New Features in 25R3 Limited Releases

25R3 Planned General Availability: November 21 & December 5, 2025

25R2.4   Release Date: October 17, 2025 

25R2.3   Release Date: October 3, 2025 

25R2.2   Release Date: August 22, 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.

Enablement Changes: The enablement of each feature is subject to change from release to release. For limited releases in the same general release, we will update this page. Enablement may also change before the general release. Refer to the Release Impact Assessment for the most up to date enablement for a general release.

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.

Block Autosave of Clinical Significance Values if Not Enabled for Entry 25R2.2

Use Case

Previously, site users were able to enter Clinical Significance values even when the field was no longer applicable due to updated lab normal range indicators. This feature prevents this behavior from occurring.

Description

The system will block autosaving of the Clinical Significance value when the normal range flag value is null, Inconclusive, or Not Applicable.

Enablement & Configuration

This feature is immediately available in studies where lab clinical significance is enabled.

Disable Bulk Signature When No Signature Definition Is Configured 25R2.2

Use Case

The behavior of the Bulk Sign Casebooks button and menu item have been updated to provide clarification to site users, reducing confusion and preventing issues when bulk signing Casebooks.

Description

In Data Entry, the Bulk Sign Casebooks button at the top right of the Subjects grid is disabled when there is no Casebook Signature Definition configured for the Study. When hovering over the disabled button, site users will see the message “This action cannot be performed because there is no signature definition for the study”. Similarly in the Site grid, the menu option will be grayed out and the same hoverover message will display.

Enablement & Configuration

This feature is automatically available.

Improved UI for Grid Views During Auto-save 25R2.2

Use Case

The user interface has been improved to reduce confusion and better support data entry for studies designed with a large number of items and item group repeats using the grid view. The auto-save feature had previously caused entered values to appear to be removed when the site user quickly tabbed and entered data into the next item. With the improved UI, it will be clearer to the Site users that the values within the grid view are being auto-saved.

Description

As Site users rapidly enter data, navigating the item repeats and tabbing very quickly across the grid view, the data they enter will be more visible as it auto-saves. While adding and editing items within the grid view, the value entered will appear grayed out (uneditable) as it auto-saves.

Enablement & Configuration

This feature is automatically available.

Pre-fill Lab Result Unit Based on Normal Range Unit 25R2.2

Use Case

Prior to this release, the system pre-filled the unit field for an analyte result with the standard Lab Unit Item Definition on that Lab Unit Definition when there is no normal range found. This feature reduces the risk of sites entering data with the incorrect unit.

Description

For lab analytes with the Unit data type, the unit of the Lab Result and Lab Normal Override (if configured) will be pre-set based on the below conditions:

  • If there is a normal range value/unit available for this analyte, then the Lab Result unit and Lab Normal Override unit should be pre-set with the same unit in the normal range.
  • If there is only one unit item definition for this unit definition, then the Lab Result unit and Lab Normal Override unit are pre-filled with this unit item definition.
  • If there is no normal range value/unit available for this analyte, then the Lab Result unit and Lab Normal Override unit should be left blank and the user should need to select a unit for the lab result from the available options.

Enablement & Configuration

Auto-on.

Show Mark Event as Did Not Occur for Confirm Value Queries on Blank Events 25R2.2

Use Case

This feature provides improved action buttons for events with quick queries. For special cases, such as an overdue or reset event, users will now see a more intuitive set of options. For example, if an event with a manual query is reset, the query remains on the event. The options displayed to the site will be to enter the event details, reply to the query, or mark the event as Did Not Occur, making it easier and more efficient to manage and resolve event queries.

Description

Confirm value quick queries showing on a blank event (for example, if the event was reset after the query was opened) now display an option for the site to mark the event as Did Not Occur, instead of Confirm Value.

Enablement & Configuration

This feature is automatically available upon release.


Assessments

The following are new features for the Assessments area of Veeva EDC.

Copy Assessment Configurations 25R2.2

Use Case

The Copy Assessment Configurations feature further enhances Studio’s copy capabilities, increases study design reuse, and reduces efforts for study designers when creating assessments similar to other studies.

Description

Study designers can more easily configure assessments in Studio by copying assessment configurations from another study. The Copy From Study button has been added to the Assessments grid in Studio. Clicking the button opens the Copy From Study dialog where a study designer can select the Vault, the Study or Library, and the Environment that they want to copy from. Study designers can copy specific assessment configurations from within their current vault or from another vault and domain where the designer has access.

