Fixed Issues in 22R2

Pre-Release Date: July 11, 2022 | CDB Pre-Release Date: July 18, 2022 | Release Date: July 29 & August 5, 2022

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.


Issue Description Issue No.
Users may receive a server error when attempting to access an Assessment. VDC-94850*

Audit Trails

Issue Description Issue No.
Audit Trail Export by Site jobs fail when running on older studies. VDC-101673
In the Review tab, Event Date and Item audit trails incorrectly show that the User Review Modified By field is set when it has been unset. VDC-102252*

Casebook Versioning

Issue Description Issue No.
Amendments fail when the new version contains changes to an Item Definition's Display Items. VDC-94443*
Subjects don't upversion when running a retrospective amendment after upversioning a site. VDC-99808

CDB - Admin

Issue Description Issue No.
CDB doesn't show an error message when a user enters an invalid email address in Admin > Source Notifications. VDC-89453*

CDB - Checks & Queries

Issue Description Issue No.
If a user performs reviews and then deletes the Review Listing, CDB may place new import packages in the Queued status when no approval is required. VDC-96729
When a user opens queries as a bulk action, they receive an error. VDC-97852


Issue Description Issue No.
Select * from @QRY shows empty results. VDC-100902*
CQL may fold unexpectedly when using a form alias. VDC-101333*
When a custom listing is enabled for review, CQL may suddenly return duplicate data. VDC-101781
CQL doesn't return a useful error message when there are incorrect aliases. VDC-86851*
Union now supports order by position. VDC-92817*
CQL returns an ambiguous form and view error when the referenced View has the same name as a Form. VDC-94017*
CQL returns an unknown column error when the statement uses an alias name in the Order clause of a single Select statement. VDC-94374
SDTMDateFormat doesn't return the correct date values when used inside a Union. VDC-94757
Select * in a subquery returns more records than expected. VDC-95119*
With this release, Union Distinct is now fully supported. VDC-95561
CQL may return an unknown header error when aliasing @HDR.Site.Name. VDC-95678*
CQL may take much longer than expected to return results for statements using CALL Sys_Forms. VDC-95681*
CQL may take much longer than expected to return results for statements using CALL Sys_Forms. VDC-95729*
When referencing @ItemGroup.SeqNbr and using DISTINCT and COMPACT, CQL returns an "0006" error. VDC-95844*
Statements using DISTINCT with a subquery may take longer than usual to return results. VDC-96037*
CQL returns a duplicate column error when "_RAW" is included in the alias. VDC-97124
The "@HDR.Site.PI" CQL function replaces blank spaces in the country name of a site with an underscore. VDC-97866*
Workbench returns a blank Label value when the user runs the codelabel function on a codelist with a defined label. VDC-98011
CQL may return a duplicate column name error when using Union Distinct and aliases. VDC-98288
CQL may return duplicate rows when selecting distinct from a subquery. VDC-99208*
When there is a non-repeating Item Group, CQL may return an empty row. VDC-99625

CDB - Dashboards

Issue Description Issue No.
CDB progress reports continue sending when they're no longer scheduled. VDC-90405
The Dashboard doesn't show the correct value for Not Reviewed. VDC-97236

CDB - Deployment

Issue Description Issue No.
The Deployment option may not show in the CDB Navigation drawer. VDC-102008*

CDB - Export

Issue Description Issue No.
Sys_Links may show more rows in the output file than in the Export Listing UI. VDC-101826
When creating a raw Export Definition, CDB duplicates Core Listings. VDC-102306
The export manifest file has an Item as the integer data type, even though the item's data contains decimals. VDC-102754
CDB may fail to generate an export package if the export contains a listing that has CQL with a union. VDC-74927*
BIGINT type fields show up blank in SAS exports. VDC-80229*
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-85472*
Users aren't able to edit the Title or Short Title when the Impacted Listings filter is applied. VDC-93708*, VDC-97251*
When a parent listing is deleted, users receive an error when attempting to sync the Export Listing with the parent. VDC-94035*
Export package generation may fail with the "Failure in Executing : Query execution was interrupted, maximum statement execution time exceeded" error. VDC-96486
Large studies take too long to export. VDC-96512
The manifest.json may show the wrong Date Applied date for export packages. VDC-96588
In some circumstances, SAS export package generation fails unexpectedly. VDC-96956*
Users may receive an error when attempting to delete an Export Definition. VDC-96998*
Workbench fails to generate SAS export packages for some studies due to an SAS server issue. VDC-97071*
In deployment-enabled studies, users may receive an error when attempting to create a new Export Definition. VDC-98323
Scheduled exports may stop running after a user adds or removes listings from an Export Definition. VDC-99332

