Fixed Issues in 21R3

Pre-Release Date: November 8, 2021 | CDB Pre-Release Date: November 12, 2021 | Release Date: November 19 & December 3, 2021

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.

Highlighted Issues

The fixes for the issues highlighted below may introduce behavioral changes from the previous release.

Category Description Issue No.

Audit Trails

Issue Description Issue No.
The audit trail incorrectly shows that a site accepted a PDF when a new PDF was being generated. VDC-82962

Blank & Detail PDFs

Issue Description Issue No.
Detail PDF jobs fail without explanation. VDC-80945

Casebook Versioning

Issue Description Issue No.
Users receive various validation errors after creating a new Casebook Version. VDC-80208


Issue Description Issue No.
CQL returns an error when the WHERE clause uses @ItemGroup.SeqNbr. VDC-70892*
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 return duplicate rows when using Union and join on subject. VDC-71958*
CQL returns extra rows for a repeating Item Group unless both @ItemGroup.Name and @ItemGroup.SeqNbr are included in the projection. VDC-72088
When a statement has a Union with a Union in a subquery, CQL returns "The used SELECT statements have a different number of columns". VDC-72381
When a statement has a Union with a Union in a subquery, CQL returns "The used SELECT statements have a different number of columns". VDC-74873
When an Item is used in both a repeating and non-repeating Item Group on the same Form, CQL returns all instances of the Item when only the non-repeating Item Group's Item is in the projection VDC-78325
The LBLOC column shows the ID instead of the Lab ID. VDC-78386*
CQL may not return any results when using on subject with only Forms from a log-type Event. VDC-79210
CQL doesn't treat CAST as a function and so doesn't parse provided parameters, resulting in unknown column errors. VDC-79239
When the date item's value is null, CQL returns "COMPLETE" instead of null for the Unknown() function. VDC-79464
If @Form.LinkID is used with On Subject, CQL doesn't return any results. VDC-79491
When using Group By, CQL returns an unknown column error for @ItemGroup.SeqNbr. VDC-79904*
The SDTMDateFormat function doesn't return datetimes in yyyy-mm-ddThh:mm format with the time in the timezone entered by the site. VDC-80072
For LBORRES and TRANSLATED_LBORRES, Workbench shows a precision of 1 instead of 2. VDC-80656*
CQL may return an unknown column error when the from clause includes the source. VDC-80744*
CQL may not return all possible results when using COMPACT. VDC-80782*
With this release, CQL is able to support statements with many union operations. VDC-80834
The DateFormat function may unexpectedly alter the time of a datetime when a time format isn't specified. VDC-80979
The SDTMDateFormat function doesn't return unknown dates correctly. VDC-82916*
For Forms with repeating Item Groups, @Form.ILB may return 'False' even when the Form is marked as Intentionally Left Blank ('True'). VDC-82999
CQL returns a "Data too long" error when the CodedTerm column value is longer than 500 characters. VDC-84489
For a UNION with UNION in a subquery, CQL returns a "The used SELECT statements have a different number of columns" error. VDC-84548

CDB - Export

Issue Description Issue No.
The Issue Log for export package generation may not display the issue list. VDC-77846*
Listings may show N/A cells with raw dates and translated units because CQL attempts to apply those functions even when a cell value is null. VDC-77936*
When copying a raw export definition using Save As, after renaming listings within that definition, Workbench shows a warning that the original listings (before renaming) no longer exist and will be discarded. VDC-78124*
Workbench may fail to generate the export package if an Export Definition contains a listing that uses SHOW or DESCRIBE. VDC-78706*
If a user attempts to edit the Title of an Export Listing, Workbench removes all listings from the Export Definition. VDC-78886*
If a user copies a raw Export Definition with valid, third party listings, they receive the following error: "Cannot save Export Definition. Export Definition contains invalid listings". VDC-78904*
The Intentionally Left Blank reason value in export packages should be in quotations. VDC-79018
Workbench doesn't show the correct error message when the Title and Short Title of a listing are the same. VDC-79024
Workbench may fail to generate export packages due orphaned reference IDs. VDC-79032
Export may fail when a Study has just finished importing a new package, but Workbench has not yet applied the new package to the export definition. VDC-79038
The error message for failed exports shows the full message from the Issue Log. VDC-79156
UOM columns are truncated in SAS packages for raw-type exports. VDC-79382
When copying a raw export definition using Save As, after renaming listings within that definition, Workbench doesn't copy any included query listings with the "The following no longer exist and will be discarded: {listings}" warning. VDC-79942*
If a user renames a Core Listing in a raw export definition and then uses to use Save As, Workbench copies that listing with the original name. VDC-79968*
With this release, export packages expire after 30 days. VDC-80206*
With this release, CDB has returned to treating BIGINT as numeric fields, so that BIGINT fields will use periods (.) for blanks. VDC-80211
If a new Source is added to a Study after a user creates a raw-type Export Definition, Workbench modifies the CQL unexpectedly when the user adds those new Core Listings to the export definition. VDC-81013
In certain studies, Workbench may not use the SDTM Name as the column label when the "Auto generate column labels with EDC SDTM name" option is selected. VDC-81174
With this release, we returned to LF line endings for CSV exports, instead of CRLF. VDC-82011

