Enablement by Feature Version

Auto-on in Studies created after 26R2 that are using the Clinical Operations – EDC Connection

Auto-on in Studies created before 26R2 that are using the Clinical Operations – EDC Connection

Study is connected to Clinical Operations vault

This feature ensures data integrity for connected Studies by establishing Veeva CTMS as the primary source of truth for site information, preventing manual edits in Veeva EDC that would otherwise be overwritten during data transfers. It is no longer possible to create or delete sites in EDC when a study is connected to Veeva CTMS. Additionally the following fields can no longer be edited in EDC: Site Name, Site Number, Status, and Timezone. These actions must now be performed within CTMS. Hovering over the disabled actions will display a tooltip indicating “This action cannot be performed because Sites are managed in CTMS”.

This feature maps to the “Clinical Operations-EDC Connection: Limit Updates to Sites for Connected Studies” (26R2-000702) feature in the Vault RIA.

Auto-on in Studies created after 26R2 that are using Person_SYS

Auto-on in Studies created before 26R2 that are using Person_SYS

Enablement of Person_SYS for the vault. Contact Veeva Support.

Study Administrators can now capture and edit PI contact information by adding a phone number via the UI. This new optional field is available when creating or editing investigator records within System Tools and EDC Tools > Sites, either manually or via import. A new column has been added to both import templates.

With the 26R2 release, Person_SYS will be automatically enabled for all vaults.

Auto-on in Studies created after 26R2 that are using Quick Queries

Auto-on in Studies created before 26R2 that are using Quick Queries

Enable Quick Queries set to “Yes” (Studio > Study Settings), Enable Team Query Restrictions set to “Yes” (Studio > Study Settings),

In Review, the Observed Source Value field for quick queries now supports up to 100 characters.

Auto-on for all Studies created after 26R2 that are using Review Plan Assignment V2 or V3 and Review Rollup V2.

Auto-on for all Studies created before 26R2 that are using Review Plan Assignment V2 or V3 and Review Rollup V2.

Run the Reevaluate Plan Assignment job ( Tools > EDC Tools > Review Plan Assignment Criteria) or manually assign a review plan (Tools > EDC Tools > Review Plan Manual Assignment).

When review plan assignments change for a subject, study administrators often want the new requirements to apply only to future data collection rather than retroactively impacting previously reviewed visits. This feature allows users to choose whether a new review plan applies to all visits, only new visits, or visits on or after a specified date. These options are available within the Reevaluate Plan Assignment Job and manual Assign Review Plan dialogs in EDC Tools. To support this, the system now tracks review plan assignments at the event and form level. A review plan will always be assigned to an event. If the assignment is based on the event date and the event doesn’t have a date yet, the current review plan for the subject will be assigned to the event. Once the event date is entered, the assignment will be updated accordingly. Since log events do not have a date, review plan assignment is at the form level for log forms. Users can view the event and form level review plan assignment via new columns in the event and form progress listings. In DQS, the review requirements will reflect the event and form level plan assignment in EDC. However, users will not be able to see which review plans are assigned to events and forms in DQS in this release.

Available for Use in Studies using Local Labs created after 26R2.

Available for Use in Studies using Local Labs created before 26R2.

Local Labs enabled set to “Yes” (Studio > Study Settings). You must run the 26R2 version of the Study Data Extract job (Tools > EDC Tools > Jobs).

The Study Data Extracts (SDE) now include the LABANALYTENAME column in the clinical datasets and the LABANALYTELABEL column in the SYS_ILB dataset. Older versions of the SDE will not include these updates.

Phased Release for all Studies created after 26R1.

Phased Release for all Studies created before 26R1.

Just-in-Time VeevaID Registration enablement by Veeva. This feature is always enabled simultaneously with Centralized Principal Investigator Management. (Track statuses or resend invites via Tools > System Tools > Users. Run tracking reports via VeevaID Registration Report in the Users grid Actions menu).

Veeva EDC is simplifying how site staff are added to studies by utilizing the person_sys record to support Just-in-Time user creation. This ensures a site user’s system account is automatically created and granted study access only after a person completes their VeevaID registration. Instead of managing inactive accounts for individuals who haven’t logged in, administrators can now invite staff and assign permissions upfront, while the system sends reminder emails every 72 hours to help ensure registration is complete. Administrators can track progress through the new VeevaID Registration Report and updated status columns in the Users grid.

As part of this feature, person_sys records will be created for and linked to existing user records at the time of the release. The person_sys object replaces the use of the custom person_v object for storing Principal Investigator information.

