Fixed Issues in 25R1

Pre-Release Date: March 17, 2025 | Release Date: April 4 & 11, 2025

This week's release includes fixes for the following issues:

An asterisk (*) next to the issue number denotes an internally found defect filed during the development of Limited Release features.

Assessments

Issue Description Issue No.
When editing an Assessment that has a Label and Name that are different, the Scope to Source Checkbox becomes unchecked and the Assessment Label is changed to match the Name when the Assessment is accessed and edited via the hyperlink in the Questions column. VDC-182661
In some cases, picklist options for Assessments are not visible in the Assessments UI but are visible in the SDS report. VDC-183553

Audit Trails

Issue Description Issue No.
The reason for change for an Imaging Item Group does not display in the audit trail when the previous Intentionally Left Blank reason was Value Not Found. VDC-168674*
Some audit rows from the Derivation Submit Value object should not be displayed in the item audit trail. With this release, these rows will no longer be displayed in the item audit trail. VDC-183800
If a query was deleted within the date range for the Audit Trail Export job, the job will fail. VDC-186130*

Blank & Detail PDFs

Issue Description Issue No.
When using the Form Detail PDF with Audits, the links for "Form Link" and "Audit Trail By Form Link" in the Bookmarks are no longer clickable. VDC-184146*

CDB - API

Issue Description Issue No.
CDB returns an unhandled exception when a user attempts to open queries on multiple Items in the same row. VDC-174004
Users without restricted data access can open queries on blinded cells if conditional unblinding is set on the row. VDC-177889*

CDB - Checks

Issue Description Issue No.
Marking a form as Intentionally Left Blank or resetting a Form deletes the system query, instead of closing it VDC-173894*
EDC Event changes on a Referenced EDC Event do not trigger a Check as expected. VDC-174058*
In some cases, a Check's CQL syntax is validated based on the study from which the job was originally initiated. VDC-175458
CDB doesn't remove the Open Query cell decoration after a query is deleted when a check re-runs. VDC-176000*
Due to concurrency issues, in some cases, checks are stuck in a "Wait" status. VDC-176728

CDB - Clean Patient Tracker

Issue Description Issue No.
In some cases, the SDV Incomplete count is incorrect. VDC-180524
In some cases, a mismatch between SDV counts in CDB and EDC result in inaccurate reporting. VDC-182951*

CDB - Configuration

Issue Description Issue No.
Core default configurations are applied while still in the Draft status. VDC-166765*

CDB - CQL

Issue Description Issue No.
Columns that select null are were incorrectly marked as derived columns. VDC-167989*
When a view contains a union with a subquery, querying the view doesn't return the same number of rows as the view itself. VDC-169162
In incremental import studies, Call Sys_Forms may return a "Failure in Executing" error. VDC-175095*
@Form.Label doesn't return the override form label. VDC-178438*
Using @Form.SeqNbr in a concatenation across unions returns a "Failure in Executing: The used SELECT statements have a different number of columns" error. VDC-179688

CDB - Export

Issue Description Issue No.
In the Issue Log, longer error messages extend outside the viewable area. VDC-155199
For some users, the link in the export download banner stays active for a previous package when changing studies. VDC-159843
In very large studies, SAS export package generation may fail with the following: "Error: Timed out waiting for SAS to complete". VDC-175054
The following system listing fields don't refresh correctly: Form.SubmitToDMR, Form.SubmitToFrozen, Form.SubmitToLocked, Form.SubmitToSign, Form.EventToSubmit, Event.DaysOutsideWindow, Event.WindowStatus, and Event.FormEntryOverdue. VDC-176263*
With Review Comments in Export, the review columns do not display data from the Review Listing. VDC-182048*

