New Features in 23R3.5

Release Date: March 8, 2024

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 Design & Configuration

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

Show Safety Configuration in SDS & Annotated PDF

After moving the Safety Integration configuration to Studio, the ‘Safety Settings’ and ‘Safety Form Configurations’ for the E2B Link configuration are now reflected in the SDS in two new tabs.

Use Case

To support the study build and review, the Safety Integrations are now traceable in the Study Design Specifications (SDS).

Enablement

This feature is automatically enabled. If a study isn’t using the safety itegration, those tabs won’t show in the SDS. In the current release, the SDS doesn’t include those tabs for VSEC studies.

Labels in Studio Added to Definition Records

In Business Admin, Studio configured labels, such as event labels, form labels, and others, assigned as part of the study design are now stored along with their applicable study definition records.

Use Case

Including the labels from Studio along with the definition records will help to facilitate future enhancements for Reports, CDB and APIs.

Enablement

These changes apply automatically and can be seen in Business Admin by Vault Owners.

Study Administration

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

Visit Method

Site users can select a Visit Method when adding an event date in Data Entry to indicate the type or location of a subject’s visit. Studies with CTMS integrations can send Visit Method data from CDMS to CTMS, and that data can be used to determine payment amounts for the subject visit in CTMS.

In Studio, users can configure a single visit method or several selections from a predefined list as options for each event. Users can also choose a default visit method for the study or utilize a library from the Study Settings. The following visit method options are available:

  • On Site Visit
  • Virtual Visit
  • At Home Visit
  • Alternate Facility Visit
  • Telephone Interview

Study Designers can also program rules that reference visit method values to open queries, trigger dynamics, create protocol deviations, and send emails using visit method as a token within the email body.
Visit Methods are fully reviewable. In Studio, Study Designers can configure Review Plan requirements for the Visit Method field.CRAs and Data Managers can also perform SDV, DMR, Freeze, and Lock actions on the Visit Method values (independently or as part of the Event). In Data Entry, PI signatures will also apply to Visit Method values. As part of this feature, the SDS, PDFs, listings, extracts, reporting templates, and job artifacts have additional columns and values added for Visit Method.

Use Case

Visit Method enhances the way visits are entered and reviewed in EDC. This feature better supports decentralized trials and remote visits where specific visits are not required to be onsite. This feature also provides sponsors with the ability to collect data on how an Event was performed directly on that Event, which enhances monitoring plans. In addition, queries in Data Entry and Review have an improved appearance to help streamline navigation.

Enablement

This feature is only available for new studies on Data Model 2. Contact Veeva Administration to turn on this feature in your vault. Existing studies in Production cannot retrospectively enable this feature. Once a study is set to use this feature, the setting cannot be reverted.

Learn More

PDF Memory Optimization

Jobs that generate Closeout or Detail PDFs which include the audit trail, and where individual casebooks within the job have over 20k data points will now complete successfully.

Use Case

The generation of PDFs with audit trail for very large casebooks will no longer need to be split into separate jobs.

Enablement

Contact Veeva Support to enable this feature.

Admin General Enhancements

When implementing a new Retrospective Amendment, Vault will no longer default the “Status for Changed Forms” setting. As such, users will need to explicitly select “Set to In Progress” or “Leave as Submitted.”

The “External Connections” tab in System Tools was renamed to “Connections.”

Use Case

This change provides more explicit control for users implementing Retrospective Amendments and prevents the unintended use of the previous default value.

Enablement

This change applies automatically.

Learn More

Support for All Timezones, Study Countries, and Site Addresses

Additional fields are now visible when adding a study site. The expanded Timezone picklist follows IANA standards, and the Country list matches ISO-3166-1 international standards.

The site address can be captured with the following new fields:

  • Address Line 1
  • Address Line 2
  • City
  • State/Province
  • Postal Code

The site import file is updated to include the new address fields, which are also visible in the import preview screen. For ease of selection, the Bulk Casebook Signature setting is now a radio button.

Use Case

The expanded lists better align with standards and support all potential site locations. The country additions help reduce connection setup time for countries that were already available in CTMS. The optional address fields allow for storing the full site location, and the radio button offers fewer clicks when choosing the Bulk Casebook Signature setting.

Enablement

These changes apply automatically.

Learn More

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 Support for Visit Method

With this release, Vault EDC introduced the Visit Method feature. This feature allows EDC users to capture how a visit was conducted (for example, at the site, at home, virtually, over the phone, etc.). In support of this feature, we made the following changes:

  • The Workbench Export job now includes details related to the visit method for export into CDB.
  • Custom listing can now reference visit method with the new header attribute, @HDR.Event.VisitMethod.
  • In the Clean Patient Tracker, CDB now includes visit method in the calculations for the Incomplete SDV and Clean columns.

Use Case

This feature allows for listings to include the visit method for an event.

Enablement

The Visit Method feature for EDC must be enabled by Veeva Support. It is only available for new Studies (those created after the 24R1 release). Once this feature is enabled for EDC, it is automatically supported in CDB.

