Fixed Issues in 20R3.5 Release
Release Date: March 5, 2021This 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* |
CDB - CQL
| 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* |
Coder
| 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* |
Integrations
| 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* |
Jobs
| 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 |
Labs
| 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* |
Localization
| 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* |
Randomization
| 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* |
SDV & DMR
| Issue Description | Issue No. |
|---|---|
| The SDV Re-assignment job fails with an error. | VDC-66213 |
Signatures
| 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* |