CDB - Import

Issue Description Issue No.
When a user imports an OpenEDC package with no primary source, CDB doesn't generate the error CSV file or send a notification email. VDC-163551*
After importing a reference data package with issues, CDB increases the error count after a user imports a third party data package into that source. VDC-163799*
After the initial incremental import, CDB may skip subsequent incremental packages. VDC-163852
When the import queue contains outdated packages that were in pending status and deleted due to age, the import job fails but the next package is not queued causing import to take an overly long time. With this release, outdated packages will be skipped during import. VDC-165654
Incremental import doesn't account for precision correctly with a maximum length on the Item. VDC-172995
Simultaneous loads of OpenEDC and third party data fail because third party import always starts a reprocess of the primary source data. VDC-173788
Data is not exporting and displaying in Workbench when a 3PD package is imported with an error and then its source is deleted. VDC-173935*
OpenEDC import fails when matching Sites by ID with the following error: "Cannot generate/retrieve sites by ID for primary sources since they're not provided in data files". VDC-176464
Third party import may result in an F-020 error when using Strict Manifest because the system-generated CDB_ROWNUM column isn't imported. VDC-177460
With this release, the UI has been changed to better communicate when packages are pending after a design change occurs. A message will be displayed in the 'Details' column of the EDC Import Daily Summary page explaining why a package is in Pending status. VDC-177848
When a subject is transferred in EDC, that subject is included in results for both sites in CDB. VDC-178183
In an OpenEDC study, if a user imports one third party package, then a second, the second import will result in a reprocessing error on the first third party package. VDC-178307
CDB may take longer than expected to process an EDC package for ingestion. VDC-178600
In studies using incremental import, CDB may not be updated with the most recent Event Date for some subjects due to an error during ingestion. VDC-178629
Incremental ingestion may take longer than usual when the import includes form-level data deletion. VDC-179638
When the Source's Name contains a period ("."), CDB sends an email notification that deletion was successful without deleting the Source. VDC-179944
When a Source is deleted, other packages may not be imported. VDC-180111
The Differences tab may not show values for "To". VDC-180272
If a user imports packages from two third party sources, but those sources have duplicate listing names, name and label overrides may not apply to both sources. VDC-180765*
In studies using incremental import, some subjects may not have values for @HDR.Site.Country or @HDR.Site.Number due to an error during ingestion. VDC-181514
In some cases, a package that fails to import due to an error is not reprocessed until after 24 hours have passed. With this release, such packages will be reprocessed faster. VDC-182085*
When using strict import, fields with a space in the name appear with underscores instead of spaces. VDC-182185
After a study design change, incremental import may fail unexpectedly. VDC-184405
In OpenEDC studies, package import may fail with an unexpected L-002 error. VDC-184805

CDB - Listing Builder

Issue Description Issue No.
For some users, Listing Builder does not display saved listings. VDC-169196*
Users encounter an error message when attempting to create a check with no items through Listing Builder. VDC-171169*
If a user adds form items, then adds a study property, a form item may be removed from the listing. Then, if the user re-adds that Item, it will show as a duplicate in the Aliases step. VDC-180252
Property column dropdown options are blank when editing a stacked listing. VDC-182791

CDB - Listings

Issue Description Issue No.
The CSV of Review Listings may not have the correct format in the Reviewed On column. VDC-142742*
In some cases for imaging items, the CDB core listing displays column headers in the wrong order, making them out of sync with the EDC form. VDC-168999*, VDC-180092*
When a user converts a review listing to a custom listing, modifies it, and then reverts it back into a review listing, the review listing shows results from the original CQL. VDC-171611
In some cases, the Last Uploaded column displays incorrect dates. VDC-171629, VDC-179083, VDC-178631
Core and Query Listings used in Export Definitions do not correctly display the change detection indicator when the export listings are out-of-sync. VDC-176829*
In some cases, the Codelabel column for a Form listing returns a value when the field is set to Intentionally Left Blank (ILB). VDC-178840
Merged with VDC-171629 VDC-179083
Public listings show an incorrect Last Modified On date. VDC-179275
In some cases, the Last Uploaded column displays an older date, even though data has been uploaded after that date. VDC-179993
Review listing displays an incorrect Last Applied Package date. VDC-180518
CDB may not initially load Study links in the Study listing page. VDC-182906
For some users, the clone object's modified date is not updated even when the listing name is changed. VDC-183856

