart sheet.
|
DEV-860383 |
|
In some cases, Viewable CP status remains a "SUCCESS" after deleting the rendition through the batch delete endpoint.
|
DEV-865059* |
|
Under certain circumstances, users may be unable to create viewable renditions of some documents.
|
DEV-868445* |
| Description |
Issue No. |
|
In some cases, Vault may erase label values for help controls.
|
DEV-722825* |
|
Under certain circumstances, the system may change the status of child records when their parent record's status is changed during data migration.
|
DEV-839127 |
|
The User Tree Assignment and Secured Record Tree Assignment objects are not included in Vault Object Configuration Reports and Compare Reports.
|
DEV-840087* |
|
Under certain circumstances, users may be able to modify User Reference Assignment secured record tree assignments, which can cause server errors.
|
DEV-842668* |
|
When users click the Fields using this picklist link on a Status picklist field, they are directed to a blank page.
|
DEV-847266* |
|
Deleting security tree nodes may take a long time if there are many related records.
|
DEV-850578* |
|
Users may encounter a server error when attempting to copy a record that contains a Local Currency field with Do not copy this field in Copy Record enabled.
|
DEV-852903* |
|
Users may encounter an error when attempting to use a legacy user field, such as Modified By (modified_by_v) or Created By (created_by_v), as the default value for a User object reference field.
|
DEV-853324* |
|
Under certain circumstances, the Show in Tab banner does not show when it should.
|
DEV-853663* |
|
When copying a record, if a controlling field does not allow copying, the controlled field is still copied, preventing the user from saving.
|
DEV-854569* |
|
Under certain circumstances, when a user attempts to create an object that has an Organization object field on it, they may receive a server error.
|
DEV-856358 |
|
When a security tree is inactive, users may incorrectly receive record access via the security tree nodes.
|
DEV-857660* |
|
When editing a multi-value picklist, the picklist field may appear out of alignment on screen in Mozilla Firefox browsers.
|
DEV-858599* |
|
Under certain circumstances, validation errors fail to appear for checkbox and certain format mask fields within the Workflow Task Dialog.
|
DEV-859917* |
|
In some cases, users may encounter picklist errors when performing an inline edit on an EDL Template in the Hierarchical Viewer.
|
DEV-860121* |
|
Users are unable to create a secured object and add a parent field in the same MDL statement.
|
DEV-860168* |
|
When users delete a Lookup field or Roll-up field on a child object, the field becomes inactive rather than deleted, and a Roll-up field calculation occurs and fails on the parent object.
|
DEV-861517 |
|
When changing the Verdict in a workflow task, picklist values may behave in unexpected ways such as unexpectedly repopulating and giving a Field Required error when already populated.
|
DEV-862374 |
|
Direct Data API files may contain deletions that do not fall within the expected 15 minute time frame of the file.
|
DEV-862993 |
|
Users may receive a server error when attempting to use RecordByUniqueField() with the api_name__v field for object_type__v.
|
DEV-864250* |
|
In legacy related object sections for Expected Document records with validation rules on a picklist field, the picklist may open when a save fails, which obscures the error message.
|
DEV-865189* |
| Description |
Issue No. |
|
The Auto-Start Periodic Review job fails to run when attempting to process more than 1,000 eligible documents.
|
DEV-780001* |
|
When users edit a cell using the Tab key in the Risk Builder in edit mode, the cursor moves to the next row and column before moving to the correct cell.
|
DEV-836797 |
|
When users select a person who is not an existing user and run the Reassign External Collaborator action, Vault reassigns the task but does not update the External Collaborator field with the reassignment.
|
DEV-839238 |
|
The Risk Builder tool can perform slowly when more than 20 records are added or edited and saved at a time.
|
DEV-843116 |
|
An unexpected error occurs when users search for single or multiple space characters in the Risk Builder.
|
DEV-843358* |
|
Vault displays a server error if users execute the Add Disposition action on a Batch Disposition Plan and they do not have Read permissions for the plan.
|
DEV-844344* |
|
The Batch Disposition Plan picklist displays all plans tied to the batch material when users do not have View permissions to the join records for the plan and organization.
|
DEV-844383* |
|
Vault creates an outbound job incorrectly when users execute the Transfer to Safety action in a Quality Vault that does not have the Quality-Safety Connection established.
|
DEV-849507* |
|
Vault can create a blocking Batch Disposition Item on a primary batch when a related Batch Disposition is cancelled.
|
DEV-853939* |
|
The Item State Check is set to Yes incorrectly for Batch Disposition Checks that have Batch Disposition Items created through the batch’s genealogy.
