New Features in 25R1 Limited Releases
25R1 Planned General Availability: April 4 & 11, 2025
24R3.5 Release Date: February 28, 2025
24R3.4 Release Date: February 7, 2025
24R3.2 Release Date: December 18, 2025
We are pleased to bring you new functionality with each limited release. These release notes are updated with upcoming new features one week before the limited release date.
Data Entry
Features in this section are changes to the Data Entry tab, a working area for investigators and clinical research coordinators to enter study execution data.
Bulk Signature Flag & Button Updates 24R3.2
Use Case
To help alleviate confusion around signature capabilities, the “Sign Casebooks” button in Data Entry has been re-labeled to “Bulk Sign Casebooks”, and the button is now viewable on the Site grid page for all studies. These changes allow Primary Investigators to be more aware of the Bulk Signature features.
Description
Previous to this release, the Sign Casebooks button on the casebook grid page in Data Entry was hidden when bulk signature settings were not used for a study or site. The button is now visible for all studies. Similarly, in the site grid, the Bulk Sign Casebooks option is now visible in the action menu next to the site number. The button and menu option will be enabled or disabled as indicated from the Enable Bulk Casebook Signature setting in EDC Tools and the Bulk Casebook Signature site setting.
Hovering over the button in the casebook grid and the site grid action menu will display the applicable reason when the button is disabled.
Enablement & Configuration
Automatically available for all studies on all vaults, the button is no longer included as part of the Vault’s feature flag. The button and menu action will be selectable based on existing study and site settings within EDC Tools. New studies and sites will have the setting set to Yes by default.
ILB Behavior Update for Queries 24R3.2
Use Case
Previously in cases where site users marked items or the whole form as intentionally left blank (ILB), an existing query would be removed when ILB was selected.
Description
This feature changes the dependency from the ILB action to the rules engine and allows the rules engine to determine if the query will close. If the conditions of the rule are no longer true, then the query will automatically close, per the existing rules behavior.
Enablement & Configuration
These updates are automatically available.
Improved Validations for Unscheduled Events 24R3.2
Use Case
Previously, while adding an unscheduled event site users were less aware that required fields were missing and in some cases confused about why the Save button was not enabled. This improvement to the unscheduled event dialog provides clarity to site users and a user experience that is more consistent with other areas of EDC.
Description
When adding an unscheduled event, the Save button now remains enabled. Required fields that are left empty are highlighted in the dialog and an error message is displayed underneath the field.
Enablement & Configuration
These updates are automatically available.
Query Team Updates for Single Team, Multi-role and Multi-site users 24R3.2
Use Case
Improvements have been made to the Query Team feature and query dialog. These enhancements help to clarify which query team is assigned while the query is being added and help automate the assignment of the accurate query team.
Description
Users with Multi-role and Multi-Site access: The system will now automatically assign the appropriate query team for the user when they are part of a single query team for that site. When using multi-role security, where the user’s roles are part of more than one query team for the site(s), the selector will display for the user to choose the appropriate query team.
Users with a single query team: When opening a query, the query dialog will immediately display the user’s query team. This helps show the user the team where they are entering the query.
Enablement & Configuration
These updates are automatically available.
Usability Improvements for Item Change Reason 24R3.2
Use Case
Previously, in some cases when revising form data, site users were not able to continually see the selected change reason while the form was In Edit.
Description
To provide clarity and better usability, after the user selects a change reason for the item, the revised change reason will now remain displayed until the user submits the form. The change reasons from prior form submissions will not display during a subsequent In Edit session. Additionally, for studies using local labs, the change reason dropdown will not show until the user edits the value in the lab header.
While editing a form, if the user clears the change reason they will no longer see a blank selection. They will continue to see the drop down and the error text will display: “Error: Change reason is required”.
Enablement & Configuration
These updates are automatically available.
Data Review
Features in this section are changes to the Review tab, a working area for clinical research associates and data managers, or to review functionality within the Data Entry tab.
Event Operational Summary Records for Log Events 24R3.2
Use Case
These updates provide increased visibility of SDV, DMR, Freezing, Locking, and PI Signature in listings, extracts, and reports that use event operational summary records.
Description
Log events will now be included in event operational summary records. Due to the differences between log events and scheduled events, some fields in the log event summary will behave differently. These behaviors will be documented on the CDMS help site following the release.
These records are visible in the Event Progress Listing, SYS_EVT dataset, Standard Template: Schedule Deviation Report (V3) standard report, and any custom report based on the Event Progress Listing or Event Operational Summary report type.
