| Description |
Issue No. |
|
Users are unexpectedly able to create QR Template records with an Inactive Document Type via API.
|
DEV-1155814* |
|
Vault removes leading backslashes upon the second transfer of a document.
|
DEV-1159367* |
|
When a user sorts a column in the matched documents grid, Vault may briefly display a "No items found" message before the results load.
|
DEV-1199484* |
|
The Self Evident Correction job encountersn an error when running on a deleted document.
|
DEV-1204607* |
|
For Monitoring Event records where the name is populated as part of the lifecycle, the Before_Insert triggger prevents Milestone creation.
|
DEV-1205258* |
|
Under certain circumstances, Milestone Planning View projections do not function as expected.
|
DEV-1211959* |
|
In some cases, Formatted Output jobs for Monitoring Events complete with errors and a status of "Error Encountered".
|
DEV-1218292 |
|
In some scenarios when excluding a parent record, Excluded from OpenData and Controlled by OpenData fields on related Location and Contact Information records incorrectly fail to update.
|
DEV-1230482* |
|
Vault does not create a new Agreement Transfer record when the Retry action is taken on the Target.
|
DEV-1230718* |
|
When Study Document Audit Export is run for the current day, future exports on that day do not contain the full day's audits.
|
DEV-1244621 |
|
DCR to Global Directory Sync job may fail with errors encountered when processing a large volume of Data Change Requests for the same Organization or Investigator.
|
DEV-1244968* |
|
When running the TMF Transfer, attachments do not transfer when the latest version of the document has been deleted in the source Vault or has failed to transfer.
|
DEV-1246277* |
|
When a user attempts to upload a non-CSV file to the Site Candidate Loader, Vault does not display the expected error message.
|
DEV-1247537* |
|
DCR to Global Directory Sync job fails with errors encountered in cases where an updated Location record fails to save due to an unhandled exception.
|
DEV-1249012* |
|
OpenData Clinical person trigger processing includes unnecessary data queries when evaluating linked user fields.
|
DEV-1254793* |
|
In some cases, the Verify Required Trip Report Questions action runs in the configured workflow and does not trigger an error for unanswered required questions
|
DEV-1257145 |
|
When creating EU Application and US Protocol Registration disclosures, non-English related objects for Eligibility Criteria, Medical Condition, Endpoints, and Objectives incorrectly prepopulate.
|
DEV-1269256* |
|
Applying advanced filters on the Feasibilty Homepage Survey Results tab leads to unexpected collapse and expanse behavior for rows and sections.
|
DEV-1269423* |
|
Protected documents are not properly retried by TMF Export and are instead treated like corrupted documents. These documents are not properly exported and the job fails when encountering them.
|
DEV-1270320* |
|
In some cases, users with Layout Profiles configured to use the Fee Schedule Builder for Fee Schedule record creation receive a server error when attempting to create a record.
|
DEV-1270772* |
|
In Vaults with Site Connect newly enabled, the In Review and In Site Review states are not available on Study Site Addresses.
|
DEV-1274453* |
|
Validation Status and Card Status values incorrectly copy over to Substantial Modification Disclosures from Non-Substantial Modification Disclosures when using the Copy Record action.
|
DEV-1274505* |
|
When creating Activities from Calls in the Clinical Operations - CRM Connection, the inbound transfer job to the Clinical Operations Vault fails with an error.
|
DEV-1274783* |
|
Study Doc Audit jobs may sporadically fail, leading to Exports with missing audit rows.
|
DEV-1279763 |
|
OpenData Clinical Generate Global Directory Match DCRs job may fail with an errors encountered when a Person record contains multiple Person Linked Contact Information records.
|
DEV-1297684* |
|
In some cases, the CDX Agreement Transfer table includes entries with null values.
|
DEV-1310452* |
| Description |
Issue No. |
|
When searching for text that only consists of numbers or hyphens in the document viewer, the system fails to highlight this text in the document.
|
DEV-1197910* |
|
Users are unable to save changes to bookmarks in cases where a bookmark title exceeds 512 characters.
|
DEV-1207179 |
|
Some PDF elements containing images may cause Vault to be less accurate in detecting differences between documents.
