Fixed Issues in 21R1.4 Release
Release Date: June 25, 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.
Assessments
| Issue Description | Issue No. |
|---|---|
| The header of the Assessment Questionnaire page doesn't show the Event Date. | VDC-74629* |
Casebook Variables
| Issue Description | Issue No. |
|---|---|
| Vault doesn't wrap error message text in the Study Reference column. | VDC-74464* |
Casebook Versioning
| Issue Description | Issue No. |
|---|---|
| Retrospective amendments that add a Form to a frozen Event unfreeze all Forms within the Event. | VDC-59311* |
| If a retrospecitve amendment changes a Codelist Item Definition, the Item for the Codelist Item includes an unnecessary audit trail entry for Change Reason Update to "Amendment update". | VDC-74989 |
CDB - CQL
| Issue Description | Issue No. |
|---|---|
| CQL now supports the use of ON SUBJECT within a subquery. | VDC-67512* |
| CQL may return an "Operand should contain 1 column" error when the statement uses IN or NOT IN on a subquery that selects from more than one Form. | VDC-72319 |
| In Sys_Forms, CQL doesn't return the @Form.DMRDate for all rows. | VDC-73400* |
| CQL returns an error when ON SUBJECT is used inside of a subquery. | VDC-74213 |
| CALL Sys_Links returns no results when a Study contains third party data. | VDC-74280* |
| CQL may return no results for Sys_Forms, even when the Study has Forms. | VDC-74585* |
| CQL doesn't indicate an error in the Workbench UI for invalid CQL (using COMPACT and Union() together). | VDC-74753* |
| The Upper() and Lower() functions return alphanumeric coded values instead of the expected uppercase or lowercase strings. | VDC-75034 |
CDB - Export
| Issue Description | Issue No. |
|---|---|
| The Sys_Forms listing may contain duplicate rows for Forms with repeating Item Groups. | VDC-63468* |
| Users with the Restricted Data Access permission can't see restricted data from third party sources in raw exports. | VDC-64388* |
| Restricted data is included in export packages that are visible on the FTP server. | VDC-68557 |
| Users with the Restricted Data Access permission can't see restricted data from third party sources in raw exports. | VDC-69196* |
| CDB excludes columns with duplicate names from SAS export files if a unique name can't be generated by adding the name of the Item Group to the column name. With this release, CDB can handle duplicate column names when there is no Item Group name to add. | VDC-74135 |
| Studies remain in Pending status after the EDC export package fails. | VDC-74602 |
| If an Export Definition contains blinded data, and a user without the Restricted Data Access permission generates a package, the filename is prefixed with "WBBlinded". With this release, Workbench appends "Unblinded" to the filename for users that have the Restricted Data Access permission and does not modify filename for users without that permission. | VDC-74612 |
| For scheduled exports, Workbench generates two packages and does not deliver either package to the specified FTP destination. | VDC-74702 |
CDB - Import
| Issue Description | Issue No. |
|---|---|
| Workbench doesn't generate the appropriate warning when a third party import package contains data for a subject that doesn't yet exist in EDC. | VDC-73500* |
| After a user clicks Download for the Issue Log, the download may not start. | VDC-73825* |
| During import, preparation for loading may take longer than expected and time out, causing the import to fail. | VDC-74340 |
| Import may not fully remove artifacts from earlier versions which can result in import failures. | VDC-75774 |
CDB - Listings
| Issue Description | Issue No. |
|---|---|
| The tooltip for Form pills shows the Last Processed Date instead of the Last Uploaded Date. | VDC-64615* |
| The Public Listings page may not display Form pills for all listings after data is imported that is referenced in a listing. | VDC-72052 |
| Workbench doesn't display query decorations on Event Dates. | VDC-74913* |
| With this release, tooltips for Form pills show the max date for Last Uploaded Date. | VDC-75105 |
| If two Studies have Forms with matching CDM Keys, Workbench may create invalid Core Listings. | VDC-75350* |
CDB - Queries
| Issue Description | Issue No. |
|---|---|
