Fixed Issues in 23R3Pre-Release Date: November 6, 2023 | CDB Pre-Release Date: November 13, 2023 | Release Date: November 17 & December 1, 2023
This week's release includes fixes for the following issues:
An asterisk (*) next to the issue number denotes an internally found defect filed during the development of Limited Release features.
|Some users are unable to generate Assessment PDFs with Audit Trails.
|Users encounter errors when attempting to create and save Assessments.
|In some cases, the Audit Trail Export by Study job fails inexplicably.
|In the Data Entry and Review tabs, the Audit Trail page displays an incorrect "Form Frozen" text.
Blank & Detail PDFs
|Detail PDFs generated with audit trails for large casebooks should skip certain casebooks.
|Some users encounter unexpected errors in the output file of retrospective amendments when attempting to apply Display Override Label changes to existing casebooks.
CDB - Checks & Queries
|CDB doesn't prevent users from removing the action object from the check's projection. This invalidates the check. With this release, CDB now shows a confirmation when a user makes this change to a check.
|CDB may open duplicate queries instead of auto-closing queries after data changes.
|CDB doesn't prevent the use of group by or having in check CQL statements, causing queries to close immediately after a check creates them.
|CDB may show the origin of EDC queries as CDB.
|With this release, checks support the use of Group By.
CDB - Clean Patient Tracker
|The Clean Patient Tracker may not get updated hourly.
|The Clean Patient Tracker doesn't properly display the following subject statuses: Started Treatment, Started to Follow Up, Lost to Follow Up, and Consented.
CDB - CQL
|CQL may be slower than usual to return results in larger studies.
|When applying the REPLACE function on a field at a view, and giving the field an alias, it isn't possible to apply a new label at the listing level for that field.
|Selecting * from an Item Group returns datetimes in the wrong timezone.
|A listing may not be sorted as expected and may be missing rows when sorting in a subquery with union distinct.
|CQL may return additional, identical columns when the statement has a function name inside a label alias.
|CQL may not return the correct results when using Union Distinct after a user applies a sort or filter with the Sort & Filter menu.
|When the Core Listing configuration sets a time only field as Raw or SDTM, CDB doesn't update the CQL or transform the field.
|When using @ItemGroup.SeqNbr and Union, CQL may return a column as an integer instead of a string, which marks the listing as invalid.
|CQL may return null when returning percentages as part of a union.
|CQL may return an unknown column error when using grouping and an advanced join.
|CQL using coalesce may return duplicate columns.
|CQL may return unexpected results when using null values with an In or Not In and a Concat function.
|CQL using CodeLabel may return unexpected results.
|For lab codelists, the CodeLabel function does not return the lab-related column.
|If a listing's CQL uses union, CQL may mark the listing as invalid after a user enables review for the listing.
|For cloned listings, CQL may return an ambiguous column error when the main select doesn't indicate which alias to select from.
|CQL returns an unknown column error when unioning two selects containing advanced joins.
CDB - Dashboards
|The Discrepancies count in the Check Summary is incorrect.
|The CDB Review Dashboard shows a colored completion bar when there's a 0 record count.
CDB - Export
|Export packages may not display in production studies.
|Study Data Extract SAS exports to CDB fail with an error when column headers are too long.
|SAS package generation fails when a column name contains "(%)".
|SAS package generation fails when a column name contains a semicolon.
|Export delivery may fail when a user doesn't have access to restricted data and the export contains unblinded data.
