New Features in 24R2 Limited Releases

We are pleased to bring you new functionality with each limited release. These release notes are updated with upcoming new features one week before the limited release date. 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.

Query Usability Enhancements 24R1.2

With this release, we have made several usability enhancements to the Data Entry and Review areas:

  • When site users select Edit Value they will now automatically be directed to the queried item on the form.
  • In Data Entry, form queries can now be collapsed and expanded.
  • In order to match Data Entry, updates to buttons and spacing have been made to queries in the Review UI.
  • In the Review tab users can cancel a manual query from a new button in the top right of the query.
  • A character counter has been added to the query message textbox.

Use Case

These updates provide quicker navigation and help reduce scrolling.

Enablement

These enhancements are automatically enabled.

Query Team Enhancements 24R1.2

The Query Team tag has been moved to the query message header.

Use Case

This update provides better visual spacing within the UI.

Enablement

This update is automatically enabled.

Clinical Coding

The following are new features for Coder, the clinical coding area for Vault Coder.

Coder General Enhancements 24R1.2

We’ve made the following enhancements to Coder:

  • Updates to Synonym List Import Validation Error Messages: Synonym List Import Validation Error Messages have been updated to be consistent with the column labels in the import file.

  • Duplicate Synonym Warning is turned into an Error: In 24R1.0 we effectively allow duplicate Synonym List detail imports as the Duplicate Synonym validation message is a warning. With 24R1.2 we are turning this warning into an error that will block import.

Use Case

These updates improve usability.

Enablement

These enhancements are automatically enabled.

Reports & Dashboards

The following are new features for reports and dashboards in Vault CDMS.

Item 2 Standard Reports 24R1.2

With this release we are introducing two new standard reports with Item-level information:

  • Items Intentionally Left Blank: This report provides a listing of Items marked intentionally left blank, filtered by Study and grouped by Site and Subject.
  • Item Reason for Change Report: This report provides a count of Items per Site per change reason entered by the Site. It excludes system-managed change reasons.

Use Case

These reports provide greater insight into Site use of Intentionally Left Blank and Reason for Change at the Item level.

Enablement

These reports will be immediately available to Vault Owners to share with other users. The reports support studies on Data Model 2.

Study Design & Configuration

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

Relabeled Rule Actions 24R1.2

To clarify rule actions, the ‘floating’ parts of User Defined Rule Action Identifiers have been relabeled. When the Dynamic Action Scope is set to Global, unspecified parts of action labels that were previously labeled “this” are now labeled with “all”. Action labels have been revised for more specific Dynamic Action Scope scenarios, and also for repeating portions of the action identifiers. The revised action labels more accurately reflect the behavior of the rule, given configuration of the action identifier and the Dynamic Action Scope.
For example, with a Dynamic Action Scope set as Global, in the Add Form rule action where only the Form (VS) is specified, the identifier would have previously been seen as “this event” and will now have the following action label:

Add Form     all events  >  VS

Additionally, when a repeating identifier is specified, the label will reflect whether the action takes place on all instances or the current one. For example, when the Dynamic Action Scope is set as Global and the rule action is Add Event, the identifier would previously have only shown the Event Group name, but will now have the following action label:

Add Event     CYCLE (all)  >  DAY5

“This” is still used in rule action labels where appropriate, to indicate that the action will occur only on the current instance.
For Open Query rules, when the configured action is set to All Instances of a repeating Event Group, repeating Form or repeating Item Group, it will be reflected accordingly in the action label, seen as (all) within the rule action.

Use Case

Previously, the floating action labels caused confusion for study designers, particularly when selecting specific Dynamic Action Scopes. This update helps clarify where the rule will perform its defined action(s), reducing errors and rework needed to correct rules.

Enablement

Contact Veeva Support to enable this feature.

Study Administration

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

PDF Enhancements: Include Organization & Site Number 24R1.2

When Detail, Closeout, and Assessment PDFs are generated, the name of the Organization (Sponsor) can now be included. When a Detail PDF is generated, the name of the site folder will now include the site number and the site name, as follows:

  • Folder name: 1001 - My Site

Use Case

These enhancements clarify sponsor and site information in PDF files and folders.