We have also updated the Retrieve Users API. With this release, this endpoint will now:

• Return person__sys records when there isn’t yet a user__sys (i.e., Pending site users that have been invited but have yet to register for VeevaID)
• Apply the following when returning person__sys because there is no user__sys: user_id will be an empty string and user_name will be the same as user_email
• No longer return Vault Owner records

Auto-on in Studies using Data Model 2

Auto-on in Studies using Data Model 2

Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

In Data Entry, events containing one or more forms with data will show a new “Clear All Form Data at Event” option in the Event actions menu. This option removes all entered data and retains externally owned data, e.g. IRT data, event data, and manual queries. Once data is cleared, users can utilize the Event Reset option, which will remove and reset all event data including data from other systems and manual queries. If there is no external data, then both the “Event Reset” and “Clear All Form Data at Event” options will be available. Dialogs have been added for both actions, which require site users to provide a reason for change and to confirm their actions by typing CLEAR or RESET in the applicable dialogs. In the item audit trail, the form and item group reset actions will now attribute the item value going blank to “System on behalf of…”, rather than the direct user.

Auto-on in Studies created after 26R1

Auto-on in Studies created after 26R1

Copying a study design when creating a new Study in Studio

The following Subject ID Generation settings are now included when copying a study to create a new study:

• Format
• Type
• Range Start
• Range End

Auto-on

Auto-on

The “Validate” option in the Studio actions menu

The Validate option in the Studio menu can now be run for any changes in DEV, including versionless changes made after a prior validation is completed (for example, rule updates, changes to form links, assessments, and review plan configurations). If there are no changes since the last time the study was validated, the Validate option will be inactive. As part of this feature, the rule Modified Date and Modified By values from the rule definitions will no longer reflect the validation and will instead reflect changes made by users.

Auto-on in Studies using Imaging or the Global version of Local Labs

Auto-on in Studies using Imaging or the Global version of Local Labs

Labs Version set to “Global” (Admin > Business Admin > Study Configuration) or Imaging enabled

Both the source and destination studies must have the Lab/Imaging setting enabled in order to copy successfully and to display in the forms listed in the Form Copy. For Lab forms, the analyte, global codelist, and units must exist in the destination study to copy the form successfully. For Imaging, the global codelist for modality must exist in the destination study to copy the form successfully.

Auto-on

Auto-on

Copying a study design in Studies created after 26R1

A new Summary tab is included in the output file when copying Studio designs. The Summary tab displays the timestamp, source vault, study and environment details, and which options were selected for the copy. More detailed messages are included in the Status Message column and a new Notes column in the Log tab provides more information in the following specific cases:

• Rule copied - updated to match destination definitions on name
• Rule copied and marked invalid - missing destination study references
• Rule couldn’t copy because one or more references could not be found in the destination
• Rule skipped, could not resolve the identifiers in the rule

Auto-on

Auto-on

Enforce Study Language set to “Yes” (Studio > Study Settings)

When Study Language is enforced, the following data points that are included in the Send Email rule (Studio, User Defined Rules) will display in the study language and locale:

• Date & Date Time Items
• Codelist Items
• Visit Method
• Event date

When Study Language is not enforced, these data points will display in the data entry user language and locale.

Auto-on in Studies created after 26R1

Auto-on in Studies created after 26R1

Enable Randomization set to “No” (Studio > Study Settings)

This release retires legacy EDC Randomization settings for all newly created studies. The options to enable randomization or import configurations have been removed from Studio for new studies created after the release and the randomization setting will be automatically disabled when copying existing studies. Consequently, randomization references will no longer be generated in Study Design Specifications, reports, or rules. Existing studies utilizing EDC Randomization will continue to function without disruption.

Auto-on in Studies created after 26R1 that are using Data Model V2

Auto-on in Studies created before 26R1 that are using Data Model V2

Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

When a rule determines that an Event Group containing data should be marked for removal, the system now prevents new forms and events from being added to it. When repeating Event Groups are Marked for Removal, Site users will not be permitted to add new Event Group repeats and the +New button will remain disabled. When running a retrospective amendment, events and forms will not be added to Event Groups that are Marked for Removal.

Auto-on in Studies created after 26R1 that are using Data Model V2

Auto-on in Studies created before 26R1 that are using Data Model V2

Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

Site users can upload file attachments of up to 4 GB directly within casebook forms when the form design includes items configured with the new File Attachment item type in Studio. Additionally, in Studio, study designers can configure user defined rules to reference file attachment items. In Data Entry, when attaching a file, the site user is required to verify the file contains no PHI/PII, after which the progress of the upload can be seen within the upload drawer. Completed uploads can be viewed and downloaded in Data Entry and Review. The file attachment can also be seen from the form view within the Coder UI. File attachment items follow the same functionality as other item types, including reasons for change, Intentionally Left Blank (ILB), restricted forms, subject transfers, queries, protocol deviations, SDV/DMR, signatures, freezing, and locking. Actions taken with file attachment items are included within the audit trail. The system-assigned, de-identified file name (and extension) will be visible in the SDE, Core Listings, Detail Listings, and CDB. A new “File Attachment Extract” is available within EDC Tools to download attachments in bulk. Users receive an email notification when the job completes. File Attachments will support most file types, except executable files for Windows, macOS, and Linux. DICOM files are also not supported for use with File Attachments as they are already supported using Veeva EDC Imaging. The system validates the file format based on its MIME type rather than the file extension. Restricted file types include the following:

