New Features in 22R3.5

Clean Patient Tracker, Sync Synonym Lists, and more...

Release Date: March 10, 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.

Clinical Coding

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

Sync Synonym Lists

Users can designate one Synonym List and Do Not Autocode List to perform all autocoding and suggestions actions for two vaults. Autocoding and Suggestions will be consistent across all Studies that span two vaults.

Coders can’t Propagate Code and Coder Managers can’t apply their approval action to the Synonym List on the secondary vault. While all updates to the Synonym List will sync across two vaults, the action to propagate the code to all Forms that are assigned to the same Synonym List is limited to the primary vault.

Use Case

Autocoding and Suggestions will be consistent across all Studies that span two Vaults.

Enablement

Contact Veeva to enable.

Study Design & Configuration

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

Enablement Change: Rules Archive

The Rules Archive feature is now automatically enabled.

Enablement

This feature is now automatically enabled. It applies to all rules versions.

Study Administration

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

Enablement Change: Disable Manual Casebook Creation

With this release, the Disable Manual Casebook Creation feature is now automatically enabled in all vaults. This means that a lead data manager can now enable it in their Studies via the Disable Manual Casebook Creation checkbox in EDC Tools > Settings.

Enablement

This feature must be enabled in a Study via the Disable Manual Casebook Creation checkbox in Tools > EDC Tools > Settings.

Enablement Change: SDE SAS Compression

This feature turns on the Enable SAS Artifact Compression feature for all Vaults, which compresses the SAS zip file. SDE Versions 22R1 and later will have SAS compression automatically enabled. Previous SDE versions will be affected by this enablement.

Use Case

SAS zip files will be compressed automatically when running the SDE.

Enablement

Automatically enabled in 23R1 for all Vaults.

Deployments

Features in this section are enhancements to deployment functionality in Vault CDMS.

Reconcile Missing References During Study Data Copy

This feature accommodates active changes to data while a Copy Study Data from Production operation is in process by only copying data that was static at the start of the copy job.

Use Case

Previously, if relevant data were actively deleted or created in Production while a Copy Study Data from Production was in progress, the copy job would fail. This feature allows the copy operation to complete even if data was actively being deleted or created.

Enablement

This feature is available by default.

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.

Clean Patient Tracker

Data Workbench will provide a new Subject-centric page for data managers to review the cleanliness of each patient. Data managers will be able to filter the grid by cleaning activities and study meta data such as site, country, cohort etc. Data managers will be able to quickly take action on a subject such as reviewing and closing answered queries.

Use Case

Data managers need to provide complete and clean patient data throughout the lifetime of a study. Today study teams use Excel and/or custom solutions to pull data together then manually mark subjects that are deemed clean and ready for lock. This process is time consuming, limited and prone to errors. With the clean patient grid, data managers will be able to track the cleanliness of the subjects and take direct action on data management cleaning activities.

Enablement

Contact Veeva Support to enable this feature.

Clone Listings from Study

Data managers and clinical programmers will also be able to select multiple Listings (Checks and Views) from a defined source study(s) and clone them into their current study. The system will provide a validation summary for each object indicating whether that object is compatible or incompatible with the target study design. The user will be able to review the validation summary, make necessary changes and import the desired cloned objects with their associated statuses (compatible, incompatible). Once imported these cloned objects can be reviewed, modified, and deployed to production.

Use Case

Clinical trials, especially those associated with the same therapeutic area share similar study designs and have very similar data management plans and reporting structures. When designing studies… reviews, edit checks and reports must be designed and built for each study. This can be time consuming and lead to unnecessary inconsistencies between similar studies. Users will now be able to easily reuse these building blocks, minimizing development time and errors that could be introduced in the process.

Enablement

The ability to clone Listings from a Study will be auto enabled in the Test environment only. All studies in the test environment, by default, will be set to not cloneable. An administrator will be able to designate which studies can be source study.

Third Party External ID Support

Users can provide a row external id in their manifest file when importing non-EDC data to be used to identify a unique row of data that queries are associated with. Once ingested, this Row External ID will be accessible via the @QRY dataset and in the Core Query Listings.

