Fixed Issues in 23R1

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

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.


Issue Description Issue No.
Users encounter a server error when attempting to view summary data in Assessments on an adverse event form that uses item linking. VDC-116060

Audit Trails

Issue Description Issue No.
The Audit Trail Export by Study job fails with errors. VDC-110155

Blank & Detail PDFs

Issue Description Issue No.
Archived Lab Modifiers are shown in Blank PDFs. VDC-106131*
Detail PDFs fail for some subjects in locked studies. VDC-111104
Vault generates an empty folder when users download a closeout PDF. VDC-113579

Casebook Versioning

Issue Description Issue No.
The Codelist/Unit column in the file resulting from a Vault Comparison job is blank despite there being codelist updates. VDC-113735*
Vault only selects sites on the first page when users click "Select All Sites" when running a new retrospective amendment post go live. VDC-115684


Issue Description Issue No.
CQL may not return all expected rows when using COMPACT. VDC-105565*
Users without the Restricted Data Access permission can't see rows from an unrestricted Form when that Form is joined with a Form containing restricted Items using COMPACT. VDC-105649*
Users receive a CQL syntax error when attempting to generate a SAS or CSV file for a listing with queries on derived values. VDC-110693*
CQL may return certain cells as data holes ("--") instead of null. VDC-111342*, VDC-111684*
CDB may not show the appropriate cell decorations for CQL where referencing a View with a UNION subquery. VDC-112103
CQL may return a "Duplicate column name" error when a user creates a View referencing lab data from EDC. VDC-112163*
CQL may return a null value when using @FormLink on a Form where both forms in the link contain repeating Item Groups. VDC-112184
When a boolean field is inside a Union, CQL returns "1/0" instead of "true/false" for the boolean Item. VDC-113547
When there's more than one Form in the FROM clause, and there is an alias on a Form header, CQL may return duplicate columns for that aliased header. VDC-113574
If a Study adds a new Item Group containing only label-type Items to a Lab Form, CQL doesn't include those label items in Core Listings. VDC-113909
CALL Sys_Links doesn't return values for Item-to-Form Links (ItemGroup.Name, ItemGroup.SeqNbr, and FormLink.Name). VDC-115634
CQL returns an unknown column error for datetime Items used in Item to Form Links. VDC-115886
CQL may return "--" instead of the sequence number when using the FormSeqNbr function on linked forms. VDC-116221
CQL returns errors when the statement uses @Form.Name or @Form.SeqNbr in a subquery. VDC-63711*
When using Union with an alias on a @Form header, CQL may return results with unexpected data holes. VDC-68349*

CDB - Deployment

Issue Description Issue No.
Users may receive an error when attempting to download the Approval Log for a listing. VDC-112133

CDB - Export

Issue Description Issue No.
Export FTP delivery may fail unexpectedly due to a timeout error. VDC-109070
Users receive an error when attempting to update an Export Listing Title in a scheduled Export Definition. VDC-111073*
When an FTP destination is deleted in EDC, CDB doesn't allow users to clear that FTP selection from the Delivery property on an Export Definition. VDC-112100*
In SAS packages, the length for columns with functions on data items is set to 512. VDC-112449*
SAS package generation may fail unexpectedly. VDC-112549
SAS package generation may fail due to swap not being updated. VDC-112782
SAS export package generation may fail when headers contain ampersands (&). VDC-112986
SAS package generation may fail when the Export Definition references a Reference Object. VDC-113025
SAS package generation may fail unexpectedly. VDC-113312*
The Exports page may take longer than usual to load. VDC-113551
In some cases, the Export > Packages page may display packages from the wrong Study. VDC-113582
In SAS export packages, @HDR fields show a length of 6000 when referenced in a subquery. VDC-114157
When a listing references a View, @HDR columns resulting from that reference show a length of 6000 in SAS exports. VDC-114651
The export audit log may not list some scheduled export jobs. VDC-116782

