New Features in 18R3.5: CDMS Role by Study and more...

Release Date: March 7, 2019

Release Date: March 7, 2019

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

Coder

Expanded Support for Codelist Coding Properties

With this release, Coder now displays the Decode value for Codelist-type Items instead of the Code value in the Coder listing page, Synonym Lists, and reports.

Coder Tools

Enablement Change: Code Request Data Export

With this release, we changed the enablement of the Code Request Data Export feature from Support to Auto-on.

EDC Tools

Renamed “Audit Export” Job to “Audit Trail Export”

We renamed the Audit Export job to Audit Trail Export to better communicate the output of this job type.

Security

CDMS Role by Study

With this release, we introduced a new, Application Role-based permission model to Vault CDMS. This new model is a more efficient way to grant users access to a Study. With this new model, a user can have a different role in different studies. For example, a user might be a Data Manager for a Veeofen study, but is only an Auditor in the Deetoza study. This feature introduces seven (7) new Security Profiles and ten (10) new Application Roles:

New Security Profiles:

  • Data Entry
  • Data Review
  • Data Manager
  • Design
  • Coder
  • Coder Admin
  • User Administrator

New Application Roles:

  • CDMS Principal Investigator
  • CDMS Sub Investigator
  • CDMS Clinical Research Coordinator
  • CDMS Clinical Research Associate
  • CDMS Auditor Read Only
  • CDMS Data Manager
  • CDMS Clinical Coder
  • CDMS Clinical Coder Administrator
  • CDMS Study Designer
  • CDMS User Administrator

These nine new Application Roles cannot be deleted or modified. To make adjustments, administrators can copy or create custom Application Roles.

Contact your Veeva Services representative about enabling this feature and migrating your existing users.

CTMS Connection

CTMS Users Open Casebooks in the Review Tab

For customers that have Vault CTMS and Vault CDMS, and have the Review tab enabled, the connection that redirects the user from a Subject in the CTMS vault the Casebook in the CDMS vault can now open the Casebook in the Review tab. To use this enhancement, an Admin in the CTMS vault must update the Web Action to point to the Review tab instead of the Data Entry tab.

Feature Enablement Details

Feature Enablement Application
Coder
Expanded Support for Codelist Coding Properties Auto-on Coder
Coder Tools
Enablement Change: Code Request Data Export Auto-on Coder
EDC Tools
Internal Only: In the current release, this area of the application is available only to Veeva Services.
Renamed "Audit Export" Job to "Audit Trail Export" Auto-on EDC
Security
CDMS Role by Study Support Coder, EDC
CTMS Connection
CTMS Users Open Casebooks in the Review Tab Configuration EDC

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.