The following applications may have different release dates: RegulatoryOne, Safety, and Veeva Claims.
| Description |
Issue No. |
|
When attempting to upload more than 1,000 milestone documents, Vault only creates the first 1,000 and the rest fail.
|
DEV-536674* |
|
When users update a draft of a milestone document using the Create Draft action, Vault does not update the milestone document version accordingly.
|
DEV-547992* |
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In some cases, Vault fails to recalculate the Expected vs Actual field when users upload a new EDL document.
|
DEV-548346* |
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In certain cases, Vault does not correctly update the Requiredness, # Expected, or Expected Vs Actual fields when users upload a new EDL document.
|
DEV-548350* |
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In certain cases, Vault does not create a new milestone document when users add an additional milestone to an existing expected document.
|
DEV-548858* |
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In some cases, Vault does not correctly update the Missing and Overcount fields when expected documents are added or removed.
|
DEV-552451* |
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In some cases, CTMS to CDMS Inbound jobs get stuck in a running state and do not complete.
|
DEV-565653* |
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Vault fails to display an error message or other notification when the TMF transfer fails due to a corrupted source file.
|
DEV-566245 |
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Under certain circumstances, Vault incorrectly allows multiple Study Organization records to be set as the primary payee for a Study Site when there are no existing Study Organizations for the site.
|
DEV-567840* |
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Vault incorrectly displays the envelope icon in the Notifications section of the Home tab.
|
DEV-574813* |
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There is an unnecessary Create button on the Matched Documents object data grid section of the Document Planning and Management display.
|
DEV-576524* |
|
There is no field indicating whether a Payee is specified in one or more Fee Schedules.
|
DEV-577283* |
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Under certain circumstances, site users may experience server errors after selecting a Study from the Tasks widget on the Site User homepage.
|
DEV-577477* |
|
When creating new Object Types for an Object with Study Migration enabled, the field is provisioned as a Custom field and can therefore be excluded despite being required for Clinical Operations.
|
DEV-578638 |
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TMF transfer fails if the document being transferred has an attachment with a long file name.
|
DEV-579170 |
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In some cases in Study Training, users are unable to create Study Site records without licenses even though Study Training is not enabled and licenses should not be required.
|
DEV-579350 |
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In some cases, the Study Migration field not provisioned on Object Types.
|
DEV-579371 |
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If a user updates a non-lifecycle field on a CDMS protocol deviation, Vault updates the lifecycle state of the Clinical protocol deviation, triggering any entry actions on the record.
|
DEV-580603 |
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Users may encounter an error when attempting to create a milestone with an object type of Sponsor Oversight Activity.
|
DEV-580827 |
|
There is an extra space in an error message Vault displays when users attempt to update a Study Organization that is used as a Primary Organization in an approved Fee Schedule.
|
DEV-581077* |
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In some cases, the Initiate Study Archival action is unavailable for Studies that are in the Closing lifecycle state.
|
DEV-582336 |
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At times, users receive an error message when attempting to test a Study Metadata Extraction model.
|
DEV-583923 |
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At times, the Study Metadata Extraction model fails to populate the Study value on a document.
|
DEV-584908 |
| Description |
Issue No. |
|
In some cases, Vault reports validation error 5057 (the document contains no text) for documents that do contain text.
|
DEV-496415 |
|
Vault fails to identify text in documents using Enhanced Suggest Links.
|
DEV-540940* |
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In some cases, user may see false validation results regarding FDA provided forms.
|
DEV-543097 |
|
In some cases, after applying a basic overlay to a viewable rendition, several pages are missing from the document and users see an error while attempting to open the document in a PDF viewer.
|
DEV-544754 |
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Vault Loader may fail to extract the document relationships for archived documents.
|
DEV-555766 |
|
In some cases, pdf renditions may appear stretched after downloading.
|
DEV-558470* |
|
When adding a reference to a claim, the plus icon in the Select Anchors Dialog may not change to a minus icon after creating a relationship.
|
DEV-560733* |
|
In some cases, MP3 audio files cause the page to reload continuously, which prevents users from listening to them fully.
|
DEV-566182 |
|
In some cases, Vault may fail to display all annotations after a user re-renders a document.