CDB - Import
|If a user imports a file with both reference and third party data, but with no Study in the manifest file, CDB doesn't return the appropriate error.
|CDB attempts to check EDC for Event Group and Event generation for OpenEDC studies instead of fully using the primary source.
|If a user imports a third party package, while an EDC package is still in progress, CDB will process the third party package before returning to the in progress EDC package job, instead of reloading it.
|If a user filters Import > Packages by the In Progress status, CDB shows packages in the Skipped status.
|The Manifest Builder removes fields from the Item Mapping list when the Item is used in other areas.
|Third party imports may get stuck in the In Progress status unexpectedly.
|The downloaded CSV of the import issue log may contain duplicate warning messages.
|If a third party import fails, and then the Source is deleted, subsequent EDC imports may not show in Workbench.
|CDB may not match on Events from OpenEDC sources.
|If a Study was processing when the 23R2.0 Part B release started, the Study enters the Skipped status when reprocessing is attempted.
|In the Import Audit Log, the Date Applied for EDC imports may have a timestamp that is earlier than the Import Completion timestamp.
|With this release, we've converted D-038 into a file-level error, F-017.
|Some CDB studies remain in Pending status after the first Workbench export.
|Users may receive an unexpected L-002 error when importing third party data.
|When the data is blinded, CDB may have a blank cell in the error log instead of the appropriate error message for the D-032 error.
|CDB doesn't show values for label items with the Help label type. With this release, CDB now imports label-type Items with the Help type (help__v) correctly.
|Studies with many completed signatures in EDC may take longer than usual to import.
|If another package is imported when the current package is still in the loading stage, the import of the subsequent package may not process .
|CDB import may get stuck with the old swap as the active swap.
|With this release, data file names can contain whitespaces.
CDB - Listings
|CDB may blind columns that weren't imported as blinded.
|CDB may apply sort and filter to the wrong column.
|A Study may remain in the Pending status unexpectedly.
|For some users, the Batch Assign Lists grid loads slowly after the list type is switched.
|Users encounter an error when coding ConMed forms.
|Drug Name columns don't sort correctly when moving between forms.
|Users are shown a blank page and an error message when attempting to approve code requests.
|When processing grouped coding requests, some users are unable to delete associated Synonym List Details causing Autocoding and Suggestion job failures.
|The All Caps Verbatim job fails for some users when attempting to set the ID on coding requests to Update and then acquiring a grouped request lock.
|In some cases, All Caps Verbatims jobs timeout.
|In some cases, All Caps Verbatims jobs fail with an Async Operation error.
|Vault encounters errors when grouping Verbatims by capitalization
|Vault encounters errors when grouping Verbatims by capitalization.
|In some cases, the query message box disappears when scrolling.
|When an event containing at least one form is set as Mark for Deletion due to dynamic changes, the event is incorrectly marked as restricted.
|In some cases, signature bindings are created with incorrect subjects.
|Some users encounter a server error when attempting to reset a form after receiving a prompt indicating that the form is no longer needed in the schedule.
|In some cases, forms are displayed twice in the casebook when viewed from the Review Tab.
|During autosaving, if either the unit or the lab modifier is saved alone, the corresponding value is null.
|For some users, in Form View, the Route and Frequency items appear twice instead of once due to a progressive display error.
|Some users encounter a server error when attempting to submit a Trigger: Endpoint Reporting form or select "Lab Test Not Performed".
|In some cases, if a single subject is deleted and a rule is created, the casebook fails to delete.
|Users encounter a server error when attempting to complete a new form that has been introduced through a retrospective amendment.
|In the Data Entry tab, the Item History continues to display unmasked data even after making an API request to mask the data.
|In some cases, if a single subject is deleted and a rule is created, the casebook fails to delete.
|Some users are unable to update the lab location in Form View due to a server error.
|For some users, the Lab panel disappears when selecting the "Missing Result" checkbox for an analyte that contains frozen normal override values. In addition, changing a lab location from "approved" to "pending" causes the lab location field to become disabled.
|For some users, the Progressive Display is not working as expected.
|In some cases, after a user resets one Event, the majority of the Events are incorrectly flagged for removal.
|Users encounter an error message when attempting to edit a form.
|In some cases, submitting a form within an Event Group changes the status of the parent event to "no longer required."
|In some cases, event groups are not deleted when triggered.
|Deployment from a CRO master to a deployment group sometimes fails without retrying.
|Deleting a study instance fails in some cases.
