Fixed Issues in 20R3.4 Release

Release Date: February 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.

Blank & Detail PDFs

Issue Description Issue No.
In Detail PDFs, Vault prepends the Analyte Units for Lab Results with "null". VDC-61199*
If a unit- or number-type Analyte returns only the "< {Normal High Value}" or "{Normal Low Value} <", Vault doesn't include those values in the Detail PDF. VDC-61222*

Casebook Variables

Issue Description Issue No.
The Sex casebook variable should only be available in Studies that are using the Local Labs module. VDC-62099*
Creating a new casebook version and adding new analytes to a Lab Panel changes the order of analytes in that Lab Panel. VDC-62595*

CDB - CQL

Issue Description Issue No.
"@Form.SeqNbr" doesn't work in functions. VDC-58247*
CQL returns an Unknown Column error for any @HDR attributes when a function references both @HDR and @Form attributes. VDC-59993*
CQL doesn't return the value for @Form.CreatedDate when it's used in a subquery. VDC-63788
CQL may return errors that a statement is invalid when the statement uses Union() or UnionAll(). VDC-64665
Null checks don't work as expected when checking an Item within a repeating Item Group across multiple sequences of the Item Group. VDC-64770*
Null checks don't work as expected when checking across Forms. VDC-65013*
In some very large Forms, Core Listings may not include all Item Groups. VDC-65460
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 Forms. VDC-65550*

CDB - Export

Issue Description Issue No.
For raw-type Export Definitions, Workbench doesn't generate a RawDate column for all date columns. VDC-62633*
The raw export manifest file describes boolean-type Items as "TINYINT" type, even when they are labeled as "BOOLEAN" in EDC. VDC-62778
Raw Exports now include Coded Terms. VDC-63304*, VDC-63477*
In some cases, the Sys_ILB system listing may not use the correct values in the Item Name column. VDC-63450*
Data exports with a large amount of items results in an error. VDC-64398*
When the Sys_ILB listing for a raw export is very large, CSV generation may fail with the "Failed to export listing Sys_ILB 10" error. VDC-64469*
When a user attempts to create a raw-type Export Definition in a Study that has a coding-enabled Form, Workbench fails to create the definition with the "Failed cloning existing listings [meddra, medical_history]" error. VDC-64640*
Raw exports may show "1" for @ItemGroup.SeqNbr on all sequences of a repeating Item Group. VDC-64724*
Workbench doesn't correctly label some coding-related columns in the raw export output file. VDC-64737*
Coded terms aren't visible in the MedDRA export CSV. VDC-64741*
Workbench doesn't display the coded terms columns for raw export listings of Adverse Event forms. VDC-64808
Users may receive an error when attempting to create a raw-type Export Definition in a Study with multiple Sources. VDC-64823
If an Item is reused on the same Form, Workbench merges all instances of the Item into a single column in SAS-format raw exports. VDC-64868
EDC workbench exports fail with 10 million items. VDC-65533*

CDB - Import

Issue Description Issue No.
Workbench can't handle EDC packages when the Study in EDC doesn't have any data. VDC-57298*
Users are unable to load studies. VDC-61829*
Imports completed after a query is created clear the query decoration from that cell in the listing until the user clicks the cell or refreshes the page. VDC-63410*
Importing a Study fails when there aren't any Subjects in the Study. VDC-64193
With this release, Workbench now displays Studies in any Status other than Archived. Archived studies are considered inactive, so Workbench doesn't display them in the Study listing. Prior to this release, only the Planning, Execution, Maintenance, and Closeout statuses were handled as active statuses. VDC-65308

CDB - Listings

Issue Description Issue No.
When a boolean-type Item is marked as Intentionally Left Blank, Workbench shows the value "false" for that Item in the listing. VDC-61092*
The EDC link from the query panel doesn't work for users with the standard LDM role. VDC-62249
In review-enabled listings, Workbench treats numeric values as strings instead of integers for sorting. VDC-62594*
Users can't save review-enabled listings privately. VDC-63602*
When a user selects all possible filter options one by one, instead of via Select All, then Workbench doesn't return all possible results for the filter. VDC-63799*
After a user clicks a listing cell to open the Cell Details panel, Workbench doesn't display a visual indicator that the Cell Details panel is loading. VDC-64745*
CQL may return no results when a user filters a review listing with the Not Entered or Overdue data filters. VDC-65633*
Workbench removes the Overdue filter when a user opens the next page of results. VDC-65634*

CDB-CQL

Issue Description Issue No.
CQL returns an error when UNION is used inside of a subquery. VDC-62675

Coder

Issue Description Issue No.
Code Requests created while upversioning is in progress may not have the correct dictionary version. VDC-61324
Users are unable to select a Dictionary Type in the Edit dialog for an Adverse Events form. VDC-61824*
Users are unable to delete study instances with synonym lists. VDC-62389
The Dictionary search doesn't return results for a specific search term. VDC-63295