CDB - Import

Issue Description Issue No.
CDB can now handle Studies with Forms that have more than 30 items. VDC-110617*, VDC-111734, VDC-114329
The Import Audit Log doesn't show audit records for deleted sources. VDC-110900*
Import doesn't fail when a reference_manifest.json file sets the source as "EDC" or "edc". With this release, we introduced a new import error to cover this case, "P-015: Invalid Source Name - EDC is a reserved source name". VDC-110936*
Reference object import fails if the related Form contains only a repeating Item Group. VDC-111355*
Some Studies may have imports get stuck in the In Progress state. VDC-112623
CDB doesn't allow import ZIP files with brackets ("[" or "]"). VDC-112677
Import reprocessing may attempt to use the last successful EDC import package, instead of the most recently imported. VDC-112694
EDC Import may fail unexpectedly without generating an issue log. VDC-113090
Transformation may fail unexpectedly. VDC-113566
When two Workbench Export jobs are initiated simultaneously, the second job will fail. VDC-114155
If a user imports a reference object package with an error, resolves the error, and re-imports, CDB may not apply the package. VDC-115002
When matching on External ID, CDB may create a new Study when importing data into an existing Study. VDC-115050*
CDB may not apply packages imported from CDMS Utilities. VDC-117131
CDB generates an extra audit entry for EDC Import jobs. VDC-95476*

CDB - Listings

Issue Description Issue No.
CSV generation from a listing may fail unexpectedly. VDC-111175
Users receive a CQL syntax error when attempting to generate a SAS or CSV file for a listing with queries on derived values. VDC-111413*
Users may receive a "No Results Found" message on the Studies page. VDC-112187
CDB may show a No Results Found message on the Studies page when there are Studies in the workbench. VDC-112448
Certain listings may not load for data providers. VDC-112586
In some circumstances, a user may log in to Workbench but not be able to see any of their Studies. VDC-116329


Issue Description Issue No.
The synonym list importer doesn't detect spaces and can't differentiate between entries with or without spaces. VDC-104211
Some Impact Report metrics are incorrect when the "Run Coding Upversioning as Bulk Job" feature is enabled. VDC-107127*
Vault doesn't show a spinner when a Code Request that is being coded isn't yet present in the Verbatims table. VDC-107755*
Users encounter an error message when running an Impact Report on certain forms. VDC-110221*
The Autocoding and Suggestions job fails unexpectedly. VDC-113733
In some cases, the Reconstitute Coding Requests job fails with an error. VDC-114445
Users encounter an error message when searching the coder dictionary. The search fails without a release appended to the dictionary detail table name. VDC-114447
Data entered in the "If Item Type Other" field in the Coding Configuration isn't reflected in the API. VDC-115742
In some cases, coding requests aren't autocoded after multiple Synonym List Detail assignments. VDC-116559*

Cross-form Derivations

Issue Description Issue No.
In some cases, derived values aren't cleared when resetting a form that's configured with Progressive Display. VDC-112065
In some cases, cross-form derivations don't populate the correct data in Data Entry on repeating forms. VDC-114516
Users encounter a circular reference error when writing a derived rule. VDC-114993
In some cases, the data that displays in Data Entry for progressive display items that are generated by a cross-form derivations rule isn't correct. VDC-115798

Data Entry

Issue Description Issue No.
Users encounter an error message when entering lab results in Data Entry. VDC-112066
Codelist item values don't automatically populate for linked forms. VDC-114200


Issue Description Issue No.
In some cases, users aren't shown an object deletion warning message after deleting an object and deploying from certain instances. VDC-111072*
In some circumstances, Vault doesn't show the warning when deploying a version that removes a Form from an Event. VDC-111916*
Deleting a PPT environment fails in some cases. VDC-112776
The Vault Comparison job fails with an error. VDC-113178
Users encounter an error message about a duplicate record that exists due to records not updating properly when deploying. VDC-113365
Production deployments fail in some cases. VDC-113628
Copying data in a PPT environment fails. VDC-113673


Issue Description Issue No.
Users receive an error when attempting to save a Transmission Profile in non-development environments. VDC-112457*
Some safety configurations show outdated E2B mappings. VDC-112990
Casebook validation fails with an error when the user deletes objects that are associated with definitions that are safety mapped. VDC-113340*
Validation fails and users encounter errors on the Safety Configuration page. VDC-113747
Safety follow-ups aren't generated for related Adverse Event forms. VDC-113836
The study drug treatment order doesn't match between DEV and non-DEV environments after a safety deployment. VDC-113935*
CDMS doesn't send a follow-up when changes are made to a form. VDC-117230