|
DEV-572356* |
|
When a user creates a new version of a document, Vault does not properly index source file text extracted with Optical Character Recognition.
|
DEV-572551 |
|
Under certain circumstances, Vault fails to render large Adobe InDesign Packages.
|
DEV-572878 |
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When a document is reclassified, Vault sends an automatic rendition request that replaces the viewable rendition of the document with a version that removes electronic signatures through Adobe Sign integration.
|
DEV-574319 |
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After users sign a document and it moves into the Steady State in which they do not have the View Document permission, Vault intermittently generates the eSignature page while updating the audit trail with the message "Signature page failed to generate." Vault will generate the eSignature Page the next time a user with the appropriate access views it.
|
DEV-576222 |
|
After users sign a document via workflow and it moves into the Steady State, Vault may not automatically generate the eSignature page. Vault will generate the eSignature Page upon the next request.
|
DEV-576718 |
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In some cases, as a user attempts to fill out a form in a downloaded PDF viewable rendition, the rendition automatically populates certain table fields and may overwrite user input.
|
DEV-577722 |
|
When selecting text that is an embedded link to an external URL for annotation, glossary search, or copying, the user is navigated to a new tab which may cause issues.
|
DEV-577973* |
|
If a user creates a pending annotation in-between two other annotations, the Annotation Traversal Count will show 0 of [total] instead of the total number of annotations.
|
DEV-577989* |
|
Viewable renditions downloaded from Vault may duplicate table values when fields are populated by a user.
|
DEV-578180 |
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Infocards disappear in Overlay mode if moved after the user draws a line annotation.
|
DEV-578245* |
|
In some cases, users are unable to download renditions with signature pages.
|
DEV-578772 |
|
Users may encounter errors when attempting to run a job to override checkout to perform a state change on a document.
|
DEV-579191* |
|
In some cases, spaces in table names may appear as " " in bookmarks.
|
DEV-579293 |
|
In previously archived studies, Sharing Settings may not have updated on all documents.
|
DEV-579366 |
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In some cases, users receive a server error when attempting to delete documents and versions.
|
DEV-579473 |
|
In some cases, after universally applying a legal hold, Vault creates a duplicate Legal Hold record with the same name but a different record ID.
|
DEV-579487 |
|
Scrolling back and forth in Overlay view may cause infocards to overlap in Sidebar view.
|
DEV-579495* |
|
In some cases, when a user reclassifies a document from a type with the Supporting Documents relationship to a type without the Supporting Documents relationship, Vault displays a "Server having problems" error.
|
DEV-579980* |
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After a user modifies the object field value referenced by a lookup field on a document, some documents display outdated values.
|
DEV-580994 |
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If certain characters are present in a document, the Suggest Links functionality is unable to find it.
|
DEV-581274 |
|
Users are unable to upload a file to a placeholder using Vault's Upload File dialog on Chrome 80.0.
|
DEV-581429* |
|
Viewable rendition of image files contain unexpected metadata in the PDF’s Title field (File > Properties > Description > Title).
|
DEV-581561* |
|
When attempting to edit labels for system lookup document fields, users may receive a Server having problems error.
|
DEV-581821 |
|
In cases where any documents exist without roles in their sharing settings, documents appear to be missing from users' Libraries after failed reindexing.
|
DEV-582041 |
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If a bookmark label in a document's table of contents (TOC) contains whitespace before the label name, the bookmark disappears from the TOC.
|
DEV-582612 |
|
In some cases, after sending a PDF for standardization, it may be falsely reported as PDF/A compliant.
|
DEV-582793* |
|
In some cases, when a source document moves to a new steady state, Vault updates the CrossLink document even if the document is bound to a specific version.
|
DEV-583396 |
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In some cases, Vault does not update controlled document templates to the document's new steady state version.
|
DEV-583411 |
|
In some cases, after sending a PDF for standardization, users may receive a Failed to parse metadata error due to a missing <?xpacket wrapper that should be optional.
|
DEV-584794* |
|
The Title value in the Doc Info pane does not update with changes if a merged document is used as the source.
|
DEV-586820* |
| Description |
Issue No. |
|
In certain circumstances in Validation Management, Vault may not display an error message when a user attempts to save a step in the Test Authoring interface without all required fields populated.