Portable executable (Windows Executable) Executable and linkable (Linux Executable) Apple disk image (MacOS Executable) Mach-O (Legacy MacOS Executable) DICOM files (Medical Imaging)

Auto-on in Studies created after 26R1 that are using the Clinical Operations - EDC Connection. Customers can choose to disable this feature after the release.

Auto-on in Studies created after 26R1 that are using the Clinical Operations - EDC Connection.

Enable the Clinical Operations - EDC Connection (Admin > Connections).

For Studies connected to a CTMS Vault, editing Protocol Deviation (PD) fields is now prevented in EDC to ensure data synchronization and integrity. While EDC users can still view full PD details and audit trails, the Edit button is disabled, and manual updates must be performed in the CTMS deviation record. A new Inactivate Protocol Deviation option has been added to EDC, allowing users to manually retire a record in EDC while triggering a status update in CTMS. Programmatic Protocol Deviations can still be automatically inactivated by the system in EDC if the data conditions are no longer true, also triggering a status update in CTMS.

Auto-on in Studies in which the study or user language is Japanese, Chinese, or Korean

Auto-on in Studies in which the study or user language is Japanese, Chinese, or Korean

Study or user language is set to Japanese, Chinese, or Korean

We’ve updated to the following fonts in Detail and Closeout PDFs for studies in which the study or user language is Japanese, Chinese, or Korean: Noto Sans Japanese (Japanese), wqy-zenhei.ttc (Chinese) and HYGoThic-Medium (Korean).

Auto-on for non-ELA customers

Auto-on for non-ELA customers

ELA Status

This feature introduces a more streamlined workflow for aligning a study’s Billing Status and data lock status. When a user sets the billing status to Locked, the system will automatically lock the study data. This feature also includes optional, configurable logic to synchronize these statuses in the reverse direction, providing flexibility for different operational needs.

Auto-on in Studies with Enforce Study Language enabled

Auto-on in Studies with Enforce Study Language enabled

Enforce Study Language set to “Yes” (Studio > Study Settings)

The Closeout Activity now displays events in the study’s selected Study Language for studies with the Study Language setting enforced.

Auto-on in Studies created after 25R3

Auto-on in Studies created after 25R3

Enforce Study Language, Enable Team Query Restrictions, and Enable Quick Queries settings in Studio > Study Settings

The following study settings will now be automatically enabled when creating new studies:

• Enforce Study Language
• Enable Team Query Restrictions
• Enable Quick Queries

Auto-on

Auto-on

–

An action menu has been added to the Rule Job page in EDC Tools that allows users to select from a list of recent Rule Jobs and quickly re-apply the same selection of rules to the current job.

By Study Build for Studies using Local Labs

By Study Build for Studies using Local Labs

Enable Local Labs set to “Yes” (Studio > Study Settings), Enable Clinical Significance set to “Yes” (Labs > Study General Settings)

Clinical Significance values in Lab Panels will no longer autosave when the lab result is not out of range per the Normal Range Flag value and Clinical Significance should not be entered.

Auto-on for customers using DQS

Auto-on for customers using DQS

Access to DQS

We’ve updated the following standard roles:

• New permission Upload 3rd Party Data Packages has been added to CDMS Lead Data Manager, CDMS Data Manager, CDB Data Provider, and CDMS Super User roles. This permission requires API Access.
• The View Protocol Deviations permission has been added to the CDMS CDB Read Only role.

Auto-on in Studies using the Global version of Local Labs

Auto-on in Studies using the Global version of Local Labs

Labs Version set to “Global” (Admin > Business Admin > Study Configuration)

The precision and length fields are no longer included in the item properties panel in Studio for studies using Global Labs, as these values come from the analyte library. The Casebook Design Export (CDE) has also been updated to reference precision and length from the analyte library values.

We have updated the default length of the following items upon creation, to minimize the need for study designers to individually update them:

• LBFAST Default Length: 100
• LBFEMALECYCLE Default Length: 100
• LBSEX Default Length: 100

Additionally, analytes of data type Text or Codelist will now also have a default length of 100 in the Analyte Library unless modified by the user.