Coding Configuration

Issue Description Issue No.
Users receive an error when attempting to delete coding configuration in Studio. VDC-63917

Coding Lists

Issue Description Issue No.
After upversioning a Synonym List from Coder Tools > Synonym Lists, Vault creates a duplicate copy of the Synonym List. VDC-61702*
After batch upversioning all Forms for a Synonym List, Vault may briefly display a duplicate Synonym List in Coder Tools > Synonym Lists before deleting the duplicate. VDC-62010*

Compare Versions

Issue Description Issue No.
The DIff Report doesn't dispaly the Subject, Message, or Binding of Send Email rules. VDC-61760*
The Diff Report doesn't include the Controlling Item, Controlling Item Values, and Display Type properties for progressively displayed Items in the Schedule worksheet. VDC-61899*

Data Entry

Issue Description Issue No.
Users are allowed to make changes to a Lab form without providing a Reason for Change under certain circumstances. VDC-60716*
The "Reason for Change" pop-up doesn't display when the user hovers over the indicator. VDC-60770*
Users receive an error message when clicking the action menu icon for Collection Date Time, Lab Location, or Age on a newly created Lab form. VDC-60849*
Users are unable to create new repeating Item Group instances and save data in those new Items when editing a Form after submission. VDC-61754*
Intentionally Left Blank actions are not available for Site users until a form is completed and edited. VDC-62628
When editing a controlling Item in such a way that a frozen Item would be removed, Vault shows the Reset Entered Values dialog instead of the Error for a frozen Item. VDC-62727*
Users receive a server error when editing a form. VDC-63219
Events that are marked for removal due to a rule evaluation remain marked for removal when the marked for removal field should be set to "false." VDC-64439*

Deployment (Study Level)

Issue Description Issue No.
A deployment may fail when the changes include the removal of a coding-enabled Form from the schedule. VDC-63705
Vault doesn't return a readable error when a Send Email rule doesn't have an email template configured. VDC-64027
Vault attempts to deploy the Locked status of the study. VDC-65471*

Deployment (Vault Level)

Issue Description Issue No.
Some users experience deployment failure deploying from DEV to UAT. VDC-63160
Deployment fails in certain vaults likely because of coding configuration. VDC-65390

Developer Features

Issue Description Issue No.
The Retrieve Events API doesn't return Events in the Planned status. VDC-52613*
For boolean-type Items, Vault doesn't return an error when the Set Item Value request doesn't include the value. VDC-56775*
Users with permission to close queries via the API are able to close queries created by users on other teams. VDC-61985*
The Retrieve Events API doesn't return SDV Mode as a picklist. VDC-62283*

Freezing & Locking

Issue Description Issue No.
If a user freezes a single Item from a composite Item row, Vault freezes both Items and doesn't allow the user to unfreeze the second Item. VDC-53910*

Integrations

Issue Description Issue No.
The Scheduler Export job runs immediately when the first send isn't scheduled as "Immediate." VDC-61205*
Users receive a server error when attempting a safety import of a JSON file. VDC-61641*
Some users receive a server error when using a CDMS spark job. VDC-62794

Jobs

Issue Description Issue No.
Vault may not show the correct status or the links to download the job files for the Workbench Export job. VDC-57907*
Audit trail exports show "null" as the Lab Result value for unit-type Analytes. VDC-61277*
In certain circumstances, users may receive a server error when opening EDC Tools > Jobs. VDC-61677
The user receives a "File not found" error when downloading Audit Trail export files. VDC-61999
Users receive an error when running a Retrospective Amendment. VDC-63707
Users are unable to execute a Rule job due to a rule execution in progress. VDC-63827
The Migration job for Reviews migrating from v1 to v2 fails with errors. VDC-65107*

