New Features in 18R2.4: Reset Event, Stop List Management, and more...

Release Date: November 6, 2018

We are pleased to bring you the following new features in this week’s release. See details about each feature’s enablement below.

Data Entry

Add Repeating Event Group Button

For studies that have Repeating Event Groups enabled, Site users can now add instances of an event group by clicking a button directly on the subject’s casebook. This replaces the feature where previously the event group was added via the Add Event button. This feature makes data entry more focused and intuitive.

Reset Event

With this enhancement, users can now reset an Event back to the Planned status, if, for example, they mistakenly started the event. When a user resets an Event, Vault removes the Event Date, if it was populated, and deletes all Forms and system-generated queries related to the Event. Vault returns the Event to the Planned state, in which the user can then enter a date or mark the Event as Did Not Occur. Vault does not allow users to reset an Event with open or answered manual queries.

Data Review

Modifying an Event Date Invalidates eSignatures

With this release, if any user modifies an Event Date, Vault automatically invalidates all electronic signatures associated with that Event.

Lock & Unlock a Subject Casebook

Data managers or users with the appropriate permissions can now lock and unlock all Items within a subject Casebook in a single action. Users can apply these actions by choosing the Lock All Items or Unlock All Items actions in the Casebook-level Actions menu. Locked data cannot be modified, and no other activities can occur on the data.

Freeze & Unfreeze a Subject Casebook

Clinical Research Associates (CRAs) or users with the appropriate permissions can now freeze and unfreeze all Items within a subject Casebook in a single action. Users can apply these actions by choosing the Freeze All Items or Unfreeze All Items actions in the Casebook-level Actions menu. Frozen data cannot be modified, but all other activities, like queries or source data verification, can still occur.

Display Locked & Frozen Status for Forms & Events

Vault now displays the Locked and Frozen status of Forms and Events via an icon in the Review tab. Now, review users can easily identify which Forms and Events are locked or frozen without having to run a report.

Overdue Forms Column in Event Listing

With this release, Vault now displays an Overdue Forms column in the Review tab’s Event listing.

Ad Hoc Data Exports

Users in the Review tab can now run or schedule Detail PDF and Data Export jobs from the new Study Jobs subtab. When running a Data Export job, users can choose to export only a single View or an entire View Set, as well as choose to export in CSV or SAS file format. When running a Detail PDF job, users can choose to export detail PDFs at the Site- or Study-level. Users are able to view previous jobs from Study Jobs > Job History, where they can also download log and output files.

Review Tab Filtering Enhancements

In the Review tab, users can now quickly filter out Events and Forms that do not have any open tasks for the user. This minimizes the noise of completed Events or Forms when users are trying to focus on their incomplete tasks. On the Event and Form listing pages, there is now a toggle that when turned on, filters the listing to display only Forms and Events with open, incomplete tasks. Vault continues to filter listings as the user navigates through different subjects within the session.

Review tab users can now more easily navigate through the different tasks on a selected Form. In the header of the Form, there is now a Next button alongside each type of task the user is able to view. Clicking Next navigates the user to the next incomplete task of that type. For SDV and DMR tasks, Next only traverses Items that are Required. When there are no incomplete tasks of that type left on a Form, Vault disables the button.

Users can now perform Subject-level actions on a subject Casebook using the More Actions menu. Actions available to each user depend on their security profile. With this release, we also updated the Event-level More Actions menu to an Actions menu.

Reporting & Dashboards

Persona-Based Dashboards

With this release, persona-based dashboards are available for study monitors (CRAs), data managers, and clinical programmers. These dashboards display core operational metrics specific to the user’s role. These dashboards may be used as they are or as a template for custom dashboard creation.

Study Design Review Dashboard for Clinical Programmers
Vault EDC Data Manager Review Dashboard
Vault EDC CRA Dashboard

In support of this feature, we also added the following reports:

Standard Template: Unique CRF Listing
Standard Template: Form DMR Summary
Dashboard: Out of Range Event Total
Dashboard: Number of Enrolled Subjects
Dashboard: Open Queries
Dashboard: Answered Queries

Coder

Open the Coding Panel in a New Window

With this release, Coder users can now open the Coding panel in a new browser window. Users with multiple screens, can work with the Code Request listing page on one screen and the Coding panel on another. Codes continue to apply to Code Requests in real-time.

