New Features in 20R2.3

Time & Events Schedule, Simple Autocoding Attribution, and more...

Release Date: September TBD, 2020


We are pleased to bring you the following new features in this week's release. See a summary of feature enablement for this release below.

Vault Coder

The following are new features for the Vault Coder application, the Vault CDMS solution for clinical coding.

"How to Code" Coding Configurations Moved to Coder Tools from Studio

While Studio will continue to be the location where we define “what to code”, it’s no longer where we will define “how to code”. All coding method configuration now resides in Coder Tools. In Studio, study designers still identify the Verbatim Item and any Related Items, but coding administrators must define the Dictionary Release, Synonym List, Do Not Autocode List, and Coding Method for each Form in Coder Tools.

Coding on a Form is unavailable until a coding administrator completes those configurations in Coder Tools. This applies to all study environments, including UAT, training, and production, as well as in customer preview (pre-release) environments.

Business Value

Now that Dictionary Releases are no longer controlled in Studio, there is more flexibility for deployments after upversioning and in changing the dictionary type for a form after coding begins.

Enablement

These changes automatically apply in vaults that contain the Vault Coder application.

Simple Autocoding Attribution

The Code Request object now stores the autocoding source, which can be either the Dictionary or the Synonym List. If the request was autocoded from the synonym list, then the Code Request record stores the name of the Synonym List and the reference to the Synonym. Users can view this information in any report that includes coding data by adding columns for Autocoding Source, Autocoding Synonym List, and Autocoding Synonym List Record. Users can also add dashboard components that compare the efficiency of autocoding from the dictionary to the efficiency of autocoding from the synonym list.

Business Value

This change applies automatically in vaults that contain the Vault Coder application, but users must modify reports and dashboards to view this information outside of Admin > Business Admin.

Enablement

These changes automatically apply in vaults that contain the Vault Coder application.

Subject Search for Coder

The Code Request Listing now includes columns and filters for Site and Subject. This allows coders to search for a specific Subject or set of Subjects to apply coding for the first time or to reevaluate coding. Note that these filters aren’t available when in Group mode.

Business Value

This feature provides a quick and easy way to filter Code Requests for one or more Subjects.

Enablement

This feature is available automatically in vaults that contain the Vault Coder application.


Study Design & Configuration

Features in this area apply to Studio, the study design and configuration area for Vault EDC.

Limited Availability: In the current release, this area of the application is only available to Studio early adopter customers. Contact your Veeva Services representative for details.

Time & Events Schedule

With this release, we enhanced the schedule design environment with a time and events schedule view of the Casebook Definition, similar to the time and events view in the protocol and Study Design Specification. This new view allows users to see and manage their Forms along the left side, and the Event Groups and Events along the top, easily setting which Forms belong with which Events in the resulting grid view.

Users can perform all standard schedule design functions (reordering, adding new or existing Event Groups, Events, and Forms). They can now also add new dynamic rules for an Event Group, Event, or Form by clicking the newly added New Rule button in the Properties panel, which opens the Rule Editor with the appropriate rule action and identifier already selected.

Users can easily switch between the new schedule and the original drag and drop viewer for flexibility and familiarity.

Time and Events Schedule

Business Value

This feature allows study designers to rapidly build the schedule in a familiar view of the study design.

Enablement

This feature is only available in Studies that are using version 2 of the expression grammar. To enable the time and events schedule, a Vault Owner must create a new record in the Study Settings object, with the name “schedule_editor_enabled”, the Study, and the value set to “true”.


Study Administration

Features in this section apply to EDC Tools, a study-level administration area for Vault EDC.

Retrospective Amendment Enhancements

Users can now select a Form Status when initiating a retrospective amendment. They can choose to set the impacted Forms in the In Progress Post Submit or Submitted statuses.

Business Value

With this feature, it is no longer required to submit a Form or mark it as intentionally left blank if the change results in the form no longer requiring data collection.

Enablement

This change applies automatically in all vaults, and users will see the new option the next time they initiate a retrospective amendment.

