New Features in 23R2.3

Import Lab Units & Codelists, Link Vault Reports to Coder, and more...

Release Date: September 22, 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.

CDMS

Features in this section are changes that apply to all application areas of Vault CDMS.

Detail PDFS: Fast Web View

With this release, we’ve optimized the Detail PDF files generated in bulk for fast web view in order to align with FDA guidance for regulatory submissions. This update applies to the files generated in the Detail PDF job and Site Closeout PDFs

Use Case

This enhancement supports FDA compliance and reduces file sizes and file opening times, allowing users to view the file before it is completely downloaded.

Enablement

Contact Veeva Support to enable this feature in your vault.

Reports & Dashboards

The following are new features for reports and dashboards in Vault CDMS.

Standard Versions of CDMS Operational Reports

With this release, CDMS operational reports (V3) are now available as Standard Vault Reports. This feature includes changes to filters, columns, type, name, and description. New standard reports are tagged with the Veeva report tag and marked as “created by the System.”

The previous versions of these reports, V1 and V2, were editable custom reports, which meant that when standard reports were edited, they would no longer be identical across all vaults. Because of this, providing updates and enhancements to these reports can be difficult. By standardizing report templates, we can easily make changes to these reports without creating a new version of the report.

If an organization requires changes to a standard report, they can use it as a template. They can copy the report and make their changes in the copy.

Note that the Label and Short Label columns will only be filled for Form Definitions created after the 23R3 release. These columns will be blank for already existing Form Definitions.

