Known Issues in 21R2 Pre-Release

Pre-Release Date: July 19, 2021 | Release Date: July 30 & August 6, 2021

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.

Maintenance Release: July 21, 2021

Release Number: 21R1.4.7 | Build Number: 12690

Category Issue Description Issue No.
CDB - Import Data transformation takes longer than expected for large studies. VDC-77493
CDB - Listings Workbench may not apply decorations based on cell-level attributes. VDC-77463
Coder For JDrug Synonym Lists, Vault doesn't save the Indication or Route to the Synonym LIst Details. VDC-77503
Coder Output files from the Code All Forms and Update Synonym List job do not include all the expected columns and data. VDC-77511
Coder If multiple Forms have the same Dictionary Release and Synonym List, the Code All Forms and Update Synonym List job may not code the verbatims from all of the matching Forms. VDC-77723
Coding Configuration Coding administrators are unable to change the Coding Method for JDrug Forms. VDC-75535
Jobs With this release, Study Data Extract SAS files treat Date, DateTime, and Time columns using the SAS formats. The three datetime columns in clinical data sets, site entered timezone, user's timezone, and UTC, are still treated as text. VDC-77274
Jobs Study Data Extract SAS jobs fail in Studies configured with both DateTime Items and custom objects. VDC-77672
Labs Vault does not open system queries on Lab Forms that are missing Normals. VDC-77831
UI & Performance In EDC Tools > Sites > Active Versions by Site, clicking an action in the subject-level Actions menu doesn't start the action. VDC-77731

CDB - CQL

Issue Description Issue No.
When using Union with an alias on a @Form header, CQL may return results with unexpected data holes. VDC-68349*
CQL may return a "folded header size should be the same as row size" error when using Union with @Form.Name. VDC-68350*
CQL may not show the correct values for @Form.SeqNbr or @ItemGroup.SeqNbr when those headers are aliased and the statement references multiple repeating Forms or Item Groups. VDC-68354*
CQL may be slow to return results when those results will have decorations. VDC-69575*
If an Item is used in more than one repeating Item Group, CQL may return rows for that Item across all possible Item Groups, instead of the selected Item Group. VDC-71759*
CQL may not return all possible results when joining on subject. VDC-71955*
CQL may return duplicate rows when using Union and join on subject. VDC-71958*
When using @Form.LinkedForm, CQL may not return the correct set of results. VDC-75141*, VDC-75142*, VDC-75148*

CDB - Export

Issue Description Issue No.
If a Form has an Item with a duplicate Name, export package generation fails. VDC-73933*
Export package generation may get stuck in progress. VDC-73934*
Raw, SAS export packages may be missing columns if the same Item is used in an Item Group and a repeating Item Group on the same Form. VDC-75340*
Users may be unable to open the SAS file for a Labs (EDC) form. VDC-75345*
If a user uses Save As from a raw-type Export Definition that contains query listings, Workbench discards the query listings during the copy. VDC-75872*
When a Study has third party data from two sources, if a user creates a raw Export Definition with both sources, and then they delete the data from one source, and a user deletes the data from one of those sources, Workbench interprets the Sys_Links listing as invalid. This causes the export to fail. VDC-76856*

CDB - Import

Issue Description Issue No.
Third party import may fail unexpectedly and leave the Study in an error state. VDC-74505*
In some cases, a third party package import may get stuck in the In Progress status after any warnings are fixed with the EDC package in Reprocess Error. VDC-75377*
Imports into an existing Study may cause the Study to get stuck in the Error state, even when the import is successful following the deletion of a bad source. VDC-77456
When the import file doesn't include a Site column, and the Subjects don't exist in CDB yet, Workbench shows the wrong error message. VDC-77488

CDB - Listings

Issue Description Issue No.
When a Form contains only repeating Item Groups, the listing may have zero rows. VDC-76128*

