Pre-Release Date: July 2, 2019 | Release Date: August 2, 2019
A * next to the issue number denotes an internally found defect filed during the development of Limited Release features.
Casebook Versioning
| Issue Description |
Issue No. |
| In Amendment History, the Start Event column entries do not include the Event Group. This does not match the naming convention for Start Event items on the Amendment page. |
VDC-26658* |
| When a user does not select the Show Order checkbox, Vault still includes order in the compare versions report. |
VDC-27594* |
| In a compare versions report with Skip “Same” records (only show differences) selected, Vault shows all records, including same records, in the Coding Configuration worksheet. |
VDC-27634* |
| In a compare versions report for two studies in different vaults, Vault shows the Modified difference status for Medical Coding Dictionary Definitions and Medical Coding Dictionary Releases even when the values are the same. |
VDC-27886* |
| The compare versions report does not handle differences in boolean fields correctly when the report skips unmodified records. |
VDC-27887* |
| When initiating a retrospective amendment, Vault attempts to check that all Studies in the vault are able to be amended, instead of only the current study, which can cause amendments to fail unexpectedly. |
VDC-28346 |
Coder
| Issue Description |
Issue No. |
| In the Dictionary panel, a user cannot select Preferred Code to display it. |
VDC-27440* |
| Items at the top of the Code Request Listing table, including Pagination, the List Mode/Grouped Mode toggle buttons, and the Autoassinged button, are not correctly aligned. |
VDC-27512* |
| When Vault autocodes from a dictionary without using ATCs, Vault doesn't autocode any Code Request where the Verbatim exactly matches the dictionary record's Drug Name. |
VDC-27637 |
| The Actions menu in the Coding panel is not clickable. |
VDC-27990* |
| In some cases, it takes longer than expected to switch from List mode to Grouped mode in a coding form. |
VDC-28118* |
| The Dictionary panel's default inclusion criteria includes Drug Code. |
VDC-28165* |
| In some cases, it takes longer than expected for the Summary page to load. |
VDC-28485* |
| When a user clicks Autoassign while in Grouped mode in the coding Listing page, Autoassign fails. |
VDC-28597* |
Coder Tools
| Issue Description |
Issue No. |
| Vault locks the Code With ATCs setting in Coder Tools when there are coded MedDRA dictionary Code Requests. With this release, Vault only locks this setting when there are coded WHODrug dictionary Code Requests. |
VDC-22983* |
| While in Coder Tools, if a user reloads their browser, Vault reloads and displays a blank page in the Coder Tools tab. |
VDC-27906* |
Data Entry
| Issue Description |
Issue No. |
| When a Casebook is locked, Vault does not disable the + New Event button in the casebook schedule. If a user attempts to add an Event to the locked Casebook, Vault does not add the Event. |
VDC-25285* |
| After a user clicks Complete to submit a Form, Vault does not update the form's Status from In Progress to Submitted. |
VDC-26672* |
| When a Disable rule disables a DateTime-type Item, and then a user edits data causing the rule to enable that Item again, Vault does not re-enable the Date control for the Item. |
VDC-27736* |
| The system allows the user to delete the subject for a casebook with an open manual query at the Event or Form level |
VDC-27929* |
| Vault does not include all possible Subject statuses when calculating the percentage of Subjects that failed screening. With this release, Vault now calculates the percentage of Subjects that failed screening by dividing the number of Subjects with the Screen Failure status by the total number of Subjects in the Study. |
VDC-28030 |
| When evaluating dynamic rules, Vault deletes blank and planned Events and Forms that contain open or answered manual queries, as well as deleting the queries. With this release, Vault prevents users from editing controlling Items that would cause Vault to remove dependent, dynamic Events and Forms that contain open or answered manual queries. |
VDC-28781*, VDC-28468* |
Data Review
| Issue Description |
Issue No. |
| When a Form is locked, the Freeze Event action continues to display, and users receive a server error when they select it. |
VDC-22075* |
| With this release, we made several fixes to Event-level freezing and locking. The Freeze Event, Unfreeze Event, Lock Event, and Unlock Event actions display appropriately based on the Casebook's status. Vault now displays helpful tooltips indicating the reason that the freezing and locking actions are unavailable. |
VDC-26278*, VDC-25894*, VDC-27253* |