Similar to other Design Copy functionality, the dialog includes a search bar and has the following options for handling duplicate definitions:

  • Create a copy
  • Use existing and Update with Changes checkbox

Study designers can preview the results of their selections without actually copying the definitions into the study by clicking the Preview button.

Clicking the Preview and Copy Assessments buttons will run the applicable job and notify the user through email when the job completes. The email will confirm the job success or failure and includes a link to download the output file in .xlsx format.

The Copy Assessments job will handle supplemental data mismatches between the source and target study’s assessments, depending if the item exists or not and if the item is visible or hidden, providing warnings and status messages within the output file.

Enablement & Configuration

This feature is automatically available in Studio upon release.


Study Design & Configuration

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

Reset Forms with External Data & Repeating Item Groups 25R2.2

Use Case

External data within repeating item groups will no longer be removed when a form is reset. This allows sites to revise enterable data after a form has been reset, reducing reconciliation efforts and removing the need for third-party vendors to resend the data.

Description

When a site user resets a form, data loaded from APIs within repeating item groups remains on the form. External data displays in its original state, before any edits were made to the form.

Enablement & Configuration

This feature is automatically available for the general release.

Copy Study Settings 25R2.2

Use Case

Study Designers can further reuse study configurations by copying Study Settings from other studies and libraries.

Description

When creating a study, the New Study dialog now includes an additional checkbox “Copy study settings only”. When this checkbox is selected, the system will only copy over the study settings from the selected source vault, Study/Library, and environment into the new study. When the checkbox is unselected, the system will copy over the study settings along with the study design configurations: Event Groups, Events, Forms, Item Groups, Items, Codelists, Rules, etc.

The study settings copied over will include the selections within the following:

  • Study configurations
  • Definition defaults
  • Study
  • Signature definitions
  • Labs > Study General Settings
  • Tools > Coder Tools > Study Settings (not including form configurations)

Copy Study Settings

When selecting “Copy study settings only”, the “Ignore import casebook version” and “Import randomization configuration” checkboxes will remain grayed out.

This option is only available at the time that the study is being created. After a study is created, the settings must be updated manually.

Enablement & Configuration

This feature is automatically available in Studio.

Correct Font Based on Study Language - Chinese, Japanese, Korean 25R2.2

Use Case

This feature corrects font inconsistencies in the Detail and Closeout PDFs for specific Chinese, Japanese, and Korean fonts in studies where the study or user has these languages selected.

Description

In studies where the Enforce Study Language setting is set to “Yes” and the selected study language is Chinese, Japanese, or Korean, or in studies where the Enforce Study Language setting is set to “No” and the user’s language is Chinese, Japanese, or Korean, the following fonts are ensured in the Detail and Closeout PDFs:

Study Language Fonts

There may be specific cases in which a given language character is unavailable. In those cases, users can expect the following behavior:

  • If the study language is Japanese and the character is not available in Japanese, the character will be seen in Chinese.
  • If the study language is Chinese and the character is not available in Chinese, the character will be seen in Japanese.
  • If the study language is Korean and the character is not available in Korean, the character will be seen in Chinese.

Enablement & Configuration

This feature is automatically available when generating the Detail and Closeout PDFs in these languages. Note that when Study Language is enforced, the font for the selected study language will display. When Study Language is not enforced, the fonts will be seen in the user’s language.

Cross-Form Derivations Update Code Requests 25R2.2

Use Case

This update allows study designers to use cross-form derivations to derive values used for Coding Configuration. For example, Indication can be derived to a Concomitant Medication form from a linked Adverse Event or Medical History form.

Description

With this release, a Code Request will update automatically if a cross-form derivation rule updates an item value included in the coding configuration, without requiring form resubmission. Note that if the coding form is in an unsubmitted state while the derived item value changes, the code request will not update until the form is submitted.

Prior to this release, cross-form derived items on Coding Forms could not effectively be included in coding configuration because Code Requests only update on form submission. Therefore, if the cross-form derived item was updated outside of a submission of the coding form, the updated information was not reflected in the Code Request.

Enablement & Configuration

This feature is immediately available.

Default Review State for Read-only Items 25R2.2

Use Case

Providing options and setting the default state for handling Read-only Items allows study teams the flexibility to include or skip these items from being counted in SDV or DMR percentages within the Studio review plan configurations.