Report Report Type Description
Event Progress Listing Template: Event Progress Listing Listing of all events and their progress in the study
Form Progress Listing Template: Form Progress Listing Listing of all forms and their progress in the study
Query Detail Listing Template: Query Detail Listing Detailed listing of all queries in the study
Standard Template: Casebook Signature Summary (V3) Casebook Operational Summary with Site A summary matrix report of signature status by Casebook. Possible values include Yes to indicate if a casebook is fully signed and No to indicate if a casebook is not signed.
Standard Template: Comprehensive Form Summary (V3) Template: Form with Event, Form Def, Site, Subject, Form Summary A tabular report detailing the form's SDV, DMR, Frozen, Signature and Locked statuses and the dates when those were completed, grouped by site and subject. Only includes submitted forms.
Standard Template: Cumulative Subject Creation per Week (V3) Template: Subject A summary matrix report of the number of subjects created per week, grouped by site. 
Standard Template: Detailed Missing Forms Report (V3) Template: Form with Event and Form Def, Site and Subject A tabular report with of non-submitted forms that are overdue. Only includes forms that have been added to the schedule but are not yet submitted. Events must be configured with Overdue Days in order for forms at that event to be marked as overdue.
Standard Template: Event Signature Summary (V3) Event with Study Site and Event Operational Summary A summary matrix report counting the signature status submitted events. Possible values include Yes to indicate if an event is signed, No to indicate if an event was signed and was unsigned, or None to indicate if an event has never been signed.
Standard Template: Event Status (V3) Template: Event with Event Operational Summary A matrix report, filtered by study, providing a count of events by site and status.
Standard Template: Form Cycle Time Summary (V3) Template: Form Cycle Time Summary A tabular report of form cycle times, broken down by site. Cycle times include: Visit to Form Submit, Form Submit to SDV, DMR, Signature, Frozen and Lock
Standard Template: Form DMR Detail (V3) Template: Form Operational Summary with Event and Form Definition A tabular report of DMR status for forms where DMR is required, grouped by site and subject. Possible values include Yes to indicate if all required items on the form are DMR Complete or No to indicate if not all required items are DMR Complete.
Standard Template: Form DMR Monitoring Activity per Week (V3) Template: Form Operational Summary with Form and Study Site A summary matrix report of the number of forms marked as DMR Complete, per week. Sites are included when at least one form has been marked as DMR Complete.
Standard Template: Form DMR Summary (V3) Template: Form Operational Summary with Form and Study Site A summary matrix report of DMR status at the form level. Only includes forms where DMR is required. Possible values include Yes to indicate if all required items on the form are DMR Complete or No to indicate if not all required items are DMR Complete.
Standard Template: Form SDV Detail (V3) Template: Form Operational Summary with Event and Form Definition A tabular report of SDV status for forms where SDV is required, grouped by site and subject. Possible values include Yes to indicate if all required items on the form are SDV Complete or No to indicate if not all required items are SDV Complete.
Standard Template: Form SDV Monitoring Activity per Week (V3) Template: Form Operational Summary with Form and Study Site A summary matrix report of the number of forms marked as SDV Complete, per week. Sites are included when at least one form has been marked as SDV Complete.
Standard Template: Form SDV Summary (V3) Template: Form Operational Summary with Form and Study Site A summary matrix report of SDV status at the form level. Only includes forms where SDV is required. Possible values include Yes to indicate if all required items on the form are SDV Complete or No to indicate if not all required items are SDV Complete.
Standard Template: Form Signature Summary (V3) Form with Study Site and Summary A summary matrix report counting the signature status submitted forms. Possible values include Yes to indicate if a form is signed, No to indicate if a form was signed and was unsigned, or None to indicate if a form has never been signed.
Standard Template: Form Status (V3) Template: Form with Event and Study Site and Subject A summary matrix report of all form statuses, broken down by site and subject.
Standard Template: Frozen Casebook Summary (V3) Casebook Operational Summary with Site A summary matrix report of signature status by Casebook. Possible values include Yes to indicate if a casebook is fully frozen and No to indicate if a casebook is not frozen.
Standard Template: Frozen Event Summary (V3) Event with Study Site and Event Operational Summary A summary matrix report counting the freeze status of submitted events. Possible values include Yes to indicate if an event is frozen, No to indicate if an event was frozen and was unfrozen, or None to indicate if an event has never been frozen.
Standard Template: Frozen Form Summary (V3) Form with Study Site and Summary A summary matrix report counting the freeze status of submitted forms. Possible values include Yes to indicate if a form is frozen, No to indicate if a form was frozen and was unfrozen, or None to indicate if a form has never been frozen.
Standard Template: JDrug Coding Report (V3) Template: Clinical Coding Clinical Coding Request and assigned codes (if assigned) for JDrug based forms; Standard Reports are updated by Veeva
Standard Template: Locked Casebook Summary (V3) Casebook Operational Summary with Site A summary matrix report of signature status by Casebook. Possible values include Yes to indicate if a casebook is fully locked and No to indicate if a casebook is not locked.
Standard Template: Locked Event Summary (V3) Event with Study Site and Event Operational Summary A summary matrix report counting the lock status of submitted events. Possible values include Yes to indicate if an event is locked, No to indicate if an event was locked and was unlocked, or None to indicate if an event has never been locked. 
Standard Template: Locked Form Summary (V3) Form with Study Site and Summary A summary matrix report counting the lock status of submitted forms. Possible values include Yes to indicate if a form is locked, No to indicate if a form was locked and was unlocked, or None to indicate if a form has never been locked.
Standard Template: MedDRA Coding Report (V3) Template: Clinical Coding Clinical Coding Request and assigned codes (if assigned) for MedDRA and MedDRAJ based forms; Standard Reports are updated by Veeva
Standard Template: Overdue Form Entry per Event (V3) Template: Event with Event Definition and Event Summary A tabular report of blank and in progress events, grouped by site and subject. Includes the expected number of forms at each event and the number of days data entry is overdue. Only include events that are configured with an overdue days value.
Standard Template: Queries Causing Data Value Change (V3) Query Operational Summary with Query A tabular report of system queries that caused the item value to change, grouped by study and query rule. 
Standard Template: Query Aging by Site (V3) Template: Query Cycle Time Summary A summary matrix report of the open and answered query counts by query age grouping (1 Week, 2 Week, 3 Week, 4 Week, >4 Weeks), grouped by site.
Standard Template: Query Cycle Time Summary (V3) Template: Query Cycle Time Summary A tabular report of all queries in a study. Cycle times include Query Age, Time to First Response and Time from Open to Closed. 
Standard Template: Query Details by Site and Subject (V3) Template: Query with Subject and Query Binding and Query Message A tabular report of query details, grouped by site and subject.
Standard Template: Query Volume by Rule Definition (V3) Template: Rule Definition with Study and Query Binding A summary matrix report of the number of queries per rule definition, grouped by site.
Standard Template: Query Volume per Form (V3) Template: Form with Form Definition and Query Binding A summary matrix report of the number of queries per form definition. 
Standard Template: Query Volume per Week by Site (V3) Template: Study Site with Query Binding A summary matrix report of the number of queries created per week, grouped by site. 
Standard Template: Safety Cases (V3) Template: Safety A tabular report of safety cases in a study. 
Standard Template: Schedule Deviation Report (V3) Template: Event Operational Summary with Event Definition A tabular report of events, showing adherence to the planned visit schedule, grouped by site and subject.
Standard Template: Site Queries (V3) Template: Query Binding with Study Site A summary matrix report of the number of queries, grouped by query status and site.
Standard Template: Study Closeout Status (V3) Template: Study Closeout A tabular report of the closeout status of each site in a study.
Standard Template: Subject Status Summary by Site (V3) Template: Subject with Study and Study Site A summary matrix report counting the number of subjects in each status, grouped by site. 
Standard Template: Subject Study Progression (V3) Template: Event Operational Summary A tabular report of planned and entered events, grouped by site and subject.
Standard Template: Unique CRF Listing (V3) Template: Form Definition A tabular report of unique CRF definitions in a study.
Standard Template: Unique Rule Definition Listing (V3) Template: Rule Definition with Study and Query Binding A tabular report of unique rule definitions.
Standard Template: WHODrug Coding Report (V3) Template: Clinical Coding Clinical Coding Request and assigned codes (if assigned) for WHODrug based forms; Standard Reports are updated by Veeva
Subject Progress Listing Template: Subject Progress Listing Listing of all subjects and their progress in the study

