New Features in 22R3.2

Object Definition Names in the SDE, Sort @PreviousEvent Rules by Schedule, and more...

Release Date: December 16, 2022

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.

Removing Legacy EDC Features

Veeva has removed the following legacy EDC features, which are no longer being used by customers:

  • PDF V1

Enablement

This change applies automatically.

Data Entry

Features in this section are changes to the Data Entry tab, a working area for investigators and clinical research coordinators to enter study execution data.

ILB No Longer Allowed for Lab Forms

Users can no longer mark a Lab Form as Intentionally Left Blank. Instead, they can mark blank Lab forms as Lab Tests Not Performed.

Use Case

This feature removes redundant form actions.

Enablement

This change applies automatically.

Query Detail Support for Multi-role Security

Users can select the Query Team they want to use when creating a manual query if the user has multiple roles on multiple query teams. The selected Query Team will then be visible in the UI and will display in the Query Detail Listing and the SYS_Q dataset of the Study Data Extract.

Use Case

This feature creates consistency among single-role security studies.

Enablement

This feature is available automatically in vaults using Multi-Role Security.

UI Text Changes for Form Submission

With this feature, the “Complete” button on forms has been relabeled as “Submit.” Users will see a warning dialog if they navigate away from an In Progress form without first submitting the data to ensure that data is submitted. When prompted with the warning dialog, users can choose to submit the form, continue editing the form, or leave the page.

Use Case

This feature ensures that site users are submitting form data.

Enablement

These changes apply automatically.

Study Design & Configuration

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

Sort @PreviousEvent Rules by Schedule

Rules containing a @PreviousEvent identifier can now be configured to sort by Schedule order.

Use Case

When locating the Previous instance of an Event or Form, Study Designers do not always want to sort by Event Date, and instead sort based on the order of Events defined in the Studio Schedule. This feature adds additional flexibility to the new @PreviousEvent rule functionality added in the last release.

Enablement

This feature is automatically available for use in Studies using Expression Engine V2.

Learn More

Study Administration

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

Audit Event for Item Change Reason on Create

With this release, Vault will audit an Item’s Change Reason when the Item is created to support migrated data. If a migrated item has a change reason, the reason will be available in the item’s Audit Trail after the item is created.

Use Case

This feature supports migrations.

Enablement

This change applies automatically and is only applicable to migrated studies.

SDE: Add Object Definition Names to Extract

In the 23R1 version of the SDE, various Clinical and System datasets will include the following object definition names as new columns: Event Group Definition Name, Event Definition Name, Form Definition Name, Item Group Definition Name, and Item Definition Name.

The datasets impacted are listed below:

  • Clinical Datasets
  • SYS_EVT
  • SYS_FORM
  • SYS_ILB
  • SYS_LINKS
  • SYS_Q
  • SYS_PD
  • SYS_ASM

Use Case

This feature will allow users to look up the definition name from the labels to help with downstream analysis and mapping.

Enablement

Automatically enabled with SDE version 23R1.

Study Progress Listing Enhancements

With this release, we’ve made some small enhancements to the Study Progress Listings. These changes will be available in the CSV version of the listings that is generated in the Review tab or EDC Tools as well as the Report tab version of the listings.

Query Detail Listing changes:

  • New column for Form Status
  • New column for number of query messages

Event Progress Listing changes:

  • New columns for Event Date frozen and locked

Subject Progress Listing changes:

  • New columns for SDV Completion Date and DMR Completion Date

Form Progress Listing changes:

  • New columns for Intentionally Left Blank and ILB Date

Form Progress, Event Progress, and Study Summary Metrics Report:

  • Values are rounded to the nearest integer

Use Case

These enhancements provide users with more reporting metrics.

Enablement

These changes apply automatically.

Feature Enablement Summary

Feature Name Configuration Dependencies Day 1 Impact to Primary Users Users with Day 1 Visibility
Data Entry
ILB No Longer Allowed for Lab Forms    
  • Sites
  • Sites
Query Detail Support for Multi-role Security    
  • Clinical Research Associate
  • Data Manager
  • Clinical Research Associate
  • Data Manager
UI Text Changes for Form Submission    
  • Sites
  • Sites
Study Administration
Audit Event for Item Change Reason on Create    
  • Super Users
  • Lead Data Managers
SDE: Add Object Definition Names to Extract    
  • Super Users
  • Study Designers
  • Lead Data Managers
Study Progress Listing Enhancements    
  • Super Users
  • Lead Data Managers
Study Design & Configuration
Sort @PreviousEvent Rules by Schedule Studio Expression Engine V2
  • Super Users
  • Study Designers
  • Librarians
CDMS
Removing Legacy EDC Features    
  • Vault Administrators

Enablement Legend

  • Configuration: This field lists the location(s) where configuration for this feature occurs, for example, "Studio" or "EDC Tools". "Support" indicates that this feature must be enabled by Veeva Support, and "Vault Admin" indicates that configuration must be performed by a Vault Owner in the vault's Admin area.
  • Dependencies: This field lists any dependencies required to use this feature, for example, Labs or Expression Engine V2. The other columns assume that the dependencies are enabled/in use.
  • Day 1 Impact to Primary Users: This feature is visible and available to one or more primary user teams (Site Users, Clinical Team, and Coders) on day 1. Otherwise, this feature is either only visible to study designers or administrator users, it requires configuration before it is visible to primary users.
  • Users with Day 1 Visibility: This feature is visible to these users on day 1 if no configuration occurs.