|
DEV-1215610 |
|
Under certain circumstances, video annotations may block certain parts of the UI and prevent users from resolving, editing, moving, or deleting them.
|
DEV-1220850 |
|
Excel files with tokens in their headers may fail to render.
|
DEV-1240339 |
|
When searching large documents, Vault may fail to return search results for text on the final pages.
|
DEV-1254888* |
|
While performing the "Make a Copy" action, Vault fails to re-evaluate document field requiredness enforced by field dependencies after an initial failed save attempt, preventing users from saving the document even after changing the controlling field to a value that no longer requires the target field.
|
DEV-1258237 |
|
Email MSG files containing multiple levels of ordered lists may not render as expected.
|
DEV-1258613 |
|
In certain cases, a video rendition may lack audio.
|
DEV-1263682* |
|
In certain cases, Korean-language characters may be displayed as unreadable text in an email MSG file viewable rendition.
|
DEV-1266764 |
|
Users with locales that do not use a period for a decimal separator are unable to make copies of documents.
|
DEV-1291432 |
|
A Vault document, after having PDF/A applied and its page rotated, may incorrectly be rendered with malformed text annotations.
|
DEV-1304266* |
| Description |
Issue No. |
|
When a user attempts to create a Word Formatted Output template with an expression using the PicklistValues( ) function, the resulting error message does not clearly communicate that this function is not supported.
|
DEV-1207970* |
|
Admins may encounter an error when attempting to delete a custom lifecycle state from a locked object.
|
DEV-1223510* |
|
Updating a field via the object record details page may incorrectly alter the state or escaping conditions of sibling fields.
|
DEV-1245655* |
|
An Action Trigger with an "IsBlank()" operator on an attachment field may not function as expected after saving.
|
DEV-1250987 |
|
Under certain circumstances, users attempting to generate a Word Formatted Output without the proper permissions for attachments and relationship fields may receive the incorrect error message.
|
DEV-1256076* |
|
When a lookup field on an object record is set to read-only, Vault may still auto-populate a value into the field instead of leaving it blank.
|
DEV-1259545* |
|
When a user opens a record from a saved view on a dynamic tab created by "Show in Tab," Vault may lose the breadcrumb label and the originating filter, so returning to the list shows all records instead of the filtered set.
|
DEV-1273991 |
|
Users may encounter a server error when performing a bulk action on more than 500 records.
|
DEV-1274061 |
| Description |
Issue No. |
|
In some cases, placeholder text may be missing from advanced search filter facets.
|
DEV-1129707* |
|
When multilingual document handling is disabled, Saved Views may appear as inconsistent in the Component Directory.
|
DEV-1191415* |
|
Users may see incorrect versions of documents when applying filters.
|
DEV-1213053 |
|
The Previous and Next arrows may be missing when viewing related object records from a related objects section.
|
DEV-1234110 |
|
When using advanced search to search by Document Number, the search returns all documents containing that number as a substring instead of only exact matches.
|
DEV-1240100 |
|
In some cases, Lifecycle banners may display incorrectly in compact view.
|
DEV-1241705 |
|
In some cases, dynamic user filters are not available on the expanded search page.
|
DEV-1248333* |
|
While using Thumbnail layout, users may see unexpected hover text for search results.
|
DEV-1248852 |
|
Record filters in the Bulk Management tool may show the number of records as 0 despite existing records.
|
DEV-1255250 |
| Description |
Issue No. |
|
When editing Entity or Requirement records in Vault, certain custom fields, such as Intended Use and Risk Justification, fail to align properly or appear cut off across specific browser window sizes.
|
DEV-1104401* |
|
Vault does not prompt Test Script Authors to reload a Test Script when attempting to save an unsaved step after several hours.
|
DEV-1117924* |
|
Vault may display extra spacing when users edit a comment within the Protocol Review interface.
|
DEV-1147939* |
|
Some fields, such as Author and Lead Executor, may fail to align properly on record detail pages for Test Script, Test Protocol, and Requirement object records in Vault.
|
DEV-1166504* |
|
When users perform the Assign Retention Schedule or Start Retention Period actions, Vault does not reload the page or display a banner to notify the user that the action was executed.
|
DEV-1187737* |
|
In some cases, when authoring, reviewing, or executing a test script with more than 25 steps, Procedure, Expected Results, and Actual Results fields load slowly and display as read-only.