Enablement & Configuration
This enhancement is automatically available in the general release.
Updates to Event Progress Listings 24R3.2
Use Case
To support study review activities, we’ve added new columns, renamed some columns, and updated the logic to improve the usability of the Event Progress Listing.
Description
- Added new columns to show where Re-SDV and Re-DMR are required when review was complete and then data changed and the review state was cleared
- The logic for Event Date and Visit Method Frozen, Locked, and Signed columns has been updated for Log events, which do not have event dates or visit methods, to display as blank instead of “No”
In addition, the following column names in the Event Progress Listing have been updated:
| Current Name | New Column Name |
|---|---|
| Event Date First SDV Complete Date | Event Date First SDV Completion Date |
| Event Date SDV Complete Date | Event Date SDV Completion Date |
| Visit Method SDV Complete Date | Visit Method SDV Completion Date |
| % Forms SDV | % Forms SDV Complete |
| Event Date First DMR Complete Date | Event Date First DMR Completion Date |
| Event Date DMR Complete Date | Event Date DMR Completion Date |
| Visit Method DMR Complete Date | Visit Method DMR Completion Date |
| % Forms DMR | % Forms DMR Complete |
| Freeze Date | Event Frozen Date |
| Lock Date | Event Locked Date |
Enablement & Configuration
This enhancement is automatically available with the release.
Extract Job Governor Enhancements 24R3.2
Use Case
These updates allow for more flexibility for studies to schedule jobs multiple times per day without worrying about job options for Restricted data.
Description
We’ve removed Job Governor restraints based on Restricted status and increased daily limitations for certain listing jobs to four jobs per study. This feature affects the Study Data Extract job, Study Progress Listings jobs, and Study Progress Versioned Extracts jobs. The Restricted status constraint will be removed from the Study Summary Metrics Report and Additive Review Listing jobs but those jobs will still be limited to two scheduled jobs per study.
Enablement & Configuration
This enhancement is automatically available with the release.
Updates to Query Detail Listings 24R3.2
Use Case
New columns were added to support the new Quick Queries feature, as well as updating the column names to improve understanding of the Query Detail Listing.
Description
The following new columns have been added to the Query Detail Listing: Item Value Confirmed and Observed Source Value. The Original Query Text, Latest Query Comment, and Latest Query Answer Text columns will maintain the formatting of Quick Queries, which uses brackets to display system generated responses.
We’ve also updated the following column names in the Query Detail Listing:
| Current Name | New Column Name |
|---|---|
| Answered Date | Query Answered Date |
| Answered By | Query Answered By |
| Closed Date | Query Closed Date |
| Closed By | Query Closed By |
Enablement & Configuration
This enhancement is automatically available with the release.
Review: Vault Owner Access to Scheduled Jobs 24R3.2
Use Case
This feature provides Vault Owners with better visibility to all jobs within the Job Schedule area of the Review tab.
Description
Vault Owners are now able to modify jobs created by other users. They can see all scheduled jobs in the Review tab and are able to edit, delete or set the job to Run now. These include:
- Additive Review Listing
- Core Listing
- Data Export (Legacy)
- Detail PDFs
- Event Progress Listing
- Form Progress Listing
- Query Detail Listing
- Study Summary Metrics Report
- Subject Progress Listing
Enablement & Configuration
These enhancements are automatically available.
Updated Column Names in Form Progress Listings 24R3.2
Use Case
This feature improves understanding of the Form Progress Listing.
Description
The following columns have been updated in the Form Progress Listing:
| Current Name | New Column Name |
|---|---|
| SDV Override Plan | Form SDV Override Plan |
| SDV Required | Form SDV Required |
| Requires Re-SDV | Form Requires Re-SDV |
| SDV Complete | Form SDV Complete |
| SDV % | Form SDV % |
| SDV Age | Form SDV Age |
| First SDV Completion Date | Form First SDV Completion Date |
| SDV Completion Date | Form SDV Completion Date |
| DMR Override Plan | Form DMR Override Plan |
| DMR Required | Form DMR Required |
| Requires Re-DMR | Form Requires Re-DMR |
| DMR Complete | Form DMR Complete |
| DMR % | Form DMR % |
| DMR Age | Form DMR Age |
| First DMR Completion Date | Form First DMR Completion Date |
| DMR Completion Date | Form DMR Completion Date |
Enablement & Configuration
This enhancement is automatically available with the release.
Clinical Coding
The following are new features for Coder, the clinical coding area for Vault Coder.