CDB - Import

Issue Description Issue No.
When CDB isn't able to read the study_name in the manifest file, CDB doesn't move the package to the _error folder or create an error log. VDC-101381
CDB may send source notification emails when there are no changes to the source. VDC-88347
Import may fail due to a timeout error. VDC-89742
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*
When there are multiple packages from a Source in the queue, CDB may not apply the "Skipped" status to skipped packages. VDC-94336
If a user imports a manifest file into the builder that has '"event":{"generate":true}', the manifest builder sets "Do you want to match on EDC Events" to "No". VDC-94640*
In the manifest builder, users may receive a network error when attempting to upload multiple large CSV files during step 2. VDC-94832*
The Form Change Log file may be empty for export listings. VDC-94914*
The import audit log now tracks the start datetime for transformation and import. VDC-95386, VDC-95597
When the audit log has more than 100 records, CDB doesn't show the correct page numbers. VDC-95511*
In the Audit Log CSV, CDB doesn't use the appropriate date format for Loaded Date. VDC-95634*
CDB may not include the Transform Completion, Import Completion, or Date Applied dates for certain import packages in the Audit Log. VDC-95644*
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
Import fails when there is a Form where the Sequence is null. VDC-96210
The manifest builder doesn't warn the user when there are multiple Items with the same Name used across multiple files, but only one of those files is blinded. VDC-96426
CDB may attempt to process multiple transformations for the same third party package at the same time. VDC-96507
CDB may take longer than usual to load the Import > Packages page. VDC-96513
If an EDC import package is skipped and then later retransformed, CDB doesn't retransform third party packages. VDC-96517
The quick filter counts for In Progress studies are incorrect after a Source is deleted. VDC-96650*
If a third party package is in an inactive swap, then CDB doesn't process new third party data packages even when there aren't manifest changes. VDC-96661
For existing Studies, CDB may not show newly created Casebooks imported from EDC. VDC-96973*
CDB may take longer than usual to load the Import > Packages page when there are many records. VDC-97052*
CDB may fail to swap to newly imported study data if reviews are deleted as part of the import. VDC-97084*
If the study's Name contains a space, the Study doesn't display in CDB. VDC-97218
If a Subject is deleted while the Workbench Export (EDC) job is still in progress, it results in an error during import into CDB. VDC-97711
Change detection may not list differences between arrays in the manifest file. VDC-97884
With this release, CDB uses text as the default data type, and character for SAS exports, when one isn't specified. VDC-98473
Import of third party data fails unexpectedly in some Studies. VDC-98761
If an EDC import removes an Event Group from a Subject, reprocessing of third party data referencing that Event Group may fail without an error. VDC-98766*
The last applied package date that displays when hovering over the form pill on a core listing should display the last date that a successful package was uploaded. VDC-99212
If the manifest file has row_blinded configured, and that column has values other than true and false, import fails without an informative error message. To fix this issue, CDB now returns the error "D-035: for this scenario. VDC-99715

CDB - Listings

Issue Description Issue No.
The Cell Details panel working is dependent on the CQL's first select statement in a union. VDC-101050
If a third party Item is restricted, and a user without the Restricted Data Access permission opens a listing with that Item, the listing is invalid with an "IndexOutOfBoundsException" error. VDC-69624*
CDB might mark a listing invalid when a user without the Restricted Data Access permission opens a Custom Listing that contains a union with a blinded third party listing. VDC-72183*
CDB may fail to create a Review Listing when the CQL contains a union between an EDC form and a third party form. VDC-74984*
Sorting doesn't synchronize across columns for aliased @HDR items. VDC-88584*
For review-enabled listings, filters in the Sort & Filter menu for integer-type columns may not be applied correctly. VDC-94682
If a listing references EDC data, CDB doesn't show an error message when a user downloads the Form Change Log. Instead, it generates an empty file. VDC-95160*
CDB may take longer than usual to sort results when the listing CQL uses coding functions. VDC-96423
For Core Listings, CDB shows the Loaded Completion date instead of the Last Uploaded date in the Last Uploaded column. VDC-96815
For sorting the Study list by Created On or Last Uploaded, CDB doesn't apply the sort order correctly. VDC-96909
When a column's name begins with a word used in a @HDR attribute, CDB may not open the Cell Details panel when a user clicks a cell in that column. VDC-97428*
After a new import of third party data from an existing Source, Core Listings from that Source may be briefly displayed twice while CDB is swapping in the new data. VDC-97743
Listings with the same Name as other listings may be marked as Invalid with the "mismatched input ','. Expecting: " error. VDC-98010*
CDB may not show referenced views for a listing in Listings > Review. VDC-98682
Users may receive an error when downloading a Review Listing. VDC-99235


