Known Issues in 23R1 Pre-Release

Pre-Release Date: March 27, 2023 | CDB Pre-Release Date: April 3, 2023 | Release Date: April 14 & 21, 2023

The issues listed below may impact Vault functionality for some users. We are actively investigating all known issues and will be providing fixes and updated information in future releases. Between the start of the pre-release period and the general release, we may remove issues that are found to be caused by user error or are working as designed. This list is subject to change until the general release.

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

Maintenance Release: March 29, 2023

Release Number: 22R3.5.7 | Build Number: 12367

Category Issue Description Issue No.
Coding With this release, Vault includes the MedDRA 26.0, Global B3 March 23, and Global C3 March 23 English coding dictionaries. VDC-119669
Coding Configuration Synonym List Assignment & Do Not Autocode List Assignment via Study Settings is blocked on Vaults where `disable_coding_list_management` is set to true. VDC-118106*

CDB - Checks & Queries

Issue Description Issue No. New Feature
Query decorations may not be applied to the correct rows for queries against Items in repeating Item Groups. VDC-116046*  
Query creation in third party data fails when the Item is on a repeating Form or Item Group and there is a row_external_id specified. VDC-116216*
Query listings may not show the correct row external ID if the Form has more than one Item Group. VDC-116305*
In the All Outstanding Queries listing, the Sort & Filter menu extends outside the viewable area. VDC-116451*  
CDB removes queries if the Event, Subject, or Site changes for that row after a new third party data import. VDC-117124*
When users with both Answer Query and Open Query permissions reply to EDC queries in CDB via the Answer button, CDB sets the query's status to Open VDC-118080*  
Check Summary links include manual queries. VDC-120255*  

CDB - Clean Patient Tracker

Issue Description Issue No. New Feature
CDB doesn't show a list of Subject Statuses available for filtering in the Sort & Filter menu for the Status column. VDC-118604*

CDB - Clone

Issue Description Issue No. New Feature
CDB may not show cloning validation for a Form with missing Items in the target study. VDC-121375  

CDB - Clone

Issue Description Issue No. New Feature
Cloned listings and views don't show the Source or Forms in the listings or views tables. VDC-117275*
Listings that use Select * are incorrectly marked as incompatible. VDC-118345*
Cloning validation messages may not show consistently for packages containing unions. VDC-121385  

CDB - CQL

Issue Description Issue No. New Feature
The defaultUnitName header is unexpectedly null. VDC-116016*  
CQL may not return the expected number of results when a third party repeating Item Group has the same Name as an EDC Form. VDC-116397*  
CQL may return empty Items in an Item Group when using Unions. VDC-121571  

CDB - Import

Issue Description Issue No. New Feature
Third party imports may get stuck in the In Progress status. VDC-108935*  
EDC import may fail in studies with Names of 100 or more characters. VDC-110877*  
Imports of very large packages may fail unexpectedly. VDC-111494*  
Ingestion may fail unexpectedly. VDC-112742*  
If a user imports reference data into a Study that has a third party package with an invalid source, CDB may not swap to the new reference data after import. VDC-113024*  
CDB doesn't return the right error message when multiple data files reference the same form. VDC-117335*
CDB may show invalid listings after importing a third party data package with the wrong study name. VDC-117503*  

CDB - Listings

Issue Description Issue No. New Feature
The Cell Details panel doesn't load for an Item reused across multiple Item Groups in the same Form. VDC-109668*  
If a user without the Browse Views permission attempts to view their favorites with the Views filter applied, the page crashes. VDC-121488  
When the CQL Editor is open, the navigation drawer opens behind it. VDC-116468*  
After a study is deleted, the Last Listing Visited link may still lead to that study. VDC-118565*

CDB - Views

Issue Description Issue No. New Feature
If a user without the Browse Views permission searches with the Views filter applied, the page crashes. VDC-120571
Users without the Create View permission are able to clone views from another study. VDC-120577*

Coding Configuration

Issue Description Issue No. New Feature
Syncing Pending Details from a replica to the master may fail when the replica and master Synonym Lists are out of sync. VDC-115376*
Synonym List Assignment & Do Not Autocode List Assignment via Study Settings is blocked on Vaults where `disable_coding_list_management` is set to true. VDC-118106*  
When a Master and Replica Sync has not occurred in 30 days, synchronization is blocked due to a "cannot exceed [30] days past" error. VDC-118664*  
Vault doesn't allow users to delete a Synonym List in the replica vault when it contains Synonym List Details. VDC-120338*
When importing synonyms for WHODrug, if the CSV file is missing a column value in the first row, users receive a server error. VDC-120502*  
Vault fails to save when users change the Store Preferred Base setting. VDC-120586*  
Synonym list approval may fail unexpectedly. VDC-120753  