|
DEV-1194599* |
|
When a user copies a prompt after adding a new prompt in the Test Authoring interface, Vault incorrectly displays validation error messages on the copied prompt instead of the newly added prompt.
|
DEV-1200968* |
|
In some Vaults, the Organization object's Health Authority object type detail page displays the Source of the Country (country__v) field as Custom instead of Standard.
|
DEV-1215796 |
|
In cases where document versions have an inactive DCC in the Change Authorization DCC field, users are unable to delete those document versions.
|
DEV-1218227 |
|
When creating or modifying an EHS Security Setup, Application Roles are not available to select from the drop-down if Admins are missing the Admin: Permission Sets: Read permission.
|
DEV-1230169* |
|
When users edit an Adverse Event Report or view delta icons and subsequently navigate away, Vault fails to reset the application state, causing unsaved change warnings and incorrect status indicators to persist across pages.
|
DEV-1230195* |
|
In the EU MIR and MHRA Adverse Event Reports Section 2, Vault displays incorrect labels for the Product Marketed checkbox field.
|
DEV-1231051* |
|
In HACCP Vaults using Upstream Hazard Management, when users click on a Process Hazard Analysis in the "Create Process Hazard Analysis from Pending" dialog, a refresh tooltip overlaps the dialog.
|
DEV-1241524* |
|
When users modify test step fields through Vault layouts, the Test Authoring user interface may fail to update and continue displaying previously cached values.
|
DEV-1245189* |
|
Vault incorrectly enables the Complete button when an executor leaves the mandatory Actual Results rich text editor field blank during test step execution, allowing users to Complete the step without saving it and without displaying a validation error.
|
DEV-1249912* |
|
When creating a Known Complaint Profile Configuration, Vault displays a server error upon selecting an object type if all fields on the Complaint object are assigned to the MedTech Known Complaint or Pharma Known Complaint object type.
|
DEV-1252167* |
|
In HACCP Vaults using Upstream Hazard Management, in some cases, the "Create Hazard Analysis from Pending" dialog displays deleted or ineligible Subsequent Step/Groups and their associated Process Hazard Analyses.
|
DEV-1255024* |
|
In HACCP Vaults using Upstream Hazard Management, under certain circumstances, when users are missing required permissions while using the "Create Hazard Analysis from Pending" dialog, Vault displays a server error.
|
DEV-1255686* |
|
In HACCP Vaults using Upstream Hazard Management, in some cases, the Remove Records dialog displays Process Hazard Analyses for Subsequent Step/Groups that have already been removed.
|
DEV-1259123* |
|
When in-line edits are enabled on smart contact blocks, Vault does not display the validation error icon for the Country field on the contact block after running validation on an Adverse Event Report.
|
DEV-1262205* |
|
When editing the Actual Results field on a completed test step, Vault fails to dismiss an error message indicating that character limits are exceeded after the user removes extra characters.
|
DEV-1267244* |
|
When a user enters text into a rich text step field using the popout editor during test script execution or dry run and closes the dialog, Vault may fail to update the character count.
|
DEV-1267247* |
|
When users without Read permission for the Complaint object's Associated Known Complaint field run the Associate Known Complaint Profile user action, the action does not fail, and Vault does not populate the Associated Known Complaint field. This issue also affects users without Read permission for the Source Complaint field when running the Promote to Known Complaint Profile action.
|
DEV-1267265* |
|
When the Update Associated Records from Profile action fails due to an empty required field, the resulting Known Complaint Profile Log Detail record does not include an error message.
|
DEV-1267782* |
|
Under certain circumstances, the Risk Builder becomes unresponsive after closing the selection dialog for Assessment Risk documents.
|
DEV-1278758* |
|
When users run the Download as PDF action on a Reason for Change record, in some cases, the Event Times in the Audit Trail section of the PDF do not match the Event Times displayed in the Vault UI.
|
DEV-809548* |
| Description |
Issue No. |
|
Rule ICH-077 may fail validation even when the Submission UUID in the XML matches the actual Submission UUID.
|
DEV-1187446* |
|
In some cases, non-Vault owners may encounter an error when accessing the Data Sync admin settings page.
