Fixed Issues in 20R3.5 Release

Release Date: March 5, 2021

This week's release includes fixes for the following issues:

A * next to the issue number denotes an internally found defect filed during the development of Limited Release features.

Audit Trails

Issue Description Issue No.
After upgrading a Study to data model version 2, users receive a server error when attempting to open the Audit Trail of a locked Item. VDC-60745*
The Audit Trail for Integration Task Bindings isn't available. VDC-63729*
The Audit Trail Export output may not include a legal reason for deleted Subjects after the Study is upgraded to data model version 2. VDC-66478*
The Audit Trail doesn't fully capture changes to review plan assignments. VDC-67109*

Casebook Variables

Issue Description Issue No.
Casebook variables show differences in the Difference Report even though no changes have been made. VDC-66061

Casebook Versioning

Issue Description Issue No.
When a retrospective amendment adds Items to a signed Form and sets the Form Status to In Progress, Vault first sets the status to In Progress Post Submit before setting it to In Progress. VDC-57082
In certain cases, retrospective amendments that add a new text-type Item fail unexpectedly. VDC-66195*


Issue Description Issue No.
CQL may return a "The used SELECT statements have a different number of columns" error when the statement uses UNION and the two SELECT statements have different numbers of columns. VDC-57791*
When a statement uses UNION ALL, CQL doesn't return values for @ItemGroup.SeqNbr. VDC-64238
In some cases, if a column uses an expression as the alias, CQL may return the expression as the column name, instead of the alias. VDC-64843, VDC-67659
In some very large Forms, Core Listings may not include all Item Groups. VDC-65460
When a statement has multiple Union sections, at least one Union section retrieves multiple Forms, one of those Forms has a repeating Item Group, and the WHERE clause references an @Form property, CQL may return duplicate data. VDC-66217
CQL may return an error when using UNION ALL and static text (' '). VDC-66301*
In some cases, CQL may not return all resulting data when the statement uses UNION. VDC-66347*
Including @ItemGroup.SeqNbr in a listing with both repeating and non-repeating Item Groups causes non-repeating Item Groups to repeat. VDC-66495
When using UnPivot and aliases, Workbench displays both the original column name and the alias in the result listing. VDC-66867*

CDB - Export

Issue Description Issue No.
After exporting, data values are shown as true/false but the type is set to "TINYINT" on a form where the item type is set to Boolean. VDC-62778
Workbench treats datetimes as strings for SAS format exports. VDC-63653
Users may receive an error when attempting to create a raw-type Export Definition in a Study with multiple Sources. VDC-64823
When an Item's value contains newline characters, Workbench splits the value's lines across columns in the exported SAS file. VDC-64888
With this release, lead data managers may now configure an FTP export destination for scheduled Workbench exports from Tools > EDC Tools > FTPs. VDC-65057*
Workbench doesn't allow users to edit the Title and Short Title of Export Listings when creating a new Export Definition. VDC-65709*
In some studies, Workbench may mark export listings for a raw-type Export Definition as Invalid unnecessarily. VDC-66143*
Workbench doesn't include coded term columns in raw export listings. VDC-67490
Users aren't able to save changes to the properties of an Export Definition when there isn't an FTP export destination configured for the Study. VDC-67836*
Workbench doesn't include coded term columns in raw export listings. VDC-67893

CDB - Import

Issue Description Issue No.
Certain forms don't load properly but no errors are reported. VDC-60613
Import fails when the manifest file uses "generate: true" for event matching. VDC-64886*
When an import package contains a column for @HDR.Event.ChangeReason, and a value is longer than 100 characters, import fails. VDC-65642
When an import package contains a column for @HDR.Event.ChangeReason, and a value is longer than 100 characters, import fails. VDC-65643
Some EDC exports fail due to a duplicate column name on import. VDC-65902
Importing a source where ItemGroup and ItemGroupSequence are both mapped in the manifest file may not import all records from the source. VDC-66280