Description

When configuring review plans in Studio, read-only Items will be set to “No Review” by default in new plan configurations. A new checkbox option, “Skip read only items”, allows study designers to exclude the read-only Items from being updated when using bulk actions to revise review plan configurations. The checkbox is selected by default. A new read-only icon and hoverover text display next to the Forms and Items, visually indicating Items that are read-only and Forms containing read-only Items.

Review Plan Editor with Read-Only Icon

Enablement & Configuration

This feature is automatically available in Studio for the General Release. Read-only Items will be set to “No Review” in configurations following 25R3. Existing plans will not be impacted. The icon will appear for new plans configured following 25R3 and also for existing plans. Changes to review plans for existing studies require a versionless deployment or can be included with a new casebook version.

Studio Copy Improvements 25R2.2

Use Case

Enhancements to Studio copy capabilities provide greater reuse across studies and vaults, with the ability to copy Imaging forms, a new Preview capability for study designers to ensure copy selection results, and improvements to the copy log.

Description

Copy Preview

A new Preview button appears in the Copy dialog when copying Event Groups, Events, Forms, Rules, and Codelist/Units. Clicking the button starts a preview job and an email notification with a download link to the copy log is sent to the user when the preview job completes. The filename is appended with “_P” to note the results are a preview.

Copy preview generates the same log as the copy operation but the definitions are not saved in the destination. This allows users who are unsure of which copy options are most suitable to understand how certain definitions may be processed in the destination.

When copy preview is selected, the copy window remains open with your selections retained so that you don’t have to reselect those values after you have reviewed the preview copy log.

Copy Imaging Forms

For vaults and Studies using Imaging, these forms can now be copied across studies within the same vault. When both the source and destination studies have Imaging enabled, the imaging Form(s) will be available to copy through the Form selection field. The system-provided Imaging Item Group, Items, and Expected Modality will not be duplicated during the copy operation. Imaging Form copy also respects other Form differences and uses the existing capabilities for the Use Existing or Make a copy, and Include Rules options. Skipped imaging exam Item Groups and Items along with noted differences will be included in the copy log.

Copy Log

The copy log is improved for archived rules. It will no longer indicate rules which are skipped when the status of the rule is archived for the source and target studies.

Enablement & Configuration

These copy improvements are automatically available in Studio.

Studio Copy: Rule Identifier Matching 25R2.2

Use Case

When copying user defined rules, rule identifiers match and update with Studio configured object names to more successfully copy rules and reduce efforts for study designers.

Description

The system uses a number of system keys to uniquely identify study definitions when copying rules. This is because definition names can change from the first Study version that they are present in. Due to this behavior, it is not always clear why a definition or rule may not be copied.

When copying rules, the system will attempt to reconcile portions of the rule identifiers that had previously been shown as “null” by using the names of the Event Groups, Events, Forms, and Items found in the destination Study/Library. The name of the definition object will replace “null” when a matching name exists between the Studies/Library. As the rule loads, the system will first attempt an exact match on the system keys of the object to which the identifiers point. If the key does not match, then the system will attempt to match on the configured names of the objects. If no match is found between the Studies or Library, then the portions of the identifiers will show “null” and the status of the copied rule will be invalid.

The object name will be shown when the keys don’t match on copy in the following scenarios:

  • If a definition of that type exists in the destination with the same name but a different key from the source Study definition.
  • If you added a definition after the copy to the destination (either via a copy or manually) and it matches the name in the rule expression.

The null value will be shown when the keys don’t match on copy in the following scenario:

  • When neither the name nor key match a definition of that type in the destination.

This change doesn’t apply to the Form or Event Group selected in the Rule Details panel or to the rule action identifier. If the keys for those objects do not match, those values will still reflect “null”. Name matching for these elements during copy operations will be evaluated as a future enhancement.

In the resulting log files, rules that could not be matched on names will be indicated in the log as “Rule copied and marked invalid - missing destination study references”.

Rules that match on names will not show as modified within the Studio Comparison Report (“Diff” report).

The Study Design Specifications (SDS) will also correspond to the updated rule expression, documenting the rule identifiers with the updated names.

Enablement & Configuration

This feature is automatically available in Studio.

Improved Studio Diff Report for Comparison Rules v1 25R2.2

Use Case

A new column in the Studio Comparison (Diff) Report helps clarify the report records when V1 Comparison Rules are changed or archived. The Rule Name column indicates which rule was updated in cases where the Event Group, Event, Form, Item Group, Item Operator, and Compare To values are blank.

