The issues listed below are fixed in the 23R1 release.
| Description |
Issue No. |
|
In certain cases, when users attempt to run the Start Trip Report action, they encounter server errors.
|
DEV-502752 |
|
The Domain Admin UI allows editing the 'My Veeva Integration' user.
|
DEV-516274 |
|
Vault fails to create any user exception messages or user exception items when the CTMS Inbound job fails with an unexpected or unidentified error.
|
DEV-517304 |
|
In some cases, negative numbers erroneously appear in the Customer Activity Report.
|
DEV-519071 |
|
In some cases, when users create multiple versions of a document in Clinical Operations in quick succession, only the latest version of the document successfully transfers to RIM.
|
DEV-523409 |
|
In some cases, Vault generates excessive CTN Data Change Log records for CTN CP/Organization Change Log records.
|
DEV-529286 |
|
In rare cases, users encounter a server error when attempting to open the TMF Viewer.
|
DEV-530752 |
|
In some cases, Vault does not correctly log the Study Country and Study Site STAT in CDMS when running the CTMS/CDMS Inbound Job for a new study.
|
DEV-531043 |
|
In some cases, Visit Definitions do not successfully transfer from CDMS to CTMS.
|
DEV-534635 |
|
In some cases, Milestone planned finish dates do not roll up correctly and Vault reports a null pointer exception.
|
DEV-538122 |
|
When the Exclude Inactive Document Types from Document Matching setting is enabled, users experience a server error when running the Match Documents action.
|
DEV-538210 |
|
In some cases, Vault does not correctly apply auto-naming rules on documents.
|
DEV-538270 |
|
In some cases, when accepting an ePRO Connected study invite and selecting an existing Study to merge to, users may receive an error.
|
DEV-539286 |
|
In some cases, when users search for documents in the TMF Viewer, Vault displays the Title field value incorrectly.
|
DEV-540039 |
|
Some users are unable to run the Create Subsequent CTN action or job.
|
DEV-540169 |
|
In certain cases, the Site Activation Progress report is slow to load.
|
DEV-540905 |
|
In some cases, the Monitoring Compliance Summary job does not complete successfully.
|
DEV-541245 |
|
When using the Generate CTN action, users may be blocked by change logs being created that they are unable to remove.
|
DEV-542190 |
|
Vault sometimes displays an incorrect error message when users attempt to save Confirmation/Follow-up Letters.
|
DEV-543398 |
|
Safety Distribution jobs fail if they do not have an email address for every Distribution Task Recipient.
|
DEV-544262 |
|
In some cases, users encounter a server error when attempting to activate a Person record.
|
DEV-545615 |
|
In some cases, users encounter an error when attempting to download the EDL Updates from Other Sites CSV.
|
DEV-545620 |
|
The YUZU version of the J-CTN Word document that Vault generates does not include empty fields.
|
DEV-548728 |
|
Some users encounter an error when attempting to update Expected Document records.
|
DEV-549270 |
|
In some cases, Vault may incorrectly change inactive lookup fields to active after object changes.
|
DEV-550264 |
|
In some cases, users are unable to delete Study records in ClinOps Vaults.
|
DEV-554100 |
|
In some cases, Vault matches Payable Events with one another even if not all criteria matches, leading to Payable Items being generated incorrectly.
|
DEV-555266 |
|
If users attempt to train a model using one or more documents for which they do not have permissions, the entire training job fails.
|
DEV-555304 |
|
When transferring a document from Clinical Operations to RIM, the document maybe incorrectly associated with all Products associated with its Study rather than the single Product (or no Product) with which it should be associated.
|
DEV-555420 |
|
When users run certain workflow actions relating to EDL Items at a Site, Vault incorrectly updates Sites that have been marked as inactive.
|
DEV-558210 |
|
In some cases, when users adjust a Holdback Payable Item, Vault fails to update the Related Holdback Payable Item.
|
DEV-558414 |
|
When running the training job for a model that has a Trained Model Type of Metadata Extraction, the resulting extracted document set is equal to the Maximum Documents in Set value, not 20% of the Maximum Documents in Set value as required.
|
DEV-558697 |
|
The CTN (Word and XML) displays the term "剤型" instead of the term "剤形", which is the new term approved by PMDA.
|
DEV-559142 |
|
In some cases, Vault Loader runs slowly and may result in errors during Study Person updates
|
DEV-559294 |
|
If users attempt to create a new Study Migration object and save the record before filling the Object Name field, Vault displays a server error.
|
DEV-561052 |
|
Under certain circumstances, Vault fails to perform the Initiate Study Archival action on Study records with related Study Country records.
|
DEV-562444 |
|
In certain scenarios, when attempting to use Vault Loader/API to batch create Study Organization records, the job fails if there is already a Primary Payee record on a Site.
|
DEV-564303 |
|
When users attempt to run the "Create CTN Data for Japanese Study Country" action with inactive records for Study Site, Study Person and Study Organization records when creating CTN Data records, Vault displays an error and does not complete the action.
|
DEV-564696 |
|
Users logged in as VMC users are unable to run the Generate Model action to train a model.
|
DEV-565625 |
|
The "Create Subsequent CTN" user action does not populate the study_migration__v field as part of the user action.
|
DEV-566162 |
|
When attempting to train an auto-classification model from production, only 10,000 documents are extracted, and users are unable to set the number of minimum documents per document type to greater than 100.
|
DEV-570172 |
| Description |
Issue No. |
|
Vault displays a blank Action menu on a linked document after a user deletes the viewable rendition.
|
DEV-359610 |
|
In cases where multiple sharing rules use different lookup fields, Vault may apply sharing rules incorrectly.
|
DEV-397560 |
|
While adding a reference to a claim, users cannot select anchors with titles that end in quotation marks.
|
DEV-403360 |
|
Users are unable to traverse video annotations when there are multiple annotations at the same timestamp.
|
DEV-413408 |
|
In some cases, when a user creates annotations during the Make a Copy action, Vault adds newly created annotations to both the original and copy documents.
|
DEV-417206 |
|
In some cases, when using the Link to Content action, Vault incorrectly creates a "Claim Link" annotation instead of a link type defined by the selected Linked Document relationship.
|
DEV-437140 |
|
In rare cases, Vault does not enforce character limits on document metadata fields.
|
DEV-451233 |
|
In some cases, after manually adding a rendition and performing the Make a Copy action, Vault lists an incorrect file size for the copied rendition.
|
DEV-452093 |
|
Vault displays an inaccurate error message after users attempt to merge a deleted anchor.
|
DEV-460882 |
|
After users perform the Export PDF with Annotations action, Vault fails to export PDF/A files with annotations.
|
DEV-481313 |
|
Locking a document that is in a Superseded state incorrectly updates the Steady State Document Count field on a Content Plan item.
|
DEV-481882 |
|
In some cases, Vault fails to include the Record No. while generating Formatted Outputs.
|
DEV-485949 |
|
Vault fails to render documents when Merge Field tokens are locked using content controls.
|
DEV-499156 |
|
Under certain circumstances, Vault fails to detect and update Merge Field tokens.
|
DEV-504981 |
|
In some cases, Vault placed annotations on video documents in a different area than where the user selected.
|
DEV-505988 |
|
In scripts that do not separate words with spaces, such as Chinese, Japanese, Korean, and Thai, Vault treats each character as a separate word, which causes issues with tone markers and vowels (Thai only), searching, and bounding boxes.
|
DEV-507153 |
|
In some cases, Vault fails to display an error message after a field is not updated as specified.
|
DEV-508507 |
|
Vault inappropriately allows users to request a PDF with Annotations before a viewable rendition has been generated.
|
DEV-511983 |
|
The Creation Date field may be missing from exported annotations and downloaded renditions.