|Some users encounter an error when attempting to restore a deleted environment from a file.
|The CDB API no longer requires the origin_id parameter when setting the origin_name or origin_sys fields.
|The Combination Update Form Data, Upsert Item, and Upsert Form APIs fail for some users.
|Some users encounter an error when their Suggestion code includes the % character.
|Start Job - Audit Trail Export Job may fail unexpectedly when attempting to include restricted data.
|We relabeled this option from 'AER Inbox' to 'AER Inbox (Do Not Use)'.
|In some cases, Safety Messages aren't generated for migrated studies, which results in an error that doesn't allow the user to run a Follow-up Scan.
|F.r.3.2 lists "Text (50)" instead of "Number (50)" for E2B Data Type.
|Safety follow-up scan jobs on studies without safety cases fail.
|On studies with legacy cases, when a Follow-up or Full scan is run on Safety Cases, the result incorrectly shows that no follow-up inspection is needed.
|For some users, the E2B XML is showing incorrectly mapped values.
|In some cases, when an ad hoc full scan is run after the first E2BLink message is sent, a follow-up safety message is generated even though no E2BLink safety data has been changed.
|In some cases, the medical coding for an adverse event does not appear in the XML generated for the first E2B message.
|For some users, the Date of Most Recent Information in the Safety Messages grid is incorrect.
|In some cases, Follow Up Safety messages remain stuck with a "sending" status.
|In some cases, XML identifiers are mismatched leading to messages being rejected.
|In some cases, nullified cases are included in a Follow-up Scan, which results in a second nullification message being sent.
|Follow-up Safety Messages are unexpectedly sent when no changes have been made.
|The Delete Study Data job fails in some cases.
|In some cases, follow-up scans don't show the correct acknowledgment status.
Freezing & Locking
|In some cases, forms in the Review tab aren't locking when users attempt to lock them.
|Some users can't freeze/unfreeze or lock/unlock forms in certain studies.
|Bulk locking or freezing with the Snapshots feature fails when a Refresh Results job is in progress.
|The "next_page" URL lacks an "include_external_suggestions" parameter, causing the current implementation to default to false and prevent external suggestions from being returned.
|When a user attempts to create an Absorb Learning account through the CDMS integration by using an email address that contains an apostrophe, the account fails to be created.
|In some cases, during a CDMS to CTMS data exchange, users are unable to remove the link to CTMS while the sites are locked, even if the overall study is unlocked.
|In some cases, the Vault Comparison job (Diff Report) doesn't display accurate Review Plan information.
|Some Delete Study Data jobs don't complete and are stuck with an "In Progress" status.
|Some Delete Study Data jobs don't complete and are stuck with an "In Progress" status.
|Users encounter an error when attempting to update the LBSEX Item Label.
|For some users, the Preview and Update Translated Values job fails if the lab location is "Lab Location Not Found".
|Some users encounter server errors when editing Lab forms.
|In some cases, users receive an error message when attempting to enable Local Labs after copying from a study that doesn't have labs enabled.
|In the Data Entry tab, some users with Korean, Japanese, or Chinese language configurations cannot input time in a 12-hour format.
|Some users are shown a blank page when attempting to change the category for a Protocol Deviation.
|Some users experience an error when setting the status of a Protocol Deviation to "Inactive".
|Some users are encountering server problems when issuing queries in the Review tab.
|Users can't upload a new Randomization List because the Upload List button is disabled after adding a new treatment.
|Changing the Allow Unbalanced Randomization setting after deployment results in Randomization records being invalidated.
Review Plan Assignment
|Users encounter an error message when navigating to the Review Plan Assignment Criteria tab if the Review Plan Assignment contains sites that the user doesn't have access to.