Study Administration Functional Enhancements

With this release, we made the following functional enhancements:

  • Site Name is no longer requires uniqueness within the Study.
  • We added hover text for the Delete Study Data and Delete Site Data job in EDC Tools > Job History.
  • System Tools > External Connections now only displays the Absorb connection, and not the vault connections required for automatic deployments.

Enablement

These changes apply automatically in all vaults.


Deployments

Features in this section are enhancements to deployment functionality in Vault CDMS.

Manage the Deployment List for Custom Roles, Reports & Dashboards from System Tools

With this release, deployment administrators can now add custom roles, reports, and dashboards to the deployment list from within System Tools, without needing to access Business Admin.

This feature adds a new section to the System Tools navigation panel, Deployment List, with links to Custom Objects, Custom Roles, Custom Reports, and Custom Dashboards.

Deployment List > Custom Roles
Deployment List > Custom Roles

Business Value

The ability to add custom roles, reports, and dashboards to the deployment safelist from System Tools, without needing to access Business Admin, increases customer independence.

Enablement

This change applies automatically in all vaults. Vault displays any existing Deployment Whitelist records for these components right away, and a deployment administrator can begin adding additional records immediately.


Role Management & Security

Features in this section are enhancements to the Role Management area and Study Roles, security and access control in Vault CDMS, and user management.

User Management Enhancements

With this release, we made the following changes to enhance the user management experience:

  • Added the new API Access permission to control the ability to access the API. This permission is automatically assigned to the CDMS Data Manager and CDMS Lead Data Manager study roles.
  • All study roles that are assigned the Manage Study Site permission are now automatically assigned the Manage Study Countries permission.
  • Added a new Study Role column to the user listing in EDC Tools > Users, which lists the Study Role assigned to the User.
  • Added the ability to show All Roles or only Active Roles in the Role Management table.
New filter to show All Roles or Active Roles
New filter to show All Roles or Active Roles

Enablement

These changes apply automatically in all vaults where Role by Study is enabled.


Integrations

Features in this section are new integrations with Vault CDMS or enhancements to existing integrations.

Veeva Learning Integration Enhancements

Site users who haven’t completed their assigned training can now view the training status and navigate to Absorb from the Data Entry tab. Also, users will now see all the studies they have access to.

Lead data managers can now set up learning systems in new studies more easily by copying a Role to Curriculum mapping from another Study in their vault. By default, the curriculum list is now sorted in ascending order. Lead data managers can now delete an existing Learning System from EDC Tools > Learning Systems.

Business Value

Site users can in real time see the training status for a study and get study access sooner than usual. Lead data managers can more easily manage their role to curriculum mappings.

Enablement

This change applies automatically in all studies where the Veeva Learning Integration is enabled.


Feature Enablement Summary

Feature Name Enablement Application
Vault Coder
"How to Code" Coding Configurations Moved to Coder Tools from Studio Auto-on EDC, Coder
Simple Autocoding Attribution Auto-on Coder
Subject Search for Coder Auto-on Coder
Study Design & Configuration
Time & Events Schedule Study Feature Flag

* In studies using version 2 of the expression grammar

EDC
Study Administration
Retrospective Amendment Enhancements Auto-on EDC
Study Administration Functional Enhancements Auto-on EDC
Role Management & Security
User Management Enhancements Auto-on

* In vaults where Role by Study is enabled

EDC
Deployments
Manage the Deployment List for Custom Roles, Reports & Dashboards from System Tools Auto-on EDC
Integrations
Veeva Learning Integration Enhancements Study Feature Flag

* In studies where the Veeva Learning Integration is enabled

EDC

Enablement Legend

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.
Study Feature Flag This feature is available by configuration within the Study Configuration object (or similar). To enable a feature using study configuration, navigate to Admin > Business Admin > Study Configuration and edit the Study Configuration record for your Study.
By Study Build The configuration options for this feature are available automatically in Studio, EDC Tools, Coder Tools, or System Tools, but you must configure them within your Study for those options to apply.
Support On/off option controlled by Support.