New Features in 19R2.2

Review UI Enhancements, Bulk Update Site's Active Version, and more...

Release Date: September 5, 2019

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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. Information on developer features (REST API) is in the Developer Portal.

CDMS

Features in this section are changes that apply to all application areas of Vault CDMS.

Audit Trail Enhancements

With this release, we made two (2) enhancements to the audit trail:

• Any audit events related to electronic signatures now display the Signature Meaning (attestation statement) in the audit event description. This allows anyone viewing the audit trail to better understand the context of the signature at the time the signature was applied.
• The audit trail now displays seconds for the Timestamp. Seconds were always captured, but they are now displayed in audit trails within the Vault CDMS user interface.

Use Case

These changes improve the ability of users to understand the meaning and intent of an action.

Enablement

These changes apply automatically with no additional action required.

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Data Review

Features in this section are changes to the Review tab, a working area for clinical research associates and data managers, or to review functionality within the Data Entry tab.

Review UI Enhancements

With this release, we made the following UI enhancements within the Review tab:

We replaced the Site Name filter with a Site Number filter in Review > Study Sites. We also relabeled the Site filter (which filtered by Site Number) as Site Number in Review > Queries. These changes help provide a more consistent experience across subtabs in Review.

We also relabeled the Schedule Task Filter as Schedule QuickView and Item Task Filter as Item QuickView. This changes the labels only, not how these filters work.

Enablement

These changes are automatically applied in all vaults where the Review tab is enabled. If the Review tab is not enabled in your vault, and you would like to enable it, contact Veeva Support.

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Vault Coder

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

Coder UI Enhancements

With this release, we made three (3) enhancements to the Vault Coder UI:

• The Listings page now automatically sorts Code Requests by the Verbatim and then by coding properties (such as Indication, Route, or Seriousness, as configure), instead of by Coding Status. This allows coders to apply a code and continue viewing that code to confirm that the action was committed successfully.
• In Coder Tools, coding administrators can now search records from the Synonym List Details page. This saves effort when looking for a single Synonym in a growing Synonym List or one that is mature but still evolving.

Use Case

Generally, we’ve made the tool a few steps more intuitive and easy to use.

Enablement

These changes apply automatically with no additional action required in all vaults that include the Vault Coder application.

Coder General Configuration Enhancements

With this release, we made the following changes in Vault Coder to increase customer independence:

• All Dictionary Release drop-down menus now only display Dictionary Releases from the Dictionary Database (new in 19R2).
• Studio users can now select a Dictionary Release after selecting Other for Form Type. This allows those users to make configuration choices based on the dictionary type, while still using a custom Form Type. Studio displays the appropriate options for Related Items and Coding Methods based on the chosen Dictionary Release.

Enablement

These changes apply automatically with no additional action required in all vaults that include the Vault Coder application.

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Study Design & Configuration

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

New Event Group & Form Dialogs

When creating a new Event Group or Form, users now see updated New Event Group and New Form dialogs, where they can define more properties during record creation. Studio users can now also create multiple Event Groups or Forms in a row with the new Save and New button. When a user clicks this button, Vault creates their record and then allows the user to create another without requiring them to click + New Event Group or + New Form again.

As part of this enhancement, we also updated the Event Group icon in the Components panel.

Use Case

This enhancement reduces the time and effort required to add new Event Groups or Forms to a study.

Enablement

These changes apply automatically with no additional action required.

Data Type Selection in the Item’s Properties Panel

We moved the Data Type property to the top of the Properties panel, as changes to an item’s Data Type can add or remove property options.

Use Case

This enhancement provides a more efficient user experience.

Enablement

This change applies automatically with no additional action required.

Study Documentation Enhancements

With this release, we added additional information to the Study Design Specification (SDS) and Annotated PDF output files for more comprehensive study documentation:

Changes to Annotated PDFs include:

• Added the following new annotations:
  • A new Read Only annotation to indicate read only Items
  • Two new annotations to indicate the ordinal direction of codelist radio buttons
  • Two new annotations to indicate Verbatim and Related Items for coding
• Renamed the “OID=” annotation as “External ID=”
• Updated the “Max Length.Precision” annotation to only display those values, and not the annotation name
• Removed an unnecessary colon from the summary
• Annotated PDF files now open with the bookmarks displayed by default

Changes to SDS include:

• Added the following values:
  • Event Group Repeat Labels (Schedule worksheet)
  • Item Group default values (Forms worksheet)
  • Hidden (Codelists worksheet)
  • Subject ID Generation Type (Study Settings worksheet)
  • Rule Expression Version (Study Settings worksheet)
• Adjusted the initial zoom and column widths in the Excel™ file to enhance readability

Use Case

These enhancements provide users with additional reporting capabilities on study design and configuration.