|
DEV-534696* |
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Users are unable to manually unenroll from a self-enrolled Classroom Training Requirement due to a missing Unenroll button on the Explore tab.
|
DEV-557175* |
|
Choosing certain items from the Risk Response dropdown in the Risk Builder may result in Vault displaying an error.
|
DEV-559790* |
|
The Risk Builder may display an incorrect Process Step under certain circumstances.
|
DEV-560217* |
|
When errors occur while attempting to save an Assessment Risk in the Risk Builder, the user may incorrectly be navigated out of editing mode.
|
DEV-560244* |
|
In the Risk Builder, an input box may incorrectly remain after switching to View mode.
|
DEV-560698* |
|
When using the QRM Risk Builder, Vault may incorrectly display an error when a user without Admin permissions attempts to copy or save a Risk.
|
DEV-561968* |
|
New Assessment Risks cannot be saved in the Risk Builder if "System manages field value (read-only)" has been deselected for the Name field.
|
DEV-563370* |
|
In certain cases, up-versioning a document in a Training Requirement with configured Training Rules may not result Vault creating a Training Requirement Impact Assessment.
|
DEV-564104* |
|
Vault may incorrectly display errors when a user without permissions to update the Risk Matrix field attempts to make changes in the RIsk Builder.
|
DEV-564662* |
|
The Initial Risk Level field on the Assessment Risk object may not have the "Do not copy this field in Copy Record" attribute selected.
|
DEV-566236* |
|
Certain special characters used when searching the Risk Builder may result in Vault displaying an error.
|
DEV-566844* |
|
In Vaults using the QMS to RIM connection, transactions may be marked with an incorrect status when certain combinations of failures and successes are processed together.
|
DEV-570715* |
|
The "Do not copy this field in Copy Record" attribute may incorrectly be editable on the Assessment Risk Order field of the Assessment Risk object.
|
DEV-572542* |
|
Some actions in the Risk Builder may incorrectly be visible to users that lack the appropriate permissions.
|
DEV-572974* |
|
In Validation Management, Vault may display an error when a user attempts to create a new version of a document which is associated with a closed Validation Deliverable record.
|
DEV-573958* |
|
In some cases, Vault may display an error when a user attempts to access the Root Cause Analysis tool.
|
DEV-574750* |
|
In some cases, lab tests are completed without corresponding Result Evaluations, which causes the Specification Criteria Evaluation Section to display a label of "0-NaN of undefined" and become stuck in a loading loop.
|
DEV-575811 |
|
In some cases, Vault may display an error when attempting to change a Root Cause Analysis record's state to Approved when there is not a "Yes" item.
|
DEV-576800* |
|
In some cases, curricula on the Learner Role Details page may have an incorrectly-applied overdue alert icon.
|
DEV-578190* |
|
In Surveillance, Vault may fail to generate XML eMDR when a Contact Information field is blank.
|
DEV-578747* |
|
In Surveillance, selecting multiple values on certain fields in EU MIR or eMDR forms may incorrectly result in a data validation error.
|
DEV-579094* |
|
In some cases, a Class page may incorrectly display the 'Submit Result' button after the Class has been completed.
|
DEV-580413 |
|
When using the QRM Risk Builder, Vault may incorrectly display an error when a user without Admin permissions attempts to copy or save a Risk.
|
DEV-580691* |
|
In Surveillance, if multiple values are selected for classification of incident or gender, the resulting eMDR or EU MIR may not correctly resolve to the correct values.
|
DEV-581851* |
|
In some cases in Validation Management, performing Create Validation Requirement Version action may result in an error.
|
DEV-584595* |
| Description |
Issue No. |
|
In some cases, the notifications for the Update Content Plan and Update Global Content Plan actions do not specify the constraints excluded during the update.
|
DEV-538745* |
|
Permalinks are not published if the link target’s Published Output Location is shared by other Content Plan Items with a DELETE operation.
|
DEV-549868* |
|
When transferring a document from a RIM Vault to a Clinical Vault, the User Exception Message does not show all document transfer errors when the RIM to Clinops Connection: Transfer steady and superseded state document versions Application Setting is enabled.
|
DEV-555305* |
|
Vault does not revalidate the STF XML when the index XML is published after continuous publishing is enabled.