Use Case

This provides a method to pass through an identifier for users to identify a row of data that is tied to a query.

Enablement

This feature is automatically enabled. A user must edit a manifest file to use it.

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.

User Access Report

The new User Access Report provides User Administrators with a convenient report that details all access related audit data for users in that vault. The existing User Activity Report historically provided some of this data, but with this release we have introduced a comprehensive chronological log of role assignments and removals, site and country access changes, study assignment and access, and training status changes. The User Activity Report will still be available, but focuses on user activity such as login attempts and password changes.

Use Case

The User Activity Report was not designed to provide a comprehensive log of all access control related audit data. The User Access Report consolidates all of this historical data, from the creation of the vault, into any easily accessible validated report that can be provided in the event of an audit.

Enablement

This feature is available by default to users with the View Users permission.

Integrations

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

E2BLink now provides the ability to include related information into a safety case beyond just what a site links to the serious adverse event. This includes medical history, concomitant medications, external lab forms, other adverse events, and study drug/product dispenses. Additionally, the ability for forms being linked by the site user as a method of inclusion can be blocked, if desired.

Use Case

Previously the only way to include related data to a safety case was through site linking, or very specific (and often less desirable) form designs. The feature allows for more flexible study design (forms), and ability to configure which related information should belong in the case. Some examples of auto inclusion:

  • All ongoing and concomitant medications at the time of SAE Start
  • All medical history ongoing or ended within 6 months
  • Include not just the study drug dispense closest to SAE start (on/before, the pre 23R1 behavior), but also others within 4 days of the SAE Start, on, or after.
  • Any other adverse event (serious or not) that has a start date +/- 3 days of the SAE’s start date.

Enablement

These settings are automatically available, but a safety administrator must configure these options before they apply to a study.

This feature accommodates two, important, time-sensitive scenarios:

  • The site user has filled out a serious AE form, but has neglected to do the first submit/complete action on the form. That action is what normally begins the safety workflow.
  • The site user has filled out a serious AE form, but neglected the AE term, by mistake. The value is required in most safety systems.

Either of these scenarios results in an email alert at 1 hour after the creation of the form. The alert goes to the user who created the form, plus any configured recipients (email groups, distribution lists). The recipients can be configured by country as well, i.e. subjects of specific countries only sent to certain email lists.

Use Case

Safety cases are most urgently time sensitive on the first report from EDC, often just a few days (if not less) for further notification to regulatory agencies. This feature will ensure the timely alerting of cases where sites are omitting important steps that are necessary to ensure the start of safety case data transfer.

Enablement

These settings are automatically available, but a safety administrator must configure these options before they apply to a study.

With this release, this feature is now automatically enabled in all vaults. Prior to this release, organizations had to contact Veeva Support to enable it.

For Vault to send non-default values in the E2B XML, a safety administrator must perform configuration in EDC Tools to use it.

Enablement

This feature is now automatically enabled, but it must be configured by a safety administrator to send non-default values in the E2B XML.

Migration Vault

Features in this section are new features for Migration Vault.

Feature Enablement Summary

Feature Name Configuration Dependencies Day 1 Impact to Primary Users Users with Day 1 Visibility
Clinical Coding
Sync Synonym Lists    
  • Clinical Coder Administrator
Study Administration
Enablement Change: SDE SAS Compression   23R1 SDE version
  • Lead Data Managers
  • Lead Data Managers
Study Design & Configuration
Deployments
Reconcile Missing References During Study Data Copy    
  • Deployment Administrators
Role Management & Security
User Access Report    
  • User Administrators
Vault CDB
Clone Listings from Study    
  • Vault Owner
Third Party External ID Support    
  • Lead Data Managers
  • Data Managers
Integrations
E2BLink: Duration Inclusion Criteria for Related Forms EDC Tools  
  • Safety Administrator
E2BLink: SAE Not Submitted Email Alerts EDC Tools  
  • Safety Administrator
Migration Vault
Limited Availability: In the current release, Migration Vault is only available to early adopter customers. Contact your Veeva Services representative for details.

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.