|
DEV-855784* |
|
Users are blocked from adding Batch Dispositions with dependencies to a related Batch Disposition Plan.
|
DEV-856206* |
|
An unexpected error occurs when users run the Generate APQR Program from Template action.
|
DEV-856469* |
|
When a Batch Disposition Check Item Requirement references a classified document, Vault fails to create the Batch Disposition Item because the classified document cannot be copied.
|
DEV-857157* |
|
Two new DocTypes and Standard Reports, Matrix Assignment: Trial Team Evidence of Training and Matrix Assignment: Site Evidence of Training, were incorrectly provisioned as Active instead of Inactive in all Quality Vaults. Customers not using Study Training can ignore the Standard Reports and ignore or inactivate the DocTypes.
|
DEV-857470 |
|
The Probability of Hazardous Situation (P1) and Probability of Harm (P2) objects have a discrepancy on the Cloning Records field.
|
DEV-857551* |
|
The Item State Check is not updated to No when a new Batch Disposition Item is added to an existing Batch Disposition Check.
|
DEV-857566* |
|
When users enter the Risk Builder in edit mode, Vault skips ahead and does not load an entire page of risks.
|
DEV-858607* |
|
An unexpected error occurs when users click Save in the Select Columns to Display dialog in the Risk Builder.
|
DEV-858650* |
|
A server error occurs on the Record Check Insights page if the CAPA action does not include a Quality Event field.
|
DEV-858804* |
|
An unexpected error occurs when users search for a numeric value in the Risk Builder.
|
DEV-862349* |
|
When users select a Deviation record, Vault loads the record and then displays a blank screen.
|
DEV-863273 |
|
Users are unable to remove documents from a Batch Disposition Check if the document name is too long.
|
DEV-868336 |
|
A server error can occur on a cloned Vault when you configure the Quality Team section on a Deviation or Complaint object.
|
DEV-868489* |
|
Items are created for a Change Control Check when the Change Control is not in a configured state for the genealogy batch.
|
DEV-869127* |
| Description |
Issue No. |
|
Vault annotation links with override or without override are still resolved when Source for Published Document is changed from VR to SD on source EDLItem.
|
DEV-667439* |
|
When exporting an ICH eCTD 4.0 submission package that reuses a file or document from a different application or submission, the sha256.txt and submissionunit.xml files may be missing from the export. This can result in an exported package that does not accurately reflect the content stored in Submissions Archive. In bulk export scenarios, an additional, duplicative folder containing only the reused file may also appear
|
DEV-843123* |
|
In some cases, a placeholder is published on Deduplication scenario when a user matches an existing document to a Content Plan Item with a duplicate Published Output Location.
|
DEV-845314* |
|
Publishing may fail when large PDFs are matched to Content Plan Items and the Source For Published Document field is set to Source Document.
|
DEV-845566* |
|
In some cases, duplicate on-demand publishing jobs are not cleared from the queue.
|
DEV-846958* |
|
The Latest for Authoring field value is not hidden from the detail page and Active Dossier viewer.
|
DEV-847363* |
|
In some cases, a user interface error occurs in the Active Dossier Viewer if the Boolean field is hidden from atomic security lifecycle state.
|
DEV-847368* |
|
Previously, during an ICH eCTD 4.0 based submission import, an internal system error was encountered if the OriginalText attribute in the submissionunit.xml (which populates the 'XML Document Abbreviated Name' system-managed field) exceeded 255 characters. This issue is resolved: the system now correctly blocks the import and displays a specific error message: 'One or more Context of Use elements in this import package has an originalText value in the submissionunit.xml that exceeds the limit that can be stored in Vault.'
|
DEV-847474* |
|
In some merge scenarios, the failure count on the user interface is different from the number of rows in the PPI.
|
DEV-847573* |
|
Previously, when filtering by 'Manufacturer' in a submission's Application View, if the manufacturers were linked via an Active Substance, the filter selection dialog would incorrectly display a maximum of only 250 manufacturers. This occurred even if more than 250 relevant manufacturers were actually associated with the submission through Active Substances.
|
DEV-847941* |
|
When the placeholder which refers to the cross application document is corrected after the harmonization job is run, the corrected placeholder document is not displayed in the viewer.