|
DEV-559866* |
|
The Global Version ID is inconsistent between the document field and the value populated on the Viewable Rendition of merged documents with overlays.
|
DEV-563241 |
|
When the Published Output Location is updated on a linked target document, continuous publishing fails to properly update inbound permalinks to named destinations when locking the target document.
|
DEV-567588* |
|
In some cases, Submissions loaded via Vault File Manager cannot move past the Transmission Initiated lifecycle state.
|
DEV-570171 |
|
In some cases, duplicate Submission Contact Records can be created with the RIM-PromoMats Connector.
|
DEV-570323 |
|
Users are able to unmatch documents from inactive Content Plan Items in the Content Plan viewer, resulting in inaccurate document counts.
|
DEV-572503* |
|
Users without Submission Metadata object permissions are not able to export the Excel Tree with all Descendants.
|
DEV-572504* |
|
When managing registered details, Vault does not include all updated fields in the CSV results file.
|
DEV-572969* |
|
In some cases, Vault does not provide details in the User Exception Message and the job log when a RIM to PromoMats Vault Connection remote query fails.
|
DEV-573109* |
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For AU submissions with a blank ARTG Number, Vault generates the ARTG Number in the XML.
|
DEV-573588* |
|
If a user sets a Global Content Plan to an unrelated event, the Global Content Plan becomes invalid and the user will need to re-create the Global Content Plan.
|
DEV-573768* |
|
The Submission Wizard is unable to load the Application Relationship page when there is at least one relationship with a populated number field.
|
DEV-574489* |
|
In some cases, Vault cannot execute the Content Plan Hierarchy State Change job when other non-conflicting jobs are in progress.
|
DEV-574705 |
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In some cases, the RIM to PromoMats Vault Connection job errors when attempting to update the Related Submission record's object_type__v field.
|
DEV-575954 |
|
When dragging and dropping a document with a Source Reference to the Active Dossier Editor, Vault does not populate it as the Submissions Archive Document in the resulting Active Dossier Item and Active Dossier Item Detail records.
|
DEV-575993* |
|
The Submissions Archive Viewer incorrectly displays the XML Element Name as the folder name.
|
DEV-576216 |
|
Vault incorrectly reports Rule 14.BP3 as failed if the file name begins with “specifications-”.
|
DEV-576693 |
|
New users created without the old Submission Archive Viewer tab permission cannot view or export submissions even if the new Submission Archive Viewer is enabled.
|
DEV-576710 |
|
In the Active Dossier Editor, Applications, Submissions, and Regulatory Objectives previously selected in a view are displayed as the default selection when users drag and drop records.
|
DEV-576833* |
|
When users search the Name column in the Set Leaf Operation dialog, then close and reopen the dialog, Vault does not refresh the binder and filters the binder based on the search.
|
DEV-576921* |
|
In some cases, the Submissions Archive Viewer displays the empty section icon for sections with leaves within published Submissions.
|
DEV-577464* |
|
Vault does not populate the country within the “specific” tag when publishing Ukraine regional XML.
|
DEV-577736* |
|
Vault fails to show more than 100 users or groups when sharing a view in the Submissions Archive Viewer.
|
DEV-577877 |
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Users without Read permission on the Product Family and Application Product Family objects receive a server error (instead of “No data found”) in the Active Dossier Viewer when applying a view including these objects.
|
DEV-577887* |
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In the cases of some large Applications, the Submissions Archive Viewer may fail to load Correspondence Documents.
|
DEV-578241 |
|
Vault creates duplicate Registered Packaged Product (registered_packaged_medicinal_product__v) records when generating combined UDI submissions.
|
DEV-578258* |
|
In some cases, users may incorrectly see 'No Items Found' when attempting to view Applications with orphaned Correspondence sections or documents.
|
DEV-578271 |
|
Users may experience performance issues with Crosslink Postmatch jobs.
|
DEV-578353* |
|
Users experience slow performance in the Content Plan Hierarchy Viewer when document reference columns are included.
|
DEV-578396* |
|
Users cannot click Save in the Set Leaf Operation dialog without selecting a document when the XML Operation is New.
