Known Issues in 22R1 Pre-Release

Pre-Release Date: March 28, 2022 | CDB Pre-Release Date: April 4, 2022 | Release Date: April 8 & 22, 2022

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.

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. New Feature
Users receive a server error when saving changes to an Assessment while the associated Site or Study is locked. VDC-94087*

Audit Trails

Issue Description Issue No. New Feature
The Audit Trail may not capture all SDV-related entries for Events when the SDV is migrated as part of study migration. VDC-93779*

Autocoding & Suggestions

Issue Description Issue No. New Feature
When Enhanced Autocoding is enabled, Do Not Autocode Lists doesn't fully prevent autocoding. VDC-94921*

Casebook Versioning

Issue Description Issue No. New Feature
Vault allows for changes to a Form Link's selected Form Definition across casebook versions. VDC-92527*

CDB - CQL

Issue Description Issue No. New Feature
CQL doesn't support the use of the CodedTerm function for a Union inside a subquery. VDC-90498*
@HDR.Site.CountryName replaces whitespace characters with underscores. VDC-92267
CQL may return "--" instead of the appropriate value for certain Item columns when an alias is used on the Form. VDC-94773*

CDB - Export

Issue Description Issue No. New Feature
Users may receive a "Column 'id' cannot be null" error when attempting to create a new Export Definition. VDC-84862*  
CDB doesn't show an error message in the Issue Log for some errors during export package generation. VDC-88376*
CDB may truncate the CQL statement in the Change Comparison panel when the CQL statement contains empty lines. VDC-91525*
CDB updates the Last Modified Date for an Export Listing if the parent listing or view is updated. VDC-93260*
CDB may not detect changes when an Item is added in EDC. VDC-93906
When a parent listing is deleted, users receive an error when attempting to sync the Export Listing with the parent. VDC-94035*
CDB doesn't provide error message details in the Issue Log when export package generation fails due to the definition having an invalid listing. VDC-94315*
Users are unable to create SDTM Export Definitions with invalid listings. VDC-94318*
In Studies that have two Core Listings from different Sources with the same Title, if a user adds a different Custom Listing to an SDTM Export Definition, Workbench uses random strings as column headers instead of the Item SDTM Names. VDC-94474*

CDB - Import

Issue Description Issue No. New Feature
Import may fail when the manifest has a rowid with no distinctid. VDC-83233*  
If a user imports a mapping key for which there is an existing Source/Key mapping, CDB creates a duplicate record. VDC-88304*
The output of the Workbench Export job in EDC may not include the Study ID in all files. VDC-89573*, VDC-92831*
CDB doesn't generate an import error when the default event configuration is invalid. VDC-90644*, VDC-91109*
When a user is reviewing an import, CDB doesn't indicate when the user has reached the character limit for Reason. VDC-91378*
The import job Status may remain In Progress even when the job is completed. VDC-91407*
In the manifest builder, CDB doesn't hide the "Does all the data on this file need to be blinded?" option when the Blinding Options checkbox isn't selected. VDC-92149*
In the manifest builder, CDB doesn't maintain the Blinding Options checkbox selection when a user navigates away from and returns to step 3.2 with the Next and Back buttons. VDC-92162*
In the manifest builder, CDB doesn't disable the page's buttons or the Edit link when a user clicks Generate Manifest. VDC-92226*
The import job gets stuck in the In Progress status if two EDC Workbench Export jobs were run for the same Study at almost the same time. VDC-92312*
The Import Audit Log may not display results when a user applies a Loaded Date Range filter. VDC-92314*
The audit log may not have an Import Completion date listed for some third party imports. VDC-92380*
In the manifest builder, adding a new file during step four doesn't return the user to step three. VDC-92403*
In the manifest builder, CDB doesn't warn a user when they're deleting a file. VDC-92559*
In the manifest builder, duplicate checks for Item columns don't function correctly. VDC-92692*, VDC-93980*, VDC-93981*
The manifest builder doesn't prevent whitespace or control characters from being used in filenames. VDC-93030*
CDB doesn't display a change indicator when there are file and package level changes. VDC-93174*
Tooltips are missing on the Form pills in the Associated Objects section. VDC-93180*
In the manifest builder, if a user uploads a manifest file with an issue, CDB may not show an informative error. VDC-93641*
The error message for D-003 displays the Site Number instead of the Subject ID. VDC-93773*
If a user creates a manifest file using the manifest builder, they may still receive a P-001 error. VDC-93782*
In the manifest builder, if a user clears the Event Default, CDB doesn't clear their selection for "Use package level Event default". VDC-93978*
In the manifest builder, CDB continues to generate an error for conflicting Item Definitions even after a user resolves the issue. VDC-93979*
When there are multiple packages from a Source in the queue, CDB may not apply the "Skipped" status to skipped packages. VDC-94336
Timeout errors may occur when loading third party data. VDC-95674  
CDB attempts to process third party data import packages while EDC package transformation is still in progress. VDC-95700  
The import audit log doesn't track the start datetime for transformation and import. VDC-96083*  