Auto-on in Studies using Local Labs

Auto-on in Studies using Local Labs

Enable Local Labs set to “Yes” (Studio > Study Settings)

This feature updates the Item Property Panel in Studio to remove the ability to configure the label and display override labels for all Lab Panel items to ensure that the analyte library is the source of truth in all areas of Clinical Data. Studio, EDC, CDB and all other areas within Clinical Data, as well as the SDS, CDE, and SDE files will use the label as specified for the referenced analyte in the analyte library.

This feature will be automatically enabled for customers who don’t have any mismatches between analyte library labels and Studio analyte label item values. For customers that do have one or more mismatches, the feature will remain off, and Veeva will contact you to discuss resolution prior to enabling the feature.

Support

Support

Labs Version set to “Global” (Admin > Business Admin > Study Configuration)

Lab unit conversions can now be disabled within Veeva EDC to support customers who manage unit conversions outside of EDC.

When this feature is enabled for the vault, users creating or editing Lab Unit Definitions have the option to Disable Unit Conversions. Selecting this option disables entry in the Standard field and the conversion-related fields. Any previously entered conversions and Standard selections will be cleared out.

Disabling unit conversion factors will affect rules using the value_translated__v or translated_unit__v identifiers, and Normal Range Flags will show ‘Not Applicable’ if the lab result and normal range units don’t match.

Vaults with this feature enabled can import lab units using a version of the import file that includes a column for the Disable Unit Conversion option.

Auto-on in Studies created after 25R3 that use Comparison Rules V1

Auto-on in Studies created before 25R3 that use Comparison Rules V1

Comparison Rules Version set to “1” (Admin > Business Admin > Study Configuration)

When Comparison Rules are changed or archived, the Studio-generated Comparison (Diff) Report shows blank values in the Event Group, Event, Form, Item Group, Item Operator, and Compare To columns. This is expected when comparing study design builds across environments since the source study no longer has the original comparison rule present in the design. A new column, “Rule” is added in the Comparison Rules tab of the Diff report to help clarify which V1 comparison rule is [not present] in the source environment and [present] in the target environment. The new Rule column indicates rule modifications in the following cases:

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

Auto-on for all Studies after 25R3 that utilize external data via API and repeating item groups with default data.

Auto-on for all Studies before 25R3 that utilize external data via API and repeating item groups with default data.

Select the Repeating checkbox in the Properties section of your item group (Studio > Item Groups). To clear external data , reset in Data Entry > Casebook > [Form] > Actions menu > Reset External Data Values.

External data (entered with APIs) within repeating item groups with default data will no longer be removed when a form is reset.

Auto-on for DQS Workbench Studies in test (TST) environments after 25R3.

Auto-on for DQS Workbench Studies in test (TST) environments before 25R3.

To initiate or restart the 30-day testing window, enable Study File Format API set to “Yes” (Tools > EDC Tools > Study Settings).

It will now be possible to enable the Study File Format (SFF) API for DQS Workbench Studies in TST environments. After SFF is enabled, it becomes disabled under two conditions: if 30 days pass since the last package download, or if the user never downloads the package. If SFF is disabled, the user can re-enable it in EDC Tools, which requires the full extract to be processed again.

Auto-on in Studies created after 25R3 that are using the Clinical Operations - EDC Connection.

Auto-on in Studies created before 25R3 that are using the Clinical Operations - EDC Connection.

Enable the Clinical Operations - EDC Connection (Admin > Connections).

For users with access to Veeva CTMS, a CTMS link and info icon displays in the top-right of the Review tab, allowing them to navigate directly to the Site page in CTMS. Clicking the link opens a new tab, which allows users to easily navigate between vaults while maintaining the same session. Hovering over the link shows the URL of the CTMS vault, and hovering over the info icon shows the name of the CTMS Vault.

Auto-on for non-ELA customers

Auto-on for non-ELA customers

ELA status

The following Billing Status option label updates for non-ELA (Enterprise License Agreement) studies have been implemented to provide greater clarity:

• The Locked option has been renamed to Post-data Lock (This does not lock the study data)
• The Archived option has been renamed to Decommissioned

Casebook creation and study deployments are not allowed for studies in the Decommissioned billing status, as is consistent with the previous Archived status. This also applies for casebook creation via the API.

See release notes for more details.

Auto-on in Studies using Review Plan Assignment V2 or V3

Auto-on in Studies using Review Plan Assignment V2 or V3

Review Plan Assignment Version set to “2” or “3” (Admin > Business Admin > Study Configuration)

Users can now view the audit trail for Review Plan Assignment Criteria records. The Review Plan Assignments action menu has been updated to reflect this change. The Delete action has been removed and replaced with the new Archive action.