CDB - Queries

Issue Description Issue No.
Workbench doesn't show an informative error message when a user attempts to open a Query on a log-type Event, which isn't allowed. VDC-76549*
After a study is amended in EDC, Workbench may not show the Event Name in the Query Details panel. VDC-76810*

Coder

Issue Description Issue No.
Vault may not autocode MedDRAJ verbatims with exact matches. VDC-76966*
In JDrug, the Verbatim's exact match isn't the first result in the dictionary results. VDC-76968*
For WHODrug and JDrug, the Route and Indication columns of the Code Request listing are in the wrong order. VDC-77574*

Coding Configuration

Issue Description Issue No.
Coding administrators are unable to change the Coding Method for JDrug Forms. *Fixed in 21R1.4.7 maintenance release VDC-75535*
Users may be unable to map Adverse Event forms to a MedraJ Dictionary Version. VDC-78212

Compare Versions

Issue Description Issue No.
The Select Second Version dialog has the label "Copy From" instead of "From" for the study selection field. VDC-75591*
In the Select Options dialog, Vault doesn't show the Studies for comparison. VDC-75607*
Vault doesn't show manual deployment Studies in the Select Second Version dialog for version comparison. VDC-75761*
The diff report may show differences in the Form Impact tab during the first deployment from DEV1 to UAT1, when there are no differences. VDC-77866

Data Entry

Issue Description Issue No.
Editable grids in "Edit" mode don't display data unless a cell is selected. VDC-71560*
Analytes remain flagged when the user overrides normal ranges to input values that are within range. VDC-72731*
The action menus that generate after marking a form as Intentionally Left Blank in an editable grid are incorrect. VDC-74640*
The "Complete" button isn't disabled when users enter incorrect characters in a number field. VDC-75315*
Users are shown an Invalid error message when the user chooses "Unknown" for Date and Datetime. VDC-75627*
The Query badge disappears from a lab result cell when a value is updated, even if the value is still out of range. VDC-75736*
Progressive display enablement doesn't enable the + New Row button on repeating Item Groups in grid mode. VDC-76426*
Users may receive a server error when clearing the AM or PM string from a time Item in Studies with a 12 hour time format. VDC-78015*

Developer Features

Issue Description Issue No.
CDMS APIs require Content-Type=application/json, but this isn't enforced. VDC-75628*
The Retrieve Queries API doesn't return Item Group or Item details in the response. VDC-76692*
If no value is provided for study_name parameter in a Retrieve Users request, Vault doesn't return the expected error. VDC-76724*
If a user has access to Sites by Country, and not all Sites in the Study, the Retrieve Users API should return country_access and site_access in the response, instead of all_sites_access. VDC-76804*
The Retrieve Users API returns the Label instead of the Name for picklist values on lms_training_status. VDC-77113*

Freezing & Locking

Issue Description Issue No.
If a user opens a query on an Item that is in the same Event as a locked Form, and a signing user signs at the Event level, Vault applies the signature to the locked Form. VDC-77441*

Integrations

Issue Description Issue No.
When an EDC user creates an Integration Configuration for Procedures, CTMS may record an error during Procedure creation, even if the Procedure is created successfully. VDC-74409*

Jobs

Issue Description Issue No.
The Study Site Number column header in the SYS_RAND dataset of the Study Data Extracts job should be "SITENUM", not "SITE". VDC-71671*
Study Data Extract jobs fail for studies with Randomization data. VDC-71829*
The SYS_ASM CSV file column headers in the Study Data Extract job don't display correctly. VDC-72156*
The SYS_ASMR CSV file column headers in the Study Data Extract job don't display correctly. VDC-72157*
The Study Data Extract job fails with an error. VDC-73437*
Study Data Extract jobs fail unless "Use Item External ID" is checked. VDC-74704*
The first three items in the "LINKEDTO" column of a Study Data Extract job should display in the same order as the items appear in Data Entry. VDC-75006*
The "LINKEDTO" column in the Study Data Extract job should display "false" for items whose values are "false" or blank. VDC-75008*
The custom object file from the Study Data Extract job uses Study, Study Country, Study Site, and Status IDs instead of labels. VDC-75294*
The Study Data Extract job fails in SAS format when a Study is configured with a "Study Data Extract Custom Object Config" record and custom object records. VDC-75349*
The "LINKEDTO" column in the Study Data Extract job should appear after SDV/DMR columns. VDC-75378*
There are missing columns in Study Data Extract JDrug exports. VDC-75715*
The custom object validation in the Study Data Extract job should check for the Study field in each object. VDC-75943*