|
DEV-515098 |
|
Under certain circumstances, Vault fails to generate 2253 forms.
|
DEV-515867 |
|
Vault may fail to generate viewable renditions of InDesign Packages.
|
DEV-516113 |
|
Vault displays a generic status message on the Rendition Status page when users attempt to render documents created in a non-supported Word format.
|
DEV-517952 |
|
Vault fails to render documents with hidden shapes in the header or footer.
|
DEV-518719 |
|
In some cases, Vault fails to render Microsoft Word documents with EMF files.
|
DEV-519000 |
|
In some cases, removing documents from a binder using the Add Existing Documents dialog results in an error.
|
DEV-520262 |
|
In some cases, Vault does not apply custom document auto-naming formats that use multi-select fields upon document creation or update.
|
DEV-520465 |
|
After failing to render Excel files with header and footers, Vault fails to provide a sufficient error message and Rendition Status page status.
|
DEV-521212 |
|
In some cases, when attempting to perform the Triage workflow action, users may receive a 'Server having problems' error and observe that the workflow action fails to complete.
|
DEV-521362 |
|
In some cases, Vault fails to render documents with fill-in fields.
|
DEV-522001 |
|
Under certain circumstances, Vault removes renditions after users reclassify documents.
|
DEV-523266 |
|
Vault may fail to generate viewable renditions of uploaded email templates.
|
DEV-524724 |
|
Vault may not properly apply auto-managed document sharing rules when a controlling field is updated.
|
DEV-525490 |
|
Vault fails to extract text when users compare document versions.
|
DEV-525700 |
|
In rare cases, Vault fails to generate a viewable rendition after receiving a Spark message via a Vault connection.
|
DEV-528435 |
|
Users may receive a 'Server having problems' error when attempting to update a crosslink.
|
DEV-528911 |
|
In some cases, users may be unable to choose cloned rendition profiles in the document field drop down which may result in rendering documents with incorrect profiles.
|
DEV-530407 |
|
Document renditions may fail to generate if their version number is changed while the rendition is being processed.
|
DEV-530938 |
|
In rare cases, Vault may show previous viewable renditions in the Document Viewer after a new rendition has been uploaded.
|
DEV-531901 |
|
In rare cases, users are unable to view or download viewable renditions after performing a custom web action.
|
DEV-532349 |
|
In some cases, Vault fails to update Merge Field values after users archive documents.
|
DEV-532373 |
|
While exporting all files, Vault exports documents with invalid characters in the filenames, resulting in hidden or missing files in the ZIP file.
|
DEV-533671 |
|
Users may encounter an error when they attempt to collapse all sections in high-volume binders.
|
DEV-534287 |
|
Vault allows read-only viewers to open the glossary and copy text.
|
DEV-537819 |
|
Users are unable to click embedded links that contain exclamation marks in the viewable rendition of a document.
|
DEV-539062 |
|
When a document is reclassified from one lifecycle to another and the two lifecycles have overlapping roles (same name, same application role) Vault will create "duplicate" roles on the document.
|
DEV-540188 |
|
Users are unable to export document fields from the Library page in grid view.
|
DEV-541562 |
|
In rare cases, renditions fail to render correctly.
|
DEV-541844 |
|
Users may experience performance issues when selecting the "Expand All" action on legal holds.
|
DEV-541953 |
|
When users attempt to save annotations to a document before the OCR process is complete, Vault displays an "Operation Unsuccessful" error message, and the annotations are not saved.
|
DEV-542282 |
|
After clicking Export Annotations in a Safari browser, users see a blank page.
|
DEV-543039 |
|
If a document text field is named score__c, it will not correctly display numbers in report and VQL output.
|
DEV-543700 |
|
In the Advanced section of the Bring Forward Annotations dialog, Japanese, Chinese (Simplified and Traditional), and Korean error messages use full-width (non-English) instead of half-width (English) punctuation marks.
|
DEV-544554 |
|
In some cases, Vault will lag in retrieving the viewable rendition of a CrossLink document if the version is changed while the rendition is being generated.
|
DEV-545748 |
|
Vault displays an unhelpful error message after users attempt to import annotations from documents with file names exceeding 218 bytes in length.
|
DEV-546105 |
|
Vault may fail to properly render a document in a multi-document workflow if a user upversions it.
|
DEV-547438 |
|
In some cases, after a user upversions an object attachment to version 5 or greater, Vault fails to generate the viewable rendition for the attachment.
|
DEV-547917 |
|
Under certain circumstances, uploading and rendering documents with custom templates results in corrupted modified source files are corrupted.
|
DEV-548417 |
|
Vault displays an unhelpful error message when a document comment contains certain special characters.
|
DEV-549770 |
|
In rare cases, manually uploaded viewable renditions may be replaced by a system-generated rendition.
|
DEV-550216 |
|
In some cases, when attempting to publish and merge a Report Level Content Plan, the documents may fail to merge.
|
DEV-550434 |
|
Users may encounter an unexpected error when attempting to check out a document for collaborative authoring in Microsoft Office.
|
DEV-550678 |
|
When naming binder sections, Vault incorrectly escapes special characters, such as ampersands.
|
DEV-550839 |
|
The "Delete minor versions" entry action does not delete binder nodes, and attempting to delete a document referenced by a deleted binder version results in a "Server having problems" error.
|
DEV-551025 |
|
When a Legal Hold record is in the Lifted state, any user can delete the document.
|
DEV-551160 |
|
When a user attempts to upload a source document to a placeholder with a filename longer than 218 bytes, Vault displays a "Server having problems" error instead of the expected error message.
|
DEV-552307 |
|
In some cases, document attachments are not rendering in the external viewer and Vault displays an error.
|
DEV-553203 |
|
Under certain circumstances, users may be unable to see document annotations in Document View.
|
DEV-553850 |
|
In rare cases, querying binders via the API results in incorrect values for the order__sys and order__v fields.
|
DEV-555140 |
|
If a user accesses a document while a manual rendition is still processing, the manual rendition may be lost.
|
DEV-555858 |
|
In some cases, pages in downloaded viewable renditions appear stretched and display incorrectly.
|
DEV-558773 |
|
After creating crosslinks on a source document and changing the document's state, users are unable to view the crosslinks.
|
DEV-559102 |
|
In rare cases, Vault fails to render documents with merge fields.
|
DEV-559844 |
|
Vault may fail to preserve annotations when users up-version a document before the OCR process is complete.
|
DEV-562251 |
|
Under certain circumstances, users may experience performance issues when generating documents with merge fields.
|
DEV-566620 |
|
In some cases, Vault incorrectly translates overlay data to match the document language rather than the user profile language.
|
DEV-570240 |
| Description |
Issue No. |
|
In certain cases when using Vault Loader to create Available Answer Designs for quizzes, quiz point values may incorrectly incremented upon a creation failure.
|
DEV-497432 |
|
With the Audit Program Planning feature configured, in some cases Vault may fail to display the Audit Program Owner for a Proposed Audit in related object sections.
|
DEV-502870 |
|
In certain cases, Vault may fail to automatically move Training Assignments from the Created to Assigned lifecycle state.
|
DEV-520136 |
|
In certain cases, configuring the System manages field value option on a Name field may result in Vault displaying a server error when attempting to save the field configuration.
|
DEV-523351 |
|
When attempting to move a Document Change Control's Change Authorization to an Approved state with missing required data, the error message does not correctly display which data is missing.
|
DEV-523546 |
|
Creating a Quality Team role with a Linked Field value which targets a base object type may result in Vault displaying a server error rather than a helpful error message.
|
DEV-525932 |
|
E-Learning courses uploaded with capitalized file extensions may not be properly detected with an e-learning standard.