CDB - Listings

Issue Description Issue No. New Feature
Core Listings use the most recent existing casebook version, even if that version isn't the Active Version for the Site. VDC-93405*

Coding

Issue Description Issue No. New Feature
Coding Requests with an Open, Updated, or Noncurrent status are not autocoded or shown suggestions. VDC-92287*
Coding Requests with an Open, Updated, or Noncurrent status are not relatively matched or shown suggestions. VDC-92305*
Coder may not display Related Items in the Code Request listing for migrated Studies. VDC-93093*

Data Entry

Issue Description Issue No. New Feature
In some circumstances, users may receive a server error when attempting to open the Data Entry tab. VDC-95016
Users shouldn't be able to set an Event Date and then mark the Event as Did Not Occur. VDC-95241  

Deployment

Issue Description Issue No. New Feature
If a user restores an Environment from a file, Vault doesn't send an email notification when the restore is finished. VDC-93702*
Restoring a deleted study environment from a file fails in some cases. VDC-95610*

Jobs

Issue Description Issue No. New Feature
Users are allowed to delete FTP connections when there is a scheduled job that exports data to that destination. VDC-91547*
The Autocoding and Suggestions job fails when the target environment contains a coding request with a Verbatim that contains a single quotation mark and Enable Autocoding Enhancements is on. VDC-92490*
The Form Progress Listing may include data from Sites that the user doesn't have access to. VDC-95422  

Publishing Validation

Issue Description Issue No. New Feature
Inactive coding configurations result in an EL-008 validation error. VDC-91961*
The validation job may fail when a Study has records created via Copy from Study. VDC-92194*

Queries

Issue Description Issue No. New Feature
In Coder, a query in the Closed status may show as remaining in the Site Responded status. VDC-94566

Randomization

Issue Description Issue No. New Feature
Randomization Managers encounter errors when attempting to verify Kits and/or Devices. VDC-88170*
Users are unable to add Treatment Name when using the Google Chrome™ browser. VDC-93824*

Review Plan Assignment

Issue Description Issue No. New Feature
Users are shown an error message when creating a study-wide Review Plan Assignment that applies to sites individually. VDC-93792*

Role & User Management

Issue Description Issue No. New Feature
Data and Definition Export jobs and Core Listing jobs fail if they're created by a CDMS API Read Write User and the Study has subjects or events where restricted__v = true. VDC-89512*
In some cases, the User Activity Report doesn't show tracked events. VDC-93731

Rule Execution

Issue Description Issue No. New Feature
Rule execution (from EDC Tools) may fail unexpectedly. VDC-86533*
Users shouldn't be able to add new repeating forms to a dynamic repeating form that contains forms that are marked for removal due to a rule. VDC-96205  

Safety Link

Issue Description Issue No. New Feature
In migrated Studies, follow-ups for Safety Cases may be unexpectedly marked as "First Send". VDC-87976*
Vault may not generate follow-ups for updates to the Item mapped for g.k.1. VDC-92561*, VDC-94019*
Vault places ConMed details before Study Drug details in the XML file, which causes the file to not be readable in Argus. VDC-95164  

SDV & DMR

Issue Description Issue No. New Feature
Vault doesn't allow the Additive Review of Event Dates. VDC-95639  

Study Data Extracts

Issue Description Issue No. New Feature
When a user includes custom objects in the SDE, the Study Data Extract job may fail. VDC-94941
Vault may not use the most up to date Event Labels in the data extract. VDC-94950

Study Design

Issue Description Issue No. New Feature
Vault doesn't check for duplicates in Unit Item Definitions within a Unit Definition. VDC-89244*
Users may receive a server error when attempting to remove an Item from a Form that has been deleted. VDC-89903*
Studio shouldn't allow empty display items. VDC-91584*
If a study designer copies an Event Group that uses "Previous Event" as the Offset Type, data entry users receive a server error when attempting to enter data within that Event Group. VDC-92610*
Users may receive an error when switching an Event Group from non-repeating to repeating, after it was switched from repeating to non-repeating earlier. VDC-92861*

Study Import & Export

Issue Description Issue No. New Feature
If the ODM XML file includes Rules using Casebook Variables (which aren't supported for import), import fails without an informative error message. VDC-92841*

UI & Performance

Issue Description Issue No. New Feature
There should be additional space at the bottom of the event tree grid in the Review tab. VDC-91171
Users are shown a server error message when resetting an event that is marked as "Did Not Occur." VDC-92842*
The Form field in the Rule Details panel isn't filtered by entered text. VDC-93552*
The inline Actions menu is misaligned in Studio > Email Groups. VDC-93711*
Users encounter an error when attempting to create specifications in Studio. VDC-95942

Vault Administration

Issue Description Issue No. New Feature
Users receive a Page Not Found error when attempting to access the Details page for a CDMS Application Role Permission record. VDC-94842