Known Issues in 20R3 Pre-Release

Pre-Release Date: November 16, 2020 | Release Date: November 20, December 4 & December 18 (CDB), 2020

The issues listed below may impact Vault functionality for some users. We are actively investigating all known issues and will be providing fixes and updated information in future releases.

An asterisk (*) next to the issue number denotes an internally found defect filed during the development of Limited Release features.

Audit Trails

Issue Description Issue No.
If a user signs an Event, and then the sponsor updates the Signature Definition, once the user edits and then re-signs the Event, Vault updates the audit trail to reference the new signature meaning on all entries, instead of only the entries after the Signature Definition was updated. VDC-57847*

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.
Vault allows users to change the Names of Casebook Variables. VDC-60728*

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*

CDB - CQL

Issue Description Issue No.
CQL returns an error when the statement uses UnPivot on multiple Forms within a subquery. VDC-56356*
Using UnPivot removes cell-level decorations in the listing. VDC-56501*
CQL returns "1" and "0" instead of "true" and "false" for boolean-type Items that are unpivoted. VDC-56502*
When using "Like" on a date-type Item in a WHERE clause, CQL returns a "Column in where clause is ambiguous" error. VDC-57246*
CQL returns an Unknown Column error when a function reference @Form.SeqNbr. VDC-58247*
CQL doesn't return the Label of an Item when that Item is used more than once on the same Form. VDC-58792*
CQL returns an Unknown Column error for any @HDR attributes when a function references both @HDR and @Form attributes. VDC-59993*
CQL fails to return results when using COMPACT on multiple Items with the same alias. VDC-60398*

CDB - Export

Issue Description Issue No.
Workbench doesn't automatically set the Domain column with the listing's Short Title in the exported CSV. VDC-56974*
In manifest.json, Vault adds "`\n`" to "where" in the CQL statement. VDC-57649*
For Export Listings in Raw-type Export Definitions, Workbench displays missing data as data holes. VDC-60790*
Export package generation fails on Raw-type definitions where all Form Names are lowercase. VDC-60791*
Users receive a "Failed cloning existing listings" error when attempting to create a raw Export Definition in a Study that contains non-EDC data. VDC-61126*
After editing an Export Definition that previously failed to generate a package, Workbench doesn't allow the user to save changes correcting issues with the "Export definition already exists" error. VDC-61129*
Workbench doesn't show the correct counts for each export definition Status. VDC-62358*

CDB - Import

Issue Description Issue No.
When a third party import package references the wrong Subject Name, Workbench logs an error against the Event Name for that row instead of the Subject. VDC-55871*
Workbench may not match a third party Event to an EDC Event when the event's Name includes a whitespace character. VDC-56544*
Workbench can't handle EDC packages when the Study in EDC doesn't have any data. VDC-57298*
Users can't download the import package when the package's filename contains whitespace characters. VDC-57393*

CDB - Listings

Issue Description Issue No.
When a user sorts or filters a listing using either the Sort & Filter menu or the CQL Editor, Workbench doesn't display the Sort & Filter icon in the column header. VDC-55514*
For Event Dates, the Cell Details panel doesn't display the correct status for SDV, DMR, Frozen, or Locked. VDC-61057*
When a boolean-type Item is marked as Intentionally Left Blank, Workbench shows the value "false" for that Item in the listing. VDC-61092*
In some circumstances, Workbench may show a value for an Item that was marked as Intentionally Left Blank. VDC-61741*

CDB - Queries

Issue Description Issue No.
Users may receive a duplicate item error when creating a query on a third party data item. VDC-56677*
Users may receive an "Event not found" error when creating a query on a third party data item. VDC-56726*
Users receive an error when creating a query on an Event Date. VDC-57218*
Vault Owners are unable to create queries on Event Dates for third party events. VDC-57790*

Coder

Issue Description Issue No.
The WHODrug synonym list fails upversion attempts. VDC-62110

Coding Configuration

Issue Description Issue No.
Vault doesn't log the "One or more Forms does not have an assigned Dictionary" error in the Autocoding and Suggestions job log file. VDC-56779*
Vault may not display all possible Synonym Lists for selection in Coder Tools > Upversioning. VDC-59360*, VDC-60064*
Vault disables the Enable SAE Prioritization checkbox for all Adverse Event or Medical History forms. VDC-60848*