|
DEV-530073 |
|
In some cases, a date field token used in a Quality External Notification may resolve to an incorrect date.
|
DEV-530398 |
|
In rare cases, users are unable to access documents in Vault due to document field security overrides.
|
DEV-530935 |
|
The Class Result dropdown on the Instructor Led Training page may not close automatically when clicked.
|
DEV-531384 |
|
Vault may incorrectly display an access error when a user attempts to execute the Review Test Set action.
|
DEV-533450 |
|
When the Document Change Requests or Periodic Review auto-link action runs at the same time that a Change Authorization is approved, the DCR or PR may not automatically link corresponding to the documents that were added via Change Authorization.
|
DEV-535391 |
|
Vault displays API names instead of labels in error messages if it fails to transition a record's state type.
|
DEV-535913 |
|
When using the Surveillance application, on generated eMDR forms, the Age value may not display as expected if no Date of Birth field value was entered.
|
DEV-538199 |
|
Users cannot remove a Lab Method from a Sample Definition where the Lab Method is the target in a Protocol Variable Target.
|
DEV-538678 |
|
Under certain circumstances, it is not possible to make new Specification versions effective without first removing the Specification Mappings on the prior version.
|
DEV-539281 |
|
Certain configurations may cause Vault to display an error when attempting to view a Quality Team Configuration.
|
DEV-542262 |
|
Some users with the All Objects - Create permission in their production Vaults may incorrectly see a new Select Person Type dialog appear whenever attempting to create new person records.
|
DEV-542349 |
|
Vault may display an error when the Issue Training Assignments entry action attempts to calculate document revision training due dates based an empty date field.
|
DEV-543022 |
|
Station Manager users may incorrectly see a user permission error message.
|
DEV-543126 |
|
In some cases, Push to Register may fail when an Assessment Risk is pushed to multiple Risk Registers.
|
DEV-543936 |
|
Under certain circumstances, the QMS to RIM connection may incorrectly generate User Exception Messages for each unconnected Activity when it enters an applicable lifecycle state.
|
DEV-544566 |
|
Documents on training assignment cards may display with additional document numbers.
|
DEV-546313 |
|
Users experience a network error message when expanding the associated change request section in a document change control record on a Quality Vault.
|
DEV-555235 |
|
In Vault LIMS, in some cases the system may display an error after clicking Evaluate after entering test results.
|
DEV-555924 |
|
Evaluated results may display with incorrect notation.
|
DEV-556240 |
|
In some cases, the Create Class dialog for Instructor-Led Training does not correctly accommodate custom object configurations.
|
DEV-556911 |
|
In Vaults using the QMS-RIM connection, in some cases, updates may fail in the QMS Vault after the Update QMS Details action is performed in the RIM Vault.
|
DEV-557321 |
|
As a one-off event, Assignment Detail failed to update the Training Assignment Lifecycle State field based on the related Training Assignment.
|
DEV-558243 |
|
In Vault LIMS, under certain circumstances the system may allow edits to a test result after the test is in an Approved state.
|
DEV-558268 |
|
In Vault LIMS, rejected Result Evaluation records may not be moved to a superseded state, and may incorrectly appear in the Specification Criteria Evaluation section.
|
DEV-559312 |
|
In some cases, Vault may incorrectly display a page not found error when attempting to use the Copy action on a Class record.
|
DEV-559588 |
|
In Vault LIMS, when Tests are added to a Test Set, Vault may not appropriately move their Sample and Batch records to an In Progress state.
|
DEV-559856 |
|
The Quality/RIM Product Inbound job fails and the Quality/RIM Product Inbound Worker job is not initiated in the Quality Vault when an Integration Rule does not have an assigned Integration Point.
|
DEV-560192 |
|
In Vault LIMS, calculated results in ad-hoc tests may not populate as expected.
|
DEV-560265 |
|
In Vault LIMS, the Retested state may not function as expected for cross-method variables.
|
DEV-560272 |
|
In some cases in Vault LIMS, a reactivated Lab Sample or Lab Test may move to the incorrect lifecycle state.
|
DEV-560710 |
|
In Vaults using the QMS-RIM connection, in some cases, the system may incorrectly inactivate previously-created Impacted Country records after performing the Update QMS Details action.
|
DEV-560725 |
|
Vault may display an error when a user attempts to edit Category and Sub-Category fields on a manually-created Root Cause record.
|
DEV-560889 |
|
The Learner Homepage Card View may not display correctly if a self-registered Classroom Training Assignment is assigned but the class is closed.
|
DEV-561214 |
|
In Vault LIMS, a result which fails only one of multiple criteria may not be displayed as out-of-specification.
|
DEV-561534 |
|
In Vault LIMS, in some cases a result may incorrectly display with an Out of Specification or Outside of Criteria icon.
|
DEV-562154 |
|
In Vaults using the QMS-RIM connection, in some cases, updates in QMS may fail if Change Control or Impact Assessment records linked to a an Event in the RIM Vault are deleted.
|
DEV-563114 |
|
When a Quality to RIM Vault Connection transaction fails, the inbound job does not update the transaction’s Pending status to Failed, preventing the job from processing the remaining transactions.
|
DEV-565095 |
|
Inactive Related Record configurations referenced in a Create Related Record entry action continue to execute even though they are inactive.
|
DEV-440256 |
| Description |
Issue No. |
|
When a user runs on-demand publishing on a single document within an STF, Vault up-versions all documents within the STF.
|
DEV-326667 |
|
During continuous publishing, Vault does not publish links to published target documents correctly.
|
DEV-372269 |
|
In some cases, Vault incorrectly reports US 2021 as failed for grouped submissions.
|
DEV-415673 |
|
When continuous publishing is enabled, if a user unmatches a document, Vault creates a placeholder document but doesn't populate the Application and Submission document fields.
|
DEV-421083 |
|
When a user matches and then immediately un-matches a target document linked to a published source document, Vault does not remove the link to the target document from the source document during continuous publishing.
|
DEV-445829 |
|
Publishing fails during the validation phase for any files containing unresolved embedded links.
|
DEV-462336 |
|
The publishing job fails when the value of the application-level folder name exceeds 128 characters.
|
DEV-464163 |
|
Vault incorrectly reports CN rule 6.26 as passed in Content Plan sections 2.7.4, 3.2, 4.2, and 5.3 when a matched PDF document contains unembedded non-standard fonts.
|
DEV-477350 |
|
Vault does not report Rule RIM 105 during continuous publishing.
|
DEV-481855 |
|
Vault displays an internal error on the Manage Submission Administrative Information screen if a Submission Country record set to be used for content planning after country-specific overrides are already excluded.
|
DEV-500556 |
|
In some cases, when a document should be matched to different Submission Content Plan Item (CPI) records for the same Application, the Match EDL Items to Documents job matches the document to the same Submission CPI records for the Application.
|
DEV-514484 |
|
The selectable area of some permalinks does not extend to the entire area selected for the link.
|
DEV-520482 |
|
Correspondence documents approved immediately after upload cannot be exported from the Submissions Archive Viewer.
|
DEV-521487 |
|
Vault incorrectly reports Rule 5110 as failed when a bookmark has associated actions.
|
DEV-521840 |
|
Vault reports validation results against US Rule 2505 for PDF forms.
|
DEV-522712 |
|
When Labeling Automation is disabled, Vault creates new Activity Labeling Concept records when a user splits Activities.
|
DEV-523013 |
|
When a document appears in multiple Submissions, the Reference Leaf hovercard displays details from a Submission other than the one selected in the new Submissions Archive Viewer.
|
DEV-523259 |
|
Vault incorrectly reports Rule 16.BP4 as failed if a document includes a hyperlink or bookmark to an external document named destination.