| The Queries page doesn't list Query Listings in the correct order. | VDC-66356* |
| Users receive an error when attempting to open a new item-level Query from a listing where the CQL uses Union across Forms with different sources. | VDC-72302* |
| Importing a new third party package into an existing third party source may remove queries. | VDC-72405* |
Coder
| Issue Description | Issue No. |
|---|---|
| In Japanese dictionaries, half-width and full-width English language search terms return different results. | VDC-72992* |
| The Coding panel for MedDRAJ displays codes as ATC instead of LLT, etc. | VDC-74670* |
Compare Versions
| Issue Description | Issue No. |
|---|---|
| Vault no longer tracks differences for the Name of Codelist Item Definitions. | VDC-73480* |
| The Compare dialog shows Studies where there isn't a Casebook Definition. | VDC-73619* |
| Vault doesn't list data types correctly in the diff report for Analytes. | VDC-74633* |
| Vault includes Lab Modifier in the diff report. This feature was postponed to a later release, so we removed this from the diff report. | VDC-74635* |
| With this release, we no longer include Clinical Insignificance in the diff report. | VDC-74680 |
Data Entry
| Issue Description | Issue No. |
|---|---|
| In an editable grid, Vault doesn't display invalid data error messages correctly on number fields. | VDC-72773* |
| When answering a query in an editable grid, a user can submit their comment multiple times on the same query until the page is refreshed. | VDC-72780* |
| In an editable grid, if a user tabs away from a unit Item after selecting the blank value in the unit drop-down, then returns to the item and selects a valid unit, Vault continues to display the error message. | VDC-73236* |
| Vault displays inactive Study Instances to site users. When a user attempts to create a Casebook in that inactive instance, they receive a server error. | VDC-73399* |
| In an editable grid, if a user enters a value for an Analyte and leaves the field, Vault autosaves but doesn't display the entered value when returning to Edit mode on that Analyte. | VDC-73530* |
| In an editable grid, Vault doesn't show the Required indicator on required Items that a user leaves before entering a value. | VDC-73892* |
| Values that have been flagged in lab panels don't update when the user clicks "Refresh Lab Normals," even though the values have been updated in the Labs module. | VDC-74017* |
| Vault incorrectly calculates subjects' age in lab forms. | VDC-74132 |
| For Lab Panels, when a user enters invalid data, Vault doesn't show the entered value alongside the error message. | VDC-74167* |
| Editable grids now support using the Backspace key to clear values from codelist items. | VDC-74260* |
| After a study is upgraded from data model version 1 to 2, users may receive a server error after attempting to mark an Item as intentionally left blank that existed before the migration occurred. | VDC-74318* |
| In editable grids, when a user clicks Edit Value in a query, Vault doesn't open the Form in Edit mode with that Item selected. | VDC-74347* |
| Users may receive a server error when tabbing through a Lab Form to enter data without entering data for the header Items first. | VDC-74451* |
| In editable grids, Vault doesn't enforce the 255 character limit for entered ILB reasons, which causes a server error at save. | VDC-74591* |
| If a user clears the selected Unit on an Analyte, Vault doesn't autosave the change and doesn't show the "Not all changes were saved" warning. | VDC-74595* |
| When editing a submittted Form, users aren't able to provide results for a blank Analyte. | VDC-74601* |
| If an Item is progressively enabled inside of an editable grid, Vault may not allow the user to enter data into that Item regardless of the controlling item's value. | VDC-74865* |
| In an editable grid, if a user enters an invalid date using the keyboard and uses the Tab key to leave the field, Vault has a server error. | VDC-74957* |
| When the controlling Item for progressive display is in an editable grid, Vault may not enable the dependent Item until the user refreshes the page. | VDC-75464* |
| In an editable grid, if a user edits an Item and selects the Null codelist value, Vault populates the Item with the previously selected value. | VDC-75465* |