CDB - Queries

Issue Description Issue No.
In some cases, queries reopen without data changes after being manually closed VDC-168901
The Query Details panel shows the Event from the leading Form in the CQL statement, instead of the Event containing the Form the query is attached to. VDC-179328
In some cases, the EDC links to close or requery a query are missing and all fields in the query panel are grayed out. VDC-179710
In some cases, right-clicking a custom listing link in the query details panel results in reloading the query listing, instead of opening a new tab. VDC-179812
The requery percentage display for the Total Queries Generated and Queries By Site/Data Provider charts has been changed. VDC-182379*
For some users the default CQL is incorrect in the Review Dashboard, preventing filtering queries directly from the grid. VDC-182467
An error occurs with the Queries By Site / Data Provider chart when grouping by site country. VDC-183964

CDB - Unblinding Rules

Issue Description Issue No.
CDB doesn't show any Items as available to when defining unblinding rules. VDC-176164
In some cases, the source name displayed on the Unblinding Rules page is incorrect. VDC-179800

CDB - Views

Issue Description Issue No.
For some users, the breadcrumb does not show the inactive status for studies that should be marked as inactive. VDC-183188

Clinical Reporting

Issue Description Issue No.
Clinical Reporting studies are running Clean Patient Tracker and Review Listing jobs, but not using their data. VDC-165310*
Toggling the Enable Clinical Reporting option off and on in the Vault Management Console (VMC) fails to execute the provisioning code, requiring manual provisioning of a new Workbench instance. VDC-179797*

Coding

Issue Description Issue No.
In some cases, the Coding Suggestion Deletion job fails when there are too many suggestions being deleted at the same time. VDC-175224
When a user enters the Name of their Study in the Filter by Study search field, Coder doesn't show the Study as a search result or a filter checkbox. VDC-182869*

Coding Configuration

Issue Description Issue No.
Some changes to the Coder system through Coder Tools increment the Study build number. VDC-178278
In some cases, an invalid coding configuration is not identified by validation, leading to orphaned coding configurations which have been marked as inactive to be deployed. VDC-178694

Comparison Configurator

Issue Description Issue No.
In some cases, for studies using Comparison Rules version 1, when multiple comparison rules are configured using the same item definition on the left hand side if the operator on either of the rules is updated, the name of the rule is also updated. VDC-121606*

Data Entry

Issue Description Issue No.
When an event group containing an event is added and configured with an event window definition, and then the event group is removed from the schedule so that the schedule only contains an unscheduled event group, event creation fails. VDC-171560
In some cases, Progressive Display Items are visible in Data Entry despite the controlling Item being "None." VDC-174229
After a user selects a Lab Location, Vault shows an Actions menu with the Intentionally Left Blank action for the other Items on the lab panel. VDC-174642*
Manually opened and answered queries are incorrectly deleted when the user performs the Event Reset action. VDC-175632*
Sorting the casebook schedule by Event Date doesn't update the sort order of the schedule. VDC-176793
Vault doesn't allow users to enter an Event Date when the user's language is set to Hungarian. VDC-178935
Vault doesn't display Items in the order defined in the Display Items property for Item to Form Links. VDC-179434
In some cases, the default value does not save on Form submission. VDC-181990*

Data Loader

Issue Description Issue No.
The error message displayed when attempting to add Forms to an Event that is frozen is incorrect. VDC-173956

Deployment

Issue Description Issue No.
Users encounter an unclear error message when deployment fails after the user attempts to rename a role with user assignments. VDC-169307
When a user puts a single quote in a study name, a server error occurs when copying study data from Production to PPT. VDC-173514*
During high traffic periods, due to cookie name creation, users may encounter a "Could not find SessionID" error when attempting to copy from Production vaults to PPT vaults. VDC-175810
When a Form that is referenced by a Vault EDC Coder item configuration is copied to another study, then the source Form is deleted, after which the Form is copied back to the original study, deployment fails. VDC-177195
A CDB Deployment error message related to Workbench enablement has been updated. VDC-177591