Description

A new column “Rule Name” has been added to the Comparison Rules tab in the Studio Comparison (Diff) Report. The new column will include the rule name where there is a difference between the study environments and helps clarify the difference in cases where the rule is reported with [not present] for the source study and [present] in the target environment. The rule name helps indicate where modifications occurred in the following scenarios:

  • The comparison rule is archived in the source study and unarchived in the target study
  • The comparison rule exists in the target study but not the source study
  • The comparison rule is present in the source and target studies, but the rule was updated in source study, resulting in separate rows to show the different rule

Enablement & Configuration

This feature is automatically available and is applicable for studies using Comparison Rules V1. This change is not applicable for studies using Comparison Rules V2.

Studio - Enable Configuration Settings for New Studies 25R2.2

Use Case

Specific study settings will now be automatically enabled when creating new studies, reducing efforts for study designers. The default settings and adoption of these features help sites and CRAs gain efficiencies with managing queries and ensure the study operates in the study language.

Description

New studies will have the Enforce Study Language, Enable Team Query Restrictions, and Enable Quick Queries settings enabled by default. Study Designers will still have the option to deselect these settings, if necessary. We encourage users to use the default settings so as to gain benefits from the associated Quick Queries and Team Query Restrictions features and to ensure the study language.

The settings for Query Team for System Queries, Study Language, and Study Locale will remain blank. Users will have to provide these settings as part of the study settings.

Enablement & Configuration

Automatically available for new studies starting after the general release. Note that settings from the source study will be used when copying a study.

Study Language Enhancements - Site Closeout Details & Site Closeout Activity Details 25R2.2

Use Case

To provide consistency and further enhancements for studies using the Study Language feature, specific text within the Closeout Activity screen has been updated to utilize the selected Study Language.

Description

When the study setting for Enforce Study Language is set to “Yes”, the Closeout Activity, located within the information icon in the Closeout Status column in EDC Tools > Sites, now displays the Events in the study’s selected Study Language.

Enablement & Configuration

Automatically available for new Closeout Activity events in studies enforcing study language. Studies that are not enforcing study language will continue to see the Closeout Activity in the user’s language.


Study Administration

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

New Locales for Veeva Clinical Data Users 25R2.2

Use Case

This feature provides consistency with user locales added at the platform level.

Description

New user locales added at the platform level are now also available for Veeva Clinical Data users. User administrators will see an additional 213 locales added to the Locale dropdown menu in the user record.

Selecting a locale from the dropdown menu

Feature support for VeevaID users will be added following the 25R3 general release. In the interim, an error message will display when attempting to set up any VeevaID user in EDC with an unsupported locale.

Enablement & Configuration

This update is immediately available.

Add Icons to Normal Range Indicator Values in the Review Tab 25R2.2

Use Case

This update provides consistency in the display of lab normal range indicator values between Data Entry and Review.

Description

Lab Normal Range Indicator icons will now also be visible on lab forms in Data Review.

Normal Range Indicator Icons

Enablement & Configuration

These icons will be immediately visible in the Review tab for applicable lab results.

Disable Audit during PPT Study Deletion 25R2.2

Use Case

This update helps to streamline deletion records and prevent performance issues which could have been encountered in a TEST or PPT vault, where the PPT environment is located, and following the deletion of the PPT environment.

Description

Following the deletion of a PPT environment, the system does not need to retain specific deletion records within the system audit trail which occur from a previous PPT environment deletion or from copying the data into the PPT environment where that PPT environment is now deleted.

The deletion records listed here from the system audit trail and which were previously retained as part of the PPT environment deletion are now cleaned up and removed from the system audit trail records. Note, actions and revisions to data within the active PPT environments are always included in the audit trail.

  • item2__v
  • item_group2__v
  • item_history2__v
  • item__v
  • item_group__v
  • item_history__v
  • query_message__v
  • review_state__v
  • execution_data_state__v
  • coding_request__v
  • rule_result__v
  • signature_binding__v
  • signature_readiness__v

Enablement & Configuration

This feature is automatically available for the General Release. This feature is not testable by study end users and is an adjustment only to the system audit trail accessible by Vault Owners.

Deployment UI & Processing Improvements 25R2.2

Use Case

We’ve introduced enhancements to the study deployment process which includes UI improvements to help clarify and reduce deployment failures and reduce the need to contact Veeva Support to help successfully re-deploy design changes.

Description

During study deployment, the deployment package will process as a series of smaller transactions grouped by casebook version and by versionless portions of the study design. Successful and unsuccessful portions of the design will be tracked in the background as part of the deployment process. When the Delete Study Data or Generate the Detailed PDF options are selected as part of the deployment, those files will be processed prior to the design import to reduce deployment failures.