Developer Features
| Issue Description | Issue No. |
|---|---|
| For the Open Query API, the response doesn't include the expected ifnromation about the Item Group and Item containing the query. | VDC-53857* |
| After a study is upgraded from data model version 1 to 2, the Open Query API doesn't return Item Group or Item details in the response. | VDC-66665* |
Jobs
| Issue Description | Issue No. |
|---|---|
| The Retrospective Amendment job fails when it could potentially break a form signature. | VDC-66955* |
| Form and Site information doesn't display correctly when configuring a Core Listing job. | VDC-69813* |
| The Upversioning job now has more detailed logging. | VDC-72831* |
| Users with the standard CDMS Super User study role are only able to run the Data and Definition Export job, instead of all jobs. | VDC-73233* |
| For Study Data Extract, the SYS_PD file may not display the values correctly (IDs instead of Labels, null instead of false) for the PDCAT, PDSUBCAT, PDSEV, PDSTATUS, and INACBSYS columns. | VDC-73441* |
| Vault doesn't honor Override Labels and Custom Labels in the EGROUP, EVENT, FORM, IGROUP, or ITEM columns in Study Data Extracts. | VDC-73502* |
| For Study Data Extracts where the Include Restricted Data checkbox isn't selected, Vault still includes restricted Protocol Deviations in the SYS_PD file. | VDC-73582* |
| For SYS_LABLOC, Vault doesn't use the correct SAS Labels for LABLOCSTATUS or GUID. | VDC-73677* |
| Some query ages show up as blank in Study Data Exports. | VDC-73791 |
| The QTEXT column in the SYS_Q dataset resulting from a Study Data Extract job shows the most recent query message instead of the first. | VDC-74103 |
| Japanese characters aren't viewable in sas7bdat files generated by the Study Data Extract job. | VDC-74536* |
| Study Data Extacts may show times in different timezones across different columns. | VDC-75154 |
Labs
| Issue Description | Issue No. |
|---|---|
| Users can save Normals without measurement units. | VDC-59478* |
| Refreshing lab normals doesn't retrieve values for analytes with a codelist Item. | VDC-64718* |
| When adding a new Lab Panel that has a duplicate Name, Vault has an error instead of appending a number (_1, _2, etc.) to the Name. | VDC-69303* |
| If a Lab Result is entered with a selected Unit that evaluates as above normal range, and a user changes the Unit to one with which the result is within normal range, Vault doesn't remove the High flag indicator or Clinical Significance. | VDC-71473* |
| After a user merges a pending Lab Location into an approved Lab Location, Vault continues to display that merged Lab Location in the breadcrumb menu. | VDC-72365* |
| Vault doesn't allow the deletion of a Lab Location that is not in use but has other Lab Locations that are in use merged into it. | VDC-72369* |
| If an Analyte is used on multiple Lab Panels on the same Form, Vault only opens queries on an Analyte once when entered data triggers query creation, instead of all instances of the Analyte across the Form. | VDC-73223* |
| Vault allows the Override Normals action, but it doesn't save the override. | VDC-73986* |
| If a user submits a Form, edits the Form to change a Lab Result to Not Done or Undetectable, Vault doesn't autosave the change. | VDC-74078* |
| The Override Normals report may not display the correct values in the Flag column. | VDC-74081* |
| For Approved Lab Locations, the exported CSV includes Pending and Merged locations. | VDC-74574* |
| Vault now handles less than or equal to and greater than or equal to for normal ranges. | VDC-74764 |
| Mass update jobs fail without explanation. | VDC-75198 |
Publishing Validation
| Issue Description | Issue No. |
|---|---|
| Validation may return WID-001 on a Create Protocol Deviation rule that was copied from another Create Protocol Deviation rule, as well as on the original rule, even if validation passed with no issues on the original rule. | VDC-68098* |
Randomization
| Issue Description | Issue No. |
|---|---|
| Randomization information hover callouts and Reveal Treatment dialogs show the current value of the checkbox field instead of the value of when the subject was randomized. | VDC-71037* |