Auto-on in Studies that are using Data Entry V2 and have Query Teams enabled

Auto-on in Studies that are using Data Entry V2 and have Query Teams enabled

Data Entry Version set to “2” (Admin > Business Admin > Study Configuration)

New buttons are available within the query UI to expedite queries and data corrections. Standard query messages will be added when CRAs open Confirm Value or Missing Value manual queries. To assist with subsequent reviews, CRAs can include observed source values, which are not seen by site users. Automated query replies are included when sites enter missing data, correct the data value, or mark data as Intentionally Left Blank or Did Not Occur. The Reply with Comment option is available to enter free text when needed.

Quick Query responses will appear in the existing columns of the Query Detail Listing and two new columns have been added to help identify where Quick Queries and Quick Responses are utilized: Value Confirmed (Yes/No) and Observed Source Value. The SYS_Q and SYS_QT system datasets within the Study Data Extract (SDE) will also include new columns: Observed Source Value (OBSSOURCEVAL) and Quick Action Type (QUICKACTTYPE). Quick Queries are visible within the audit trail, where observed values can only be seen by users with the View Observed Source Value permission.

The following permissions have been added to the listed standard roles and will only take effect when the Quick Queries study setting is “Yes”.

• Edit Observed Source Value
  • CDMS Clinical Research Associate
  • CDMS Super User
• View Observed Source Value
  • CDMS Clinical Research Associate
  • CDMS Super User
  • CDMS Data Manager
  • CDMS Lead Data Manager

Auto-on in Studies created after 25R2 that are using Local Labs

Auto-on in Studies created after 25R2 that are using Local Labs

Enable Local Labs set to “Yes” (Studio > Study Settings)

This release introduces Local Lab support for the collection of Unknown time in the Normal Range effective datetimes.

We’ve also added a required Timezone field to Lab Locations to support evaluation of normal ranges for subject data and ease of use for normal range record creation.

In the Study Data Extract (SDE) and EDC Core Listing, unknown time values will be formatted similar to other unknown datetime items, and the datatype of the field will be a string/char in the SDE SAS datasets.

See the release notes for full details on these updates.

Auto-on in Studies created after 25R2 that are using Local Labs and Data Model V2

Auto-on in Studies created after 25R2 that are using Local Labs and Data Model V2

Enable Local Labs set to “Yes” (Studio > Study Settings), Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

This release introduces support for the collection of Unknown time in the Lab Collection Datetime.

Lab Collection Datetime configuration is found in Lab Study General Settings / System General Settings (defaults). The new Lab Collection Time setting can be set to:

• Required (default)
• Allow Unknown
• Always Unknown

In the Study Data Extract (SDE) and EDC Core Listing, unknown time values will be formatted similar to other unknown datetime items, and the datatype of the field will be a string/char in the SDE SAS datasets.

See the release notes for full details on these updates.

Auto-on in Studies created after 25R2 that are using Global Labs

Auto-on in Studies created after 25R2 that are using Global Labs

Enable Global Labs set to “Yes” (Studio > Study Settings)

We’ve made the following changes to Local Labs to support a future release:

• In Studio, editing the Name is disabled for system-generated items such as LBSEX, LBAGE, and LBFEMALECYCLE. This release extends the behavior to the system-generated LBHEADER item group instead of individual items
• We’ve introduced a new system-managed Fasting Status codelist, with options Yes, No, and Unknown
• We’ve added a Pregnancy codelist value to the Female Cycle codelist. This codelist value will only be present for new vaults provisioned after the 24R3 release. Any existing vaults will not have this value added with the release, though users can edit the codelist definition for existing vaults

The codelist updates do not impact Normal Range evaluation in this release.

Auto-on in Studies created after 25R2 that have Study Language enabled

Auto-on in Studies created after 25R2 that have Study Language enabled

Enforce Study Language set to “Yes” (Studio > Study Settings)

Blank PDFs generated from Data Entry or Review will use the specified study language and locale when Enforce Study Language is set to ‘Yes’. When Enforce Study Language is set to ‘No’, the blank PDFs will default to the user’s language and locale.

Auto-on in Studies created after 25R2 for Veeva ID users with a Veeva ID account in RTSM. Other users must contact RTSM Services

Auto-on in Studies created after 25R2 for Veeva ID users with a Veeva ID account in RTSM. Other users must contact RTSM Services

RTSM Services

Site users can navigate to the subject in Veeva RTSM from a new link that displays for the subject casebook in EDC. This link is also available to CRAs and Data Managers in Review. This feature will not be available in Pre-Release.

Auto-on in Studies created after 25R1 that have Veeva EDC Imaging enabled

Auto-on in Studies created before 25R1 that have Veeva EDC Imaging enabled

Data Model Version set to “2” (Admin > Business Admin > Study Configuration), Imaging enabled

When navigating Imaging data grids using arrow keys, the focus will move from cell to cell based on the key pressed, with the focus being placed on interactive elements within the cells. A blue box will display on actionable elements (e.g., links, action menus, sortable columns) and a grey box will surround unactionable cells.