CDB - Import

Issue Description Issue No.
Transformation of third party data may take longer than usual. VDC-78367*
Workbench may change the timezone to the site's timezone when importing datetimes from third party sources. VDC-78799
Import and study load may fail due to a lockout error. VDC-78843*, VDC-82102
The Import > Packages page may take a long time to load or not load at all in Studies with large numbers of packages. VDC-79028
A Study may get stuck in the New status for import. VDC-79744
If the import manifest has "generate" set to "false", and the import CSV contains an unmatched Event, the import fails without an assigned error code. VDC-80203
When Workbench is importing packages for multiple Studies at the same time, import may fail due a timeout error. VDC-80247
With this release, all number Items for Labs are imported into Workbench as strings. VDC-80583
Workbench may not create TRANSLATED and UOMTRANSLATED columns for low and high Lab Items. VDC-81119
The In Progress filter on the Import > Packages page doesn't display the correct number of results in the filter menu. VDC-82123
When two sources have a listing with the same Name, and one of those sources is deleted, after Workbench imports data for the other source, the listing may be incorrectly marked as Invalid. VDC-82161
Workbench may not display the data from the most recent import even when that import finishes successfully. VDC-84579*

CDB - Listings

Issue Description Issue No.
Users receive an error when attempting to filter a listing by @ItemGroup.SeqNbr with the UI Sort & Filter menu. VDC-73687
Workbench doesn't apply any filters when generating CSVs for Review Listings. VDC-78203*
Workbench may not display the Filter icon on filtered columns when the column is an Item within a repeating Item Group. VDC-78700
If a Study includes multiple Sources, or if multiple Studies have Forms and Item Groups with the same Names, listings may get stuck in the Pending status when a user attempts to enable Review for those listings. VDC-79127
When a listing includes data from many instances of repeating Forms and Item Groups, Workbench may unexpectedly truncate records in the Listing UI, while still including those records in the generated CSV. VDC-79144
With this release, we removed the row-level decoration for Item Group Sequence. VDC-80018*
The Batch Action buttons may wrap unnecessarily on Review Listings. VDC-85608*

CDB - Queries

Issue Description Issue No.
Users may receive a "failed to retrieve cell details" error when attempting to open a query against a third party data item. VDC-78818*
The EDC Closed Queries listing includes the @QRY.Name column twice. VDC-79140

CDB - Views

Issue Description Issue No.
Workbench doesn't show the appropriate error message when a user attempts to use @Form or @ItemGroup attributes other than SeqNbr in projection of a View's CQL. VDC-83530*


Issue Description Issue No.
For WHODrug and JDrug, the Route and Indication columns of the Code Request listing are in the wrong order. VDC-77574*
Impact reports fail when a Synonym is missing an Assigned code. VDC-77827
The Query Status on Medical Coding Request Queries doesn't update to "Closed" when the query is closed. VDC-77841
When a Code Request is approved, Vault doesn't populate the Indication or Route to the newly created Synonym. VDC-78169*
The Code All Forms and Update Synonym List email notification doesn't display the number of Code Requests for which coding or synonym creation failed. VDC-78182*
Even after autocoding from dictionary, MedDRAJ may not return any search results for a Verbatim. VDC-78387*
If a Verbatim contains an apostrophe ('), coding managers are unable to approve the Code Request if Apply to Synonym List was selected. VDC-78402
Not all expected coding requests are generated after running the Reconstitute Code Request job. VDC-80710
Partial verbatim matches don't garner suggestions in Coder. VDC-80816*
Propagate Code autocodes the selected Coding Request and matching requests on other forms but doesn't autocode matches in the same form. VDC-81044*
The ID column is in the incorrect position on the Verbatims page when a study uses a third party coding system. VDC-82116*
Some users experience slow performance and backup while autocoding. VDC-82637
Synonym list dictionary releases can be set to reference non-existent records when upversioning. VDC-84460
Users are shown an error message and are unable to lock a study in Coder Tools. VDC-85386