Internal issue published in error.
|
DEV-848222* |
|
In the Submissions Archive Viewer for ICH eCTD 4.0 submissions, when a Clinical Study section (identified by a sender-defined keywords using ICH Keyword Definition Type 'study id_study title') was expanded manually level-by-level, columns such as 'XML Clinical Study', 'ICH Document Type', or 'XML Clinical Site' could appear blank for documents and sub-sections within that study. A similar issue occurred if these columns were added to the view after the study sections were already expanded.
|
DEV-852007* |
|
Users may receive a false positive for US rules 1734 and 1738.
|
DEV-852375 |
|
In some cases, priority numbers are duplicated when two priority number update actions are performed back to back.
|
DEV-852398* |
|
Dispatch comparison includes the CPI since it is under a parent section which has CPT Constraint and dispatch status is Ready for Review.
|
DEV-852841* |
|
Active Dossier inline editing for Date fields cannot input from keyboard.
|
DEV-853199* |
|
CMED wizard users are unable to select the Apply button when the Contains Core Safety Information field on the Labeling Concept object is configured to be required and selected as “No” (false).
|
DEV-853767* |
|
Active Dossier and Active Dossier Item Detail are not created when the Submission's Application's ADT field is not configured / blank / not active.
|
DEV-854223* |
|
Keywords get incorrectly filtered out if keywords with identical code values exist.
Internal issue published in error.
|
DEV-854971* |
|
In some cases, the Active Substance name does not update appropriately.
|
DEV-856016 |
|
In some cases, Rule4.7.10 fails when Singapore Registration number is empty and product-type is "DMF" for the submission types.
|
DEV-856108* |
|
Required custom DateTime fields display as optional within the Create and Manage Event Details wizard.
|
DEV-856153* |
|
Previously, after expanding / collapsing a section and or applying a sort order to an expanded section (such as 'Sort By Descendants A-Z') within a section of the Submissions Archive Viewer, performing actions like scrolling the screen could cause the sort functionality to behave erratically. This could result in the sort options becoming unresponsive to clicks and the incorrect sort option appearing as disabled (greyed out).
|
DEV-856416* |
|
When using the Download Notes action from a document in Submissions Archive Viewer, the message "403. Sorry you do not have permission to view this page. Contact us if you feel you have reached this page in error" would appear.
|
DEV-856997* |
|
When managing registered details, users may experience extended wait times while Vault commits unverified data.
|
DEV-857182 |
|
A server error occurs for an Active Dossier calculation if there is no Active Dossier Item Detail records for the application.
|
DEV-857638* |
|
In some cases, publishing fails when the "Related Submission Id" field is empty.
|
DEV-857848 |
|
Previously, when multiple submissions were selected using the Submission Filter in the Viewer, the order in which these selected submissions were displayed within the Submission filter interface and the "Submission in" filter in the header area could be incorrect or unpredictable. For example, they might not have consistently appeared in ascending numerical or alphabetical order.
|
DEV-857977* |
|
When the Enable Labeling Automations setting is enabled and the Activity object does not have a configured lifecycle, users updating Activity records receive a generic Server having problems error.
|
DEV-858765* |
|
In some cases, Rule 3.4.9 passes when 5.3.6 node extension title is PBRER/PSUR.
|
DEV-859272* |
|
When multiple page layouts apply to a Registration or Registration join record, the first created page layout determines the input fields displayed for the record on the Edit and Verify page instead of the default page layout.
|
DEV-860397 |
|
Users may receive false positives for CA region rules B35 and B37 on published documents with the .docx extension.
|
DEV-861547 |
|
The Submission Type filter is not displayed when when View_isEmpty is applied.
Internal issue published in error.
|
DEV-861889* |
|
In some cases, when presentation strength values are blank on a source record, Vault miscalculates the corresponding PLL Denominator field values on the resulting idmp_manufactured_item_ingredient__v records.
|
DEV-862410 |
|
Single submission export may fail for submissions if a metadata field that forms part of the submission's source file path (per the Dossier Format: Parameter field, which could contain for e.g., Submission Name, Application Folder Name, Sequence ID) ends with an ellipsis ('...'). Users may encounter an error such as 'Unable to Export Submission, The selection contains zero (0) files.' As a workaround, submissions affected by this issue can typically be exported using the bulk export feature.
|
DEV-863029 |
|
Submission publishing may fail when a Published Output Location contains special characters.
|
DEV-863775 |
|
In some cases, users without permission for the Activity object’s Related Application field receive errors when attempting to create Regulatory Objective records in bulk.
|
DEV-865393 |
|
When automatically generating a Content Plan in RIM via the RIM-PromoMats Connection, if CPI splitting first fails and later succeeds, the Source for Published Document field may be set incorrectly.
|
DEV-865576* |
|
Users may receive false positives on EU v8.1 rules 16.5 and 16.1 due to an issue with PDF validation.