When a deployment fails, the appropriate transaction causing the failure will be noted in the log.

In the study environments page in Studio, UI updates help notify designers and testers when the environment is temporarily unavailable and that a re-deployment step is needed. A red error icon and a link to the Deployments page in help will display in the new hover over message.

In Studio, if an environment is temporarily unavailable, users will not be able to copy casebook definitions to or from other studies. Users will be prevented from selecting the environment when running Diff reports while it is unavailable.

In EDC Tools, while attempting a deploy action for an unavailable environment, the system will display the following error message: “This study has a casebook definition failed deployment and has been marked unavailable.” When attempting to restore another study design to an unavailable environment, the dropdown menu will not include this environment in the selection list. On the Sites page, setting the active version will not be allowed in the UI or through the import and a new dialog will display if the user attempts to run a Retrospective Amendment for the unavailable environment.

Additionally, as part of this feature, if a user attempts to alter the URL to navigate to a study environment, they will be automatically re-directed to the Study Master page for that study.

Note that this feature will not impact Production environments, as a successful deployment to TEST is first required before deploying the version to PROD. To make a TEST environment available again, the user can remove data that would be impacted by the design changes prior to attempting to re-deploy the new version.

Enablement & Configuration

This feature is automatically available for the General Release.

Job Site Selection Enhancement 25R2.2

Use Case

Improvements to the site selection within job dialogs provide a consistent experience and help Data Managers differentiate between sites. This is particularly useful in cases where two sites have different numbers but the same site name.

Description

The Source and Target site selections have been updated to include both the site name and site number when running these jobs. The search feature within the dialog now additionally supports searching on the site number. Jobs impacted by this update include the following:

  • Detail PDF
  • Core Listings (EDC Tools and Review tabs)
  • SDV Re-assignment
  • DMR Re-assignment
  • Recalculate Normalized Datetime Values

Job Setup Dialog with Site Numbers

The hoverover information has also been updated to include the site name along with the site number.

Job History with Hoverover Text Showing Site Number

Enablement & Configuration

This feature is automatically available.

Pre-deployment Difference (Diff) Report 25R2.2

Use Case

In cases where study designers forget to generate the Studio Comparison Report prior to deployment, the system will now automatically generate the Diff report.

Description

When deploying study design changes, the “Diff” report (Comparison report) will automatically generate prior to the deployment import process. Included in the Deployment History files, the Excel formatted file will include the “_pre” suffix, after the date/time stamp. For example:

Diff_StudyName_TST2_3_to_StudyName_DEV1_3_073120251245_pre.xlsx

These files will generate regardless of whether the deployment succeeds or fails.

Enablement & Configuration

This feature is automatically available for the General Release.

SDE - Support Lab Localization Timezone & Fasting Status in SYS Files 25R2.2

Use Case

These additions provide additional information from EDC in the SDE exports.

Description

The 25R3 version of the SDE includes the following updates to Lab system files:

  • To support new data elements added in a previous release, we are including Lab Location Time Zone (as LABTIMEZONE) in the SYS_LABLOC file and Fasting Status (as LBFAST) in the SYS_LABRANGES file.
  • We have renamed the column for Female Cycle to LBFEMALECYCLE in the new version of the SDE, located in the SYS_LABRANGES file.

Enablement & Configuration

These new columns are available when using the new version of the SDE.

Study Locking & Billing Enhancements 25R2.2

Use Case

We’ve updated dialogs and confirmations that are seen when setting Billing Status and locking the study data to help study administrators better manage the sites from continuing to enter data and to help avoid additional invoicing.

Description

When selecting Study Data Lock, non-ELA customers will see an updated dialog with the following checkbox option, which will be automatically selected: Set Billing Status to Locked.

When locking the study data from the Billing Status action, the study administrator will be prompted to type the word LOCK to ensure confirmation of the Study Data Lock action.

Set Billing Status Confirmation Dialog

When unselecting the checkbox, the user is presented with additional information and a link to the help pages.

Lock Study Data Dialog

When selecting Study Data Unlock, an updated dialog will notify users that the Billing Status will automatically be updated to Deployed/In Progress.

Unlock Study Data Dialog

When setting the Billing status to On Hold, Deployed/In Progress, or Decommissioned dialogs provide informative text to notify study administrators of potential changes to billing based on the selection.

Set Billing Status Dialog

The Billing Status picklist label has been updated from Post-data Lock (This does not lock the study data) to Locked.