Use Case

Veeva can update standard reports without creating a new version, and organizations can use those reports as templates to create their own reports.

Enablement

These reports and the dashboard are automatically available, but a Vault Owner must update the sharing settings for the reports to be visible to other users.

Standard Coding Reports & Dashboard

With this release, coding reports are available in the Veeva Standard Report format. All CDMS vaults (new and existing) will have the following standard reports:

  • MedDRA Standard Report V3 (supports MedDRA and MedDRAJ)
  • WHODrug Standard Report V3 (supports both B3 and C3)
  • JDrug Standard Report

This feature also makes available the Coder Dashboard V3 dashboard, which includes the following components:

  • Coding Statuses
  • Pending Coding
  • Percent Coded vs. Autocoded
  • Query Statuses
  • Pending Queries
  • Query by Site

If all features are enabled in Coder Tools, the standard reports for all dictionaries will include all of the relevant columns for those features. Because these reports are Veeva Standard Reports, users can’t customize them. Instead, a user can copy the report and make their changes in the copy. For example, an organization may want to remove the Preferred Base column from the WHODrug Standard Report V3.

Use Case

These reports and the dashboard provide coders with reports in a standard format, which can help coders make coding decisions and track required coding metrics. Through Standard Veeva Reports, we can now issue updates directly to the reports, which isn’t possible with custom reports.

Enablement

These reports and the dashboard are automatically available, but a Vault Owner must update the sharing settings for the reports to be visible to other users.

Route Coding Reports to Coder

Links for the Name columns in Vault Coding reports now lead directly to the related Code Request pages in Vault Coder. Links in the Name column of Coding Reports have the format VV-XXXX., When routed to the respective Code Request page, the page is filtered for that specific Code Request record. A new filter for Name will be displayed and has been added to the Code Request page. If the Name link for a coding query, coding note, or coding property is clicked then that will be in focus on the Code Request page. The same applies to when the Name link is clicked for a Grouped Code Request. If the Name link for a Medical Coding Item Definition is clicked, then the respective Code Request page will load showing all the respective Coding Requests. A name filter on the Code Request Page can be removed at any time by the Coder.