|
DEV-1207640* |
|
In some cases, the Drug Product Brand Name dropdown in EU 4.0 Manage SAI may not display all available values.
|
DEV-1229405* |
|
Users may be unable to clear the Days Before Expiration field when editing an FDA gateway profile.
|
DEV-1230569* |
|
In some cases, Rule JP-eCTD4-268 may report a false positive when related Japanese applications use eCTD 3.2.
|
DEV-1234588 |
|
Rule 4.8.1 may fail to flag required documents for South African renewal submissions.
|
DEV-1236462 |
|
In some cases, XML details may not be copied to a Submission Product Form join when a Global Content Plan is dispatched.
|
DEV-1237592 |
|
The retrieve-details API may omit root content plan results when the request combines the ALL scope with other sub-requests containing CPI ID and document ID parameters.
|
DEV-1239897 |
|
In some cases, the pre-export size calculation may report an incorrect file size for submissions exceeding the 5 GB limit, delaying permission checks.
|
DEV-1240402* |
|
For EU eCTD 4.0 submissions, Submissions Archive Viewer hovercards for XML Languages display the Code System OID field as "null" instead of blank.
|
DEV-1241577* |
|
In some cases, content plans may be baselined before all associated documents are matched.
|
DEV-1244513* |
|
Rule 002 may incorrectly fail validation when reporting XML that is not valid against the ICH schema.
|
DEV-1249492* |
|
Rules 081 and 083 may return an internal error during submission validation.
|
DEV-1249515* |
|
In some cases, the mode element may be generated for submissions where it is not applicable.
|
DEV-1249696* |
|
Submission metadata records for correspondence may remain visible after the Show Correspondence in Viewer setting is disabled.
|
DEV-1249958* |
|
When setting a reference leaf, a leaf operation, or a document update operation, RIM Publishing users are able to view the Folder Path action from the Content Plan's actions menu.
|
DEV-1255668* |
|
Rule EU-010 may not correctly fail validation when an IMAA submission has a sequence ID other than 1.
|
DEV-1255812* |
|
Users may be able to access data sync failure CSV files through a URL without the required permissions.
|
DEV-1255868* |
|
In some cases, the retrieve-details API may omit root Content Plan results when the scope is set to "ALL" alongside requests containing CPI ID and document ID parameters.
|
DEV-1257376* |
|
When an Event Product matches multiple Application Products, the Create Related Records wizard matches existing Application Inactive Ingredient Records with a blank Application Product, allowing downstream Regulatory Objective Inactive Ingredient and Submission Inactive Ingredient records to be created with a blank Product reference.
|
DEV-1257632 |
|
In some cases, data sync jobs may fail when the remote RIM PM Sync platform flag is not enabled.
|
DEV-1258499* |
|
Match Document Mode may fail to launch from the CPI record action menu when the suggested action is disabled.
|
DEV-1259933* |
|
Users may be unable to launch Match Document Mode from a Content Plan Item record when Suggested Actions are disabled.
|
DEV-1261975* |
|
Files may fail to be transmitted through the gateway when the initiating user lacks Download Source permission.
|
DEV-1262080 |
|
When replacing details on an Event with an impacted Product Family, the Create and Manage Event Details wizard does not filter the Active Substance dropdown by Product Family. This allows users to select invalid Product Family-Active Substance combinations that fail or disappear upon saving.
|
DEV-1262815* |
|
In some cases, the "Items with issues" count in Content Plan Readiness notifications may be incorrect.
|
DEV-1264960* |
|
In some cases, error messages may omit the Global Submission object label when the user lacks view permission for Global Submission.
|
DEV-1264975* |
|
The Readiness Summary API may return the last job run time in UTC instead of the user's configured time zone.
|
DEV-1269719 |
|
Rule ICH 076 may incorrectly fail validation during cross-application document reuse.
|
DEV-1270164* |
|
Users may experience an error when publishing files with hyperlinks that include special characters.
|
DEV-1270190 |
|
In some cases, XML details are not copied to the Submission Product Form when a Global Content Plan is dispatched.
|
DEV-1272497* |
|
The Readiness Summary API may not return findings for archived documents.
|
DEV-1272501* |
|
The Fetch Readiness Summary API may fail to return findings for archived documents.