|
DEV-866322 |
|
Submission publishing may fail when a Published Output Location contains special characters.
|
DEV-866981* |
|
When generating Event Shelf Life records via the CMED wizard, users may create records with invalid field combinations.
|
DEV-869256* |
|
In some cases, new Active Dossier Templates have the incorrect Reference Model set.
|
DEV-869904* |
| Description |
Issue No. |
|
When a Validation expression fails while the Void Case action is running, Vault moves the Case to the subsequent lifecycle state without completing all of the expected entry actions.
|
SAF-68736 |
|
When automated Case promotion fails, Vault does not apply Access Groups to the related Inbox Items.
|
SAF-72212 |
|
When attempting to promote an Inbox Item that has no patient information and is in the Marked for Follow-Up state, if Vault matches to a domestic Case, an error appears when loading the Inbox Item to Case Compare page.
|
SAF-73298 |
|
Inbox Items cannot be merged to in-flight Cases or promoted to follow-up Cases if the matched Case has any Localized Cases and the user deletes a Case Product on the Inbox Item to Case Compare page.
|
SAF-73315 |
|
When generating PMDA E2B(R3) files for follow-up Cases initially created by the Safety-Medical Connection, Vault does not format the C.1.4 data element correctly when exporting the Initial Receipt Date from the global Case.
|
SAF-73738 |
|
When a user runs the Void Case action multiple times in quick succession, Vault generates duplicate Transmissions.
|
SAF-74432 |
|
In Vaults configured to isolate blinded clinical trial information, Vault prevents promoting a localized Inbox Item as a follow-up to a global Case that includes a blinded External Product through the Inbox Item to Case Compare page.
|
SAF-75482 |
|
When an Adverse Event is added to global follow-up Case through the Inbox Item to Case Compare page, Vault syncs the data from both the follow-up global Case and the previous foreign Localized Case to the follow-up foreign Localized Case.
|
SAF-75571* |
|
In rare instances, if a difference between the expectedness on the global Case and the local Japan Case causes the most conservative expectedness and Case Tags to be updated multiple times, Vault displays an error if the changes result in a non-unique Case Name.
|
SAF-75656 |
|
In Vaults with incorrect aggregate report templates, when attempting to generate any type of aggregate report, reports remain in the Generating state instead of moving to the Error state.
|
SAF-75862* |
|
In some cases, when updating the Indication (Reported) field on a Case Product record from a nullFlavor to a coded term, Vault fails to update the Product Indication card header to the coded MedDRA term.
|
SAF-76828* |
|
When attempting to promote an Inbox Item created through tabular data import, if Parent age number and unit values exist but Patient age number and unit values are blank, Vault prevents Case promotion.
|
SAF-76901 |
|
When generating E2B readable renditions, Vault does not display the G.k.5a and G.k.9.i.3.2b data element codes correctly and does not include all Case Assessment Results.
|
SAF-76920 |
|
In Vaults configured to always use the CBER Study Transmission Profile when the Study Product Type is Biologic and the CDER Study Transmission Profile for any other Study Product Type for clinical trial study Case submissions with no Transmission Profile specified on the Study Registration, Vault does not evaluate Inv. to Marketing (same agency) cross reporting when generating FDA E2B(R3) files.
|
SAF-76982 |
|
When merging an Inbox Item with a non-Japan Case Product Registration into an in-flight Japan Domestic Case with a Japan Case Product Registration that is not linked to a Local Reporting Details record, Vault displays an error message and prevents the merge.
|
SAF-77047 |
|
When users generate a Case Collection from a Workbench Case Series with 1,000 Case Numbers, Vault does not export any forms to the generated binder.
|
SAF-77069* |
|
If a user edits the WWUID, but not the Case Identifier, on an initial Case and then attempts to promote an Inbox Item with the original WWUID and Case Identifier as a follow-up, Vault displays an error message and prevents the merge.
|
SAF-77083* |
|
In Vaults configured to isolate blinded clinical trial information, after generating a Transmission with PMDA as the destination for an unblinded global Case, when Vault performs the one-time data sync to the Japan Localized Case, it populates the Blinded Reference field on unblinded Localized Case Assessment and Localized Case Assessment Results records, which prevents follow-up creation.
|
SAF-77141 |
|
On FDA E2B(R3) files, for non-clinical trial study Cases, Vault incorrectly exports values to the FDA.C.5.5a IND Number where AE Occurred, FDA.C.5.6.r IND number of cross reported IND, and G.k.1.a FDA Other Characterisation of Drug Role data elements.