|
DEV-526768 |
|
When a user sets a reference leaf from a Content Plan Item containing documents matched to multiple Content Plan Items, Vault selects the first document in the hierarchy instead of the one selected in the UI.
|
DEV-527263 |
|
In some cases, Vault incorrectly reports Rules 12.9 and 15.BP3 as failed.
|
DEV-528064 |
|
In some cases, on-demand publishing does not up-version source documents and remove the Vault link when a target document is updated.
|
DEV-528177 |
|
Users without permission to view the Dossier Details object cannot view Submissions in the new Submissions Archive Viewer.
|
DEV-528249 |
|
When a grouped Submission is created in PromoMats and the xml_ich_dtd_xsd_version__v field rule is inactive in RIM, the connection does not populate the XML Sequence ID field in the related submission records.
|
DEV-530176 |
|
In some cases, Vault displays an error message after successfully generating IDMP data.
|
DEV-530409 |
|
In Vaults with multiple gateway profiles, Admins cannot set each profile with a separate corresponding message sender.
|
DEV-530762 |
|
When saving Notification Templates, users receive invalid token errors for previously-saved tokens.
|
DEV-531153 |
|
Vault does not create Activity Dependency records when the Product Family field on the related Country Dependency record is populated.
|
DEV-531535 |
|
The new Submissions Archive Viewer is slow to load when the ID column is displayed.
|
DEV-531692 |
|
In some cases, users cannot navigate links within the pop-up mini-browser window opened from document or leaf hovercards.
|
DEV-532155 |
|
In some cases, Vault cannot create Application join records with custom matching fields during bulk creation and bundling.
|
DEV-532223 |
|
In some cases, Vault incorrectly reports Rule CH11.10 as failed.
|
DEV-532721 |
|
In some cases, the continuous publishing job remains In Progress after documents included in the job are published.
|
DEV-533278 |
|
In some cases, the Publishing Progress Indicator shows completed on-publishing tasks as in progress.
|
DEV-534258 |
|
Users without Application field Read permission on the Submission Active Substance and Submission Drug Product objects cannot filter the new Submissions Archive Viewer by the Submission Manufacturer object.
|
DEV-534262 |
|
When copying a content plan, the source content plan changes state from Locked to Draft.
|
DEV-534425 |
|
When saving the rim_async_query_failed__v Notification Template, users receive invalid token errors for previously-saved tokens.
|
DEV-535151 |
|
In some cases, the Edit & Verify button is not available to users verifying registration data.
|
DEV-535256 |
|
While the Source for Published Document field is set to a custom rendition, Vault incorrectly uses the viewable rendition as the source for published outputs.
|
DEV-535985 |
|
Vault incorrectly reports Rule 1221 as passed when the folder in a Content Plan Item’s Published Output Location is longer than 64 characters.
|
DEV-536164 |
|
Submission import fails when the M5 leaf title exceeds 512 characters.
|
DEV-536267 |
|
In some cases, when permalinks target a document matched to a Content Plan Item that is locked to a previous version, the permalinks are removed during continuous publishing.
|
DEV-536633 |
|
In some cases, users may receive errors when attempting to create Submission/Regulatory Objective joins via the Submission Wizard.
|
DEV-536996 |
|
In some cases, users are unable to remove duplicate Submission Modes or experience missing Submission Modes within the Submission Administrative Information for EU worksharing submissions.
|
DEV-537733 |
|
Vault does not create IDMP Pack Size records when the Registration or Registered Packaging fields are not populated on a related Pack Size record.
|
DEV-537749 |
|
When a source document is linked to a matched target document and the source document is matched during continuous publishing, Vault does not execute some PDF validation rules.
|
DEV-537808 |
|
When the Content Plan Hierarchy State Change asynchronous system action is executed, Vault notifies the last user to complete the workflow task instead of the workflow initiator.
|
DEV-538017 |
|
The Lead Market filter is selectable but not automatically displayed in the Create Related Records wizard when pairing Countries with Applications.
|
DEV-538216 |
|
Active Dossier Viewer may show rows that do not reflect the user's selected region filters.
|
DEV-538228 |
|
If a user runs on-demand on an item in an ad promo section with inactive promotional material sections in the same content plan, they receive an error and the item fails to publish.
|
DEV-538667 |
|
In some cases, while using the Manage Registered Details wizard, Vault fails to display registrations on the "Add New Details" page.
|
DEV-538706 |
|
Publishing jobs may fail if the application folder name or document name in POL contains the "%" character.
|
DEV-539059 |
|
When defining Clinical Study relationships in the Submission Wizard, users without appropriate permissions cannot select specific Clinical Study relationship records.
|
DEV-539481 |
|
In some cases, hovering and clicking on documents in the New Submissions Archive Viewer results in an error.
|
DEV-539626 |
|
Under certain circumstances, Vault fails to publish US AdPromo Submissions if there are inactive EDLs.
|
DEV-539688 |
|
The new Submissions Archive Viewer displays nodes expanded (instead of collapsed) if the Submission join filter returns multiple submissions.
|
DEV-539692 |
|
If a document is open in the new Submissions Archive Viewer, users receive a network issue error message when applying a filter to the Name column.
|
DEV-539753 |
|
Users may receive a server having problems error when editing an application record.
|
DEV-539791 |
|
In some cases, Vault fails to correctly display Japanese Submissions in the New Submissions Archive Viewer.
|
DEV-539835 |
|
Submission Wizard users are able to create Submission Active Substance and Regulatory Objective Active Substance records, even if a user does not have read access to fields on the Application source record.
|
DEV-540440 |
|
If a user does not have access to view an application record, they may see an unhelpful error message rather than the empty viewer.
|
DEV-540744 |
|
Vault incorrectly reports Rules 16.BP2 and 16.BP3 as failed when a link begins with a “mailto:” prefix.
|
DEV-541079 |
|
Users cannot export EAEU submissions imported into Submissions Archive.
|
DEV-541345 |
|
In some cases, users are unable to complete checklists due to issues with dependent question behavior.
|
DEV-541611 |
|
When Vault sends a compliance package from PromoMats to RIM, the RIM CrossLinks Post Processing job fails if the package contains approximately 10 or more CrossLink documents.
|
DEV-541697 |
|
In some cases, Vault fails to save and load user preferences in the Submissions Archive Viewer.
|
DEV-542031 |
|
In some cases, Vault fails to discard unsaved changes after users modify and refresh the Active Dossier viewer.
|
DEV-542167 |
|
In rare cases where it is necessary, users are unable to have duplicate Application UUIDs in the same Lead Market.
|
DEV-543291 |
|
In the new Submissions Archive Viewer cumulative view, leaf title text exceeding 512 characters overlaps other leaf cards in the view.
|
DEV-544257 |
|
The new Submissions Archive Viewer displays STF XML in the current view.
|
DEV-544259 |
|
Under certain circumstances, Vault displays an incorrect error message when users attempt to dispatch a Global Content Plan with missing records.
|
DEV-544344 |
|
Vault incorrectly reports Rule 14.BP3 as failed if the file name begins with “specifications-”.
|
DEV-544364 |
|
The new Submissions Archive Viewer grid does not load when a text filter includes a blank space at the end of the alphanumeric search term.
|
DEV-544856 |
|
In some cases, Vault incorrectly creates duplicate Activity Dependency records.
|
DEV-545064 |
|
In some cases, when the Registration lifecycle includes entry criteria fields to which a user does not have edit permission, Vault does not display the Save and Verify button when managing registered details.
|
DEV-545640 |
|
Vault incorrectly reports Rule G32 as failed when two submissions within the same CA application have different published XML language values.
|
DEV-546087 |
|
Users receive a “Page Not Found” error when attempting to access a Submissions Archive export from the notification.
|
DEV-548163 |
|
Vault incorrectly reports Rule 1154 as failed when the target submission has a previous Regional XML version (2.01).
|
DEV-549242 |
|
In some cases, the RMS Integration and Synchronization job creates duplicate Controlled Vocabulary records with the same SPOR IDs.
|
DEV-550815 |
|
When the Published Output Location of an STF XML Content Plan Item is updated, Vault does not up-version the STF XML during continuous publishing.
|
DEV-551332 |
|
Users are unable to view the Submission Wizard's result CSV files on any Regulatory Vault that does not have the RIM Submissions app enabled.
|
DEV-551963 |
|
When validating AU 4.3.2 and 4.3.3, Vault returns ambiguous error details when elements are missing.
|
DEV-552047 |
|
Vault incorrectly orders Content Plan Items in the new Submissions Archive Viewer after on-demand or continuous publishing.