Coding Source for Propagate Code Action 24R3.2
Use Case
Coding updates applied due to the Propagate Code action are now clearly identified via the manual source field on the impacted code requests, regardless of the final status that is configured.
Description
When coders use the Code All Forms and Update Synonym List action to propagate a coding decision to all matching, coded Code Requests and Synonym List records, Vault will reflect these coding updates as a manual coding action. The Manual Source field is updated to Propagate Code and all previous autocoding property fields are cleared out for impacted code requests.
Enablement & Configuration
These updates are automatically available.
Column Updates to Coder Summary Page 24R3.2
Use Case
We’ve updated the Coder Summary page to provide greater visibility of Coding Query statuses.
Description
The Open Queries column will now reflect the count of queries waiting for site action. A new column, Answered Queries reflects the count of queries answered by the site, awaiting review and closure.
Enablement & Configuration
These updates are automatically available.
New Validation for Synonym List Record Approval 24R3.2
Use Case
This update improves the user experience during synonym list record approval.
Description
This release adds a new validation warning to synonym list record approval. When a user is attempting to approve a synonym list record, the action will be blocked if an active matching synonym list record already exists in the same synonym list with a different code.
Enablement & Configuration
These updates are automatically available.
Code Request Listing Filter and Column Updates 24R3.2
Use Case
In this release we are making updates to the Coder Code Request Listing filters and columns to increase usability and efficiency for users.
Description
THe following updates have been made:
- The following filters will be made ‘sticky’ and once configured will persist across all coding form types within a single session:
- List View: Coding Status, Query Status
- Group View: Coding Status
- Updates to Subject Filter to show all subjects regardless of subject status. Previously, subjects with Pre Screening, In Screening, or Screen Failure status were not shown.
- A Study Country column is now available to be added to List View
- Enable sorting for the Code Request Age (D) column, if added. The calculation logic for this field has also been updated to derive age in days as Today’s date - Last Uncoded Date.
Enablement & Configuration
These updates are automatically available.
Study Design & Configuration
Features in this area apply to Studio, the study design and configuration area for Vault EDC.
Importing Items
Use Case
This update enhances efficiency for Study Builders when creating item definitions.
Description
This feature enables Study Builders to create items by importing a CSV file, potentially saving hours in the study-building process.
After completing templates provided in CDMS Help, users can import files via the drag and drop interface, and preview the results. Upon import, the system validates the file’s completeness, ensuring it contains the proper columns and required values, enforcing character limits, uniqueness, and required field completion. Errors and warnings are displayed to assist with corrections. This feature complements, rather than replaces, the manual creation of items.
Enablement & Configuration
Contact Veeva Support to enable the Import Item feature.
Importing Codelists
Use Case
This update enhances efficiency for Study Builders when creating codelists.
Description
This feature enables Study Builders to create codelists by importing a CSV file. It complements, rather than replaces, the manual creation of codelists.
After completing templates provided in CDMS Help, users can import files via the drag and drop interface, and preview the results.
Enablement & Configuration
This update is immediately available to any user with the Design Study permission, including the standard CDMS Super User, CDMS API Read Write, and CDMS Study Designer roles.
Study Administration
Features in this section apply to EDC Tools, a study-level administration area for Vault EDC.
Show Deleted Queries in the Audit Trail Export 24R3.2
Use Case
Data Reviewers can now understand which queries were previously opened and acted upon before query deletion occurred.
Description
Deleted queries now display in the Audit Trail Export job output. Prior to this release, the audit history for deleted queries was only visible to Vault Admins. Queries can be deleted when a form or event is reset or marked for removal, or when a coding request is deleted because the verbatim term value was deleted.
Enablement & Configuration
These updates are automatically available.
Export Job History 24R3.2
Use Case
Previously, users could not obtain an audit trail of the job creations without contacting support. Users are now able to obtain an audit trail of job creations directly from the Job History area within EDC Tools to obtain Job History records.
Description
We’ve added a gear icon to the top right of the Job History grid which allows users to download the Job History records in either CSV or Excel format. After selecting the format, the export file will be generated. The user receives an email notification with the link to retrieve the file in the application. If the user has logged out themselves or has been logged out due to inactivity, they will be prompted to enter their credentials before retrieving the file. Example file name: $Study_Job Export_$DateTime.xlsx where the DateTime is indicated in the user’s timezone.
The following columns are included in the file in this order:
- Study
- Job ID
- Job Type
- Job Status
- Created By
- Job Detail Information
- Created Date
Enablement & Configuration
This enhancement is automatically available with the release.
FTP Connection Enhancements 24R3.2
Use Case
The FTP Configuration report has been updated to include more information about the study to improve consistency in displaying study information.