CDB - Listings

Issue Description Issue No.
Workbench creates Core Listings for Forms that aren't used in the study schedule. VDC-49722

CDB - Queries

Issue Description Issue No.
If a user doesn't have the View Listings permission, but still has querying permissions, Workbench returns an invalid listing error for any query or export listings. VDC-65939*
Users may not be able to create queries after a listing is deleted in the Study. VDC-67383
Users accessing Workbench with a custom Study Role can't view queries in the Cell Details panel, even if they have the required permissions. VDC-67537*


Issue Description Issue No.
Selecting all rows across multiple pages for batch upversioning doesn't actually select all rows. VDC-65956*
Users may receive a server error when attempting to reject a Code Request without entering a Comment. With this release, Vault disables the Reject button until the user enters a Comment. VDC-66079*
The Coding Status filter now includes the Pending Approval and Rejected statuses. VDC-66322*

Data Entry

Issue Description Issue No.
A user may receive a server error when resetting a Form containing only repeating Item Groups and label Items that doesn't have any existing Item Group sequences. VDC-54223*
When using Firefox™, Vault leaves a checkbox Item selected even after a user attempts to clear it when that checkbox Item is the Controlling Item for progressive display. VDC-56327*
Users are able to provoke a hidden query dialog when clicking the action menu of any Item in the Lab panel grid. VDC-60227*
Integration task fails with an exception error after a form is reset. VDC-61857*
Integration task fails with an exception error after a form is linked or unlinked. VDC-61875*
The action ellipsis icon doesn't display when the user hovers over Lab header items in Data Entry. VDC-63079*
If the Reason for Change on a Lab Form is "Other specify," the text doesn't apply correctly when values are changed. VDC-64561*
Clicking the Query row in a Lab Panel should open the Query dialog. VDC-64637*
Users receive a server error when hovering over the information icon next to a Randomized subject. VDC-64866*
Vault doesn't allow a user to complete a Form until lab data in the editable grid is finished autosaving. VDC-66086*
Users can't edit a field that was intentionally left blank. VDC-66202
Vault may hide Items with default data when loading a Form. VDC-66578*

Freezing & Locking

Issue Description Issue No.
Users with the correct permissions can't unfreeze a dynamic, restricted Form that is Marked for Removal. VDC-59038*


Issue Description Issue No.
EDC Tools > Integration Configurations shows Lifecycle and State as field mappings for Procedures. VDC-65888*
Procedure creation fails in CTMS because CDMS treats the Procedure Date as a datetime, while CTMS expects a date. VDC-66545*


Issue Description Issue No.
The EDC Data Export job fails without explanation. VDC-64898
Data and Definition Extracts don't match the entered event dates. VDC-66310
The User Activity Report shows logins for studies before the studies existed. VDC-66813


Issue Description Issue No.
Changing a lab location in Data Entry updates normals for analytes that are marked as Intentionally Left Blank. VDC-64122*
The value for the Clinically Significant field remains the same and some menu items aren't available when the Flag changes from Low to High or from High to Low. VDC-64602*
When the dropdown of a Labs codelist overlaps with a Lab Panel in Studio, users can't select that codelist's menu items. VDC-65178*
The Mass Update - Outdated Normals Report includes Item Groups marked as Intentionally Left Blank. VDC-66454*
The Lab Collection Date Time field changes to the incorrect time after the user enters the correct time. VDC-66852
An Out of Range query doesn't fire when the user enters normal ranges in Data Entry that are out of range. VDC-66888
With this release, Vault no longer includes default Analytes, Units (except Age), or Codelists (except Specimen Types And Testing Methods) automatically in new Studies. VDC-67099*

Library Collections

Issue Description Issue No.
With this release, the Library Report no longer includes system-generated rules. VDC-65959*
Publishing validation causes the Library Report to indicate that a Rule was updated. VDC-66290*
The Library Report only lists the first Codelist Item or Unit Item for a Codelist or Unit. VDC-66480*
Studies with multiple casebook versions can't be seeded into library Collections. VDC-66530*