Labs

Issue Description Issue No.
The Update New Lab Locations job fails with errors. VDC-78062
Vault doesn't display the appropriate error message when a site user attempts to create a pending Lab Location when another location already exists with the same Name. VDC-78170

Publishing Validation

Issue Description Issue No.
Vault may not generate WR-021 (Rule evaluation might result in too many permutations) during validation for all rules that meet the warning's criteria. VDC-77055*

Queries

Issue Description Issue No.
Users with custom Study Roles that grant the Close Query permission may receive a server error when attempting to close a system-generated query. VDC-75318*
Users with multiple roles are prompted to select a query team when creating a manual query when "Enable Team Query Restrictions" is set to "No." VDC-75920*

Randomization

Issue Description Issue No.
In Internet Explorerâ„¢, the Randomization ID tooltip is missing field labels. VDC-75696*
In Internet Explorerâ„¢, Treatments don't display, and Vault doesn't allow users to add new Treatments. VDC-78511

Role & User Management

Issue Description Issue No.
Users may receive a server error when attempting to access a Permission Set from Tools > System Tools > User Defined Permission Sets. VDC-74604*
Vault doesn't display a helpful error message when a user attempts to assign another user a permission that the assigning user doesn't have. VDC-75407*
Users with a custom Study Role intended for user administration receive an insufficient permissions error when attempting to delete a custom Study Role. VDC-75840*

Rule Editor

Issue Description Issue No.
Vault doesn't show a validation warning when an expression would result in too many rule permutations. VDC-75530*
Rules on common Forms with repeating Item Groups that use only aggregate identifiers return [null]. VDC-78395

Rule Execution

Issue Description Issue No.
Users receive a server error after deleting an Unscheduled Event in which the Event Date is the controlling value for a dynamic Event in that Event Group. VDC-72978*

Safety Link

Issue Description Issue No.
Vault attempts a Safety Transmission even when a user enters a value on the Seriousness item that isn't the set value in Safety Configuration. VDC-73990*

SDS & Annotated PDFs

Issue Description Issue No.
SDS generation fails if there is no value for Default Day for Age Calculations on the Study Configuration record for the Study. VDC-71071*
The SDS doesn't show the correct Rule Bindings for rules that reference Form Links. VDC-72423*

Study Design

Issue Description Issue No.
In the Copy From Study dialogs in Studio, Vault doesn't show values in the Vault drop-down. VDC-74964*, VDC-75021*
The Future Date property on Events isn't editable after the first version is published. VDC-76427*
Users with access to multiple vaults may not have all those vaults as options in the Vault drop-down of the Copy From Study dialog. VDC-78467

UI & Performance

Issue Description Issue No.
Users are shown a server error when attempting to create an open query on a blank frozen form. VDC-72078*
Forms don't change back to "In Progress" after the user selects "Set back to In Progress" in the Retrospective Amendment settings. VDC-72809*
Vault is slow to load the list of Rules in the Copy From Study dialog. VDC-75265*
Repeating editable item group unit items with multiple unit item defs incorrectly default to the first unit item def. VDC-75604*
The "View as Site" window doesn't display any values for analytes with non-unit items. VDC-76441*
The Review tab is displaying DateTimes with the Normalized Value instead of the Value. VDC-78052*