Description
We’ve added a new column for study label to the FTP Configuration Report.
Enablement & Configuration
This enhancement is automatically available with the release.
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.
Query Metrics: Total Queries Generated Chart 24R3.2
Use Case
We’ve introduced graphs on the new Query Metrics page to provide insights into how queries are generated for a study.
Description
The Total Queries Generated chart is broken down into two parts:
By type (the inner circle)
- Automated by the CDMS system
- Manually created by a user
- Generated from an external source via the API
By source (the outer circle)
- EDC Rules
- EDC Manual
- CDB Checks
- CDB Manual
- External Sources
Enablement & Configuration
The Total Queries Generated chart is available to users with permission to View All CDB Query Listings in CDB Workbench.
CQL Support for New Header Attributes 24R3.2
Use Case
In the 24R3 release, we added new attributes to system listings. WIth this release, we updated CQL to support these new attributes in custom listings and the listing builder.
Description
The following attributes were added to CQL:
| Attribute Name in SYS Listings | CQL Syntax |
|---|---|
| Study.Label | @HDR.Study.Label |
| EventGroup.ExternalID | @HDR.EventGroup.ExternalID |
| Event.EventDateLastModifiedDate | @HDR.Event.EventDateLastModifiedDate |
| Casebook.Version | @HDR.Casebook.Version |
| Event.WindowStatus | @HDR.Event.WindowStatus |
| Event.DaysOutsideWindow | @HDR.Event.DaysOutsideWindow |
| Event.ExpectedForms | @HDR.Event.ExpectedForms |
| Event.FormEntryOverdue | @HDR.Event.FormEntryOverdue |
| Event.FrozenDate | @HDR.Event.FrozenDate |
| Event.LockedDate | @HDR.Event.LockedDate |
| Event.SignedDate | @HDR.Event.SignatureDate |
| Form.FirstSubmissionDate | @Form.FirstSubmissionDate |
| Form.SDVOverridePlan | @Form.SDVOverridePlan |
| Form.SDVCompleted | @Form.SDVCompleted |
| Form.FirstSDVDate | @Form.FirstSDVDate |
| Form.SDVLastModifiedDate | @Form.SDVLastModifiedDate |
| Form.SubmitToSDV | @Form.SubmitToSDV |
| Form.DMROverridePlan | @Form.DMROverridePlan |
| Form.DMRCompleted | @Form.DMRCompleted |
| Form.FirstDMRDate | @Form.FirstDMRDate |
| Form.DMRLastModifiedDate | @Form.DMRLastModifiedDate |
| Form.SubmitToDMR | @Form.SubmitToDMR |
| Form.SubmitToFrozen | @Form.SubmitToFrozen |
| Form.SubmitToLocked | @Form.SubmitToLocked |
| Form.LastSignatureDate | @Form.LastSignatureDate |
| Form.SubmitToSign | @Form.SubmitToSigned |
| Form.EventToSubmit | @Form.EventToSubmit |
| ItemGroup.Label | @ItemGroup.Label |
| ItemGroup.ExternalID | @ItemGroup.ExternalID |
We also updated the Core Data Listing Configuration with a subset of these attributes:
- Study.Label
- EventGroup.ExternalID
- Event.EventDateLastModifiedDate
- Casebook.Version
- Event.WindowStatus
- Event.DaysOutsideWindow
- Event.ExpectedForms
- Event.FormEntryOverdue
- Event.FrozenDate
- Event.LockedDate
- Event.SignedDate
Enablement & Configuration
These attributes will be automatically available to be included in a custom listing written in CQL or via the Listing Builder. The Core Listing default values can be updated to include the subset of attributes in Core Listings, and as default selected in the Listing Builder.
New Columns for CDB Export 24R3.2
Use Case
We’ve added additional event information to exports.
Description
For the Raw export type, we added Event.VisitMethod to Core Listings.
Enablement & Configuration
These new columns are automatically available. Existing exports will display a change notification and allow users to accept the update to the listings if they choose.
Migration Vault
Features in this section are new features for Migration Vault.
Coding Updates 24R3.2
Use Case
This update provides improved visibility of the progress and status of migration loads with Medical Coding.
Description
We have revised the Med Coding Summary table to display both the Create and Send stage of the migration process.
The Create stage references the point at which coding requests are created. The Send stage references the point at which the migration coding requests are sent to EDC Coder. The counts in this stage are populated once the Create stage is fully complete.
Enablement & Configuration
These updates are immediately available in the general release.