Enablement

These changes apply automatically with no additional action required.

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Study Administration

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

Compare Casebook Versions in EDC Tools

Lead data managers can now run a report to easily view the differences between two Casebook Definition versions within EDC Tools > Casebook Versions > All Versions. They can also choose to compare two versions across two different Studies or vaults. This comparison report is the same comparison report that is available with the Compare Versions action in Studio.

Use Case

By comparing versions, users can more easily identify changes and required actions across versions. Lead data managers can use the comparison report to identify all the changes and share that information with a study designer.

Enablement

This feature is available automatically in all vaults. Lead data managers can begin using this feature immediately with no additional configuration.

Bulk Update the Active Version for Sites

With this release, lead data managers can now update the Active Version for multiple Sites at once from EDC Tools > Sites.

As part of this feature, the list of Sites now includes a column for Active Version. Lead data managers no longer need to open a specific Site to see its Active Version.

Use Case

This enhancement saves those users time, as they no longer need to manually update the Active Version for sites one-by-one.

Enablement

This feature is available automatically in all vaults. Lead data managers can begin using this feature immediately with no additional configuration.

Relabeled Connections as FTPs

With this release, we relabeled EDC Tools > Connections as EDC Tools > FTPs. Because there is a Vault Platform feature called Connections, there was potential for confusion between that functionality and Connections created in EDC Tools. This change eliminates that confusion.

Enablement

This change applies automatically with no additional action required.

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Role Management & Security

Features in this section are enhancements to the System Tools > Role Management and System Tools > Users areas, as well as changes to standard Study Roles, security, and access control in Vault CDMS.

Display the Number of Users Assigned a Study Role

Within Tools > Role Management, Vault now displays the number of Users assigned to each Study Role, both custom and standard, across all Studies. Users can click on that number to view a list of all Users assigned that role.

Use Case

This enhancement enables lead data managers and user administrators to easily audit end user assignment across all Study Roles.

Enablement

This feature is available automatically in vaults where Role by Study is enabled. Lead data managers and user administrators can view these changes immediately with no additional configuration. If Role by Study is not enabled in your vault, contact your Veeva Services representative.

New Permissions Available for Role Management

With this release, we added two new functional permissions in Role Management: View Casebooks and Design Study.

The View Casebooks permission provides the ability to view Casebooks in the Data Entry tab. This permission is assigned to the following standard Study Roles:

• CDMS Principal Investigator
• CDMS Sub Investigator
• CDMS Clinical Research Coordinator

The Design Study permission provides the ability to create a Study Master, edit study settings, create all design definitions, and build a study schedule from within Studio. This permission is assigned to the CDMS Study Designer study role.

Use Case

These new permissions allow more granular control over user access.

Enablement

These changes apply automatically in vaults where Role by Study is enabled. Contact Veeva Services to enable Role by Study in your vault.

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Feature Enablement Summary

Feature Name	Enablement	Application
CDMS
Audit Trail Enhancements	Auto-on	EDC, Coder
Data Review
Review UI Enhancements	Auto-on	EDC
Vault Coder
Coder UI Enhancements	Auto-on	Coder
Coder General Configuration Enhancements	Auto-on	Coder
Study Design & Configuration
New Event Group & Form Dialogs	Auto-on	EDC
Data Type Selection in the Item’s Properties Panel	Auto-on	EDC
Study Documentation Enhancements	Auto-on	EDC
Study Administration
Compare Casebook Versions in EDC Tools	Auto-on	EDC
Bulk Update the Active Version for Sites	Auto-on	EDC
Relabeled Connections as FTPs	Auto-on	EDC
Role Management & Security
Display the Number of Users Assigned a Study Role	Auto-on	EDC
New Permissions Available for Role Management	Auto-on	EDC, Coder

Enablement Legend