Use Case

Coders can access a Code Request, a specific Query, Note, Property, or Group on the Code Requests page by clicking the link in the Name column of coding reports. This helps coders take quick actions on Code Requests.

Enablement

This change applies automatically inany re3ports that reference coding objects.

Study Design & Configuration

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

Rules: Usability Improvements

This release includes the following updates to improve rule usability:

  • @PreviousEvent identifiers can now be used with Set Derived Value rules
  • We’ve updated how rules are evaluated when they contain multiple Item to Form links (such as from a repeating Item Group, for example) and Item to Form links to the same Form. Previously, the link identifiers were grouped at the Form level and evaluated once. With this release, individual link identifiers will be evaluated separately to ensure that linked information from a specific Item Group is correctly associated in rule processing.
  • Vault will no longer prevent users from submitting a form when submission would result in a query being opened on a locked object (Form, Event). With this release, Vault will allow form submission but skip opening a query on a locked object.

Use Case

These enhancements provide improved rule capabilities and execution.

Enablement

This improvements are automatically applied.

Study Administration

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

Import & Export Training Mapping

Vault now supports the import and export of training mappings for the Veeva Learning Integration. This allows organizations to easily copy curriculum assignments from one vault to another.

This feature introduces two new actions: Load from File and Export to File.

The Export to File action generates an Excel™ file (“StudyName_LearningSystemName_Timestamp.xlsx”) of the current curriculum assignment grid.

Users can edit that file and then use the Load from File action to import it into the current study or another study to use those mappings. Import supports both CSV and XLSX file formats.

As part of this feature, we made the following UI changes:

  • We moved the Edit and Copy from Study actions from buttons into the new Actions menu.
  • After the initial add of curriculums, the button is now lableled Sync Curriculum.

Use Case

This feature helps support operational processes for revising training mappings where importing is preferred. For CROs who manage multiple sponsor vaults, the import capability alleviates the need to re-create the individual mappings in each new sponsor vault.

Enablement

Contact Veeva Support to enable this feature in your vault. The curriculum itself must be added first before import of training mapping is allowed.

Labs: Import Lab Units and Codelists

Lab Data Managers can now import multiple Lab Units and Codelists at once. Like importing Analytes, importing Units and Codelists will be validated by the system and Vault will display feedback on what records need attention. Once the file is fully validated, the file can be imported. Users can export Units and Codelists in CSV format or as an Excel™ file.

Use Case

This feature allows users to save time by importing multiple units and codelists at once instead of adding each unit or codelist individually. Users can also easily move Lab Units and Codelists between non-connected Vaults by exporting from one Vault and importing into another Vault.

Enablement

Auto-on with the 23R3 general release.

Learn More

Study Priority & Job Governor Enhancements

We’ve made the following general enhancements to the Study Data Extract job:

  • Study Priority: Priority expiration will be reset to 7 days after a priority study is locked
  • SAS Enhancements: XPT files can now be opened in the SAS Universal Viewer

Use Case

These updates improve usability.

Enablement

This enhancements are automatically available.

Review Plan Assignment V3 Enhancements

This feature includes the following new option in the Assignment Criteria section when creating a Review Plan Assignment: “Apply Review Plan Assignment to all sites within selected countries individually.” This setting will respect the assigned ordinals and percentages individually for each site within the selected country.

In addition, the Reorder Assignment job has been renamed to Reevaluate Plan Assignment for clarity, as the job runs through the history of each subject and applies Review Plans based on the current/updated criteria. A downloadable report and log file are provided in the Job History tab that detail the subjects whose review plans were changed as a result of the job. Options to select Specific Sites and Preview the job’s output are also available with this release.