This fix was postponed to a later release.
|
DEV-553061 |
|
Users are unable to add more than 12 Regions to the 'Automatically generate medicinal product records' setting.
|
DEV-553932 |
|
When a Correspondence document is associated with at least one Null-status submission record, any subsequent Correspondence documents are not picked up by the Correspondence feature.
|
DEV-553956 |
|
In some cases, the Delete Inactive Content Plans SDK job may fail.
|
DEV-554413 |
|
When Vault imports a submission, the import notification includes a false warning message if the submission’s index-md5.txt file contains a checksum value with a trailing new line character.
|
DEV-554719 |
|
When users click a document’s “Where used in archive” link, Vault opens the new Submissions Archive Viewer to the default view instead of the document’s section.
|
DEV-555445 |
|
Users who have unchecked the requiredness on Administered Products and then attempt to load them into a Vault may experience errors that prevent the SDK from triggering and the expected joins from being created.
|
DEV-555466 |
|
The new Submissions Archive Viewer displays rows referencing deleted Submissions Archive documents.
|
DEV-555934 |
|
When a document for a Japanese submission is up-versioned, Vault displays the latest version in the new Submissions Archive Viewer.
|
DEV-555937 |
|
Vault incorrectly fails CA rule F05 when an M1 reference leaf Content Plan Item’s xlink_href__v field is a relative path.
|
DEV-556051 |
|
Vault does not fail Rule CA C05 when a Content Plan Item’s Published Output Location contains an uppercase letter.
|
DEV-556177 |
|
Validation rule US 5205 incorrectly fails for PDF forms that have embedded links.
|
DEV-556520 |
|
The new Submissions Archive Viewer displays duplicate eCTD sections for US region v3.3 and 2.01.
|
DEV-556523 |
|
When applying a Product Family filter in the Active Dossier Viewer and Editor, Vault allows users to select inactive records.
|
DEV-557603 |
|
Vault incorrectly reports Rule 1221 as passed when the folder in a Content Plan Item’s Published Output Location is longer than 64 characters.
|
DEV-557832 |
|
Publishing jobs fail when an embedded permalink URL includes a single quotation mark ( ‘ ).
|
DEV-557998 |
|
When using the Export Tree with All Descendants action in the Content Plan, Active Dossier, and Submissions Archive viewers, users without Business Admin access cannot view links from the resulting Excel file.
|
DEV-558157 |
|
As a one-off event, Content Plan Item failed to update the Match Document field based on the related Content Plan.
|
DEV-558243 |
|
Vault incorrectly reports Rules 1551, 1554, and 1681 as failed for Promotional Label Advertising submissions.
|
DEV-558250 |
|
For Japanese submissions, the new Submissions Archive Viewer incorrectly displays the operation name.
|
DEV-558594 |
|
Upon re-publishing, Vault does not clear resolved Rule A06a validation errors in CA submissions.
|
DEV-559063 |
|
Vault does not create Global Content Plans when the Repeat on Submission Grouping field is not enabled on the “Other” Content Plan Item Template object type.
|
DEV-559192 |
|
Notifications for Registered Site Role Vault Loader files are generated in English only.
|
DEV-560699 |
|
Embedded permalinks with broken links may cause publishing to fail.
|
DEV-562410 |
|
Vault does not create Active Dossier Item and Active Dossier Item Detail records when an English-language document in a translation relationship is matched to two different Content Plan sections.
|
DEV-563246 |
|
Users are unable to view some older submissions in the new Submission Archive Viewer.
|
DEV-564140 |
|
Users attempting to create a Global Content Plan receive an error when the Event record’s Name includes single quotation marks (‘).
|
DEV-565008 |
|
When a Quality to RIM Vault Connection transaction fails, the inbound job does not update the transaction’s Pending status to Failed, preventing the job from processing the remaining transactions.
|
DEV-565103 |
|
In rare cases, when Acknowledgements are attached to different submissions at the same time, the Acknowledgements may be added to the incorrect submission record.
|
DEV-565247 |
|
Publishing jobs fail when a corrupt PDF is matched to a Content Plan Item.
|
DEV-565460 |
|
In rare cases, users cannot filter matched documents by Lifecycle State in the Content Plan Hierarchy Viewer.
|
DEV-566751 |
|
In some cases, users are unable to delete Activity records created using the Quality to RIM Vault Connection.
|
DEV-567364 |
| Description |
Issue No. |
|
Fixed an issue with FDA E2B(R2) files where, when there was no patient death or parent information, blank tags were exported for the B.1.9 Patient Death and B.1.10 Parent data elements.
|
SAF-13587 |
|
Fixed an issue where page layout rules with field-level conditions were not immediately executed in the same edit session when a field was part of a control. For example, when a case was promoted for a male patient, and then the Gender field was subsequently changed to Female, the gender-specific fields such as pregnancy information did not appear immediately.
|
SAF-29964 |
|
Fixed an issue where, when searching by Preferred Name in the WhoDRUG Browser, generic drugs were not returned in the search results. Now, you can filter on generic drugs by entering "generic:y" in the Search bar.
|
SAF-31080 |
|
Fixed an issue where, when a primary non-serious adverse event was added to a Case, Case Assessments were not updated.
|
SAF-31894 |
|
Fixed an issue where, when user actions were prevented while the system generated Case Narratives, error messages did not describe the cause of the issue.
|
SAF-33377 |
|
Fixed an issue where, when Combination Products included more than one (1) device constituent with a lot number, the system did not generate FDA VAERS E2B(R3) files correctly.
|
SAF-33478 |
|
Fixed an issue where, when voiding a Case and generating a Transmission with the One Last Time parameter set to "Yes", the Previously Submitted reporting rule parameter evaluated only the previous Case version. Now, all prior Case versions are evaluated and the Transmission is generated with the One Last Time parameter set to "Yes" only when the most recent Transmission for the same destination has the One Last Time parameter set to "No".
|
SAF-33974 |
|
Fixed an issue where Watchlist Tags were applied to Cases when the associated Organization was not on the Watchlist record.
|
SAF-34282 |
|
Fixed an issue where, when errors occurred during import of multi-E2B XML or Zip files from an API Transmission, system error messages did not describe the cause of the errors.
|
SAF-34296 |
|
Fixed an issue where Cases did not appear on PADER 15-Day and Non-15 Day Summary Reports due to page count limitations.
|
SAF-34380 |
|
Fixed an issue where, in some instances, system performance was slow during Case promotion and duplicate detection.
|
SAF-34694 |
|
Fixed an issue with E2B(R3) validation where the ICH.C.5.1.r.1 data element always required that the Study Registration Number was populated with a valid unique EU trial number or EudraCT number. Now, this validation criteria applies only to Transmissions to the EudraVigilance Clinical Trial Module (EVCTM).
|
SAF-34818 |
|
Fixed an issue where, when promoting an Inbox Item, the audit trail did not log Potential Matches search results if the Create New Case, Mark as Duplicate, Mark as Follow-Up, or Create Follow-Up actions were used.
|
SAF-34932 & SAF-36564 |
|
Fixed an issue with E2B import through API transmission where, in some instances, the Retrieve Job Status API call did not return acknowledgments after successful imports.
|
SAF-34985 |
|
Fixed an issue with E2B(R2) import where, when a file included thousands of Cases, in some instances not all Cases were imported successfully.
|
SAF-35077 |
Fixed an issue with CIOMS I and FDA 3500A preview generation for Study Cases without Case blinding, when a blinded Study included open Study Arms, the report data was masked. Now, when a Study Case is not set to be blinded and the blinded Studies included open Study Arms, Vault Safety includes the option to generate unmasked report previews.
