New Features in 23R2.2

Date of First Review, SDE Enhancements, and more...

Release Date: August 25, 2023

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.

Study Administration

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

Date of First Review

With this release, the date of the first SDV and DMR review for an Item or Event Date will display as columns in the Form Operational Summary report, Form Progress Listing, Event Progress Listing, and the SYS_FORM dataset in the Study Data Extract job.

Use Case

This update improves cycle time metric reporting by differentiating between the initial and most recent SDV/DMR date in cases where SDV/DMR is updated due to study or data changes.

Enablement

This change applies to all new studies created after the 23R3 release.

Date of First Submission

For studies created after 23R3, the system will track the date that a form is first submitted in the Form Progress Listing job, Core Listings, and Study Data Extracts. Once set, the date won’t be cleared unless the form is reset. The Date of First Submission doesn’t change if the form is submitted multiple times.

See below for details about the impact of this feature:

  • Form Progress Listings:
    • Added First Submission Date and Latest Submission Date columns
  • Study Data Extracts(23R3 Version):
    • Added First Submission Date (FIRSTSUBMITDT) and Last Submission Date (LASTSUBMITDT) columns to the SYS_FORM dataset
    • Added First Submission Date (FIRSTSUBMITDT) column to Clinical Datasets and updated the SUBMITDT column to LASTSUBMITDT
  • Core Listings:
    • Added Form First Submission Date column and renamed the Form Submission Date column to Form Last Submission Date

Use Case

This feature can be used to calculate cycle times, such as the time from form creation to first submit or the time from first submit to lock, etc.

Enablement

This change applies to all new studies created after the 23R3 release.

EDC General Enhancements

We’ve made the following enhancements to EDC:

  • Snapshots: We’ve removed the refresh/sync icon from the snapshots results page. Users should refresh their browser to view updated results.
  • Small Screen Size Warning: We’ve updated the warning message window to more prominently guide the user. The “Test My Setup” option has been relabeled “Help Me Fix It” and is the primary action.
  • Prior to this release, Vault only showed repeating forms in the Review UI when data was present. With this release, the Review UI display will match the Data Entry display. An empty form icon will display, along with an indicator that no form instances exist. When selected, the form name will show in the right panel with an indication that there are no records to display.

Use Case

These updates improve usability and user experience.

Enablement

These updates apply automatically.

Fire Query when ILB Setting

With this feature, users in Studio have the option to choose whether or not a required item can be set to Intentionally Left Blank (ILB). Sites will receive a query in Data Entry when selecting ILB on items that are configured with this setting. The SDS has been updated to include this setting which will appear on the Excel-formatted specification and annotated CRF.

Use Case

Studies have required critical data points that, in most cases, shouldn’t be left blank. This feature automatically generates a query when data is marked as ILB by Site users in order to verify that the data was marked correctly.

Enablement

This feature can be enabled in the Study Configuration and is available for new and existing studies. Apply to existing studies by deploying the updated item settings.

Job Governor & Study Priority Enhancements

We’ve made the following updates to the Job Governor and Study Priority options:

  • Job Governor:
    • Users can’t start an ad hoc Unique Terms Report if one is already queued or in progress
    • Users can’t schedule more than two Audit Trail Export jobs at once per study
  • Study Priority:
    • Users can set an expiration date when setting study priority. The default value is 7 days from the current date
    • Priority expiration will be reset to 7 days after a priority study is locked

Use Case

These updates improve system usability.

Enablement

These updates apply automatically.

Study Data Extract Enhancements

We’ve made the following changes to Study Data Extracts:

  • SDE Sent to CDB: Starting with this release, users can only include SYS datasets and Custom Objects when sending SDE data to CDB. The option to include clinical datasets is disabled. This applies to both the 23R2 and 23R3 versions of the SDE.
  • SAS enhancements: With this release, we’ve increased the compression for SDE jobs being exported as an SAS file to minimize processing time.
  • The 23R3 version of the SDE includes the following changes:
    • Clinical Datasets now include columns for Date of First Submission (FIRSTSUBMITDT), Form Created Date (CREATEDT), and Form (Latest) Submission Date (LASTSUBMITDT)
    • The column header for the Last Submit Date column in SYS_FORM dataset has been changed from SUBMITDT to LASTSUBMITDT for consistency.

Use Case

These updates provide greater detail to the user and improve usability of the Study Data Extract job.

Enablement

These updates are available immediately upon release and are limited to the 23R3 version of the SDE unless indicated otherwise.

Form Progress Listing: SDV & DMR Re-review Columns

With this release, the Form Progress Listing identifies when a form that has been previously reviewed (SDV/DMR) requires re-review. The CSV output for this listing now includes Requires Re-SDV and Requires Re-DMR columns. If the Date of First SDV/DMR field is populated but the Date of Latest SDV/DMR field is blank, the Requires Re-SDV/Re-DMR columns will be marked with “Yes.” Conversely, if both the Date of First SDV/DMR and Date of Latest SDV/DMR fields are populated, the Requires Re-SDV/Re-DMR columns will be marked with “No”.

Use Case

Differentiating between forms that require SDV/DMR for the first time and forms that require re-review due to configuration or data changes increases clarity of reporting and metrics.

Enablement

New columns are automatically included in the Form Progress Listing upon release, but will be blank for studies that were created prior to the 23R3 release.

Study Progress Listings Enhancements

This release includes the following Study Progress Listing job enhancements:

  • Query Detail Listing: Renamed the Created Date column to Query Created Date, and the Created By column to Query Created By
  • Form Progress Listing: Updated the SDV Required and DMR Required fields to support Data Model 1 studies when the Form Progress Listing is sent to Vault Reports

Use Case

These changes provide consistency with other query reporting and add support for Data Model 1 studies.

Enablement

These changes apply automatically.

Clinical DataBase (CDB)

The following are new features for the CDB application, the Vault CDMS solution for data cleaning and reporting.

Availability: Clinical DataBase (CDB) is only available to CDB license holders. Contact your Veeva Services representative for details.

CDB Listing Builder: Create & Select Properties

With this release, we introduced the CDB Listing Builder. This is a user interface for creating Listings, Checks, and Views without using CQL. We will enhance this functionality throughout the limited releases in 23R3.

In this release, users can create and save simple Listings, Checks, or Views from scratch. They can select Forms and Items to include in the listing, as well as certain Study and Item properties. When creating a new listing, CDB will automatically select all of the study and item properties, such as Site Number, Subject Name, etc., as defined by the CDB Vault Configuration. Then, users can add and remove properties as needed.

Use Case

CDB Listing Builder enables data managers to build listings by pulling data from multiple Sources and Forms using an intuitive drag and drop user interface.

Enablement

This feature is automatically available. Users with permission to create listings, checks, or views can use the Listing Builder to do so.

Integrations

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

Feature Enablement Summary

Feature Name Configuration Dependencies Day 1 Impact to Primary Users Users with Day 1 Visibility
Study Administration
Date of First Review    
  • Lead Data Managers
  • Lead Data Managers
Date of First Submission    
  • Lead Data Managers
  • Lead Data Managers
EDC General Enhancements    
  • Lead Data Managers
  • Lead Data Managers
Fire Query when ILB Setting    
  • Study Designers
  • Study Designers
Form Progress Listing: SDV & DMR Re-review Columns    
  • Lead Data Managers
  • Lead Data Managers
Study Progress Listings Enhancements    
  • Lead Data Managers
  • Lead Data Managers
Vault CDB
Integrations

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.