New Features in 23R1.2

Batch Assign Lists, Import In Progress Post Submit Data, and more...

Release Date: May 5, 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.

Job Governor Enhancements

This feature introduces the Queued status in the extract job governor to improve processing efficiency.

Use Case

This feature ensures that multiple jobs for the same type of data aren’t scheduled to run concurrently.

Enablement

This feature is automatically enabled.

Query Team Selection Enhancements

This release includes the following updates to the options for assigning a query team in multi-role security vaults:

  • If a user has multiple roles on different query teams and creates a query, the query team dropdown list will only contain teams associated with the roles with the query permission. If a role does not have a query permission, the associated team will not display in the query team dropdown list
  • If a user with multiple roles only has one role with a query permission, the query team will default to that role’s team

Use Case

This update simplifies the query workflow for multi-role security.

Enablement

This feature is automatically enabled.

Recalculate Normalized Datetime Values Job

This feature includes a job which will update the normalized values for datetime items in a site based on the current site timezone. The job will run automatically when the timezone is changed for a site that has existing subjects. This includes when the timezone is changed through EDC Tools or when the timezone changes come from CTMS. The option to manually run the job is also available out of EDC Tools in cases where jobs may not have completed successfully.

Use Case

A site that has existing subjects with form data containing datetime items that have values were previously impacted when the site’s timezone changed. The forms that contain the datetime items are not usually re-submitted, and the normalized values for the items were not updated based on the new site timezone. This feature avoids the possibility of having incorrect normalized values for datetime items in a study. It is important to have correct normalized values as they are used for rules, extracts, etc.

Enablement

This feature is available automatically.

SDE: Enhancements

The following enhancements have been made to the 23R2 version of the SDE:

  • Item columns in the Clinical Datasets will be sorted based on their order on the form
  • The following columns were added:
    • Form Status to Clinical Datasets
    • Last Modified Date to SYS_SUB dataset
    • Source Form Restricted to SYS_ASM and SYS_ASMR and Restricted to SYS_Q and SYS_QT datasets
    • Created By and Assessment External ID to SYS_ASM and SYS_ASMR datasets
    • Reassessment to SYS_ASM dataset
    • Assessment Name and Question Text Definition to SYS_ASMR dataset
  • Additional error logging when a job fails due to user permissions

Use Case

These updates provide additional metadata about forms in the extract.

Enablement

This feature is automatically enabled with SDE version 23R2.

Study Progress Listings Enhancements

The following enhancements have been made to the Study Progress Listing:

  • Study Summary Metrics: Updated several column names to clarify that the data refers to forms that are SDV / DMR Complete
  • Subject Progress Listing: Added columns for form SDV and DMR Completion status
  • Subject Progress Listing: SDV/DMR Complete columns will be blank if SDV/DMR Plan is blank
  • Event Progress Listing: Added new columns for Submitted Forms SDV Required and Submitted Forms DMR Required
  • Event Progress Listing: Event Date SDV Required and Event Date DMR Required columns will only be populated for events with an event date field

We’ve also enabled the Study Progress Listings in the Reports tab feature for all Vaults. Users will still need to schedule listing jobs to populate the corresponding listing reports in the Reports tab.

Finally, we relabeled the columns in the Study Summary Metrics report to include “Forms”.

Use Case

These updates improve the usability of and clarity for Study Progress Listings.

Enablement

This feature is automatically enabled.

Learn More

Review Plan Job Enhancements

This feature confers performance enhancements to the Review Plan Reorder and SDV/DMR re-assignment jobs, particularly for complex casebook designs and large number of casebooks. In addition to these strictly performance-based enhancements, the Reorder job will now clean up Review Plan Casebook records that have become corrupted due to either a subject transfer or inadvertent deletion of manual assignments when a Review Plan Assignment record is changed. Previously these invalid records would have needed to be removed via CC before a customer could become unblocked.

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.

Import In Edit Data from EDC

The Workbench Export job now includes data from forms in the In Edit status for transfer from EDC to CDB. Forms enter this status when the form is submitted then reopened for edits. Prior to this release, the job only included data from forms in the Submitted status.

Use Case

This allows custom listings to include data that was previously available as Submitted, and users can now reference it in the CQL WHERE clause: WHERE @Form.Status in ('submitted__v', 'in_progress_post_submit__v')

Enablement

This feature is automatically enabled. All jobs after the release will include form data in the In Edit status.

Learn More

Migration Vault

Features in this section are new features for Migration Vault.

Abandon Loads

Users can now stop a step that is in progress from within Migration Vault. Once this happens, Migration Vault abandons the Load, and a user must start a new Load to migrate data.

Use Case

Prior to this release, there wasn’t a way to stop a step after it started. Users could only stop the Execute All workflow, which prevented the next step from starting. This inability was troublesome for steps that take longer to complete, such as Run or Dynamic Rules. Users can now stop steps whenever needed, instead of waiting for the step to complete.

Enablement

This feature is automatically enabled and available on any In Progress steps.

Migration Vault: General Enhancements

During Step 2 of the migration process, it is best to deactivate any system rules first to prevent a mass amount of system queries from being triggered. As part of this feature, any system generated rules and queries will be deactivated as part of Step 2 in the migration process. Once migration is completed, the rules and queries will be reactivated so that they will fire if new data is entered or a form is submitted.

Use Case

These features and enhancements are necessary in order to successfully migrate a study though its DEV, UAT, or even PROD cycle.

Enablement

These changes apply automatically.

Migration Vault: Reconcile Listings

Currently, there is an existing defect in CDMS in which the UI and the Database records can get out-of-sync after a successful migration due to the amount of migrating data and CDMS’ inability to process it all. When this occurs in Production, there is a “Sync-job” that repairs any discrepancies, but there is no job that will sync the data in DEV and UAT/TEST environments. This new feature and step will allow users to run the Reconcile Listings job from within the Migration Vault after a Load is complete to ensure that the UIand Database records in CDMS are synchronized.

Use Case

Ensures that the data is synchronized so that Professional Services can determine whether the data successfully migrated. By making it available as another optional Step (for UAT & PROD Loads) in the workflow, it offers the following advantages:

  • It may not always need to run, so we can avoid extending the length of the Load.
  • With the new vault-per-study, the job is run every day at 6 PM PST. So if a Load is executed before but around that time, it may not need to be executed via the MigVault.
  • If the issue is ever fixed in CDMS so that the job is no longer required, then the MigVault UI does not have to be redesigned. The job can be kept as back-up.

Enablement

These changes apply automatically.

Feature Enablement Summary

Feature Name Configuration Dependencies Day 1 Impact to Primary Users Users with Day 1 Visibility
Study Administration
Query Team Selection Enhancements    
  • Super Users
  • Lead Data Managers
Study Progress Listings Enhancements   Review Rollup V2
  • Study Designers
  • Lead Data Managers
Review Plan Job Enhancements    
  • Lead Data Managers
Vault CDB
Import In Edit Data from EDC    
  • Lead Data Managers
  • Data Managers
Migration Vault
Limited Availability: In the current release, Migration Vault is only available to early adopter customers. Contact your Veeva Services representative for details.
Abandon Loads    
  • Migration Users
Migration Vault: General Enhancements    
  • Migration Users
Migration Vault: Reconcile Listings    
  • Migration Users

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.