|
DEV-578743* |
|
When bundling Regulatory Objectives using the Safari browser, the bundling wizard skips the Define Regulatory Objectives page.
|
DEV-578867* |
|
When the href is updated after initial publishing, Vault does not update the Published Output Location during continuous publishing.
|
DEV-578909 |
|
In some cases, users may receive a server error when attempting to load a checklist.
|
DEV-579074 |
|
The Submissions Archive Viewer intermittently flickers when loading.
|
DEV-580171* |
|
If a user does not have permissions to certain fields, Vault prevents navigation to some steps in the UDI viewer.
|
DEV-580221* |
|
The Submissions Archive Viewer displays Correspondence documents tagged with only an Application at the top of the Correspondence section instead of the bottom.
|
DEV-580835* |
|
Permalinks on approved documents are not properly embedded on PDFs in archives.
|
DEV-581388 |
|
In some cases, Vault erroneously creates Active Dossier Item records if there is no Submission Country join record.
|
DEV-583077* |
|
In some cases, users may see a max row limit warning in the new Submissions Archive Viewer when it does not apply.
|
DEV-585283* |
The RegulatoryOne release, including all Platform fixed issues, is targeted for tentative availability on June 20, 2023.
The Safety release, including all Platform fixed issues, is targeted for tentative availability on June 15, 2023.
| Description |
Issue No. |
Fixed an issue with E2B export where nullFlavors for Case Product Dosage Batch/Lot Number Reason Omitted field values were incorrectly populated in the G.k.4.r.7 - Batch / Lot Number data element.
Now, Reason Omitted field nullFlavors are exported as follows:- EMA E2B(R3): Blank or Unknown = UNK, Masked = MSK, Asked But Unknown = ASKU
- ICH E2B(R3), FDA VAERS E2B(R3), and PMDA E2B(R3): Blank, Masked, Asked But Unknown = no nullFlavor exported
Validation Criteria updates are as follows:- FDA.G.k.4.r.7 Batch/Lot Number is no longer mandatory.
- PMDA.G.k.4.r.7 Batch/Lot Number is now mandatory only if PMDA Reporting Category (J2.1a) is 'AA' or 'DA'.
|
SAF-38644 |
|
Fixed an issue where, when Inbox Items were promoted to Follow-up Cases or merged to In-flight Cases, Case-level Seriousness was not updated.
|
SAF-39584 |
|
Fixed an issue where, after upgrading to the latest MedDRA version, auto-coding was prevented for terms that were not active in the latest dictionary.
|
SAF-39837 |
|
Fixed an issue where, when Inbox Items were created from ZIP or E2B files with multiple cases, values entered in the Origin field of the Case Information section was not imported.
|
SAF-40033 |
|
Fixed an issue where on Cases for Double-Blinded Studies manually created Expectedness records did not roll up to the Case Assessment level.
|
SAF-40114 |
|
Fixed an issue with switching between view and edit mode on Inbox Items where the Study and Study Arm fields loaded slowly.
|
SAF-40167 |
|
Fixed an issue with setting a Product or Study Registration to Inactive where, when the registration included a MAH/Reporting Organization, the registration was not removed from the corresponding Reporting Family.
|
SAF-40229 |
|
Fixed an issue with deep duplicate detection where, on the Potential Matches page, some cases with matching Gender and Country fields were ranked higher than expected, while some with matching Patient Initials were ranked lower than expected.
|
SAF-40847 |
|
Fixed an issue where, when a suspected and unexpected assessment was added to a Case created from a Clinical Trial study, the Assessment Tag did not change from SAE to SUSAR.
|
SAF-41079 |
|
Fixed an issue where, when voiding a Case and submitting one last time, the Previously Submitted Reporting Rule Parameter specified that Transmissions in only the "E2B ACK Accepted" or "Completed" states were evaluated. Now, a new option, All Transmission States, supports evaluating Transmissions in any lifecycle state, unless the Transmission is inactive or deleted.
|
SAF-41082 |
|
Fixed an issue where, when users did not have Read permission for Product Dose Form, a system error occurred and Inbox Items would not load.
|
SAF-41292 |
|
Fixed an issue where, during deep duplicate detection, Study and Study Number matching was completed within Reporter matching and was also assigned the same priority as Reporter matching.