Auto-on in Studies created after 25R1 that have Veeva EDC Imaging enabled

Auto-on in Studies created before 25R1 that have Veeva EDC Imaging enabled

Data Model Version set to “2” (Admin > Business Admin > Study Configuration), Imaging enabled

For uploaded DICOM files, the de-identification process now assigns the Subject ID to the Patient Name field. The Subject ID will be seen when the file is downloaded or viewed outside of EDC.

Auto-on in Studies created after 25R1 that have Veeva EDC Imaging enabled

Auto-on in Studies created before 25R1 that have Veeva EDC Imaging enabled

Data Model Version set to “2” (Admin > Business Admin > Study Configuration), Imaging enabled

Imaging exams can be extracted in bulk using the new Imaging Extract job available in EDC Tools. This feature sends the extracted exams directly to File Staging and which can be accessed using Veeva’s Vault File Manager client or an FTP client.

Auto-on in Studies created after 25R2 that are using Data Model V2

Not available for Studies created before 25R2

Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

The following changes have been made to the treatment of default data when set as Intentionally Left Blank (ILB) or upon form reset:

Default items are reset to the original defaults when the Form or section is reset.

When a row or Form is marked as ILB, the read-only default values are retained.

Rows containing one or more default data items cannot be removed.

Auto-on in Studies created after 25R2 in vaults using the EDC Sync Coding Lists connection across multiple Production vaults

Auto-on in Studies created before 25R2 in vaults using the EDC Sync Coding Lists connection across multiple Production vaults

Multiple PROD vaults using the EDC Sync Coding Lists Connection

Prior to this release, customers with multiple PROD vaults using the EDC Sync Coding Lists Vault connection could only use the option to Apply to Synonym List when approving/rejecting a code and the Propagate Code function in the primary Prod Vault. This release makes these functions available in the secondary Prod Vault, supporting bi-directional updates of synonym list details. The name of the Vault connection was updated to ‘EDC Sync Coding Lists’ for clarity.

Auto-on in Studies created after 25R2 that are using the Clinical Operations – EDC Connection

Auto-on in Studies created before 25R2 that are using the Clinical Operations – EDC Connection

Study is connected to Clinical Operations vault

Site Closeout PDFs generated in Veeva EDC can now be transferred via the Clinical Operations-EDC Connection to Veeva eTMF. This functionality has no impact on the EDC user experience and can’t be tested in EDC. The appropriate Closeout PDF transfer must be traced in Veeva Clinical Operations.

Auto-on for all Studies after 25R2 that have CDMS Training enabled.

Auto-on for all Studies before 25R2 that have CDMS Training enabled.

Enable CDMS Training for at least one study (Tools > EDC Tools > Study Settings > Enable Learning System) and ensure the Learning System is added and configured for your study (Tools > EDC Tools > Learning Systems)

The following enhancements have been made to the Training Report and My Training tabs to improve the user experience and increase the visibility of the training username:

• Add columns to the Training Report to display “Learning System Username” and “VeevaID Registration Status” (where applicable).

• Update the table on the My Training tab to display the training username for every training requirement.

• Clicking the training link on the My Training tab auto-fills the login screen with the training username if it’s different from the current one.

This feature cannot be tested in pre-release.

Auto-on for all Studies after 25R2 that have Vault Platform and VeevaID enabled.

Auto-on for all Studies before 25R2 that have Vault Platform and VeevaID enabled.

Requires Vault Platform and VeevaID.

To support the 25R2 Platform feature allowing VeevaID users to update their email address, we are making the following changes in EDC to track and provide visibility of this change:

Update the User Activity Report to include Username and Email changes for both VeevaID and Sponsor users. Ensure that the User Access Report references both the new and old usernames when access events occur after a VeevaID user updates their email address/username.

Auto-on in Studies using Review Roll-up V2 and with First Review Date enabled

Auto-on in Studies using Review Roll-up V2 and with First Review Date enabled

Presence of a Review State Definition record for item__v, First Review Date enabled

We’ve made the following updates to the Event Progress Listing:

• 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”
• Renamed multiple columns in the Event Progress Listing

By Study Build in Studies created before 25R1

By Study Build in Studies created before 25R1

Enforce Study Language set to “Yes” (Studio > Study Settings)

The following new Studio study settings have been added: Enforce Study Language, Study Language, and Study Locale. When Enforce Study Language = Yes, the data entered, viewed, and saved is seen in the selected study language and locale. The following areas will display in the study language:

• Labels buttons and filters in the site list page, casebook list page, task bar, signature pages
• Study related labels for forms, events, codelists, etc.
• Date formats and date pickers
• Change reasons
• Audit display
• Review activities: system queries and query dialogues, protocol deviations, assessments
• Listings & exports
• Snapshots
• Job Schedule page
• Detailed and Closeout PDFs

Study Designers will be responsible for uploading translations for dynamic messages in their selected study language. If translations are not available, the Vault language will be the default. Note: the user’s language is still utilized for the application settings (areas not part of the study setup e.g. the names of the tabs).