Data Entry

Issue Description Issue No.
Users receive a "Failed to save the date" error when entering the Date for an Event. VDC-56965*
Users receive an error message when clicking the ellipsis icon of the Missing Result item. VDC-58303*
The Age field is displayed incorrectly on Lab forms. VDC-58953*
A merged Lab location shows the incorrect value in the Lab location field of a Lab form in Data Entry. VDC-59504*
Users are able to provoke a hidden query dialog when clicking the action menu of any Item in the Lab panel grid. VDC-60227*
The query dialog doesn't open when the user clicks on the query row in the Lab panel grid. VDC-60240*
Cells in the Lab panel grid remain in edit mode even after the user moves to the next row of cells. VDC-60248*
Users receive a server error when attempting to complete a Lab form that contains a number of analytes that is much less than the maximum records allowed. VDC-60256*
The browser becomes unresponsive when navigating to a Lab form with a Lab panel containing a large amount of Analytes. VDC-60257*
Text-type Analytes shouldn't be case-sensitive in the Lab panel. VDC-60411*
Users receive an error message when hovering over the Change Reason indicator on a Lab form. VDC-60479*
Users receive a server error when marking an Analyte row as a Missing Result and intentionally left blank if navigating using the form crumb. VDC-60560*
The "Reason for Missing Result" is not specified for number, text, and codelist Analyte types. VDC-60569*
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*

Deployment (Study Level)

Issue Description Issue No.
Vault doesn't set the status of the Casebook Definition correctly when a deployment is in the Completed with Documentation Errors status. VDC-58702*
Vault doesn't allow the deletion of an environment if the study contains Randomization Strata Groups. VDC-59271*

Developer Features

Issue Description Issue No.
When a user doesn't have access to the Site, Vault returns the error message as if the user did not have access to the entire Study. VDC-59176*

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*

Jobs

Issue Description Issue No.
Vault doesn't show a link to download the job files from Admin > Operations for the CLINICAL_CODING_DICTIONARY_UPVERSION_IMPACT job. VDC-57830*
Vault may not show the correct status or the links to download the job files for the Workbench Export job. VDC-57907*
When exporting Users to CSV, Vault doesn't show the download link in the Available Files section of Admin > Operations > Job Status. VDC-58651*
When initiating an Audit Trail Export by Subject job, Vault enables the Run Now button even when the user hasn't selected any Subjects. VDC-59249*
Audit trail exports shows "null" as the Lab Result value for any unit-type Analytes. VDC-61277*
In certain circumstances, users may receive a server error when opening EDC Tools > Jobs. VDC-61677

Labs

Issue Description Issue No.
Users can't add a Lab location to a Site in the Site Lab Assignment subtab. VDC-58216*
The New Lab Locations report should be labelled as the Preview New Lab Locations Update job. VDC-59366*
Users may receive an error when copying Lab Locations. VDC-59466*
Users can save Normals without measurement units. VDC-59478*
Users receive an error when attempting to retrieve a lab result for a subject whose sex information isn't provided but the casebook variable is configured. VDC-59491*
Vault doesn't disable the Done button when autosaving isn't finished. VDC-59630*
When editing in Lab Tools, Vault checks for errors when autosaving, instead of when the user clicks Done. VDC-59632*
When editing in Lab Tools, users must click on a cell to view any errors associated with it. VDC-59633*
In Lab Tools, Vault doesn't show a blank value row in the codelist dropdown to allow users to clear their selection. VDC-59634*
Clicking on the Specimen Type or Testing Method in the Lab General Settings codelist causes the page to freeze. VDC-59651*
Normal Ranges columns are ordered incorrectly. VDC-60024*
Users are unable to delete effective end dates for normal ranges. VDC-60095*
Vault displays the incorrect unit value and unit measurement for the Age field when a unit can't be found. VDC-60157*
Exporting Normal Ranges exports all analytes found in all Lab locations instead of only the ranges related to that particular Lab location. VDC-60366*
Clinical Significance doesn't update after override values are entered. VDC-60598*
The action menu in some Lab panels displays an incorrect menu action item. VDC-60817*
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 includes all records in the Outdated Normals Report, instead of only the records where the Site Lab Form Normals are different from the Lab Location Normals. VDC-60917*
Vault doesn't display a callout showing the Reason for Override in the Normal Override column. VDC-60965*
Normal ranges that are imported into an approved Lab location are given a "Pending Approval" status instead of "Active." VDC-60968*
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*
The Lab location isn't shown in the Lab form header after its status has changed from "pending" to "approved." VDC-61018*
Labs queries don't close automatically after the user addresses the issue that produced the query. VDC-61024*
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 from 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*
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*
CDMS Lab Data Managers are unable to view or edit System General Settings. VDC-61632*
Data entry users aren't required to provide an Override Reason when overriding a normal range. VDC-61716*