E2BLink

Issue Description Issue No.
When Reporter/Sender Comments by System references a unit-type Item, E2B uses the translated value. VDC-173569*
Follow up scans may fail when a study has a safety form that uses reporter or sender comments by system in more than one Event. VDC-174023*
For the system comments value, Vault appends the sequence number to values from non-repeating objects. With this release, Vault only appends the sequence number to values from repeating objects. VDC-176893
In some cases, safety messages lack a safety transmission date value, causing the Safety Follow Up Job to fail. VDC-177836

EDC API

Issue Description Issue No.
When a Retrieve Sites API call is made for a study that has no Active Version assigned to any sites, the API call fails. VDC-173661
The Retrieve Study Roles API returns roles that are not present in the associated Vault. VDC-180348
Requests with the Combination Update Form Data endpoint may fail if the targeted Form is referenced by multiple rules. VDC-180375
When using External Suggestions, when a request that contains no defined Suggestions is sent to the Set Coding Suggestions endpoint, existing suggestions are not deleted as expected. VDC-181339

Integrations

Issue Description Issue No.
With this release, CDMS only creates a procedure when the rule evaluates as true for the first time. VDC-165021, VDC-162836
As part of the EDC-Clinical Operations Connection, records that have unmapped reference lookup values cause the integration to fail and display incorrect User Exception Messages. VDC-177279

Jobs

Issue Description Issue No.
A Study Data Extract job may get stuck in the In Progress status and prevent further scheduled instances of that job from running. VDC-175779
In some cases, users encounter a server error when clicking on the Job ID in Job History. VDC-177735
In some cases, when a Protocol Deviation Change Reason is created and then the Protocol Deviation is deleted, the Audit Trail Export job fails. VDC-177890
In Audit Trail Export, when the job is filtered by User, EDC doesn't include entries where the user match is "on behalf of" or "initiating" for system actions. VDC-178123*
When the Subject Status of a Rule Action is null, the Study Data Specifications job may fail with an error. VDC-179313*
Information provided when the system cannot resolve a private key to a record for a Difference Report has been improved. This may occur when the item definition no longer exists or has never existed in the study. VDC-179576
When multiple instances of a Coding Form exist in a Study, the Casebook Design Export (CDE) includes each instance of the Coding Form Definition. With this release, the CDE will only include one instance of Coding definitions, and will also only include definitions that are active. VDC-181648
In some cases, when a Reevaluate Plan Assignment job is run in a study that contains both locked and unlocked Sites, the job fails even when it is only run on unlocked Sites. VDC-182339
In some cases, the Rule Execution Report unexpectedly does not include Add Event Rules. VDC-183679*

Labs

Issue Description Issue No.
In some cases, Vault does not identify duplicate values during import, resulting in a failed deployment. VDC-174794
When a Normal Range doesn't have an Upper Normal, the Outdated Lab Normals report doesn't show a Unit Normal value. VDC-179269
Missing analyte import validations prevent users from importing analytes with lengths that exceed EDC limits. VDC-182483

Library Collections

Issue Description Issue No.
In some cases, when there are a very large number of records for an object across all casebook versions for a Study, copying to the Library fails. VDC-182642

Queries

Issue Description Issue No.
In some cases, a server error occurs when commenting on an open query on a Lab Analyte where the "Missing Result" checkbox is marked as true. VDC-166104*
For studies with Query Teams enabled, when a user who is assigned to multiple query teams opens a query from Coder, the query team field in the query is blank. With this release, any query opened from Coder will be stamped with the Coder Query Team. VDC-179270
When a query is closed with no query message and is later deleted by a retrospective amendment, the Audit Trail Export incorrectly shows it as having been closed at the time it was deleted. VDC-180398

Review Plan Assignment

Issue Description Issue No.
With this release, when multiple Review Plan Casebooks exist for the same subject, the system retrieves the most recent Review Plan Casebook and logs a warning, enabling the Review UI to function as normal. VDC-174651
With this release, a process has been implemented to automatically find and remove duplicate review plan casebook records. VDC-177868
With this release, a process has been implemented to automatically find and remove duplicate review plan casebook records. VDC-179672