Labs

Issue Description Issue No.
Vault displays the incorrect unit value and unit measurement for the Age field when a unit can't be found. VDC-60157*
Text-type Analytes shouldn't be case-sensitive in the Lab panel. VDC-60411*
The Clinical Significance field isn't updated after override values are entered. VDC-60598*
Clicking the actions menu in the Lab result field of a Lab panel doesn't show available menu items. VDC-60822*
Cells shift in Data Entry in the Lab units field when selected. VDC-60851*
Vault incorrectly displays Normal results that are only configured with one value. VDC-60975*
The Age item value isn't displayed when viewing a query. VDC-60976*
For unit- and number-type Analytes, if only the "< {Normal High Value}" or "> {Normal Low Value}" is returned after a user clicks Refresh Lab Normals, Vault doesn't update the Normal cell. VDC-61225*
Users receive a server error when clearing the value ferom the Clinically Significant column of the lab panel. VDC-61329*
Vault doesn't update the Normal Results on the labs Form after a user edits an Item to change the subject's sex from Male to Female. VDC-61331*
Vault applies changes any changes to the Normal Range of an analyte even when that analyte's Item in the lab panel was marked as intentionally left blank. VDC-61489*
If a Form was frozen while the chosen Lab Location was still pending, and a labs data manager later approves the location and adds normal ranges, Vault updates the frozen form with the updated normal range. VDC-61490*
After a Study has a new casebook version, users receive a server error when attempting to save a Lab Header Item in a new Casebook. VDC-61494*
After creating a new version of a Study, Vault lists both versions of the same Lab Panel in Studio > Lab Panels, instead of only the current version. VDC-61495*
If a user edits a previously submitted lab form, and changes the Lab Location to a location that doesn't have a configured normal range for one of the form's analytes, Vault doesn't clear the normal results cell. VDC-61498*
Data entry users aren't required to provide an Override Reason when overriding a normal range. VDC-61716*
Users receive a server error when configuring Labs on a pre-release vault. VDC-61903
Instead of showing the appropriate error message when a study designer attempts to add more than 25 Analytes to a single Form, Vault shows an endless loading spinner. VDC-61970*
Vault assigns new normal ranges an "Active" status instead of "Pending Approval" in Labs configured to enable approvals for normals. VDC-62155*
Labels are missing for Age "lab_unit_item_def__v" records. VDC-62176*
The Lab Results table fields don't show dropdown menus. VDC-62198*
Users are unable to save a new codelist in Labs. VDC-62246*
The Lab Result unit picker icon closes the field's editable state instead of triggering a dropdown menu. VDC-62322*
Vault only counts Analytes towards the study's limit when the analyte's Lab Panel is used in a Form. VDC-62423*
Some Mass Updates jobs don't process forms unless all updates can be made. VDC-62463*
When the user attempts to edit an existing codelist, the save button does not become enabled unless they make changes to the Codelist Values section. VDC-62541*
Sex codelist Item defs in Studio aren't being populated from the label field in the Labs tab. VDC-63009*
Newly-imported normal ranges are marked as "Pending Approval" when the approval setting is set to "No." VDC-63296*
Users can't use the same Name and Label for Lab Units. VDC-63324*
Units that are configured to be hidden in Studio are visible on Lab Forms. VDC-63411*
In Data Entry, a subject's Age field is populated with units that should be hidden. VDC-63442*, VDC-63443*, VDC-63444*
The Normal Range unit displays on the wrong row when the user adds a new Normal Range. VDC-63519
Users receive an error when attempting to save a lab panel in Studio. VDC-63529
Lab Normal export files are missing the Status column. VDC-63571*
Lab unit labels aren't deployed by Vault Deployment. VDC-63588
Lab location and normal range imports aren't available in non-control center vaults. VDC-63589
Normal values are cleared instead of updated when the user clicks "Refresh Lab Normals." VDC-64499*
In Data Entry, the Normal Override column is visible even when "Allow Site Override" is set to "No." The Clinical Significance column is displayed as an empty column when "Allow Clinical Significance" is set to "No." VDC-64651*
After a user copies Lab Normals, and approval is enabled, Vault moves the Lab Normals into the Active status, instead of Pending Approval. VDC-65267*
When users attempt to deploy Vault-level Labs settings from the DEV to the UAT vault, the deployment fails without explanation. VDC-65386

Localization

Issue Description Issue No.
Studies with Labs enabled are missing translations in Studio. VDC-59864*

Queries

Issue Description Issue No.
Vault doesn't allow users to reset or delete Events with open, manual queries. VDC-62655*

Randomization

Issue Description Issue No.
The Randomize Subject dialog should appear after a form is submitted that causes a form to be ready for randomization. VDC-57834*
When a Study doesn't allow unbalanced randomization, Vault doesn't detect unequal numbers of tratment records during the import of a Randomization List. VDC-61767*
Vault doesn't recognize duplicate Kit or Device IDs during the import of a randomization list. VDC-61941*
Data enty users may receive a server error when editing the Kit or Device for a subject using the Kit or Device ID manually added on another subject. VDC-62019*
If a user copies a study design of a randomzation-enabled study into a Study where randomization is not enabled, and then enables randomization in the target study, Vault creates duplicate records for randomization configuration. VDC-62805*
Randomization masks data when masking is no longer configured. VDC-64912*

Review Plan Assignment

Issue Description Issue No.
The SDV/DMR columns are missing in the subject review grid for subjects configured with Manual Review Plan Assignment. VDC-53294*
Vault doesn't disable the Edit Site Templates button for users who don't have All Sites access. VDC-61740*
In certain circumstances, the SDV Re-assignment job may fail unexpectedly after an amendment. VDC-61810*
The Reorder Assignment job doesn't reorder existing casebooks. VDC-63775