Review Listing Enhancements

With this release, we’ve removed the Data Filters from Review Listings (filters on metadata in the first column), to improve performance. Filters for these data can be added to a Review Listing CQL to better focus the listing.

To improve system performance, CDB will reduce the times when a Review Listing is refreshed, and flag long running Review Listings and provide a mechanism to improve the listing so it is performant. Review Listings will only be refreshed once per hour, and on creation. Listings that take more than 30 seconds to complete will be marked in the review dashboard for update, and given 50 refreshes to improve the performance. If the listing runs in under 30 seconds, the counter will reset to zero. If a listing takes over 90 seconds to complete, it will be disabled after three runs that are greater than 90 seconds. Disabled Review Listings with reviews can be migrated to a new performant review listing with Veeva Support.

Use Case

These enhancements are automatically available to studies using CDB Workbench review listings.

Enablement

These enhancements ensure review listings do not slow down the entire system or time out and never refresh.

CDB Ingestion Improvements

Import logs will only capture up to 10,000 warnings and errors and will stop recording when this threshold is met.

Use Case

This enhancement improves performance during ingestion.

Enablement

This enhancement is automatically available for customers using CDB.

Data Review Enhancements

CDB users can now use comparison filters and search for form items in the Listing Builder. Users can now download a Listing Definition and copy a single Listing to another Study.

Use Case

Listings are now easier to use and distribute across studies.

Enablement

These enhancements is automatically available for customers using CDB.

Integrations

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

Vault Safety: EDC Connection

In this release, we are introducing the new Vault Safety - EDC Connection between Vault EDC and Vault Safety.

The initial release of the connection includes:

  • ‘Vault Safety - EDC Connection’ as Safety Integration and Vault Safety Inbox Type
  • Configuration in Studio, including new Item Configuration options: Static Value (e.g. static unit), Paired Date (e.g. transfer of weight paired with the event date), Auto-matching of identical EDC and Safety codelist entries
  • Deployment to other environments
  • Synchronisation of Vault Safety design elements
  • Safety case count and safety case listing per subject at the Data Entry and Review UIs.
  • Safety Case ID banner for the key Serious Adverse Event form showing the Vault Safety latest Inbox and/or Case location of that SAE. This is shown at both the Data Entry and Review UIs.
  • New Safety-relevant permissions

Use Case

Vault Safety EDC Connection represents an unprecedented Safety Integration to propagate safety-relevant data from Vault EDC to Vault Safety. While any data send based on the E2B format is limited to a given set of data points, it can transfer any case-relevant data to Vault Safety as required by the pharmacovigilance team. Beyond the data belonging to the actual safety case based on the respective inclusion rules, additional subject and safety-relevant data will be made available for look-up in Vault Safety. This additional information can be added to a safety case on the Vault Safety side without callbacks to data management and sites. Beyond the extended transfer of safety case and subject data, the Vault Safety EDC Connection allows a true two-way communication, including case id backpropagation, which will be further expanded in the upcoming releases.

Enablement

Contact Veeva Support to enable this feature.

Safety Message Enhancements

New Safety Message statuses have been added to reflect failed E2B XML generation, transmission profile issues, or failed file send. Additionally, the E2B XML will also be created for inactive or faulty connection to allow for a better testing and error investigation.

Tracing a failed send of a Safety Message must be traceable on EDC side. For this the following new statuses will help with the error evaluation:

  • System Error: failed E2B XML generation; case will be excluded from follow-up scan
  • Connection Issue: issue with the transmission profile
  • Failed Delivery: failed send of the file.

Use Case

Failed sends are now traceable from EDC.

Enablement

This feature is automatically enabled.

Feature Enablement Summary

Feature Name Configuration Dependencies Day 1 Impact to Primary Users Users with Day 1 Visibility
Study Design & Configuration
Show Safety Configuration in SDS & Annotated PDF    
  • Study Designers
  • Librarians
Labels in Studio Added to Definition Records    
  • Vault Owners
Study Administration
Visit Method Studio Data Model V2
  • Clinical Team
  • Clinical Research Associates
  • Data Managers
  • Librarians
  • Sites
  • Study Designers
PDF Memory Optimization    
    Admin General Enhancements    
    • Sites
    • Sites
    Support for All Timezones, Study Countries, and Site Addresses    
    • Super Users
    • Lead Data Managers
    • User Administrators
    • Study Designers
    • CDMS API Read Write
    Vault CDB
    CDB Support for Visit Method    
    • Lead Data Managers
    • Data Managers
    • Lead Data Managers
    • Data Managers
    Review Listing Enhancements    
    • Lead Data Managers
    • Data Managers
    • Lead Data Managers
    • Data Managers
    Data Review Enhancements    
    • Lead Data Managers
    • Data Managers
    • Lead Data Managers
    • Data Managers
    Integrations
    Vault Safety: EDC Connection Support  
      Safety Message Enhancements    
      • Study Designers
      • Librarians

      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.