Use Case

This feature provides more clarity when assigning Review Plans and using the Reevaluate Plan Assignment job and additional options to further meet configuration requirements with targeted SDV and DMR Review Plans.

Enablement

Auto-on with the 23R3 general release.

Study Data Extract Enhancements

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

  • The SYS_SUB dataset will include columns for Latest Arm (LATESTARM), Latest Cohort (LATESTCOHORT), and Latest Substudy (LATESTSUBSTUDY) if the study includes these subject group definitions.
  • The SYS_PD dataset has been updated with four new columns:
    • Protocol Deviation Restricted (RESTRICTED): visible only when the user selects the Include Restricted Data option
    • Event External ID (EVENTEID)
    • Form External ID (FORMEID)
    • Item Group External ID (IGROUPEID)
  • Item Group External ID (IGROUPEID) has been added to the following datasets:
    • SYS_LINKS (if Item to Form Linking is enabled)
    • SYS_ILB
    • SYS_Q
    • Clinical Lab datasets
  • The SYS_ASM and SYS_ASMR datasets have been updated to include the following new columns:
    • Event Group (EGROUP)
    • Event Group Definition (EGROUPDEF)
    • Event Group External ID (EGROUPEID
    • Event (EVENT)
    • Event Definition (EVENTDEF)
    • Event External ID (EVENTEID)
    • Event Group Sequence (ESEQ)
    • Form (SOURCEF)
    • Form Definition (SOURCEFDEF)
    • Form External ID (SOURCEFEID)
    • Form Sequence (FSEQ)
  • The SYS_ASMR dataset includes the following columns in addition to the columns listed above:
    • Question Number (QUESNUM)
    • Question External ID (QUESEID)
  • For studies using a Safety configuration, the 23R3 version of the SDE includes 2 new SYS datasets for Safety Cases (SYS_SAFEC) and Safety Messages (SYS_SAFM)

Use Case

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

Enablement

Auto-on.

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: Define Structure

This release of the Listing Builder includes new options that allow users to define the row and column structure for listings, checks, and views.

The row structure of a listing can be defined by either of the following options:

  • By Subject: This option attempts to display data from multiple forms across events in a single row for the subject, independent of the study schedule, and displays all data where subjects match across events. Any selected schedule-related fields, such as Event Date or Event Name are set to null in the listing.
  • By Schedule: This option displays form data from different events on separate rows. We recommend this option if schedule-related fields are required. This is the default option for all core listings.

The column structure of a listing can be defined by either of the following methods:

  • Wide (Side by Site): With this option, each column represents a single unique item or item property.
  • Stacked (Union): With this option, each column can contain multiple items or item properties stacked together, where the user can include up to five (5) items and/or item properties per column.

Use Case

Selecting the row structure enables the end user to choose whether or not to align the data dependent or independent of the study schedule. Defining the column structure enables the user to combine for instance lab data from different sources into stacked columns lending to a more narrow readable Listing.

Enablement

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

CDB Listing Builder: Validate & Modify

This release of the Listing Builder brings a guided experience for validating and modifying a listing against the current study design. CDB automatically validates the selections made in each step of the Listing Builder, checking for issues such as duplicate aliases or required fields not defined.

For any simple listing created via the Listing Builder, users can modify it using the Listing Builder and/or CQL.

Modifying Listings with Stacked Columns: In the current release, the Listing Builder doesn’t allow users to modify listings with stacked columns.

Use Case

This feature provides users with a guided way to identify and update their listing definitions in response to study design changes.

Enablement

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

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.

Roles, Permissions & Security Enhancements

To support new features in the 23R3 release, we made the following changes:

New Study Roles:

  • CDB API Read Write: This role allows for an API user to interact with CDB to open, answer, and close queries from both EDC and third party data sources.