Auto-on

Auto-on

Derivation Version set to “Cross Form” (Admin > Business Admin > Study Configuration)

When conflicts occur between Set Derived rule results, Vault will determine which rule takes precedence and update the result accordingly.

Auto-on in Studies created after 25R1 with Bulk Signature enabled

Auto-on in Studies created after 25R1 with Bulk Signature enabled

Enable Bulk Casebook Signature set to “Yes” (Studio > Study Settings)

The Bulk Casebook Signature study setting in EDC Tools will be auto-on for new studies when Bulk Signature is enabled.

Auto-on in Studies created after 25R1

Auto-on in Studies created before 25R1

Enable Team Query Restrictions set to “Yes” (Studio > Study Settings),

For users with multiple roles and access to multiple sites with different query teams, the applicable query team will be automatically assigned and immediately visible in the query based on the user’s role at that site. If the user has access to multiple roles at that site, they can only select a team associated with the roles at that site. When a user with a single team is opening a manual query, that team will display in the new query UI.

Auto-on in Studies created after 25R1 that are using Local Labs

Auto-on in Studies created before 25R1 that enable Local Labs after this release

Enable Local Labs set to “Yes” (Studio > Study Settings)

The No Future Date edit check is added to the Lab Collection Date Time (LBDTC) item in the Studio Lab Panel header for configuration on the item property panel. The default length for the system generated Sex (LBSEX) item is updated to 6.

Auto-on in Studies created after 25R1 that are using Data Model V2

Auto-on in Studies created before 25R1 that are using Data Model V2

Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

The temporary lookup field for Event Date is deprecated from the Event Operational Summary. It will still be available from the Event object. The calculation for “Form Entry Overdue Days” has been updated to support Studies using Data Model 2.

Event Date change applies to Studies on Data Model 1 and Data Model 2. The Form Entry Overdue Days update applies to only Studies on Data Model 2.

Auto-on in Studies created after 25R1

Support in Studies created before 25R1

Comparison Rules Version set to “2” (Admin > Business Admin > Study Configuration)

Comparison Rules V2 introduces a new UI that allows study designers to configure rules more efficiently and with greater flexibility. All query rules comparing two date and datetime values can now be programmed as system-managed Comparison Rules. Key enhancements include:

Support for comparisons between date and datetime data types, including automatic timezone handling for datetime conversions

Allowing non-fully qualified identifiers, including floating Forms, Events, and Event Groups

Configurable Min/Max setting for automatic handling of unknown values

Comparisons between two Event Dates or Casebook Variables

Configurable sequence numbers for repeating Event Groups, Forms, and Item Groups

Option for the rule action to target either identifier used in the Comparison Rule

Ability to copy comparison rules from other Studies/Library Collections

Ability to rename Comparison Rules

Added UI validations to display configuration errors immediately to the user

Ability for users to inactivate and archive Comparison Rules (see note)

Note: Archiving a Comparison Rule now permanently removes it from the Study, functioning like object deletion. This behavior is unique to Comparison Rules in V2 and does not impact archive behavior for User Defined Rules.

Auto-on in Studies created after 25R1 that have Veeva EDC Imaging enabled

Auto-on in Studies created before 25R1 that have Veeva EDC Imaging enabled

Data Model Version set to “2” (Admin > Business Admin > Study Configuration), Imaging enabled

Imaging exams can now be viewed from Assessments if they are configured for visibility.

Auto-on in vaults where the VeevaID Security Policy is configured for optional local SSO usage after 25R1.

Auto-on in vaults where the VeevaID Security Policy is configured for optional local SSO usage before 25R1.

Configure the VeevaID Security Policy (Admin > Settings > Security Policies) in the domain for local SSO usage.

Site users with a VeevaID security policy can utilize either VeevaID or the sponsor’s or CRO’s localized SSO to perform e-signatures depending on how VeevaID is configured and according to how they have logged into the vault.