Data Entry

Issue Description Issue No. New Feature
Vault may not allow users to reset forms or events that are marked for removal. VDC-117835*  
Users may receive a server error when deleting a subject. VDC-118310*  

Deployment

Issue Description Issue No. New Feature
The Copy Study Data from Production job may fail unexpectedly. VDC-118302*  

E2BLink

Issue Description Issue No. New Feature
When a medical history form's date range changes in such a way that it no longer qualifies for the duration rule, Vault doesn't send a follow up. VDC-115160*
The integration task.may fail when sending a safety message with Forms included by duration rules. VDC-116420*
If a study has a deployed safety configuration that includes duration rules, users may receive an error when updating the transmission profile in a non-development environment. VDC-116875*
Vault doesn't send a follow up when a user edits the related study drug form and clears the primary field. VDC-116956*
Vault doesn't update the status of the safety message when an adverse event form is updated and that form is linked by a duration rule. VDC-117004*
Vault doesn't update the status of the safety message when a Study Drug form is submitted if g.k.4.r.4 & g.k.4.r.5 are mapped to dates instead of datetimes. VDC-117136*
When an External Lab form qualifies for a duration rule, Vault may not include that form in the E2B XML. VDC-117212*
When in view mode, Vault doesn't show "0" duration values. VDC-117725*
Users may receive a server error when opening a related Serious Adverse Event form when the study uses the Duration overlaps any part of the SAE duration inclusion rule. VDC-118588*
Vault may not generate a follow up after a user adds an item to form link between the SAE and an External Lab form. VDC-119883*  
Vault may fail to send email notifications for an unsubmitted form when configured. VDC-120431

Integrations

Issue Description Issue No. New Feature
If a user updates a site's Active Version, Vault doesn't indicate that the Site was updated in EDC Tools > Integrations for Procedures. VDC-117060*  
Integration tasks may fail when a Procedure references a derived value for the definition. VDC-117558*  

Jobs

Issue Description Issue No. New Feature
The Audit Trail Export job may take longer than expected. VDC-114798*  
The Delete Site Data job may fail unexpectedly. VDC-114998  
When two Workbench Export jobs run simultaneously, one is successful and one is stuck in the In Progress status. VDC-115352*  
In the SDE's casebook_definition_summary.csv and casebook_schedule.csv files, forms aren't listed in the designed schedule order. VDC-118766
Vault allows users to start a Study Data Extract job without selecting an option for Boolean Format, which causes the job to fail. VDC-120162  
Users are able to click the Schedule button twice before Vault closes the dialog, which results in duplicate jobs. VDC-120907*  
In the Study Data Extract, the ESEQ column may be unexpectedly blank in the SYS_LINKS file. VDC-121674  

Review Plan Editor

Issue Description Issue No. New Feature
In studies using Review Plan Assignment V1, users receive a server error when attempting to edit the Study Template. VDC-117712*  

Role & User Management

Issue Description Issue No. New Feature
The User Access Report doesn't account for deleted study environments. VDC-120424*

Rule Editor

Issue Description Issue No. New Feature
Users can't search for rules by Rule Action Type. VDC-117636*  
If a user saves a rule using @PreviousEvent, that rule may not display in the list of rules in Studio > User Defined Rules. VDC-118666  
When a user changes the Evaluate Rule When property, Vault clears the rule action, even if the action is valid after the change. VDC-118992  

Rule Execution

Issue Description Issue No. New Feature
Vault runs required edit checks against derived items. VDC-116852*  

Study Design

Issue Description Issue No. New Feature
Users may receive a server error when deleting an unscheduled-type Event from the study schedule. VDC-109837*  
Users are unable to view Coding Configuration from Studio in published casebook versions. VDC-117489*  
Codelist Items are case sensitive. VDC-117909*  

UI & Performance

Issue Description Issue No. New Feature
Vault is not consistent in how disabled fields in the Rule Properties panel are displayed. VDC-117828*  
The Tools and Deployment menu items don't show in the navigation drawer when a user opens a Study from the search results. VDC-117956*  
CDB may be slower to load for users with multiple Study Roles assigned. VDC-119040*  

Views & Data Export

Issue Description Issue No. New Feature
The Data Export (Legacy) job fails when run with the SAS with XPT and CSV file type. VDC-115819*