Role & User Management

Issue Description Issue No.
When a user that does not have a role containing "Manage Deployments", "Design Study" or "Design Library" permissions performs an action that should increment the build number of the study, the build number fails to increment only on the Study Instance record due to lack of permissions. With this change, study build number changes due to such actions will be properly reflected on both Study and Study Instance records. VDC-175557
The Vault Comparison Report may show tab permissions assigned to user roles that aren't actually assigned if an administrator edits user administrator and non-user administrator roles one after another. VDC-177595
If certain time zones are configured for a user's VeevaID, a server error occurs when creating or importing the user in a vault that has VeevaID User Creation enabled. VDC-177768
During a subject transfer, when a set of events is updated, all events for the entire study are loaded. VDC-178900
After a user renames a Study Role or edits the assigned Query Team, Vault may remove any custom object permissions assigned to that role. VDC-184471

Rule Editor

Issue Description Issue No.
With this release, Set Subject Status rules cannot be saved with a null Subject Status. VDC-178759

Rule Execution

Issue Description Issue No.
In some cases, dynamic rules that were not taking action on a casebook were being excluded from the rule job files. VDC-168668*
In some cases, Set Derived Value rules incorrectly display a casebook validation error for a circular reference, even if the rule is actually referencing the previous event. VDC-170233
When a subject is deleted from a study after a Run Rules job has been queued that includes that subject, the job fails. VDC-172511
For studies using Rule Expression Engine V1, some rules referencing blank values display an unexpected error upon Form submission. VDC-175238*
Users are unable to delete Unscheduled Events that contain an Item set with a Set Item Value rule (derived items). VDC-175319
The Rule Details file doesn't show all expected forms when running a preview job of the rules. VDC-178064
In some cases, forms are added to events when rule conditions aren't met. VDC-178313
When the Rule Actions of two dynamic study building rules add the same form to different events, but the dynamic scope of one rule is Event Group and of the other is Event, in some cases the form added by the Event-scoped rule may be inadvertently marked for removal. VDC-180516, VDC-186881

Safety Integration

Issue Description Issue No.
The JSON file shows the codelist Name instead of the Label on "result_text". VDC-167509*
When a user extends the Expiration Date for the Safety Follow-up Scan job on the expiration date, the job is still automatically deleted on the original Expiration Date. VDC-170620
With this release, we no longer prevent users from changing the Safety Integration Type after deployment, as long as the Study doesn't contain any Form Configurations. VDC-172468
Vault doesn't show the correct error message when a user attempts to save invalid safety form Inclusion Criteria. VDC-173466*
Users incorrectly receive an error message about configuration when attempting to generate the User Training Report from System Tools. VDC-176044
When "Repeating item group in form" is selected for "Each Entry In", Vault may mark multiple cases under the same Form as Primary. VDC-176788*
Vault shows duplicate Subject Groups in the "Only Include When Subject Group Is" drop-down menu. VDC-176816
Follow up scans may fail when a study has a safety form that uses reporter or sender comments by system in more than one Event. VDC-176884
During casebook upversioning, safety definition forms may reference outdated "include only when" subject groups, leading to incorrect evaluations. VDC-177059
When a study isn't using Coder, Vault now uses an Item's value for the "llt_code" field instead of leaving this field as null. VDC-178976*
When a user extends the Expiration Date for the Safety Follow-up Scan job on the expiration date, the job is still automatically deleted on the original Expiration Date. VDC-179043
The PC_GENDER Safety Field Connector Definition for Vocabulary Sync Record Information is incorrect due to a new safety field gender_identity__v which has the same label, "Gender". With this release, we updated PC_GENDER to use the "Sex" definition label. VDC-180273
The First Administration Date and Last Administration Date aren't populated for the Concomitant Medications form. VDC-181233
When a Site is renamed, Safety Cases sent after the rename may still list the site's original name in reporter fields. VDC-181659*
The Vault Safety EDC Connection fields "event_country", "reporter_country", "reporter_first_name", "reporter_last_name" are null in the subject data JSON. VDC-183293*