| When a planned Event is locked, Vault does not disable the Enter Date and Did Not Occur buttons. |
VDC-27938* |
| When a planned Event is frozen, Vault does not disable the Enter Date and Did Not Occur buttons. |
VDC-28053*, VDC-28059* |
| Vault deletes open and answered queries on blank Items after a retrospective amendment, the SDV and DMR re-assignment jobs, the Form is frozen or locked, the Item is frozen or locked, or the Item is marked as Intentionally Left Blank. |
VDC-28443* |
eSignature
| Issue Description |
Issue No. |
| When user signs a Casebook, repeating Forms that are in an in progress state are also signed. |
VDC-28304* |
PDF Export
| Issue Description |
Issue No. |
| In Detailed PDFs, after casebook amendments, Item Groups and Items are not arranged in the correct order. |
VDC-28393* |
| Blank PDFs do not contain codelist items which were added in an amendment. |
VDC-29128 |
Review Plan Editor
| Issue Description |
Issue No. |
| When a user edits Review Plan properties in the Properties panel, Vault does not disable the Copy and Delete actions. |
VDC-26680* |
| If a user sorts Forms in the Driving panel by a Requirement Mode, and then updates the requirements of a Form, Vault automatically resorts the Driving panel. |
VDC-27371* |
Rule Editor
| Issue Description |
Issue No. |
| Rule for checking that a date on a form is earlier or later than an Event Date only fires when the date on the form is completed first. |
VDC-29001* |
| Two rules which compare the Start Date and Date Resolved in a adverse event form do not fire and prevent the form from saving if one or both dates has an unknown component. |
VDC-29007* |
Search & Filter
| Issue Description |
Issue No. |
| Vault does not preserve pagination or sorting when a user clicks into the Rules Editor and then returns to the Rules listing in Studio. |
VDC-25921* |
Study Administration
| Issue Description |
Issue No. |
| When a user attempts to import users, and the CSV includes duplicate cross-domain user rows or cross-domain users that already exist in the vault, Vault only shows the related Warnings and not the Errors. The import job then fails. |
VDC-27353* |
| Vault duplicates Role names in User exports. |
VDC-27534 |
Study Design
| Issue Description |
Issue No. |
| When a user attempts to add more than 150 codelist values to a codelist and attempts to save the codelist, the user receives an Unresponsive Webpage error. |
VDC-26919 |
| Vault does not allow Studio users to edit the Display Format property after the initial version is published. |
VDC-27933* |
| SDS and Annotated PDF generation may fail unexpectedly. |
VDC-28537* |
| When a user resets an Event that contains a controlling Item for a dynamic rule, Vault removes any Forms that were added based on the controlling Item. Vault still attempts to evaluate dynamic rules against controlling Items on the removed Forms, which can cause dependent Forms to be added to the Casebook in error. |
VDC-28550* |
| Add Event Date rule is not producing an Event. |
VDC-28588 |
| When a Studio user imports a casebook version using the V1 formula grammar, Vault does not import the Blank Handling property. |
VDC-28900 |
UI & Performance
| Issue Description |
Issue No. |
| Events with locked forms display an active Freeze Event action in the More Actions menu. |
VDC-25893* |
| In Amendment History, the Target Version column is not the expected width of 100px. |
VDC-26156* |
| While locking a casebook, the system should display an icon or message that an action is taking place. |
VDC-26634 |
| Vault allows users to click to sort by the Event Dates Review column in Studio > Review Plans but does not sort the records correctly. With this release, we removed the ability to sort by this column. |
VDC-26674* |
| In some cases, the Casebook Versions tab in EDC Tools does not display any content. |
VDC-26776* |
| The link to the Site import template now leads to the page containing the template file on CDMS Help. |
VDC-26783* |
| If a user accesses Vault with Internet Explorer™, Vault may be slow to load Forms in the Review tab. |
VDC-27032 |
| After a user clicks + New Casebook, the confirmation dialog refers to creating a "Subject", instead of a "Casebook". |
VDC-27741* |
| When a user sets a repeating Item Group to Intentionally Left Blank and then submits the Form, Vault does not display the selected Reason in the tabular view. |
VDC-27895* |
| The system does not prevent users from deleting a Subject when the subject's Casebook contains open, manual queries. |
VDC-28600* |
Views & Data Export
| Issue Description |
Issue No. |
| When a view uses a derived column to calculate a date, based on data from repeating Forms, Vault adds the derived values to different rows, instead of the source data row. |
VDC-24886* |