Enablement

For vaults that have enabled the Studio PDF feature from 24R1 to add Organization in the Studio PDF, the additional PDF updates for Organization will automatically be included with this setting. Contact Veeva Support if the feature wasn’t previously enabled in your vault. The addition of the Site Number to Detail PDF folders is automatically enabled.

Enablement Change: Frozen Form Support for Amendments Enabled in All Vaults 24R1.2

In 23R3, Veeva released the Frozen Form Support for Amendments feature, which streamlined the Retrospective Amendment process. This feature was initially enabled upon request to Veeva Support.

With the 24R2 release, this feature will be automatically enabled on all vaults.

When enabled, Vault automatically retains the frozen status on data that isn’t impacted and will unfreeze data as appropriate where there are changes to forms during a retrospective amendment.

After the retrospective amendment is applied:

  • If any of the following item properties are changed, the Item will be unfrozen: Type, Label, Short Label, Hint Label, Override Label
  • Unit/Codelist item label changes will not have an impact on Frozen status.
  • Form property changes (e.g. form label or description) will leave the form frozen
  • Event changes will leave the Event frozen
  • Frozen casebooks will remain frozen and can still process retro updates
  • Newly added Items, Item Groups, Forms, and Events will be added in an unfrozen state

Use Case

This feature allows the system more control regarding managing frozen data when running a retrospective amendment. As a result, Data Managers no longer have to manually unfreeze casebook data in order to apply the amendment.

Enablement

This feature is now automatically enabled.

Enablement Change: PDF Memory Optimization Enabled in All Vaults 24R1.2

In 24R1, Veeva improved the job performance for generating large Closeout and Detail PDFs through memory optimization. Initially, this update required enablement by Veeva Support at the vault level.

With this release, this feature will be applied to all vaults.

Use Case

This feature improves the generation of PDFs with audit trail for very large casebooks.

Enablement

This feature is now automatically enabled.

Extract Job Governor Enhancements 24R1.2

With this release, we’ve added Audit Trail Export Jobs to the total scheduled job count for the Vault.

Note that there is a limit to the total number of scheduled jobs allowed in a Vault to help control the amount of scheduled jobs created across the System. When a scheduled job is added to the job governor framework, it must be included in the total count for the number of scheduled jobs in the Vault.

Use Case

This enhancement provides consistency for the Audit Trail Export job within the job governance framework.

Enablement

This feature is automatically enabled.

Study Data Extract Enhancements 24R1.2

With this release, users can send test data to validate Test Connection for External Connections. While setting up an External Connection, users can test the transfer of data. This new option sends the data file while testing the connection, and will alert the user once the file is sent successfully.

Use Case

These updates improve usability.

Enablement

This feature is automatically enabled.

Integrations

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

Migration Vault

Features in this section are new features for Migration Vault.

Support for DMR 24R1.2

Migration Vault now manages the migration of Data Management Review (DMR) attributes from the Legacy EDC System.

Use Case

This feature expands migration support for workflows found in the Legacy EDC System.

Enablement

This feature is automatically available when DMR is set in the Attributes CSV File.

YAML Builder 24R1.2

This release adds a YAML Builder within Migration Vault to support the creation of mapping files for study migrations.

For Forms without repeating Item Groups, the system generates a single YAML mapping file for each form definition retrieved from the CDMS target Study. For Forms with repeating Item Groups, the system generates a single YAML mapping file for each repeating Item Group definition retrieved from the CDMS target Study.

After the YAML file generation is complete, the user receives a notification. The YAML file is then placed in the Attachments section. It can be manually modified and re-uploaded if needed, for example, if the source definition name does not match the Veeva EDC definition.

All users with Migrator, System Administrator, or Vault Owner access to Migration Vault can access the YAML Builder, if enabled.

Use Case

With this feature, Migration customers can now generate most of their Form YAML mapping files directly from their study’s EDC Studio design.

Enablement

Contact Veeva Support to enable this feature.