|
SAF-77145 |
|
For imported Inbox Items, the Source Data pane for Patient information displays labels with "Gender" instead of "Sex".
|
SAF-77263* |
|
For exported NMPA E2B(R3) files, Vault does not populate the G.k.CN.3 element as expected.
|
SAF-77509 |
|
When generating EU Convention E2B(R2) files with Patient Content Protection set to Mask PII, Vault does not apply masking correctly, which sometimes results in NACKs.
|
SAF-77512 |
|
When the A.2.2 or C.4.r.1 Literature Reference(s) data element exceeds 500 characters, Vault does not truncate the value, resulting in NACKs from agencies.
|
SAF-77604 |
|
When attempting to merge an Inbox Item to an in-flight Case, if a user selects Ignore on any Product or Adverse Event on the Inbox Item to Case Compare page, Vault displays an error message and prevents the merge.
|
SAF-77677 |
|
After running the Retrieve Reportable Case Product Registrations action on a blinded Japan Localized Case, Vault incorrectly generates investigational registrations on the Case Product.
|
SAF-77682 |
|
In Signal, running the Calculate action for the EBGM Signal Calculation Run results in an error when the expected or actual counts return a value of zero (0).
|
SAF-77749* |
|
In Vaults created from the 25R1.0 template, columns and filters in Workbench Views are empty.
|
SAF-77951* |
|
When generating E2B(R2) formats, Vault exports more than five (5) characters to the B.4.k.13.1a and B.4.k.13.2a data elements, resulting in NACKs.
|
SAF-78049 |
|
When generating Transmissions from a Transmission Output Template for a destination with a previous Transmission, Vault populates some fields based on the Transmission Profile instead of the previous Transmission.
|
SAF-78066 |
|
When generating FDA E2B(R3) files, validation fails when the FDA.C.5.5a IND Number where AE Occurred data element is populated and the associated Transmission Profile is a postmarket CDER or CBER.
|
SAF-78067 |
|
When importing custom E2B formats with many Case Assessment updates, in some instances, Vault displays a memory usage error.
|
SAF-78087 |
|
Vault prevents copying Workbench Views that include SQL-restricted terms anywhere in the View.
|
SAF-78100* |
|
If a user disconnects from the Internet while viewing the Case Volume Metrics page, Vault does not display an error message and reduces the header size.
|
SAF-78120* |
|
On adverse event terms coded using the multilingual MedDRA Browser, Vault displays the Non-Primary tag for terms with Yes in the Primary SOC field.
|
SAF-78149* |
|
In some instances, E2B-imported Cases do not include all expected Case Assessment Results.
|
SAF-78168 |
|
In some instances, Vault does not create any Correspondence records due an exceedingly large number of MedDRA Criteria object records with the Include Lower Level field set to Yes.
|
SAF-78204 |
|
In Vaults with the "Suppress File Generation for Auto-Submit Transmissions" application setting enabled, for Email Profile-type Transmission Profiles with Auto-Submit set to "Yes", after running the Case-level "Async Submit to Gateway" action, the Transmission remains in the "Queued for Submission" state and no Submission document is generated.
|
SAF-78218 |
|
When generating NMPA E2B(R3) files, for External Products Vault exports the Generic Name from other Case Products to the G.k.CN.1 data element, although External Products should be excluded.
|
SAF-78250 |
|
For Product Registrations with a Registration Applicant/Holder value that exceeds 60 characters, Vault prevents saving the related Case Product on a domestic Case because the number of characters cannot be mapped to the same field on the Localized Case.
|
SAF-78265 |
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When migrating study data through the Safety-Clinical Operations Connection, Vault creates Study and Study Registration records in Safety Vaults for Study and Study Country records in Clinical Operations Vaults with "M" in the Study Migration field.
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SAF-78309 |
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When coding adverse events through the MedDRA Browser, if a user selects a term that is not in the MedDRA Dictionary and selects the Confirm button twice, Vault creates duplicate MedDRA Term records.
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SAF-78364* |
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On Cases created from E2B(R2) files, if the B.1.9.3 data element value is "3", Vault populates "No" in the Autopsy field on the Case Patient record.
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SAF-78417 |
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When the Reason field on a Transmission is blank, Vault does not generate PMDA MHLW Paper Forms.
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SAF-78452 |
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On generated Workbench Serious Adverse Reaction (SAR) Line Listings, if the active date of the selected Datasheet does not match Case expectedness evaluations based on date range, Vault leaves the Listedness column blank instead of populating "Unlisted".
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SAF-79089* |