Updates to existing Study Roles:

  • Added the Manage Email Group Assignment permission to the CDMS API Read Write role
  • Assigned the following permissions to the CDMS API Read Only and CDMS API Read Write roles:
    • View Library
    • View Study Design
    • View Classification
  • Assigned the following permissions to the CDMS API Read Write role:
    • Design Library
    • Design Study
    • Edit Classification
  • Assigned the Manage Jobs permission to the CDMS Safety Administrator role

New dependencies:

  • The Manage Safety Integrations permission now requires the Manage Jobs permission.

Enablement

These changes apply automatically to all CDMS standard Study Roles. If an organization uses custom Study Roles, a user administrator must update their Study Roles after the release to use these permissions.

Migration Vault

Features in this section are new features for Migration Vault.

Retrying TAPIs & Runs

This feature retries connection-related errors, such as client-side connection issues and read timeouts. Previously, since there were no retries, connection-related errors required a remigration. Now Migrations engineers can retry the Run, Med Coding, and Post-Run steps for loads should they fail in certain situations.

Use Case

Prior to this feature, once a connection was lost or a read timeout occurred, it could not be retried. In non-production environments, this required study data to be deleted and remigrated, which is not applicable to production environments. While this feature doesn’t eliminate the need to delete study data in production environments, it will help mitigate certain issues that require a Migration Reset. Migration Resets should be the last resort.

Enablement

For retrying TAPIs, this feature is automatically enabled. For Retrying Runs, assistance from a Migration engineer is required.

EDC Duplicate Detection Job

This feature helps Migration engineers find duplicate objects created during the recovery process of a failed production run. Duplicate Detection Job results are generated in batches of CSVs and shared with Migration stakeholders.

Use Case

Migration engineers can run the Duplicate Detection Job after a migration recovery and share the results with stakeholders. The results can then be analyzed to provide details on next steps. The job report provides one of three results:

  • No duplicates found: recovery a success, proceed as normal
  • Manageable amount of duplicates found: manual subject deletion in EDC required
  • Too many duplicates found: Migration Reset required

Enablement

Migration engineers must run this job.

Separating Form Submission from Post-Run Step

This feature separates Form Submissions, making it a distinct step within the Workflow Progress table. Previously, it was included within the Post-Run step.

Use Case

Form Submissions were previously included within the Post-Run step. When separated, forms can be submitted before applying attributes. This helps avoid concurrent, asynchronous jobs and provides more consistency across loads, preventing notable variations in _Post-Run _times.

Enablement

This feature is automatically enabled.

Migration Report & Log File Enhancements

This feature enhances the existing Migration Report by improving the way errors appear in Log Files, such as log time for the entire load and each workflow step. Users now have more insight into how long each step or load takes based on Study size.

Use Case

This enhancement provides users with more information on migrated Studies, which can be used to help troubleshoot errors and plan for future migrations.

Enablement

This feature is automatically enabled.

Feature Enablement Summary

Feature Name Configuration Dependencies Day 1 Impact to Primary Users Users with Day 1 Visibility
CDMS
Reports & Dashboards
Standard Versions of CDMS Operational Reports    
  • Vault Owners
Standard Coding Reports & Dashboard    
  • Vault Owners
Route Coding Reports to Coder    
  • Vault Owners
Study Design & Configuration
Rules: Usability Improvements    
  • Study Designers
  • Librarians
Study Administration
Labs: Import Lab Units and Codelists Labs  
  • Clinical Team
  • Lab Data Managers
Review Plan Assignment V3 Enhancements    
  • Clinical Team
  • Lead Data Managers
  • Librarians
  • Study Designers
  • Super Users
Role Management & Security
Roles, Permissions & Security Enhancements    
  • Lead Data Managers
  • User Administrators
  • API Read Only
  • API Read Write
Vault CDB
Migration Vault
Limited Availability: In the current release, Migration Vault is only available to early adopter customers. Contact your Veeva Services representative for details.
Retrying TAPIs & Runs    
  • Migration Users
EDC Duplicate Detection Job    
  • Migration Engineers
Separating Form Submission from Post-Run Step    
  • Migration Users
Migration Report & Log File Enhancements    
  • 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.