|
DEV-1275159 |
|
In some cases, users may not see all related Application Document IDs when filtering by Product Family for product families with more than 2,000 applications.
|
DEV-1275423* |
|
The Readiness Summary API may return the last job run time in UTC instead of the user's or Vault's local time zone.
|
DEV-1275471* |
|
In some cases, data sync logs may report an error when notification recipient groups have no valid recipients.
|
DEV-1275682* |
|
The Fetch Detailed Issues API may fail to return findings for archived documents.
|
DEV-1276444 |
|
Rows with Device Exempt from Premarket Submission = true may appear in the UDI viewer despite being labelled exempt.
|
DEV-1280366* |
|
Users are unable to create new App Inactive Ingredient, App Clinical Study, or App Extended eCTD Keyword records through the Create Related Records, Update Local Regulatory Information, or Bundling actions in cases where there are multiple existing matching records for the special fields on these objects.
|
DEV-1296119* |
| Description |
Issue No. |
|
When a user accepts an auto-calculated Age (normalized) value on the Inbox Item to Case Compare page for an initial Case that includes Age and Age (Unit) values, Vault displays two conflicting Age at Onset values on the follow-up Case.
|
SAF-107896 |
|
When promoting an Inbox Item to a follow-up Case through the Inbox Item to Case Compare page, if the PQC Product field is blank on a Product Quality Complaint type of Case Adverse Event, Vault deletes the related Case Assessments and updates the Case Adverse Event type to Adverse Event.
|
SAF-108997 |
|
When processing follow-up information for migrated Cases, if users update External Product information other than the Product (Coded) value, such as changing the dosage or indication details, Vault deletes the related Case Product Substance records.
|
SAF-117180* |
|
Vault populates an MPID Version on Case Products when the related Product Registration does not include an MPID value.
|
SAF-117692* |
|
When the primary Reporter type of Case Contact changes, Vault does not update the Source Type on Case Assessment Result records.
|
SAF-120467 |
|
When promoting an Inbox Item to a follow-up study Case, for Combination Products that include an unblinded drug and an open-label device, the Inbox Item to Case Compare page displays Open Label as the Blinded value for both constituents.
|
SAF-120963* |
|
On Localized Cases for China, Vault does not populate the Local MAH field for Case Products with a Drug Role of Interacting.
|
SAF-122673 |
|
Performance issues occur when users delete a Case Product Registration on a Japan Localized Case with Localized Case Assessments that are missing Case Assessment links.
|
SAF-122681 |
|
When importing Inbox Items with PQC events using the Intake API, Vault populates the Type field with Adverse Event and does not populate the Affected Product field.
|
SAF-123865* |
|
When generating follow-up questionnaire documents, Follow-Up Questionnaire Rules do not consider the Extend Suspect Definition to Include Drug Not Administered setting when matching AESI Questionnaire (Template) document templates.
|
SAF-124085* |
|
When generating Case Product Registrations for Case Products that are part of a Combination Product, if the related Product Constituent includes a Product Variant, Vault searches only for PMDA Product Registrations with a matching Product Variant.
|
SAF-124965 |
|
Vault does not notify users when a Transmission being distributed by email moves to the Error state because an attachment exceeds the 15MB limit.
|
SAF-125265 |
|
On readable renditions of FDA VAERS E2B(R3) files, the FDA.G.k.12.r.8, FDA.G.k.12.r.9, FDA.G.k.12.r.10a, and FDA.G.k.12.r.11 data elements appear under the FDA.G.k.12.r.7 header.
|
SAF-125637 |
|
On a Workbench Report or Workbench Dashboard, Vault does not identify when the Case series MedDRA version is different from the active MedDRA dictionary version in Vault.
|
SAF-125654* |
|
When opening a Workbench Dashboard for a Signal Case Series from a Signal Reporting Period, the Apply button is inactive on the dashboard.
|
SAF-125812* |
|
When opening a Workbench Dashboard for a Safety, FAERS, or VAERS Case series from a Statistical Data record that also has field values linking to the dashboard, the Statistical Data drop-down in the dashboard does not display any values.