Issue Description Issue No.
Users receive an error when entering an Event Date in Japanese. VDC-66209*

Protocol Deviations

Issue Description Issue No.
Vault shows the Create Protocol Deviation action even when required Protocol Deviation configuration is incomplete. VDC-65516*
In some cases, the Protocol Deviation dialog may not show the correct field labels and may be missing field values. VDC-65812*, VDC-65813*
If a user attempts to open an item-level Protocol Deviation from Review > Protocol Deviations, Vault shows a blank page instead of the Protocol Deviation. VDC-65816*
Vault doesn't populate the Created By, Last Modified By, or User Modified By columns in the CSV export file. VDC-65817*
Users with the Restricted Data Access permission may receive a server error when attempting to access Review > Protocol Deviations. VDC-65822*
In Review > Protocol Deviations, Vault doesn't show the Restricted indicator on restricted Events, Forms, and Items. VDC-65825*
Users are able to create Protocol Deviations when the Study is locked. VDC-65826*
When a study designer doesn't select a "Link to" value for a Create Protocol Deviation rule, Vault doesn't display the correct validation message. VDC-65835*
If a study designer configures a Create Protocol Deviation rule with a certain Subcategory, and then that Subcategory is deleted, Vault doesn't mark the rule as invalid. VDC-65836*
Users are unable to edit Protocol Deviations while using Firefox™. VDC-65886*, VDC-65901*
When the Date of Deviation is blank, Vault shows the Date Identified as the Date of Deviation in the Protocol Deviations listing page. VDC-65900*
If a user edits a Protocol Deviation to enter a new Date of Deviation, Vault automatically applies the same change to the Date Identified. VDC-65910*
For programmatic Protocol Deviations, Vault doesn't set the Date of Deviation to null when the mapped datetime value is unknown. VDC-66017*
The Create Protocol Deviation dialog doesn't display correctly in Internet Explorer™. VDC-66041*
The New Category, New Subcategory, and New Severity buttons aren't disabled for the CDMS Study Designer Read Only study role. VDC-66838*


Issue Description Issue No.
Randomization fails with error message: "Subject cannot be randomized because there are no available records matching the strata group of the subject." VDC-65922*
Lead Data Managers can view and download Randomization lists through EDC Tools even though they shouldn't have access. VDC-67635

Review Plan Assignment

Issue Description Issue No.
The Multiple Site Selections dialog doesn't display the correct text. VDC-66879*

Review Plan Editor

Issue Description Issue No.
Vault may take a long time to open the Review Plan Editor for larger studies. VDC-40881*

Role & User Management

Issue Description Issue No.
With this release, users can no longer be assigned the CDMS Librarian study role in production environments. VDC-65769*
Vault doesn't disable the Reset Password action in Tools > System Tools > Users when Single Sign-on is enabled for the vault. VDC-65808*
Vault shows deleted environments as available environments for user role assignment. VDC-65861*
The CDMS Librarian study role doesn't have the Library Tab permission. VDC-66129*
Study designers with access to all Studies in a vault may be unable to access study objects. VDC-67772*

Rule Editor

Issue Description Issue No.
When viewing rule bindings for a non-current casebook version, users receive an error if the identified definitions in the rule expression don't exist in the chosen casebook version. VDC-65302*
Vault may not enable the Save button even after a user has updated the rule expression to resolve all errors. VDC-65520*
Users receive an error when attempting to enter a Form Link identifier for a Form Link where the Form links to itself (e.g. linking adverse events to other adverse events). VDC-66207*