Enablement: Auto-On
Default Impact: Visible to All Users
GxP Risk: N/A
|
SAF-35118 |
|
Fixed an issue where, when strict case locking was enabled, Vault Owners were prevented from editing Cases.
|
SAF-35166 |
|
Fixed an issue with E2B-imported Cases where the Blinded Name (Placeholder) field on the Case Product record was not populated when the reported name was an exact match for the Blinded name.
|
SAF-35176 |
|
Fixed an issue where non-Vault Owners could not void Cases in the Approved state.
|
SAF-35534 |
|
Fixed an issue with copying patient information from an existing Case to a new Case where, when Narratives were copied, additional Narrative documents were generated and prevented Case processing.
|
SAF-35553 |
|
Fixed an issue with generating FDA E2B(R2) files with device-specific adverse events where International Medical Device Regulators Forum (IMDRF) codes for Medical Device Problems and Investigation Conclusions were not exported correctly.
|
SAF-35844 |
|
Fixed an issue where, when Follow-up Questionnaires were created for Inbox Items without a specified Company Product, the generic product template was not selected for the questionnaire and the questionnaire was not sent.
|
SAF-35889 |
|
Fixed an issue where, when an Inbox Item was merged to an in-flight Case and the Adverse Event was changed, after the merge the Case Assessment name was not updated, although the Case name and Adverse Event record were updated correctly.
|
SAF-35938 |
|
Fixed an issue with E2B import where, when the Auto-select Inbox Item Localization by Reporter Country feature was enabled and an Inbox Item had a Localization Type of Local, the system mapped the Name (Reported) field to the localized field instead of the global field (English).
|
SAF-35958 |
|
Fixed an issue with E2B file export where, when a Case with a Combination Product also included a non-Combination Product with a Drug Role of "Similar Device", the Product with the Drug Role of "Similar Device" was exported to all E2B Transmission formats. Now, those Products are exported only to FDA E2B(R2) and FDA VAERS E2B(R3) formats.
|
SAF-35963 |
|
Fixed an issue with generating FDA 3500A forms where the Due in Days calculation was not updated to reflect the Due Date calculation.
|
SAF-35964 |
|
Fixed an issue where, when the value in the Case Test Result (Unit) field did not comply with the EMA Unified Code of Units of Measure (UCUM) list, the Submit to Gateway action was not prevented, resulting in Negative Acknowledgement (NACK) messages.
|
SAF-36122 |
|
Fixed an issue with E2B export where values in the Study Name (Continued) field were not populated in the C.5.2 Study Name data element of E2B(R3) files.
|
SAF-36184 |
|
Fixed an issue where, when creating a new Case and copying patient information from an existing Case, the system did not generate all of the expected Assessments on the new Case.
|
SAF-36191 |
|
Fixed an issue with E2B(R3) import where, when the C.5.2 Study Name data element included more than 1,500 characters, import failed instead of populating the additional characters in the Study Name (Continued) field, as expected.
|
SAF-36218 |
|
Fixed an issue with evaluating the Downgrade reporting rule parameter for Clinical Trial Cases where, when the Safety Rule Set had Product Selection set to "Most Conservative Product", the most conservative product on the original Case was not considered. Now, the most conservative product on both the original and Follow-up Case is evaluated to determine if the Clinical Trial Case's seriousness, expectedness, and relatedness have been downgraded or upgraded.
|
SAF-36440 |
|
Fixed an issue with E2B(R2) file export where, when only a non-primary Case Adverse Event was Serious, the A.1.5.1 Serious data element was set to "No" although the A.1.5.2 Seriousness Criteria was set to "Yes" for the applicable Seriousness Criteria. Now, when any Case Adverse Event includes Seriousness Criteria, the A.1.5.1 data element is set to "Yes".
|
SAF-36441 |
|
Fixed an issue where, when creating binders with custom document types, after selecting Save the system displayed an error message although the binder was saved. This issue did not prevent merging binder documents into a PDF.
|
SAF-36450 |
|
Fixed an issue where, when voiding localized Follow-up Cases, generated Transmission records linked to the original Localized Case, instead of the Follow-up Case.
|
SAF-36554 |
|
Fixed an issue with Localized Cases where values in the English Event (Reported) field were overridden with MedDRA terms when adverse events were coded through the MedDRA browser.
|
SAF-36617 |
|
Fixed an issue where, when Inbox Items were created through email intake, the Receipt Date field was populated with the date the email was sent. Now, when Inbox Items are created through email intake, the Receipt Date field is left blank.
|
SAF-36707 |
|
Fixed an issue where global Case data was not synchronized to follow-up foreign Localized Cases when the associated Transmission records were created by rules evaluation.
|
SAF-36713 |
Fixed an issue with manual Submission and Distribution creation where, when a Transmission Profile was selected, the system did not apply some settings to the Submission or Distribution record. Now, the following Transmission Profile settings are applied to the record:- Outbound Format
- Additional Output Formats
- Sender User
- Message Subject (including tokens)
- Message Body (including tokens)
- Cover Letter Template
Enablement: Support
|
SAF-36734 |
|
Fixed an issue where, when promoting an AER to a Case, UID was not included in the Potential Match criteria.
|
SAF-36803 |
|
Fixed an issue where, when promoting an AER to a Case, system performance was slow when running duplicate detection.
|
SAF-36803 |
|
Fixed an issue where Read access permission for localized objects was required to view Inbox Items without localization.
|
SAF-36824 |
|
Fixed an issue where, when a Transmission was created manually and then the Transmission Document Type was later changed to E2B, the E2B Message ID was not generated.
|
SAF-36831 |
|
Fixed an issue where, when 22R3 deep duplicate detection was enabled, in some instances the Potential Matches page displayed more results than the maximum number configured in Case Promotion Settings.
|
SAF-36852 |
|
Fixed an issue where it was not possible to enter "--" in Reporting Rule Parameter fields to indicate that a parameter should not be inherited from the parent Rule Set.
|
SAF-36853 |
|
Fixed an issue with rule parameter evaluation for AE in Jurisdiction where, when the Primary Reporter Country field was blank, the system did not fall back to the Adverse Event country, resulting in under-reporting.
|
SAF-36865 |
|
Fixed an issue where, when a Case Product had a Drug Role of "Concomitant" and the related Dosage record had partial dates (for example, YYYY-MM) in the First Admin Date or Last Admin Date fields, the New Case - Copy Patient Information action was prevented.
|
SAF-36913 |
|
Fixed an issue where, if a triage workflow was configured to populate a specified field with a value if that field was blank on intake, when an Inbox Item was created from an E2B file the lifecycle state was updated before the workflow was complete.
|
SAF-36974 |
|
Fixed an issue where, when the Cumulative Dose field on the Case Product was missing a unit value, E2B(R2) export failed.
|
SAF-36989 |
|
Fixed an issue where, when a Case with an External Product had a Localized Case Submission, changing the External Product and its Substance on a Follow-up Case was prevented by the system.