Open EDC Forms from Coder

If a Coder needs more contextual information to apply or review a code, they can now open the Form that originated the Code Request from within the Coder tab.

Primary Path Filter for MedDRA Dictionary Search

With this release, Coder users can filter MedDRA Dictionary search results to show only records marked as Primary Paths.

Properties Card Displays Site & Subject

With this release, Coder now displays the Site and Subject Number in the Properties card for each Code Request.

Default Sorting for Code Requests

With this release, Vault now sorts Code Requests by default. For WhoDrug, Vault sorts alphabetically by Verbatim, Indication, Route, and Status. For MedDRA, Vault sorts alphabetically by Verbatim, Seriousness, and Status.

Hover to Display Truncated Text

With this release, Coder users can now hover over an area of truncated text to display the full text.

Coder Tools

Coder Administrator Role

With this release, we added the Coder Administrator application role. Coder Administrators are responsible for upversioning, managing Synonym Lists and Stop Lists, and managing application- and study-level settings.

Coder Tools Study Settings

Coder Administrators can now set Coding settings at the Study level from Tools > Coder Tools > Study Settings. Changes in Study Settings apply only to the selected Study. By default, these settings are a copy of the General Settings. Any changes made in Study Settings will not apply to the default application settings, and vice versa.

Synonym List Management

With this release, Coder Administrators can create new Synonym Lists, edit existing Synonym Lists, and approve or reject terms added to a Synonym List. A Synonym List contains verbatim terms with their assigned dictionary definition and code. Each Synonym List is associated with a specific dictionary version. Once a new Study is added to Coder, Coder Administrators can create a new Synonym List or assign an existing one to that Study. Coder Administrators must create a Synonym List before Coders are able to code.

Upversion a Study’s Forms & Synonym Lists

Dictionary providers (WHODrug and MedDRA) release updated dictionary versions a few times a year. As soon as a new version of dictionary is made available, Coder Administrators can choose whether or not to upversion their Synonym List to use the new dictionary version. Upversioning to a new dictionary version can affect the Coded Terms assigned to Synonyms. Coder Administrators can initiate a dictionary upversion by selecting Upversion from a Form’s Actions menu, in Coder Tools > Study Settings. Vault begins a job to upversion the Form, and the Study is locked for coding until each Synonym and its associated dictionary term and code are reviewed. When complete, Vault unassigns the previous Synonym List. Coder Administrators can then manually assign the new, upversioned Synonym List to their study.

Stop List Management

With this release, Coder Administrators can manage their study’s Stop List from Coder Tools > Stop Lists. With Stop Lists, Coder Administrators can define a list of Verbatims to exclude from a Synonym List.

Studio

Compare Study Versions

Studio users can now run a report to show the differences between two Casebook Definitions or two Casebook Definition Versions. This illustrates added, removed, and changed components. Users can also compare two different versions across two different vaults, as well as compare a limited release vault to a general release vault. This feature allows Studio users to more easily identify changes and required actions across versions.

Check Event Group Sequence in Rules

Studio users can now reference an Event Group sequence number within a rule expression. This feature allows for more flexible study design. When a study has rules that generate dynamic Events or Forms in a repeating Event Group (such as unscheduled Events or treatment cycles), Vault only adds the dynamic Event or Form the same Event Group. For example, an unscheduled Event contains a field on a Form that if answered as ‘Yes’ adds a dynamic Vital Signs form. If there were three unscheduled Events, and in the second unscheduled event a user answered ‘Yes’ to the controlling Item, Vault only adds the Vital Signs form to the second unscheduled Event, and not the first or third.

As part of this feature, Studio users can now also specify when to evaluate a rule and the rule scope during rule creation.