Issue Description Issue No.
Users receive a server error when attempting to delete a Synonym from a Synonym List. VDC-102516
Selecting the "Select All" checkbox in the Upversioning tab only selects forms on the current page. VDC-97104
In some cases, Synonym Lists fail to upversion when performing batch upversioning that includes forms and the Synonym List. VDC-97147
Forms are marked as "Upversioning" before the batch upversioning job begins. VDC-97364
Coding requests take longer than expected to upversion. VDC-97383
Users can upversion locked studies in Coder Tools. VDC-97629
Vault may attempt to autocode locked Studies. VDC-97714*
The WHODrug Synonym List fails to upversion when batch upversioning the WHODrug Forms and Synonym List. VDC-98120*
Vault Coder marks terms not coded to ATC level 4 as "Noncurrent" when performing a dictionary upgrade. VDC-98695
Users encounter error messages when attempting to edit study settings or upversion in a locked study. VDC-98745*

Data Entry

Issue Description Issue No.
Users encounter a server error when selecting a query in the Site Tasks sidebar menu. VDC-100352
When users create and then quickly delete an unscheduled Event or repeating Item Group instance, Vault may orphan Review State records. VDC-101089
Users don't have the option to reset a repeating Item Group instance with migrated data until a field in the Item Group is updated or changed. VDC-94618
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
In some cases, dynamic forms aren't being created when they should be. VDC-97289*
Vault doesn't trigger an Event to display after an Event Date is entered for the first Event in a repeating Event Group when configured. VDC-97776*
Vault doesn't show users the option to add an "Early Termination" Event when adding a new Event. VDC-98966
Users can't enter normal range data for certain Items. VDC-99081


Issue Description Issue No.
Restoring a deleted study environment from a file fails in some cases. VDC-95610*
Analyte Library deployment fails with an error in some cases. VDC-98477*

Developer Features

Issue Description Issue No.
If multiple Upsert Item Groups requests are sent at the same time, Vault may create Item Groups with the same Sequence Number. VDC-100097
For the Create Casebook API, when on the site's Active Casebook Version, Vault returns an invalid JSON response. VDC-100964


Issue Description Issue No.
Users receive a server error when attempting to save training mapping to multiple Studies. VDC-102676
When Study Countries aren't properly linked, the inbound job from CTMS fails without a useful error. VDC-95790
The CTMS outbound job isn't triggered when enabling the CTMS connection. VDC-98360


Issue Description Issue No.
The Data and Definition Export job fails with an error in certain studies. VDC-87960*
The Unique Terms Report fails in some cases. VDC-95344*
The Form Progress Listing may include data from Sites that the user doesn't have access to. VDC-95422
Users are shown an error message regarding their FTP external connection when running older scheduled Study Data Extract jobs. Users running other scheduled jobs can't access files in the FTP server. VDC-96491
The Query and Form Progress Listing jobs fail for some users when run from EDC Tools. VDC-96654
Users may receive an "'ids' must be !null" error when attempting to download a job's output file. VDC-96665*
Audit Trail Export by Study jobs remain "In Progress" and don't complete. VDC-96807
Study Data Extract jobs and Listing jobs created by CDMS API Read Write users with access to all studies fail. VDC-96966*
In some cases, there are no files attached to SDE or listing job records in the audit trail. VDC-97138*
Restricted forms are included in SDV/DMR counts in the Event Progress Listing when "Include Restricted Data" isn't selected. VDC-97867*
The Review Metrics Report includes Restricted Data even when the "Include Restricted Data" checkbox isn't selected. VDC-97942*
The Created By column in the CSV file of the Query Detail Listing shows the wrong user. VDC-98156
Vault may not show all available subjects in the dialog for Run Rules. VDC-98901
Users may receive an error when attempting to navigate to EDC Tools > Jobs when there are Sites without values for Name. VDC-99470*


Issue Description Issue No.
Users receive an error when attempting to delete a lab unit. VDC-94454*
In some cases, users are shown incorrect error messages when entering reference range data. VDC-96522
The "Enable Approvals for Lab Normals" option should be deployable. VDC-97634
Lab panels in Data Entry should display override labels for analytes, not default labels. VDC-98084

Library Collections

Issue Description Issue No.
The "pediatrics" classification is missing its label. VDC-93874*
The "pediatrics" classification is missing its Label. VDC-94961*
Users receive an error message when attempting to copy forms from the Library. VDC-98691