Issue Description Issue No.
Vault doesn't disable the Edit button in EDC Tools > Safety Configuration when publishing validation is in progress. VDC-107284*


Issue Description Issue No.
The Audit Trail Export By Site, Audit Trail Export by Study, Audit Trail Export by Subject, Code Request Export, Data Export (Legacy), and Data and Definition Export may fail unexpectedly. VDC-110518
The error message for a Retrospective Amendment with destructive changes should include specific relationship information. VDC-111038*
Users with restricted data access that run a Core Listings job including restricted data should encounter an error message if restricted data access is later removed and the job is run again. VDC-111656*
If a user runs a job and includes restricted data, then has their role updated to no longer provide the Restricted Data Access permission, their job outputs from jobs post-change may still contain restricted data. VDC-111663*
The Audit Trail Export by Study job fails in Production. VDC-111678
Some Core Listings columns pull from fields that are blank in Data Model 2.0. VDC-112744*
Log files in Admin > Operations may record errors for successful User Import jobs. VDC-114840
Editing priority Listing jobs adds an expiration date to the first scheduled job. VDC-114968*
When a subject is deleted, Vault should also delete Listing object records associated with that subject. VDC-115157
When a subject is transferred to another site, Listing object records that are associated with that subject should refer to the subject's new site and study country. VDC-115338
In some cases, the Event Progress Listing report shows the same date for the Planned Date, Early Planned Date, and Late Planned Date columns. VDC-116333
The Event Progress Listing job fails with errors. VDC-117134*


Issue Description Issue No.
Users may receive a "Measurement Unit Cannot be Hidden" error when attempting to modify a range's Effective End Date. VDC-111511
The Update Translated Values job fails for Global Labs studies. VDC-113206*
When importing normal ranges, Vault doesn't show an error when a Unit is archived. VDC-114837
Some users encounter an error message when attempting to increase the precision of an In Use analyte in DEV. VDC-115039
In Data Model 1.0, the Item Audit Trail for items in a lab form in Data Entry incorrectly displays item and unit values. VDC-115727*
Form Progress Listings show unexpected differences before and after Labs migration. VDC-116163


Issue Description Issue No.
In some cases, translated labels display in English after exporting. VDC-107870*


Issue Description Issue No.
The "Item Value Before" and "Item Value Now" fields in the Query Detail Listing job show only numeric values before data model migration but both numeric values and units after migraiton. VDC-114878
Some Subject Progress Listing fields show different outputs before and after data model migration. VDC-114879
For some users, the Update Translated Values job reopens out of range queries after labs migration. VDC-120171

Publishing Validation

Issue Description Issue No.
SAF-006 and SAF-007 are now treated as errors instead of warnings during publishing validation. VDC-113255, VDC-113364


Issue Description Issue No.
Query messages should display a query team badge when created by a multi-role user on the same query team. VDC-114144*
When Vault automatically answers a query, the query team is changed to Data Management. VDC-116694


Issue Description Issue No.
The Stratification page doesn't load after a Lab demographics form is added. VDC-106270*

Review Plan Assignment

Issue Description Issue No.
The Review Plan Re-assessment job removes SDV/DMR requirements from all forms. VDC-114503
Vault now prevents concurrent Reorder Assignment jobs. VDC-115820*

Review Plan Editor

Issue Description Issue No.
The View Plan link in Studio's rule editor shows the wrong review plan. VDC-114345*

Role & User Management

Issue Description Issue No.
Some users aren't assigned newly mapped curriculum based on their roles after the 22R3 release. VDC-113257
With this release, Vault disables the Reset Password link for SSO users and doesn't include a username and temporary password in the welcome email for those users. VDC-113831
During user creation, Vault doesn't show a warning when a user enters a user name for a user account that already exists. VDC-113841
Vault no longer allows users to edit their own study access. VDC-114593
Some users experience slowness and delays when changing and saving account details. VDC-115235
Some users encounter errors when attempting to run the User Activity Report from Production. VDC-115591

Rule Editor

Issue Description Issue No.
Users are able to save a rule with "@Form" in the syntax without defining a form. VDC-112815