|
SAF-37129 |
|
Fixed an issue with promoting Cases from the Case Compare page where, when an error occurred due to missing Read permission for the Language field, the system error message did not describe the cause of the issue.
|
SAF-37207 |
|
Fixed an issue where, when errors occurred when adding Study Registrations, system error messages did not describe the cause of the issue.
|
SAF-37267 |
|
Fixed an issue with merging Inbox Items into in-flight Cases where Case identifiers doubled with each merge. This led to a high number of duplicate records with the potential to impact system performance.
|
SAF-37300 |
|
Fixed an issue with Case validations where all duplicate Case identifiers were validated, which caused system performance issues.
|
SAF-37303 |
|
Fixed an issue where, when Expectedness was overridden at the Case Assessment level on a Study Case for a blinded Study, if the Case was unblinded the overridden value for Case Assessment Expectedness was cleared and Case Assessment (Status) was reset to Auto-calculated. This fix addresses an unexpected behavior change caused by SAF-34161, which has been reverted.
|
SAF-37392 & SAF-40201 |
Fixed an issue where, when Atomic Security was configured to hide fields with protected health information (PHI) and personally identifiable information (PII), some values still appeared on the Potential Matches page during Case promotion. Now, Vault Safety includes the option to hide all Reporter, Patient, and Adverse Event Onset field values on the Potential Matches page.
Enablement: Admin Checkbox
Default Impact: Visible to Admins Only
GxP Risk: High
|
SAF-37499 |
|
Fixed an issue where, when promoting an Inbox Item and merging it into an in-flight Case or creating a Follow-up Case, if a Case child object on either the Inbox Item or the matched Case exceeded the system limit of 300 records, none of the Inbox Item records for that object were applied to the new Case version. Now, the system limit for Case child objects is 500 records.
|
SAF-37528 |
|
Fixed an issue with 22R3 deep duplicate detection where Study Number was included in the ID match criteria, resulting in too many Likely Match suggestions. Now, Study Name and Study Number are included in the Matching Reporter criteria.
|
SAF-37574 |
|
Fixed an issue with Strict Case Locking where, when Assign Due Date was configured as an Entry Action and included in the Case Locking criteria, moving Cases to the Approved state was prevented by the system.
|
SAF-37656 |
|
Fixed an issue where, when Strict Case Locking was enabled, after promoting an Inbox Item to multiple Cases only the first created Case entered the Triage lifecycle state.
|
SAF-37657 |
Fixed an issue with E2B(R3) report generation where the G.k.2.1.1a MPID Version/Date Number data element exceeded 10 characters. Now, the value is exported as YYYYMMDD. The same format is now also applied to the following data elements:- G.k.2.1.2a PhPID Version Date/Number
- D.8.r.2a MPID Version Date/Number
- D.8.r.3a PhPID Version Date/Number
- D.10.8.r.2a MPID Version Date/Number
- D.10.8.r.3a PhPID Version Date/Number
|
SAF-37771 |
|
Fixed an issue with Case promotion where, when the Potential Matches page included both likely and possible matches, the possible match results were not ranked in the correct order.
|
SAF-37847 |
|
Fixed an issue where, when a Custom Rule Set did not have the Agency set to "PMDA" and a Case Product Registration did not have the Country set to "Japan", expected Distributions for the PMDA were not generated.
|
SAF-37856 |
|
Fixed an issue where, when auto-calculation was turned off, Age fields were auto-calculated after Case promotion for Inbox Items created through E2B-import.
|
SAF-37874 |
Previously, when merging to an in-flight Case or creating a Follow-Up Case, if either the Inbox Item or matched Case included at least one (1) Case child object that exceeded the system limit of 500 records, the action was prevented by the system. Now, Vault Safety supports up to 1,500 Case child objects on a maximum of three (3) objects.
Enablement: Support
|
SAF-37884 |
|
Fixed an issue where, when a User Profile was set to any value other than English, the Dosage Frequency Unit field did not display selected values.
|
SAF-38025 |
|
Fixed an issue with automated Case promotion where, when 22R3 deep duplicate detection was enabled and set to consider Inbox Items, promotion failed when the most likely ID match was an Inbox Item.
|
SAF-38058 |
|
Fixed an issue where Products with a Drug Role of "Similar Device" were being included on non-FDA Transmission documents.
|
SAF-38225 |
|
Fixed an issue where, when the Device Code entered in the Case Product Device Code field was not a level 3 code, the corresponding FDA code was not exported to FDA E2B(R2), FDA VAERS E2B(R3), and FDA 3500A files.
|
SAF-38235 |
|
Fixed an issue where, when voiding a Case and nullifying all previous Transmissions, the New Info Date token in the message body of email Transmissions was populated based on the previous version of the Transmission.
|
SAF-38266 |
|
Fixed an issue where, when the Potential Matches screen returned more than 20 results, reviewing the left pane list of all potentially matching Cases was difficult. The pane now includes a scrollbar for better usability.
|
SAF-38284 |
|
Fixed an issue with FDA E2B(R2) export where, when a Combination Product included Drug and Company Product constituents and the Company Product had a Drug Role of "Similar Device", the Company Product was not included in a B.4 Drug(s) Information block of the file.
|
SAF-38297 |
|
Fixed an issue where, when generating reports for Combination Products, Product constituents with a Drug Role of "Similar Device" were included on CIOMS I forms (in section II. Suspect Product(s) Information) and FDA 3500A forms (in section C. Suspect Products or D. Suspect Medical Device).
|
SAF-38301 |
|
Fixed an issue where CIOMS I and FDA 3500A forms failed to generate when Case Result (Text) fields included non-numeric values.
|
SAF-38302 |
|
Fixed an issue where, when a Case included a Company Product with a Product Type of Device and the associated Malfunction field was set to Yes, the Case-level Device Report Type field was not populated with "Malfunction".
|
SAF-38312 |
|
Fixed an issue where, when a Study was set up with Unspecified Products, Watchlist tags were not applied to associated Study Cases. Now, when a Study has Unspecified Products, Watchlist tags are applied to Case Products.
|
SAF-38355 |
|
Fixed an issue where, when sending Submissions and Distributions over email, the full email body was captured in the Initial Message Sent event type of the Email Events Log. This created the potential for personally identifiable information (PII) to appear in the log.
|
SAF-38460 |
|
Fixed an issue where, when a PSMF Document was approved by a non-Vault Owner user, the lifecycle state of the PSMF Logbook Entry was not updated to "Final".
|
SAF-38473 |
|
Fixed an issue with Inbox Item promotion where, when the rank 1 Product or Adverse Event was edited to rank 2, Case Promotion was not prevented by the system although there was no rank 1 Product or Adverse Event.
|
SAF-38668 |
|
Fixed an issue with Case promotion where, in some instances, the Potential Matches page did not appear and a system error was displayed but the Inbox Item was promoted.
|
SAF-38785 |
|
Fixed an issue where, when an Inbox Item was received through an AS2 gateway Transmission and auto-promoted, auto-calculations occurred when the related Transmission Profile had the Auto-Calculation Options field set to "Disable".
|
SAF-38808 |
|
Fixed an issue where, when an Inbox Item was edited, the Last Modified Date value was not snapshotted to the Section Last Modified Date field.
|
SAF-38822 |
|
Fixed an issue with Combination Products where, when the Drug Role of one Product constituent was changed, the Drug Role of related constituents was not updated.
|
SAF-38928 |
|
Fixed an issue where, in some instances, Products with a Drug Role of "Similar Device" were exported on FDA VAERS E2B(R3) reports when they should have been excluded.