Publishing Validation

Issue Description Issue No.
Studio may return WPD-004 unnecessarily. VDC-100965


Issue Description Issue No.
Users may receive a server error when attempting to edit a query comment on a required, Item Link type Item that was marked as Intentionally Left Blank. VDC-93912*
In Coder, a query in the Closed status may show as remaining in the Site Responded status. VDC-94566
Out of range system queries don't fire for studies with event windows set. VDC-97088
Queries don't show as closed unless the user manually refreshes the page. VDC-99229

Review Plan Assignment

Issue Description Issue No.
In some cases, the SDV assignment criteria for review plans does not apply correctly. VDC-98352

Review Plan Editor

Issue Description Issue No.
Review Plans may get stuck in the Validating status. VDC-101793

Role & User Management

Issue Description Issue No.
Users without the Design Study permission may be able to edit Repeating Event Group Overrides in the Library. VDC-95849

Rule Editor

Issue Description Issue No.
Studio allows users to reference @Form identifiers when using the Set Item Value rule action. VDC-93974*
French-language users can't save rules without encountering errors. VDC-94615

Rule Execution

Issue Description Issue No.
In some cases, queries don't fire according to the rule expression after an Event Date is entered but will fire when the user refreshes the browser or resubmits the form. VDC-101374
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
For some events, a query will fire when users enter a date that is within the date range. VDC-97263
Vault clears the Marked for Removal status from dynamic Forms when the form's Rule Restult is false and the form's event's Set for Removal status changed from Yes to No. With this release, these forms retain their Marked for Removal status. VDC-97472*
The "Reset Event" action in Data Entry doesn't perform in accordance with dynamic rules when marking an event as "Did Not Occur." VDC-98290

Safety Link

Issue Description Issue No.
Failed integration tasks block subsequent integration tasks from running successfully. VDC-92903*
ACK contents aren't imported when a case is accepted. VDC-93682
After the import of a closed Safety Case, Vault still generates a Safety Message when a site user edits the associated Form. VDC-94592*
Vault places ConMed details before Study Drug details in the XML file, which causes the file to not be readable in Argus. VDC-95164
Users are shown an error message when attempting to import a JSON file. VDC-96315
The Primary Treatment form should be the first treatment displayed in the E2B XML file. VDC-96797
When two instances are submitted to a repeating Treatment Form, the Safety Message is created but the E2B XML isn't attached. VDC-96799
In some cases, jobs aren't scheduled when conditions are met. VDC-97650

SDS & Annotated PDFs

Issue Description Issue No.
With this release, Vault checks for duplicate definitions that may prevent successful SDS generation before starting to generate the SDS. VDC-100297
Annotated PDFs may have text in the wrong color. VDC-94515*
The SDS fails with an error. VDC-95942
Users encounter an error when attempting to create specifications in Studio. VDC-96666
The SDS fails for certain studies. VDC-97385
The Form Repeating and Item Group Repeating columns in the SDS don't populate for some users. VDC-97473
Vault is unable to generate Unique CRF and SDS for certain studies. VDC-97722
The SDS/PDF job fails when the "Indent Progressive Display" field is checked in the Create Specification dialog. VDC-98206*
Users encounter errors when performing SDS, unique CRF generation, and copying forms from the Library. VDC-99051
The Create Specifications job fails when all CRFs and Unique CRFs are included. VDC-99578


Issue Description Issue No.
When Additive Review isn't enabled for a Study, but an Form is configured with some but not all Items as required, if a user performs SDV at the event level, Vault applies SDV to all Items on that Form. VDC-101508
While in Additive Review mode, users receive a server error if they click DMR In the header when the Study has no DMR Review Plan. VDC-95080*
Event Dates can't be additively reviewed, even when the assigned review plan has event dates set as "No Review." VDC-95639


Issue Description Issue No.
Users are able to sign repeating forms with open queries. VDC-101348*

Study Administration

Issue Description Issue No.
Vault doesn't successfully copy system rules in Studio. VDC-100611
Running Rules Preview results in multiple different results for the same form/event. VDC-96832
Deletion of a Study Environment fails when the environment doesn't contain a Casebook Definition. VDC-97557