Copy Form Definitions across Studies

Studio users can now copy Form Definitions from other studies in the same vault. With this feature, users can choose a Study, select the Form to copy, and select what to do when the Form, or its related Item Groups, Items, Codelists, etc. already exist in the current Study. This feature speeds study design through allowing reuse.

Manage Repeating Event Group Labels

Studio users can customize the labels for repeating Event Groups. Instead of displaying the sequence number of the event group within the casebook, users can configure a customized label to replace the sequence number. This allows for flexible study design and naming conventions for studies that implement treatment cycles.

Improved Validation Messages for Views

Study designers now receive additional information for view-related warnings found during study validation. Validation messages for those warnings will now include the view set, view, column, and row identifiers to allow Studio users to more easily find and fix the affected view.

CDMS

Event Level SDV and DMR Timestamps

Vault now captures timestamps for Event-level Source Data Verification (SDV) and Data Management Review (DMR). This enhancement supports future enhancements for the Veeva Vault CTMS connection.

Feature Enablement Details

Feature	Enablement Setting	Application
Data Entry
Add Repeating Event Group Button	Auto-on	EDC
Reset Event	Auto-on	EDC
Data Review
Modifying Event Date Invalidates eSignatures	Auto-on	EDC
Changes to Intentionally Left Blank Remove Review Status	Auto-on ⁴	EDC
Lock & Unlock a Subject Casebook	Auto-on	EDC
Freeze & Unfreeze a Subject Casebook	Auto-on	EDC
Display Locked & Frozen Status for Forms & Events	Auto-on ¹	EDC
Overdue Forms Column in Event Listing	Auto-on ¹	EDC
Ad Hoc Data Exports	Auto-on ¹	EDC
Review Tab Filtering Enhancements	Auto-on ¹	EDC
Review Tab Navigation Enhancements	Auto-on ¹	EDC
Reporting & Dashboards
Persona-Based Dashboards	Support ²	EDC
Coder
Open the Coding Panel in a New Window	Auto-on	Coder
Open EDC Forms from Coder	Auto-on	Coder
Primary Path Filter for MedDRA Dictionary Search	Auto-on	Coder
Properties Card Displays Site & Subject	Auto-on	Coder
Default Sorting for Code Requests	Auto-on	Coder
Hover to Display Truncated Text	Auto-on	Coder
Coder Tools
Internal Only: In the current release, this area of the application is available only to Veeva Services.
Coder Administrator Role	Auto-on	Coder
Coder Tools Study Settings	Auto-on	Coder
Synonym List Management	Auto-on	Coder
Upversion a Study’s Forms & Synonym Lists	Auto-on	Coder
Stop List Management	Auto-on	Coder
Studio
Internal Only: In the current release, this area of the application is available only to Veeva Services.
Compare Study Versions	Auto-on	EDC
Check Event Group Sequence in Rules	Auto-on ³	EDC
Copy Form Definitions across Studies	Auto-on	EDC
Manage Repeating Event Group Labels	Auto-on	EDC
~~Views Support for Medical Coding Requests~~	~~Auto-on ⁴~~	~~EDC, Coder~~
Improved Validation Messages for Views	Auto-on	EDC
CDMS
CDMS Permissions by Application Role	Support ⁴	EDC, Coder
Event-Level SDV and DMR Timestamps	Auto-on	EDC
Enablement Notes
¹ In vaults where the Monitoring Review Tab feature is enabled. ²Contact your Veeva Services representative to enable this feature. ³This option is automatically available in Studio, but a clinical programmer must a create or edit a rule to use it. ⁴ This feature was postponed to a later release.

Enablement Legend

See the following explanations for feature enablement options:

Enablement	Description
Auto-on	Automatically activated and no configuration is required before using the feature; note that in some cases, a new feature is dependent on another feature that must be enabled or configured.
Admin Checkbox	Admins must turn on the feature with an Admin checkbox. Note that some “Auto-On” features have a checkbox setting that hides the feature; these will show “Auto-On.”
Configuration	Admins must configure the feature (separately from an Admin checkbox) before it is available to use or is active; for example, a Clinical Programmer must create an Item Definition of a certain new Item Type.
Support	On/off option controlled by Support.