Enablement & Configuration

This feature is automatically available for the General Release. Only non-ELA customers.

Timezone Label Sync 25R2.2

Use Case

Specific time zone labels have been updated to ensure consistency with Vault platform and prevent mismatches when configuring ClinOps (CTMS) to EDC Connections.

Description

We’ve updated timezone picklist labels for timezone__v, which is utilized for sites and lab locations, to match the platform (and CTMS) timezone labels for timezone__sys. The updated timezone labels are viewable in these screens and dialog picklists.

  • New/Edit Study Sites dialog
  • Sites grid (EDC Tools)
  • Site import file
  • New/Edit Lab Locations & Normal Ranges
  • Lab Locations & Normal Ranges grid
  • Import Lab Locations

Customers should update the timezones in their CSV files used to import EDC sites and lab locations. During the import of sites and lab locations, users may encounter an error in the import preview if the updated timezone labels are not used. Following the release, the CSV files can be exported and used for subsequent imports to ensure the import file will include the updated labels.

Enablement & Configuration

This feature is automatically available.


Clinical DataBase (CDB) & EDC Clinical Reporting

The following are new features for the Veeva CDB application, EDC Clinical Reporting (the Veeva Clinical Data solution for data cleaning and reporting), or both.

Availability: Clinical DataBase (CDB) is only available to CDB license holders. Contact your Veeva Services representative for details.

Reference Data Import: Increase the Maximum Number of Columns to 35 25R2.2

Use Case

Reference data is imported into a CDB study to allow for custom listings to reference things like excluded medication lists or always Serious Adverse Event terms in the listing. This enhancement allows for more item data to be included in the reference data import.

Description

Imported reference data can now include up to 35 columns.

Enablement & Configuration

This feature is automatically available upon release.


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 Veeva Clinical Data.

User Defined Permission Set Enhancements 25R2.2

Use Case

This change makes the UI for permissions easier for users to interpret.

Description

With this release, the behavior of the Object Field Permissions Dialog for User Defined Permission Sets in System Tools is updated to match the UI experience in Admin, where the “All Object Fields” checkbox represents the total value state of all individual permissions underneath.

Object Field Permissions Dialog

Enablement & Configuration

This update is immediately available.


Connections & Integrations

Features in this section are new connections or integrations with Veeva Clinical Data or enhancements to existing ones.

Safety Integration: Suppress Study Drug When Classified Not Administered 25R2.2

Use Case

Adverse Events can be recorded before a study drug has been administered. Prior to this release, the study drug details were transferred with a Safety Case with a drug role of “Drug Not Administered” (E2B code=”4”) even if the study drug had not yet been dispensed . Now, a form configuration setting on the Study Drug safety type is available that will suppress the transfer of the study drug information if it has not yet been administered. This will reduce noise in the Safety Case processing in the safety system.

Description

In E2BLink, if the study drug information is embedded on the Safety Case Initiation Event (for example, the Adverse Event form) and when using “Each Entry In: Repeating item group in form”, the new setting will be available in the Inclusion Criteria tab.

While the setting will be set to “No” for all existing studies and Form Configurations, it will default to “Yes” for new studies and new Form Configurations.

Enablement & Configuration

For testing in Limited Releases, contact Support to enable this feature.

This feature is automatically available for configuration in the General Release for studies using either the Safety-EDC Connection or the E2BLink. Configuration for a live study might result in follow-up safety messages for existing Safety Cases.


EDC Migrator

Features in this section are new features for Veeva EDC Migrator.

Support for Migrating Fasting Status & Female Cycle 25R2.2

Use Case

The 25R2 EDC release introduced Local Lab support for Fasting Status and Female Cycle parameters in lab normal range management. This release extends that support to studies migrated from other EDC systems.

Description

This feature supports migrating lab source data with Fasting Status and Female Cycle parameters. For lab forms with Fasting Status and/or Female Cycle enabled in Studio, EDC Migrator will provide mapping and validation support for the new lab header (which was introduced in 25R2). This includes YAML Builder mapping support.

Enablement & Configuration

This feature is immediately available for studies being migrated.

YAML Builder Support for Item Units 25R2.2

Use Case

Previous enhancements supported mapping for “unit” item types but required you to manually create them. With this update, the YAML Builder automatically inserts these mappings.

Description

The YAML Builder inserts mappings into the applicable form YAML files for items that are units.

Enablement & Configuration

This feature is immediately available for studies being migrated.