Role & User Management

Issue Description Issue No.
When Study Access is set to Disabled, a user can still view that Study in CDB. VDC-53282*
Users without the "Create Event" permission are able to create events. VDC-54655*
LDM aren't given the permission to Close All Queries. VDC-63412*

Rule Editor

Issue Description Issue No.
The Form field isn't required when creating a new Add Event Group rule but the field becomes required when the user tries to save. VDC-61445*
Users receive an error when searching Rule Definitions in Studio VDC-62390*
Vault doesn't support the "did_not_occur_v" and "change_reason_v" tokens for Send Email rules. VDC-62588
Vault throws an error on identifiers that include a sequence number ([#]). VDC-65459*

Rule Execution

Issue Description Issue No.
Queries using the date comparator feature show the Item label text instead of the display override text. VDC-61516
In some cases, repeating Event Groups are removed if they invalidate a rule and are unable to be added back. VDC-64453

Rules Execution

Issue Description Issue No.
The rule execution job fails when a Rule Definition doesn't have a value in the Reciprocal field. VDC-61902*

SDS & Annotated PDFs

Issue Description Issue No.
The SDS shows "null" instead of actual values for Subject and Message for Send Email rules. VDC-61778*
Annotated PDFs and SDS are missing several forms. VDC-63830

SDV & DMR

Issue Description Issue No.
In some cases, the SDV job fails. The user also has trouble assigning SDV to some sites. VDC-63835

Signatures

Issue Description Issue No.
Vault should use the most recent signature meaning so that signatures can be added or updated in live studies. VDC-65506
Signature bindings fail due to the V1 to V2 migration. VDC-65652*

Study Administration

Issue Description Issue No.
Study deletion jobs fail in certain instances. VDC-62689*
The scheduled Data and Definition job fails for all studies. VDC-63747*
Difference reports incorrectly report vault identifiers for short labels. VDC-64031

Study Design

Issue Description Issue No.
When copying from study, Vault may create duplicates of system-generated Rules. VDC-55445
When copying a study, Vault doesn't remove the Lab Codelist Link from the Sex or Female Cycle codelists. VDC-58089*
Users have to double-click the "Save" button to save a new Item that's been created in Studio. VDC-62943*
Users receive a server error when creating a new Object in Studio. VDC-63294*
Users are unable to copy certain forms from various studies. VDC-63462
Users receive an error message that reads "Cannot read property 'id' of undefined" when creating a new Item. VDC-63882*
Creating a study by copying a study design from another study fails but is shown as successful in the log. VDC-64126

UI & Performance

Issue Description Issue No.
Progressive display doesn't work as it should. VDC-60039
Users receive a network error when attempting to view the Change Reason for an Item on a Lab Form using the View as Site option in the Review tab. VDC-61202*
Several controls in Lab Panels don't display correctly in Internet Explorer™, Microsoft Edge™, or Google Chrome™ on Windows™. VDC-61504*
The "Sponsor" field in the Verbatim Listings page header in Coder is blank. VDC-61637*
On the Code Request Listing, selecting the Edit Columns action for the first time results in a blank page. VDC-61759*
The search results in the Items tab in Studio resets after returning results. VDC-61958*
Users receive a server error when navigating to a Study in the breadcrumb menu in the Review tab. VDC-61996, VDC-64666
Migrating items from Data Model 1.0 to 2.0 takes much longer than it should. VDC-63006*
Consistency Checker fails to run due to an error. VDC-63018
Coder tools navigation tabs are misplaced. VDC-63104*
Repeating forms don't show the correct SDV/DMR status in the events panel in the Review tab. VDC-63203
Users receive a server error when clicking on the Amendment History page in EDC Tools. VDC-63360
The SDV column doesn't appear in the Events view for some subjects. VDC-63746
Some items are missing when the user uses the "View as Site" option in the Review tab. VDC-63885
Users receive a server error when trying to complete a Subject Visit. VDC-64435
Users receive a server error when completing a common form in a specific study in Data Entry. VDC-64614
When a user clicks + New Connection, Vault doesn't open the New Connection dialog. VDC-64646*
Progressive display fields don't open correctly when the user edits a form that has previously been edited. VDC-64663
Users are unable to select "Other Specify" to specify another reason for Reason for Change and Intentionally Left Blank fields. VDC-64736
A pop-up about expanding log forms should appear in the Review tab when configured. VDC-64829*
The Casebook Schedule may not have the correct sort order after a retrospective amendment. VDC-65039
Users receive a server error when navigating to certain study Sites. VDC-65079
The second instance of a repeating event group is added twice due to a rule but doesn't change when the rule is invalidated. VDC-65095*

Vault Administration

Issue Description Issue No.
Users are unable to delete casebooks in Data Entry and EDC Tools in Data Model 2.0. VDC-65083