|
SAF-41329 |
|
Fixed an issue with E2B import through the AS2 Gateway where, when import failed, the file was saved in the Audit Log. This created the potential for personally identifiable information (PII) to appear in the log.
|
SAF-41346 |
|
Fixed an issue with creating Follow-Up Cases from the Case Compare page for Japan Localized Cases where, when Primary Case Product Registration records and Local Reporting Details were included, a system error occurred.
|
SAF-41372 |
|
Fixed an issue with multilingual MedDRA where English translations for Japanese Localized Cases were not updated when Indications, Adverse Events, or Medical History information was updated, and translations and codes were missing when new Indications were added.
|
SAF-41603 |
|
Fixed an issue where, when cloning a Vault, Translation Settings, Translation Connection Language, and Translation Localization were not cloned by default.
|
SAF-41606 |
|
Fixed an issue with coding Japanese MedDRA terms where terms with English characters were not auto-coded.
|
SAF-41665 |
|
Fixed an issue where the Translation Connection Languages and Translation Settings records were not included in the Vault Safety template.
|
SAF-41671 |
|
Fixed an issue where, when the Enable Smart MedDRA Autocoding and Enable Smart MedDRA Coding Predictions settings were not turned on, the Coding Method fields for Indication and Event were populated on Inbox Items.
|
SAF-41674 |
|
Fixed an issue with local language intake for Russian (Russia) where, when a local language value was entered in the Inbox Item Product Indication field, after saving the local value appeared in the English Indication field.
|
SAF-41726 |
|
Fixed an issue with calculating Age Groups for Infants and Children where the definition was out of date. Now, to align with the latest EMA and FDA definitions, Infant is defined as "1 month to less than 24 months" and Child is defined as "2 years to less than 12 years".
|
SAF-41781 |
|
Fixed an issue where, in some instances, Case Adverse Events were not displayed and a system error occurred when the event included a MedDRA term that had undergone a hierarchy change and was in a Closed state.
|
SAF-41825 |
|
Fixed an issue with promoting manually created Inbox Items to Follow-Up Study Cases where, when the Study Product was open-label, an additional blinded instance of the same Study Product appeared on the Follow-Up Case and had to be manually deleted.
|
SAF-41860 |
|
Fixed an issue with promoting AERs to Cases where, if the AER included special characters, during duplicate detection the system displayed error messages and prevented promotion.
|
SAF-41888 |
|
Fixed an issue where PSMF Logbook comments did not upgrade to the latest document version, making the comment unavailable on the latest PSMF Logbook.
|
SAF-41942 |
|
Fixed an issue with manual Inbox Item creation where, when Enable Auto-Set Inbox Item Localization by Reporter Country was turned on, the system allowed selecting inactive Localizations, which caused Inbox Item creation to fail.
|
SAF-41949 |
|
Fixed a caching issue that, in some instances, prevented users with the Case Processing security profile from viewing the Drug page on Study Cases.
|
SAF-42003 |
|
Fixed an issue where, in some cases, users may have experienced performance issues when processing Cases.
|
SAF-42023 |
|
Fixed an issue with limits on the number of users allowed in a single role within a Case Access Group. This fix affects only POD VV1-1150.
|
SAF-42068 |
|
Fixed an issue where, when you switched from the PSMF Document panel to the Document Information panel, the Document Information Panel icons did not appear until the page was refreshed.
|
SAF-42319 |
|
Fixed an issue where, when Case Processors did not have Read permission for the Dose Unit of the Case Product Dosage field, a server error occurred when trying to view the Medical Review Timeline.
|
SAF-42415 |
|
Fixed an issue where, when some E2B XML files encoded as UTF-16 were received through an AS2 gateway, the Transmissions were not imported as Inbox Items.
|
SAF-42519 |
|
Fixed an issue where, when the MedDRA dictionary language was set to two languages and the Update to Latest Version action was run, an error appeared. This was due to duplicate Localized MedDRA records being created.
|
SAF-42520 |
|
Fixed an issue with Pregnancy Cases where, when the Linked Cases section included a Non-Child information Case, Follow-up Case creation was prevented.
|
SAF-42579 |
The Veeva Claims release, including all Platform fixed issues, is targeted for tentative availability on June 20, 2023.