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SAF-38929 |
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Fixed an issue with FDA 3500A form generation where, when Combination Products included Product constituents with a Drug Role of "Similar Device", the constituents were not exported to overflow pages. Now, Products with a Drug Role of "Similar Device" are exported to overflow pages under the heading "C/D. Similar Device(s)".
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SAF-39054 |
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Fixed an issue with PMDA E2B(R3) export where the E2B Code was not exported correctly in the J2.13.r.3 Development phase data element.
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SAF-39326 |
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Fixed an issue where, when editing a previously saved Inbox Item, the system prevented saving new data in a blank custom long text field.
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SAF-39327 |
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Fixed an issue with manually created Inbox Items for unarmed studies where, when the Inbox Item included one Study Product, after promotion all Study Products appeared on the Case.
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SAF-39633 |
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Fixed an issue with E2B(R3) file export for Follow-Up Cases where the C.1.8.2 First Sender of This Case data element was populated with the value in the First Sender field of the follow-up Inbound Transmission, instead of the original Inbound Transmission.
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SAF-39660 |
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Fixed an issue with PSMF PDF generation where the lifecycle state was not updated to Generated.
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SAF-39665 |
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Fixed an issue on the Potential Matches page where, when 22R3 deep duplicate detection was enabled, Case Identifiers were not considered when searching for potential matches.
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SAF-39774 |
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Fixed an issue where, when a Follow-Up Case was created for a Pregnancy Case, Case Test Result records for the 1-, 5-, and 10-minute APGAR scores were added to the Parent Information Case, instead of the Child Information Case.
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SAF-39815 |
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Fixed an issue on the Potential Matches page where, when 22R3 deep duplicate detection was enabled, Inbox Item Case Identifiers were not considered during duplicate detection.
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SAF-39869 |
Fixed an issue with intake through E2B or JSON where, when the Safety General Settings "Enable auto-set Inbox Item Localization by Reporter Country" and "Enable Localization-based Mapping on Import" checkboxes were both selected, when Inbox Item localization was Global, the following issues occurred:
- Patient RoA was not displayed in the Inbox Item, but was imported and snapshot to the Case on promotion
- Product (Reported) was not imported to the Inbox Item, nor snapshot to the Case on promotion
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SAF-39945 |
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Fixed an issue where, when the Upgrade to Latest Version action was run to download the latest MedDRA dictionary version, the MedDRA version number on some Preferred Terms (PTs) was not updated.
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SAF-40125 |
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Fixed an issue with Inbox Items where, in some instances, after entering the required details, the Identifiable Patient and Identifiable Reporter fields were not set to Yes.
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SAF-40223 |
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Fixed an issue where, when 22R3 deep duplicate detection was enabled, in some instances Promote to Case was prevented when Inbox Items included the words "and", "not", or "or" in Adverse Event or Product fields.
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SAF-40685 |
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Fixed an issue where, when Case Access Group Security was enabled, the system prevented completing workflow tasks with prompts.
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SAF-40707 |
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Fixed an issue with creating Inbox Items where, when Case Access Group Security was enabled, PII-protected Case Validity and Source fields were not populated if the Inbox Item was created by a user without PII access.
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SAF-40887 |
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Fixed an issue where invalid E2B files were generated when Case Study Registrations were set up with Country Unknown (2-letter Code "ZZ"). Now, Study Registrations set up with Country Unknown are not downloaded to Cases.
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SAF-40941 |
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Fixed an issue on the Potential Matches page where, when 22R3 deep duplicate detection was enabled, some Inbox Item Case Identifiers for migrated Cases were not considered during duplicate detection.
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SAF-41154 |
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Fixed an issue with MedDRA coding where, in some instances, the Auto-Code button was not available in all expected Case Drug History fields.
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SAF-41465 |
| Description |
Issue No. |
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When an HVO Object is used for a related object section and a VQL filter is applied to that section, selecting Show in Tab for that section will show all related records rather than the filter.
This fix was postponed to a later release.
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DEV-441776 |
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In some cases, the Library page masks the incorrect user names for multi-value user references.
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DEV-512527 |
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Under certain circumstances, users cannot export and migrate search collections.
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DEV-516488 |
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In some cases, an expanded search for related objects may return too many results.
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DEV-525599 |
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In rare cases, Vault fails to accurately count the number of searches made in the Library's grid view.
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DEV-532106 |
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Advanced search and searches done from unrelated tabs may not return the correct results.
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DEV-538681 |
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When selecting a user for Delegate Access, user names are case-sensitive.
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DEV-538699 |
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In some cases, after a user clicks "Show in Tab," the resulting dynamic tab incorrectly does not show any records.
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DEV-539360 |
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Under certain circumstances, users see a "Page not found" error after opening a shared saved view.
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DEV-539924 |
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Searching with quotes may return incorrect results.
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DEV-541068 |
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When searching Quality Event objects, users may need to perform the search twice before the search results are filtered properly.
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DEV-542109 |
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Text fields in search results may be inconsistently displayed in their entirety or truncated.
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DEV-544069 |
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In some cases, the Where Used page is not exported properly for exported documents.
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DEV-545755 |
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In some cases, users are unable to open EDL records in a new tab or window after clicking 'Show in Tab' from a Study record.
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DEV-545872 |
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When exporting Submission records from Tab View to Excel, users may observe that the Date field is formatted incorrectly and not recognized as a date field by Excel.
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DEV-545873 |
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In some cases, users searching for text values may see unexpected characters in text fields in the results.
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DEV-547371 |
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Users may be unable to perform a bulk action on an object after searching for a matching record ID. Additionally, they may notice special characters when viewing the audit trail for a matching document number.
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DEV-548525 |
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In cases where users search for specific record IDs, they may be unable to inline edit objects with atomic field security.
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DEV-551521 |
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When navigating to a tab with a default view to which they do not have access, users may receive a 'Server having problems' error.
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DEV-551870 |
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In some cases, after freezing a column in a search grid, the drag line and cursor do not disappear.
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DEV-553399 |
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Reindedexing of metadata may be skipped for documents larger than 4 GB, which prevents them from appearing.
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DEV-554064 |
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Excel exports on dynamic object/document tabs fail when the "Include search criteria when exporting results to Excel" option is selected in the search settings.
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DEV-554204 |
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In some cases, Advanced Search does not work as expected when Include attachments is selected.
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DEV-555075 |
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In some cases, users may see highlighting symbols around document numbers on the version history dialog.
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DEV-555282 |
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When attempting to perform an inline edit after searching for a matching record ID, users may receive a server error.
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DEV-555425 |
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Users are unable to complete other actions on the same page after performing an inline edit.
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DEV-556589 |
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In some cases, users may receive a "The documents for filtering and display have been limited because there are too many tasks." warning banner when it does not apply.
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DEV-559253 |
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In some cases, users may receive a server error when attempting to view a record's audit trail.
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DEV-559323 |
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Users with saved views on tasks that are sorted by document fields may experience performance issues.
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DEV-559369 |
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In some cases, users may not be able to see some legacy workflow document tasks that they have permission to see.
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DEV-560018 |
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Users with older versions of Chrome as their browser may observe that the Library fails to load after applying filters.
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DEV-560702 |
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In some cases, users are unable to update or remove Study filters from saved views.
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DEV-560766 |
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Clinical Vault users may observe empty ID filters on the Site Activation Progress page that should not be there.
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DEV-562265 |
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Clinical Vault users may see the "Some filters are no longer available" warning on the Site Activation Progress page, where it does not apply.
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DEV-562275 |
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Users searching for document numbers may see unexpected highlight symbols around document numbers in Workflow History or Training reports.
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DEV-565444 |
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After navigating via a URL with an 'fcah' parameter, users may receive an error when attempting to update or remove a filter from a document or object tab.
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DEV-566512 |