Coding Configuration

Issue Description Issue No.
Users may be unable to map Adverse Event forms to a MedraJ Dictionary Version. VDC-78212

Compare Versions & Vaults

Issue Description Issue No.
In some cases, outputs resulting from vault comparison jobs are missing rules. VDC-72708
Vault doesn't show the Name of the Study for Study 2 in the Select Options dialog when Study 2 is in a different vault than Study 1. VDC-78674
Some users can't compare study versions between a dev study and production study because the production vault doesn't appear as an option to compare. VDC-79760

Data Entry

Issue Description Issue No.
Users receive a server error when freezing an Item after unfreezing an Event or Form. VDC-68024*
Editable grids don't display or save all entries. VDC-79051
Users receive a server error message when attempting to submit SAE forms. VDC-79377
In some cases, users can't edit the first row of an Editable Grid after selecting a new row. VDC-80111
Progressive Display doesn't work correctly on forms using Editable Grids. VDC-80127
A linked ConMed form shows two ID's for the same link. VDC-80408
Users may receive a server error when attempting to reset an Event. VDC-80684
Date Item values aren't reformatted and stored in the correct format. VDC-81216
Lab forms don't autosave in Data Entry. VDC-81375*
Users may receive a server error when attempting to enter dates and datetimes in Japanese. VDC-81651
Users may receive a server error when attempting to enter 12 hour format dates in Japanese. VDC-81652*
Vault creates a new reference instead of a new row within the editable grid when users click "+New Row." VDC-81825
Users are shown an error message when completing a Protocol Deviation form for a subject that was transferred to a new site. VDC-83213
When a user attempts to edit a Form that uses an editable grid Item Group and has a Form Link, Vault may show a blank page. VDC-86857


Issue Description Issue No.
Deployment fails in vaults where the Multi-Role Security feature is enabled. VDC-78162*
In multi-role security vaults, deployment may fail if a permission set is assigned to two custom Study Roles, but only one of those roles is on the Deployment List. VDC-78278*
Users are shown an error message when attempting to delete an environment in some cases. VDC-78792
500+ warnings display in Validation reports when users are attempting to deploy to Production. VDC-79130
Users may find unexpected differences related to Review State when running a Vault Comparison job (Diff report). VDC-79421
Users may find unexpected differences related to Review State when running a Vault Comparison job (Diff report). VDC-79527
Deployments fail with an error message regarding the dictionary release version when using a third party coder. VDC-80712
Study deployments may fail unexpectedly. VDC-85134

Developer Features

Issue Description Issue No.
The Retrieve Queries API doesn't return Item Group or Item details in the response. VDC-76692*
Site and Subject IDs are missing leading zeros in the Retrieve Code Requests response. VDC-78754
Users can't set Items marked as derived via API. VDC-79036
With this release, CDMS APIs (starting with v21.2) accept both simple and complex values for the Content-Type parameter ("application/json" or "application/json; charset: utf-8"). VDC-79368


Issue Description Issue No.
SDV Complete Dates don't transfer. VDC-78496


Issue Description Issue No.
The Preview for the Run Rules job may show queries being opened on the wrong Item for lab panel Items. VDC-70877
In study data extract output, for a custom object that has a field referencing the Event object, the custom object's file shows the ID for the Event, instead of the Event Name. VDC-78150*
Vault lists the Override Lab Normals Report operation in the Job History. VDC-78512*
The Audit Trail Export by Study job fails in Production. VDC-79903
Closeout PDFs download with multiple issues including incorrect subjects and error messages. VDC-81916
When the Workbench Export job fails, Vault applies the Cancelled status instead of Failed. VDC-82015
The EDC Workbench job fails due to errors and with a "cancelled" status but no errors are identified in the error log. VDC-82361
Study Data Extracts jobs in SAS format may fail if the Name of an Item that is not of the date data type ends with "DT". VDC-82541
Audit Trail Export by Subject jobs fail inexplicably. VDC-82938
Users can only generate audit trails for one subject at a time when using the Audit Trail by Export job. VDC-85193


Issue Description Issue No.
The Override Normals report doesn't have the columns in the correct order. VDC-75571*
Users are able to run labs reports for locked Studies. VDC-77989*
A query doesn't fire in Labs when units don't match. VDC-78106*
Users can't add certain approved Lab Locations. VDC-78403*
The Outdated Normals Report job and the Update Outdated Lab Normals job fails with errors. VDC-79034
Users are prompted to run the "Update New Lab Locations" job after running the "Outdated Normals Report" but the lab locations job fails. VDC-81075
Lab Managers can't run any normals-related jobs if a restricted form is present in the same event as a form. VDC-81946*
Excel and CSV exports of Lab Locations & Normal Ranges display "0.00" as "0E+00." VDC-82153