Role & User Management
|Some users encounter a server error when attempting to add a user using the User Import template.
|Some users encounter an error when attempting to import users.
|The User Training History Report doesn't show the Site Country for some Sites.
|In some cases, rules that are run after form submission take longer to execute than rules that are run on form submission.
|Some users encounter incorrect error messages for progressive display rules.
|In some cases, queries don't fire as configured by rules.
|For some users, derivation rules don't display for previous casebook versions.
|In some cases, Vault doesn't send an email notification when specific forms are marked as ILB and a Send Email rule has been configured for that action.
|Some users encounter a server error when resetting a form.
|VDC-136086, VDC-136201, VDC-135861
|Some users encounter a rule error when attempting to submit a form in a migrated study.
SDS & Annotated PDFs
|In some cases, the Display Format column in the SDS is blank for some Item Groups.
|The SDS fails with an error for some users.
|In some cases, the SDS doesn't reflect changes that have been made to the user's DMR plan.
|Annotated CRFs don't display Code values for lab codelists.
SDV & DMR
|In some cases, subjects appear as Requires DMR, preventing locking, even when DMR has been completed and is not required for the event in range.
|Vault disables SDV and DMR for Forms that only contain label-type Items.
|Some users encounter a server error when attempting to use the Snapshot feature to freeze forms.
|Users encounter an error message when attempting to SDV or DMR an event with a locked form.
|In some cases, when locking an event date in the Review tab, the system adds a DMR option at the event level, when it should not be added.
|In some cases, when running the Additive Review repair endpoint, the job fails if sites are locked.
|When a user edits an FTP Connection in EDC Tools, Vault doesn't display an previously entered value for Destination Path.
|Attempting to copy from a study results in an error due to an invalid Item Definition reference.
|Users aren't able to delete Post Production Test environments.
Study Data Extracts
|The Study Data Extract job is failing for some studies, requiring users to run the job manually.
|Some users with a legacy SDE job encounter a server error when attempting to navigate to Job History or Job Schedule.
|Datetime items for Labs aren't split into separate columns in the SDE when configured.
|Some users experience an error when submitting more than 128 characters in the meaning field for Signature Definition.
|When an event group is copied with rules from one study to another, the copy operation is successful but the protocol deviation is not copied.
|When switching from date to number type, the date range minimum and maximum fields on the Item Property Panel should clear, but instead, they remain and show date values for minimum and maximum number fields.
|Some users encounter an error when creating difference reports.
|Users receive a "No valid unit/codelist" error when attempting to edit the properties of LBSEX , LBFEMALECYCLE, or LBAGE.
|Vault doesn't correctly identify duplicates when deduplicating rule definitions.
|In some cases, the Item Group sequence in the study design does not align with the Item Group sequence in the SDS.
|In some cases, the integration task fails when resubmitting the same SAE form with or without a seriousness value.
|Users can't change an Item Type from "Derived and EDC" to "EDC."
|In some cases, when validating a study containing both procedures and safety integration task bindings, the procedure validation fails with a Null Pointer Exception (NPE).
|Users can't edit other fields in the Properties Panel after saving a minimum and maximum value for the Edit Checks field.
UI & Performance
|In Workbench > Import > Audit Logs, the horizontal scrollbar is outside the viewable area.
|If a user selects multiple checkboxes in administrative areas, then checks Select All, and then they uncheck Select All, Vault may remember those selections when applying filters.
|When performing a bulk DMR action, the batch review input already defines another record.
|When clicking the Study breadcrumb on a Casebook page in Review, some users are sent to the Sites tab instead of the Queries tab.
|In some cases, a pair of objects, "Item2" and "Item Group 2", do not show up correctly on the Business Admin page at certain data volumes.
|In the Review tab, a white block appears at the bottom of the page when it shouldn't.
|For some users, when creating a new casebook, the entered date is not displaying correctly.
|Some users encounter a server error when logging in to Vault.
|Running a Retrospective Amendment on a new casebook results in a dialog with a continuous spinning icon.
|In the coding columns of the Study Definitions file, when a repeating item group with coding is configured, the coding columns appear twice.
Views & Data Export
|For some users, when Study Data Specifications are generated, the Item Group order is displayed incorrectly on blank and unique CRFs.