Localization

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

Queries

Issue Description Issue No.
Vault doesn't display the Team badge on queries created via the API by a Lead Data Manager. VDC-58871*

Randomization

Issue Description Issue No.
In Randomization > Stratification, Vault doesn't display the available Strata Variables in the order they occur in the study schedule. VDC-56051*
The Randomize Subject dialog box doesn't show configured stratas. VDC-57444*
The Randomize Subject dialog should appear after a form is submitted that causes the subject to be ready for randomization. VDC-57834*
Users receive an error message when adding a kit/device to a subject that has the same ID value as the kit/device in another subject. VDC-59247*
While Vault is auto-saving changes to Randomization Settings, Vault shows validation messages for each field when the entered values don't trigger validation. VDC-59299*
The Kit/Device Audit Trail event descriptions are incorrect. VDC-59301*
Vault doesn't disable the Generate Strata Groups button when there are no changes that would require generation. VDC-59450*
In Randomization > Randomization Lists > Uploaded Randomization List, the Actions menu includes the CSV action for export, which is unavailable in this release. VDC-60412*
Vault doesn't display Randomization Criteria Met information as expected in the Data Entry tab. VDC-60548*
When Enable Kit/Device List is set to No for the study, Vault doesn't hide the Kit or Device tabs. VDC-60720*
Vault doesn't show records where Restricted for Randomization is set to Yes in the lists of uploaded kits or devices. VDC-60980*

Review Plan Editor

Issue Description Issue No.
When a user marks all Forms as No Review, Vault doesn't save their changes to the Review Plan. VDC-59215*

Rule Editor

Issue Description Issue No.
After copying a study without selecting the Import Randomization Configuration checkbox, users can't open Ready to Randomize rules. VDC-59013*

Rule Execution

Issue Description Issue No.
Vault doesn't populate the Subject or Event Group columns for an Add Schedule or Add Event rule that removes the Event Group or Event. VDC-56691*
Vault doesn't add log content to the "create_delete_dynamics_details.csv" and "dynamics_summary.csv" log files when a Form or Event is added or deleted via a dynamic rule. VDC-56693*
Vault doesn't record the Action correctly in the rule execution job log for Override Review Plan rules when the criteria isn't met. VDC-56719*
Vault doesn't record the correct value in the Forms column of "rule_details.csv" for the execution of Add Assessment rules. VDC-57776*
When a rule expression references the Event Group Sequence, Vault creates a dynamic event when the rule evaluates to false. VDC-60419*

Study Design

Issue Description Issue No.
SDS generation fails when a study's Twelve Hour Time setting is "null" instead of Yes (true) or No (false). VDC-57164*
Vault doesn't display the correct Repeat Maximum value for repeating Event Groups in the Properties Panel in Studio > Schedule. VDC-57428*
When copying a study, Vault doesn't remove the Lab Codelist Link from the Sex or Female Cycle codelists. VDC-58089*

Study Import & Export

Issue Description Issue No.
The ODM XML file includes Ready to Randomize and Date Comparison rules. VDC-57469*
Users may receive a server error when attempting to import a study. VDC-58664*

UI & Performance

Issue Description Issue No.
Workbench may take longer than expected to load the Listing Details panel on the very first load. VDC-55184*
The Properties Panel in Studio > Schedule has two scroll bars. VDC-56026*
Users are unable to change the "Enable Local Labs" study setting back to "No" in the Studio tab. VDC-56860*
The Schedule Editor doesn't immediately show the new form order after a user saves the new form order. VDC-56872*
In the Schedule Editor, Vault doesn't display the green line when reordering schedule components. VDC-56873*
The contents of a recently closed Lab form are not automatically hidden after the last Query/Review task is closed. VDC-57934*
CRA users aren't shown the selected Lab Location the View as Site. VDC-59648*
Users receive an error when clicking the action menu items for Lab forms in View as Site. VDC-59649*
The help icon for Studio Lab panels doesn't direct to a help page. VDC-59862*
In the Review tab, the panel for a repeating Form overlaps with the panel for the repeating Form above it. VDC-59911*
Users may receive a server error when navigating between Sites and Subjects from the Review tab's breadcrumb menu. VDC-60201*
The Dynamic Rule link for Event Groups doesn't open the Rule Editor. VDC-60921*
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*
For Lab Results cells on text and codelist items, clicking the Query row opens the Query dialog, but then Vault immediately closes the query. VDC-61215*
Several controls in Lab Panels don't display correctly in Internet Explorer™, Microsoft Edge™, or Google Chrome™ on Windows™. VDC-61504*
When a user deletes a Form in Studio, Vault doesn't display the related objects when the user clicks See Related Objects. VDC-61666*