Issue Description Issue No.
Tools > EDC Tools > Safety Configuration doesn't load for users with a non-English language. VDC-80525*

Protocol Deviations

Issue Description Issue No.
Users aren't shown an error message when Summary field text exceeds 250 characters. VDC-81182
When users edit a Protocol Deviation, Vault changes the date of deviation and the date identified by one day. VDC-83782

Publishing Validation

Issue Description Issue No.
Users receive errors when running the validation job. VDC-79062


Issue Description Issue No.
The Audit Trail for Unmasked Data should show kits/devices. VDC-69600*
In Internet Explorer™, Treatments don't display, and Vault doesn't allow users to add new Treatments. VDC-75377*
Multiple pages in the Randomization tab don't display in the Internet Explorer™ browser. VDC-77871*
The "Reveal Treatment" action is disabled in Data Entry until the user views a form. VDC-79225
The Treatment Arm Data column in the Unmasked Data tab doesn't show any data. VDC-82936*

Review Plan Assignment

Issue Description Issue No.
Review Plan Assignment version 3 doesn't assign review plans to casebooks correctly in some cases. VDC-78029*
Users are shown an error message in the New Assignment Criteria dialog. VDC-79480*
Users are shown an error message when attempting to create a Country review plan after creating a Site review plan using Review Plan Assignment v3. VDC-84448*

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*
Read Only roles can't view queries in 21R2. VDC-79202
Users with the "Close Query" permission receive an error when attempting to reply to a query. VDC-79259*
Users with Read permissions can't access Subject records. VDC-79772
Unused sites don't get deleted when the user clicks "Delete." VDC-81595
Vault doesn't clear leading spaces during user import, which can cause issues for Federated ID and SSO. VDC-82730

Rule Editor

Issue Description Issue No.
Users may receive an "Undetermined" error when writing a rule expression using the Max() function. VDC-78800
The sequence numbers for aggregate objects should be sorted numerically, not alphabetically. VDC-79697*
Item groups on some forms don't display in the Rule Details section when the form is first selected. VDC-80330

Rule Execution

Issue Description Issue No.
Vault doesn't populate the Subject or Event Group columns for an Add Schedule or Add Event rule that removes the Event Group or Event. VDC-56691*
Vault doesn't record the correct value in the Forms column of "rule_details.csv" for the execution of Add Assessment rules. VDC-57776*
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*
Rules on common Forms with repeating Item Groups that use only aggregate identifiers return [null]. VDC-78395
Users receive incorrect data validation errors when attempting to execute a rule. VDC-79217

SDS & Annotated PDFs

Issue Description Issue No.
The first section of the Labs tab in the SDS should be titled "Local Lab Configuration" instead of "Randomization Configuration." VDC-81330


Issue Description Issue No.
In certain cases, the Event & Form List panel may not display the expected SDV and DMR status icons, even though those statuses are correctly represented in the Content panel. VDC-78411*, VDC-78385


Issue Description Issue No.
Users are shown an error message when attempting to edit a signature definition in Studio in a study that is configured with Data Model 1.0. VDC-80256*

Study Administration

Issue Description Issue No.
With this release, testing Connections in EDC Tools now performs additional checks. VDC-81209*

Study Data Extracts

Issue Description Issue No.
The Study Data Extract job fails when the user adds a "Space" field to the Page Layout of the Custom Object. VDC-78067*
Scheduled SDE jobs fail with errors when the user selects "Run Now." VDC-78712*
The Study Data Extract job fails inexplicably. VDC-78829
New SDE jobs fail inexplicably and current jobs remain "In Progress." VDC-79117
Extracts going to vaultloader are saved in a new vaultloader folder instead of the user's home directory. VDC-80057*
The Study Data Extract job fails with an error for some users. VDC-80120
The ESEQ column labels should say "Event Group Sequence" in the 21R3 version of the SDE. VDC-81079*
SDE jobs for a UAT3 study include study labels from a UAT6 study. VDC-81669
The SYS_PD dataset should have an integer, not text, data type for the ESEQ column. VDC-81901*
Scheduled SDE jobs fail unexpectedly. VDC-82037
SDE jobs fail when extracting data for Form Links. VDC-82120
The SDE job fails due to duplicate column names when exporting as an SAS file. VDC-82641
Users can still run an SDE job with an invalid zip file name. VDC-82662*
Users are unable to download extract files for certain studies after the SDE job has completed. In addition, when the user chooses SAS with XTP files as the extract type, only CSV files are created. VDC-82890
The SDE job fails when exporting as an SAS file. VDC-82988
The SDE job takes too long to run after another SDE job fails. VDC-83587
The SDE job fails when exporting as an SAS file. VDC-83588
The arms and cohorts columns in the SYS_SUB dataset should show the label, not the Vault ID. VDC-84188*
The COLNAME column should be relabeled as FORMEID. VDC-84783*