|
SAF-125873* |
|
When adding related PVA Obligations to a PVA Multi-Agreement Activity, upon adding a filter for PV Agreement lifecycle state, the drop-down displays PVA Obligation lifecycle states rather than PV Agreement lifecycle states.
|
SAF-125957* |
|
For Signal Case Series Workbench Dashboards at the Signal Reporting Period level, Vault does not display a banner to notify users that required filters are optional.
|
SAF-125975* |
|
When promoting an Inbox Item with a Study Product with MPID or PHPID values to a Case, Vault does not populate the MPID Version or PHPID Version fields on the generated Case Study Product.
|
SAF-126025* |
|
Readable renditions of EMA E2B(R3) files exclude the G.k.4.r.10.1 data element.
|
SAF-126099 |
|
An error displays when attempting to submit Web Intake Forms that include Form Fields with Conditional Field Display Rules where the Source Field references a Controlled Vocabulary and the Target Field is hidden by default.
|
SAF-126236* |
|
Vault runs the MFDS.C.5.4.KR.1 validation criteria for Study Types other than Other Study (E2B Code 3).
|
SAF-126307 |
|
When generating FDA FAERS and VAERS E2B(R3) files for Cases involving a Combination Product with a device malfunction, on G.k blocks for Similar Devices, Vault populates the Similar Device name in the G.k.2.2 data element, instead of the name of the primary constituent or Combination Product.
|
SAF-126479* |
|
Upon running the Start PSMF Contributor Review action on a PSMF Binder, if the application role selected in the PSMF Contributor Role setting maps to multiple PSMF document lifecycle roles, SafetyDocs generates PSMF Contributor Review Tasks for only the first instance of the lifecycle role.
|
SAF-126481* |
|
When users run the Duplicate Search on Case action, Vault displays a server error if potential ID matches exist but the user's Case Access Group does not include permission to view those Cases.
|
SAF-126525 |
|
In some instances, when filtering for MedDRA terms using the "not In" or "is not equal to" operator, filters do not properly exclude results.
|
SAF-126595* |
|
Signal Case Series Workbench Dashboards at the Signal Reporting Period level may fail to load or run if no filters are set on the dashboard.
|
SAF-126657* |
|
When follow-up data excludes an Onset date for a new Case Adverse Event, Vault turns off auto-calculation of First Dose Latency on newly generated Case Assessments for that adverse event.
|
SAF-96496 |
| Description |
Issue No. |
|
Under certain circumstances, document inbound jobs may fail unexpectedly, preventing crosslinks from being created.
|
DEV-1126304* |
|
In some cases, when users run the Transfer PQCs to Quality action on a Case in a Safety Vault, Vault creates duplicate Complaint Intakes in the Quality Vault.
|
DEV-1143322 |
|
When users run the Transfer PQCs to Quality action multiple times on a Case in a Safety Vault, in some cases, Vault does not create the expected Complaint Intake records in the Quality Vault, and does not create User Exception Messages to capture the failure.
|
DEV-1262136 |
|
Under certain circumstances, admins may receive an error when attempting to use the Copy Connection action.
|
DEV-1270077* |
|
The Quality-Safety Connection ignores filtering criteria in Query Object Rules configured on the qs_intake_contact_ir__v integration rule, which may result in the creation of more Complaint Contacts than expected in the Quality Vault.
|
DEV-1274849* |
|
The Event Management transfer job fails with a User Exception Message when Vault does not truncate the Name field properly because the source Event Management Catalog name in Vault CRM exceeds the maximum limit.
|
DEV-1286180* |
|
In some cases, users may be unable to close a Product Quality Complaint in MedInquiry that was transferred through the Medical - Quality Connection.
|
DEV-1322732 |
|
The Quality-Safety Connection does not transfer documents attached to Quality Events in Quality Vaults to Inbox Items generated in Safety Vaults.
|
SAF-125324* |
|
Running the Create Follow-Up or Merge to Current actions on an Inbox Item generated by the Safety-EDC Connection results in an API error if a Case Product Dosage contains a Link value but the associated Case Product does not.
|
SAF-126855 |
|
When running the Create Follow-Up action on an Inbox Item generated by the Safety-EDC Connection, Vault does not track safety decisions to remove child records if the record's Link field is configured to not copy in the Safety Vault.
|
SAF-127040* |