SDV & DMR

Issue Description Issue No.
When a Study on Data Model 1 which contains a locked Casebook is migrated to Data Model 2, after migration the unlocked Casebook cannot be manually assigned an override SDV or DMR plan. VDC-169056*
In some cases, for studies on Data Model 2, when DMR or SDV is performed at the Event level on an Event containing a form that is locked, the DMR or SDV checkbox is unchecked after the page is refreshed. VDC-169083*
Data may be incorrectly marked as No Review. This fix may result in existing data being marked as Required for review that was incorrectly marked as No Review prior to the release. VDC-175463*

Signatures

Issue Description Issue No.
In Studies created after the 24R1 release, when a custom role has the Sign permission but not the Data Entry permission, users with that custom role will receive a server error when attempting to sign an event. VDC-176530

Study Administration

Issue Description Issue No.
Downloading a Site Export file with a study whose name contains a "/" results in the user being directed to an error page. VDC-173596*
In some cases, the Vault Configuration Report incorrectly shows that LMS is disabled when it isn't. VDC-174894
Users encounter an error when copying Production subjects to a PPT environment. VDC-175843
In the Sites export CSV file, Vault lists "null" instead of the Principal Investigator's First Name. VDC-179440
In some cases, queries can be closed by progressive display during retrospective amendments. VDC-180396
In some cases, Copy to PPT jobs fail. VDC-182080
A user with the standard Vault Owner security profile is unable to delete Study Data with Form Linking VDC-183304

Study Data Extracts

Issue Description Issue No.
The Subject Listing displays an incorrect count in the Event Dates Not Signed column due to a log event under an unscheduled event group. VDC-175733
Different values are displayed for SYS_Forms Form.EventToSubmit in Study Data Extracts and CDB. VDC-175916
The LBTEST column doesn't display the Analyte Label that is present in the SYS_ANALYTES and SYS_LABRANGES files. VDC-182543

Study Design

Issue Description Issue No.
In some cases, when a user changes a rule action to Override Review Plan and then attempts to view a review plan, only the form name and no other content is displayed in the dialog. VDC-171428*
When configuring progressive display with the "null" data type, Vault creates the rule definition without the rule action. VDC-175092
When a form is reset in a study with study language configured, the Data Change Extract job shows the form reset in the user language instead of the study language. VDC-184372*

UI & Performance

Issue Description Issue No.
When an Imaging Item Group is set or unset as intentionally left blank after the form containing the Exam is reset, an incorrect reason for change displays. VDC-168828*
In some cases, search boxes within a breadcrumb menu are populated when they should be blank. VDC-170347*
The EDC source does not appear in the source dropdown menu in the CDB Audit Log. VDC-172678
The EDC UI may show incorrect values for the count of subject casebooks in a Site. VDC-175799
Some users encounter a server error when attempting to access a study in Data Entry. VDC-175905
In some cases, a Form that contains a derived Codelist item field and has not had data entered displays the codelist code of the derived item rather than the label. VDC-177625
With this release, the error message that is displayed when an item referenced in an @Form rule is deleted from the form that contains it and the Form is then submitted, triggering the rule to attempt to run is updated for clarity. VDC-178461
In some cases, the Review module takes an overly long time to load. With this release, a fix has been implemented to prevent some unnecessary queries from running, improving performance. VDC-178758
In some cases, the review tracker warning icon is not visible for long listing names on CDB's Listings page. VDC-179681
The color of radio buttons in Data Entry is different when Show Progressive Display is enabled than when it's not enabled. VDC-180283
In the Review UI, the Form name displayed for Item-to-Form links should be read only. VDC-182911
When a custom ILB reason contains a comma, Form submission fails. VDC-184344

Vault Administration

Issue Description Issue No.
Vault Clinical Data Manager loads vaults overly slowly. VDC-157903*
All custom triggers using emails fail due to a "ClassNotFoundException". This is because the "UserService" was removed as part of the reparenting feature. To resolve this, we returned the "getUserIdsInGroup" method to availability. VDC-176694