| The Treatment callout shows the Treatment Name instead of the Treatment Label. | VDC-73200* |
| In Internet Explorer™, Vault displays the Settings navigation panel text vertically. | VDC-73429* |
| Users aren't able to derive certain data from the Randomization module to be used in EDC. | VDC-73753 |
Review Plan Assignment
| Issue Description | Issue No. |
|---|---|
| The Review Plan Reorder job doesn't assign the correct review plans to casebooks. | VDC-75040 |
Role & User Management
| Issue Description | Issue No. |
|---|---|
| With this release, all roles with the Manage Study Deployment or Manage Amendments permissions have the Restricted Data Access permission assigned. | VDC-71937 |
| Users may receive a "Syntax error" when attemtping to add a tab permission to a custom Study Role. | VDC-74457* |
Rule Editor
| Issue Description | Issue No. |
|---|---|
| Vault doesn't display an informative error message when a Create Protocol Deviation rule action is invalid for LinkTo: Event/DateOfDeviation:Item. | VDC-72453* |
| Rules (expression grammar v1) copied from one Study into another may be incorrectly marked as invalid. | VDC-73091* |
| When Randomization is not enabled for a Study, Vault still shows Randomization tokens in the Rule Editor for Send Email rules. | VDC-73226* |
| Rules with the following actions now automatically have the Delayed checkbox selected: Send Email, Add Assessment, Create Protocol Deviation, and Override Review Plan. These rule actions are by nature asynchronous. | VDC-73485* |
| Vault marks valid Create Protocol Deviation rules as invalid during copy. | VDC-74566* |
Rule Execution
| Issue Description | Issue No. |
|---|---|
| Vault doesn't show values for Event Group, Event Group Sequence, Event, Link, and Randomization ID in the Error Details dialog in the Error Console. | VDC-73910* |
| Event-level queries don't fire when the date is changed. | VDC-73953 |
Safety Link
| Issue Description | Issue No. |
|---|---|
| Vault shows "No values available" in the Item drop-down. | VDC-72799* |
| EDC may not send an initial Safety Message upon submission of a the configured SAE form. | VDC-74550 |
SDS & Annotated PDFs
| Issue Description | Issue No. |
|---|---|
| Vault doesn't list the Event annotations in the expected order. | VDC-74042* |
SDV & DMR
| Issue Description | Issue No. |
|---|---|
| The Item QuickView filter doesn't filter out completed SDV on repeating Forms. | VDC-55269* |
Study Administration
| Issue Description | Issue No. |
|---|---|
| Vault now enforces uniqueness on the Study Instance Keys. | VDC-70889 |
Study Design
| Issue Description | Issue No. |
|---|---|
| The Subject Id Gen Format setting is requiring the use of either the {site.number} or {site.oid} tokens to save, when it should be allowing users to save without either of these. | VDC-70249* |
Study Import & Export
| Issue Description | Issue No. |
|---|---|
| Import fails when the imported Study is on version 1 of the expression grammar and contains unit conversions. | VDC-31899* |
UI & Performance
| Issue Description | Issue No. |
|---|---|
| When the Expand Log Forms feature is enabled, the page hangs when a user attempts to SDV an Event Date that contains a repeating Form. | VDC-63719* |
| Users receive a server error and experience long loading times when opening Coder in "Approve Mode." | VDC-74039 |
| Users are shown a server error when adding a new Principal Investigator to sites. | VDC-74493 |
| If a site timezone is updated after event dates have been saved at the site or if a subject is transferred to a site in a later time zone, the event date displays incorrectly in the Data Entry and Review tabs. | VDC-74495 |
| Users are shown a server error when adding repeating forms. | VDC-74615 |
| Event dates don't display in the Subject Casebook schedule in the Review tab. | VDC-74676* |
| Some users can't access their CDB Workbench studies if the Study status is "Pending." | VDC-74875 |
| All scrollbars in the Review tab blink. | VDC-74909 |
Vault Administration
| Issue Description | Issue No. |
|---|---|
| Vault now prevents the creation of multiple Study Configurations for a single Study. | VDC-73888* |
Views & Data Export
| Issue Description | Issue No. |
|---|---|
| The Data Export job fails in production. | VDC-71719 |