Study Design

Issue Description Issue No.
Copying an Event Group fails when that Event Group contains a Form with a Lab Panel. VDC-77927*
Users are shown an error message when attempting to copy a form with rules. VDC-79374
The rule link in the hover-over text of the lightning icon in the Studio > Schedule grid redirects the user to the wrong rule editor version. VDC-79946*
Users are shown an internal exception error message when copying a form in Studio. VDC-81967

Study Import & Export

Issue Description Issue No.
Study imports fail when an environment other than development is selected. VDC-77932

UI & Performance

Issue Description Issue No.
If a statement has multiple uses of the Label function within a union, CQL may take a very long time to return results. VDC-69648
Workbench may be slow to load the Public Listings page. VDC-71512
Users are shown a server error when attempting to create an open query on a blank frozen form. VDC-72078*
The comparison rules grid in Studio should be able to expand and collapse. VDC-74710
Vault is slow to load the list of Rules in the Copy From Study dialog. VDC-75265*
In Labs > System General Settings and Study General Settings, the subtab header and scrollbars flicker. VDC-77501*
EDC Tools doesn't show all studies that the user has access to unless a specific organization is selected. VDC-77565*
Users experience performance issues in the Data Entry tab when using the Chrome™ browser on Microsoft® Windows 10. VDC-77764
In EDC Tools > Review Plan Assignment, subtabs may not display correctly. VDC-78079*
Users are shown an error message when resetting an event that is Marked for Removal. VDC-78139*
The help content set in the Properties Panel in Studio doesn't match the help text displayed in the Review tab. VDC-78529
In certain circumstances, Vault may not display the SDV or DMR status icons in the Event & Form List panel. VDC-78769*
Derived items don't populate in the Data Entry or Review tabs for certain forms and subjects, despite being visible in audit trails, detail PDFs, and data extracts. VDC-78813
Users are shown a network error message when copying a training mapping from a previous study. VDC-79213
Certain database tables may have extra rows, resulting in performance issues. VDC-79429*
Users are shown a server error message when entering a Query ID in Review > My Studies > Queries. VDC-79525
The Synonym List detail approval suggestion generation takes too long. VDC-79619*
The Clinical Assessment text is cut off and the user can't see the full question in Data Entry. VDC-79767
Users are shown a server error message when attempting to open associated links in a Concomitant Medication form in Data Entry. VDC-79899
For certain custom listings, CQL may take longer than usual to return results. VDC-79933*
Users are redirected to their subject list in Data Entry after entering data into a form. VDC-79999
Users are redirected to the bottom of the page when clicking "Close Query" in the Review tab. VDC-80207
Editable grids with multiple item groups that begin with a question and are configured with Progressive Display don't allow the user to enter data in the first row. VDC-80308
Users are shown an error message when attempting to view an Event Audit Trail and failed Detail PDF job. VDC-80320*
Users are redirected to the subject list when completing a form that triggers Progressive Display in Data Entry. VDC-80559
The correct SDV/DMR status isn't reflected in the Event/Forms tree panel for some forms. VDC-80579
The deployment history page doesn't load in EDC Tools. VDC-81078
In Studio, the "Copy" button doesn't disable after the user clicks it, allowing users to click the button multiple times during the copy. VDC-81423
In EDC Tools > Sites, the "(GMT+03:00) Eastern European Time (Europe/Istanbul)" is incorrectly labeled. VDC-81646
Some users can't close queries in Coder Tools. VDC-81648
Form names and labels disappear when the user scrolls to the right while viewing the schedule in Studio in a windowed browser. VDC-81939
The audit trail UI can be inconsistent when User Defined Rules and Custom Triggers attempt to update the derived value at the same time. VDC-82989
Users are shown a server error message in Coder Tools when attempting to update study settings for studies with Review Plan Assignment v2 that has been individually assigned. VDC-85293

Vault Administration

Issue Description Issue No.
Admin users can't delete subjects or set event dates. VDC-80814*