Safety Link

Issue Description Issue No.
Editable grid items aren't saved in some situations. VDC-64596*
When the integration task to send the safety case to the safety system fails, and then is able to successfully send, Vault completes the task but without the correct result. VDC-65417*
In certain circumstances, Vault may not send the appropriate email notification when the Safety Message delivery fails. VDC-65622*
If a CDMS Safety Administrator makes changes to the Safety Configuration, their changes aren't saved. If a user with a custom role that grants Manage Safety Configuration permission attempts to make those changes, they receive an insufficient access error. VDC-65859*
Vault doesn't correctly apply the Study filter to the standard Safety Messages report. VDC-65866*
The CDMS Safety Administrator study role doesn't have the Report Dashboards Tab permission. VDC-65867*
Vault may not set the Safety Message status to Failed Delivery when delivery fails. VDC-65977*
In the Edit Connection dialog for an AS2 Gateway connection, Vault doesn't show the Email or URL fields. VDC-65983*

SDS & Annotated PDFs

Issue Description Issue No.
The SDS may not include the Date of Deviation for Create Protocol Deviation rules when the rule action has a fully-qualified identifier for Date of Deviation. VDC-64918*


Issue Description Issue No.
The SDV Re-assignment job fails with an error. VDC-66213


Issue Description Issue No.
In data model version 2 studies, Vault doesn't invalidate all signatures after a study designer modifies the Signature Definition in Studio. VDC-61005*

Study Design

Issue Description Issue No.
Users can still create Lab panels with more than 25 collective analytes after receiving an error message. VDC-65443*
For Studies using V1 of the expression grammar, in the TIme & Events Schedule Editor, the New Rule action opens the V2 Rule Editor. VDC-66167

UI & Performance

Issue Description Issue No.
Adding an Item Group section in Data Entry takes too long to complete. VDC-31826*
Items that are taken out of composites retain the composite label instead of the item label in Studio. VDC-55846
The error log takes much longer to load than it should when importing in Data Workbench. VDC-58354
Using the tab key to navigate to the Add Codelist button when creating a codelist in Studio causes the Edit Codelist dialog box to close. VDC-63014*
The calendar icon doesn't appear as it should in the Lab Collection Date Time field in Data Entry for certain browsers. VDC-63897*
Users receive a server error when entering the single quote symbol ( ' ) in the search box in Studio. VDC-64010*
Users receive a server error when hovering over the Change Reason subscript in a Lab Panel. VDC-64085*
Users are unexpectedly shown a spinner icon when hovering over a query icon in a Lab Panel. VDC-64642*
The search field text in Studio changes when the user copies forms from another study. VDC-64661*
Query Event Date icons in Review Listings in Data Workbench don't refresh when the user refreshes the page. VDC-64792*
Users experience slow performance and multiple crashes while using Vault. VDC-65112
Users receive an error when attempting to load users in utilities. VDC-65427*
Vault may take a long time to load all Rules in the Copy From Study dialog. VDC-65476*
Adding Lab Panels with more than 25 collective analytes in Studio doesn't produce an error message but displays a continuous spinner. VDC-65511*
When dragging Lab Panels with more than 25 collective analytes in design view in Studio, the user has to click the error modal twice to close it. VDC-65513*
Users receive errors when attempting to add users in utilities. VDC-65517
If a rule creates a query when a Form has a new Form Link, and then a user removes the Form Link, Vault doesn't remove the Open Query badge from the Form in the Schedule. VDC-65627*
Users experience errors and job failures when importing in EDC Tools. VDC-65917
Fields in the New Collection dialog are misaligned. VDC-66117*
Users receive an error message when attempting to hide a codelist value in Studio. VDC-66397
Users receive a server error when navigating to Review Plan Assignments in EDC Tools. VDC-66446
Users receive a server error when marking a composite Item as Intentionally Left Blank in Data Entry. VDC-66461
The Select Columns to Display dialog doesn't display correctly for the Lab Locations & Normal Ranges. VDC-66473*
Data extracts may show a time that is different from the user-entered time. VDC-66848
Users are shown a dialog asking to turn on the Repeating Form Expansion feature when Repeating Form Expansion is already configured. VDC-67229*
Users receive a server error when attempting to sort by Translated Label in Tools > System Tools > Change Reasons. VDC-67255*

Views & Data Export

Issue Description Issue No.
Item groups can't be added to views in Studio. VDC-63004*