Rule Execution

Issue Description Issue No.
Users encounter a study rule error message when submitting forms. VDC-112573
Users encounter an error when completing a form associated with a previous event group rule. VDC-112708*
Users encounter an error message in the rule expression for rules that have already been deployed. VDC-113211, VDC-114139
Not all attributes of a rule are copied when copying rules across vaults. VDC-114187
In rare cases, some users may encounter a server error when attempting to edit a casebook that is locked due to a post-save rule that is currently running. VDC-115419

SDS & Annotated PDFs

Issue Description Issue No.
The Origin Name, Origin Type, and Origin Definition Name values are missing in the SDS for items set with progressive display. VDC-115028*
The Name row shouldn't display on the SDS Summary page. VDC-115166*
SDS generation fails with an error for studies with labs. VDC-115263*
Labels in unique CRF PDFs are listed in case-sensitive alphabetical order instead of case-insensitive. VDC-115506


Issue Description Issue No.
Vault produces a server error when saving SDV. VDC-112685


Issue Description Issue No.
Users experience slow performance and data not loading properly in Data Entry. VDC-112546
Signature history doesn't display the proper data for Casebooks Signed when casebooks include restricted forms. VDC-112777

Study Data Extracts

Issue Description Issue No.
Coding fields don't display in the SDE for certain forms. VDC-110689
The SDE length limits may be incorrect for user-created Lab Items that are duplicates of standard Lab Items. VDC-112329*
The SDE fails when a site is missing a Principal Investigator. VDC-112607*
The SDE fails for studies with datetime item definitions but no sites. VDC-112767
SDE jobs fail for some studies. VDC-113632*
Coding column labels are incorrect for some SDE versions. VDC-113749
Vault shouldn't allow users to create a new SDE custom object configuration record using non-custom objects. VDC-116100*

Study Design

Issue Description Issue No.
Users receive a server error when deleting an unscheduled Event from the schedule tree editor. VDC-109837*
Users encounter an error message when navigating through a new study in Studio. VDC-110215*
Updating the data type of an Item Definition should inactivate univariate rules that are no longer applicable. VDC-110274
Users encounter an error message when saving Event Window information in the Study Schedule. Vault doesn't display the error if the Offset Type is set to "None." VDC-112136, VDC-113394
Users shouldn't be able to create duplicate Event Window Definitions. VDC-112252
When copying a study design, Studio may not copy Lab Items that are user-created duplicates of standard Lab Items. VDC-112339*
Users can't add previously deleted events back to the study schedule. VDC-114168

UI & Performance

Issue Description Issue No.
In vaults with many users, System Tools > Users may take longer than usual to load. As part of this fix, Vault will now display all users in the vault instead of filtering users by study. VDC-103945
Users experience slow performance when loading Global Lab forms in Data Entry. VDC-109582*
The Display Type tooltip value in the properties panel in Studio is incorrect for Progressive Display items and item groups. VDC-109810*
The bottom of the E2B grid is cut off when the user is using the Mozilla Firefox® browser. VDC-110280*
Local lab forms take too long to load in Data Entry. VDC-110943
Users experience SDV/DMR import failure when attempting to copy production data to a PPT environment. VDC-111876
Sites are still visible after being deleted in Production. VDC-112138
Ingestion may take longer than expected for some studies. VDC-112534*
The Safety Configuration page in EDC Tools doesn't load after an item definition is deleted. VDC-112630
Users experience slow performance when navigating to the study instance grid in EDC Tools. VDC-112686
Users can't scroll to view all forms in the Common Forms panel in Data Entry. VDC-112814
In some cases, the Deploy Study Design dialogue in EDC Tools takes longer to load due to an extended study definition object deletion check. VDC-112816*
The numbers that display in the "Forms Not SDV" and "Event Dates Not SDV" columns in the Subject Progress Listing don't match the total "Ready for SDV" count in the Review tab UI. VDC-113550
Page numbers don't display correctly when applying a filter in the 22R3 version of Coder. VDC-113554
Users encounter an error message when attempting to save Visit information in the Study Schedule with the "Save" button but data is saved when they cancel the save. VDC-113941
Users are redirected to an error page when clicking the help icon in Data Entry. VDC-114425
Users encounter a server error when attempting to save ConMed forms in Data Entry. VDC-114823
Users encounter an internal exception error message when copying a form to another study. VDC-117200
This release includes minor adjustments to the alignment of elements on the Import > Packages page. VDC-94370*