Study Data Extracts

Issue Description Issue No.
Daily SDE jobs fail with errors for some users. VDC-100098
Korean language SDE outputs have unexpected truncation on column headers and values. VDC-102865
In repeating Item Groups, all linked forms appear in the ITEMLINKEDTO column. VDC-94492*
Display items that are left blank on a linked form show as "null" in the ITEMLINKEDTO column. VDC-94582*
The Item Group Sequence number should be included in the LINKEDITEM column. VDC-94922*
When a user includes custom objects in the SDE, the Study Data Extract job may fail. VDC-94941
The SYS_FORM dataset incorrectly reports forms marked as ILB as "true." VDC-97418
Not all custom object columns are exported as expected in the SDE. VDC-97704
SDE jobs fail with an error when the user that scheduled the job is no longer active. VDC-97861
The EGROUP column length in the SYS_PD dataset should be 200 to match EGROUP column lengths in other datasets. VDC-97876
The data type in the IGSEQ column in the SYS_PD dataset is incorrect. VDC-98033*
With this release, Vault checks for the Restricted Data Access permission when the SDE contains restricted data and the user is opening the download link from the job completion email. VDC-98107
Users can select the "Include Randomization Treatment" checkbox when switching to an earlier SDE version that doesn't have randomization treatment information. VDC-98254*
The NSUBMITS column in the SYS_ASM dataset should have an "integer" data type. VDC-99026*
The CASEBDEF columns in the SYS_EVT, SYS_SITE, and SYS_SUB datasets should have an "integer" data type. VDC-99027*
The MANUAL column in the SYS_Q dataset should have a "boolean" data type. VDC-99355*
The LABMODIFIER column in the SYS_LABRANGES dataset should have a "boolean" data type. VDC-99358*
The SYS_ANALYTES dataset contains columns with the incorrect data type. VDC-99359*
The INACBYSYS and LASTINACDT columns of the SYS_PD dataset have incorrect data types. VDC-99360*
The SDE job fails with errors due to custom object length limitations. VDC-99559

Study Design

Issue Description Issue No.
Users may receive a server error when attempting to remove an Item from a Form that has been deleted. VDC-89903*
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*
Vault displays "Null" instead of the form's Label in the Display Items dialog. VDC-94338*
Users are shown an error message when attempting to change an Event Type to "log." VDC-96525*
Users can't generate Blank and Unique eCRFs without errors. VDC-96801
Users experience performance issues when attempting to remove an Item from a Form in Studio. VDC-97964
Codelists duplicate after creating a new casebook version. VDC-99653*

UI & Performance

Issue Description Issue No.
In Coder, the Verbatims grid doesn't fully display. VDC-100420*
Vault changes the collection hour to the wrong time when users enter lab results in Data Entry. VDC-85380
The Deployment status shows as "Failed" then "Completed" when restoring an environment from a file in EDC Tools. VDC-93252
The Form field in the Rule Details panel isn't filtered by entered text. VDC-93552*
The "Run Now" button in Labs > Reports Mass Updates should be disabled after it's clicked. VDC-93761*
Editing a scheduled Study Data Extract job after restricting a form causes the New Job dialog to disappear and redirects the user to a blank Job Schedule page. VDC-94414*
The Birth Year field label in Studio displays as "Date of Birth" in Data Entry. Item labels should be the same across Studio and Data Entry. VDC-94430
When changing SDE versions in the Study Data Extract New Job dialog, the System Datasets checkbox is selected when it previously wasn't. VDC-94468*
Vault takes a few seconds to produce a confirmation dialog when the user restores an environment via file in EDC Tools. VDC-95294
Vault displays a server error message when the user attempts to input/save analyte values in a Lab Panel in Data Entry. VDC-95319
Hidden labs codelist options still show in Data Entry. VDC-95389
Users are shown a server error message after completing an Informed Consent form in Data Entry. VDC-95650
In some vaults, navigating to Studio and selecting a study produces a blank page. VDC-96106
The "Close Query" button becomes inaccessible when hovering the mouse over the query text in the Review tab. VDC-96414
Users can't select a form in the Link and Copy dialog when linking forms in Data Entry. VDC-96713
Some users are shown an error message when attempting to link an Adverse Event form and Serious Adverse Event form in Data Entry. VDC-96714
Vault displays a server error message when users navigate to sites in certain studies in the Review tab. VDC-97423
Rules are listed multiple times, each page lists more than 100 rules per page, and rules aren't ordered alphabetically when sorted by Name in Studio > User Defined Rules. VDC-97748
CDB Deployment page filters are non-responsive. VDC-98014
CDB may take longer than expected to open a listing. VDC-98353
Vault displays a server error message when users attempt to check the "Lab Tests Not Performed" checkbox in a repeating lab form in Data Entry. VDC-98481
Users encounter errors when attempting to remove an Item in the Study Design. VDC-98693*
Users can't click the Repeating Event Overrides link in the properties panel in Studio. VDC-99579

Vault Configuration

Issue Description Issue No.
Change Reasons shouldn't be editable in UAT environments. VDC-94540
The Standard Date Format field shows as blank in the Vault Configuration Report for most studies in the Study Configuration tab. VDC-97342