Auto-on

Auto-on

Enable Local Labs set to ‘Yes’ (Studio > Study Settings)

We’ve made the following changes to Local Labs to support a future release:

• In Studio, editing the Name is disabled for system-generated items such as LBSEX, LBAGE, and LBFEMALECYCLE. This release extends the behavior to the system-generated LBHEADER item group instead of individual items
• We’ve introduced a new system-managed FastingStatus codelist, with options Yes, No, and Unknown
• We’ve added a Pregnancy codelist value to the Female Cycle codelist. This codelist value will only be present for new vaults provisioned after the 24R3 release. Any existing vaults will not have this value added with the release, though users can edit the codelist definition for existing vaults

The codelist updates do not impact Normal Range evaluation in this release.

Auto-on

Auto-on

Enable Local Labs set to ‘Yes’ (Studio > Study Settings)

Users can now hide analytes in the Analyte Library in DEV to prevent an analyte from being selected in future Lab Panel configurations. Existing uses of the hidden analyte are not impacted and can continue collecting data.

As part of this feature, the Analyte Library export has been updated to include Analyte Status. This column will be ignored if used in an analyte import.

Auto-on in Studies using Review Roll-up V2 and with First Review Date enabled

Auto-on in Studies using Review Roll-up V2 and with First Review Date enabled

Presence of a Review State Definition record for item__v, ‘First Review Date’ enabled

In this release, we’ve added the following additional new columns to the Event Progress Listing for First Event Review Date:

• First Event SDV Complete Date and First Event DMR Complete Date columns display the initial date when SDV/DMR is complete for all forms, event date, and visit method (where required). The value is a roll-up of Review State > First Review Date
• After being set, the First Event Review Date will not be updated if a review value changes (SDV broken). It will, however, be cleared if the Event is reset
• The roll-up will be re-evaluated if review states are added, removed, or updated
• For studies where First Review Date is enabled, the First Event SDV/DMR Completed Date value will be backfilled for all events since the 23R3 release when First Review Date began being captured

By Study Build in Studies created after 24R3

By Study Build in Studies created after 24R3

“Show Queries in User Language” enabled

The following extracts were updated with new columns to show the translated value of the query text:

• Query Detail Listing Report v2 Template
• Query Detail Listing
• SDE SYS_Q and SYS_QT datasets

Auto-on in Studies using Review Roll-up V2 and Data Model V2

Auto-on in Studies using Review Roll-up V2 and Data Model V2

Presence of a Review State Definition record for item__v, Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

The following changes have been made to the Subject Progress Listing:

• New columns have been added for Subject SDV/DMR Required & Completion Date. These values will only populate for Studies using Review Rollup V2 & Data Model V2
• The SDV/DMR Complete columns have been relabeled to Subject SDV/DMR Complete. Additionally, the logic for these columns has been updated to use the Casebook Operational Summary instead of calculating from other columns in the listing for Studies using Review Rollup V2 and Data Model V2
• We have updated the logic for displaying the Frozen, Locked, and Signed columns for Studies using Data Model V2. We now pull from the casebook summary record

Auto-on in Studies using Review Roll-up V2

Auto-on in Studies using Review Roll-up V2

Presence of a Review State Definition record for item__v

This feature includes the following changes to the Event Progress Listing:

• Added new columns to track Event-level SDV/DMR Required, Complete, Complete Date, and % Complete. These values will be blank for log events and will only populate for Studies using Review Rollup V2
• Relabeled existing column for Event SDV/DMR Completion Date to Forms SDV/DMR Completion Date, as these columns only take forms into account
• Added a new column for Marked for Removal

Auto-on

Auto-on in Studies created after 24R3

“Suppress Repeating Item Groups in PDF” set to “Yes” (Admin > Business Admin > Study Configuration)

In the Blank CRF generated from Studio, only one copy of the repeating item group is created when there is no default configured.

Support in Studies created after 24R3 that are using Data Model V2

Support in Studies created before 24R3 that are using Data Model V2

Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

This release introduces Medical Imaging. This feature supports the following capabilities:

Site upload of DICOM images De-identification of the image file name and DICOM metadata tags Imaging Exam Validation (file type, size, duplicate detection, etc.) Imaging Exam Viewer and Download

This feature is available only to early adopters. Where enabled, a new standard role will be added to the vault. Additionally, new permissions will be added to existing standard roles. Details are available in the release notes.

Auto-on in Studies created after 24R3 that are using Data Model V2

Auto-on in Studies created before 24R3 that are using Data Model V2

Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

To prevent ingestion errors that can occur outside of EDC, full width numeric characters entered into EDC will be automatically converted to half width numbers as the data is saved for items with a number or unit data type. Entering number values using scientific notation, “E” and “e” into items with a number or unit data type, will result in an error (“This field only accepts numeric values.”) that will prevent the data from being saved. Further details and examples are available in the Release Notes.

Support in Studies created after 24R3 that have External Suggestion enabled and Approval Workflow enabled.

Support in Studies created before 24R3 that have External Suggestion enabled and Approval Workflow enabled.

Enable Approval Workflow set to “Yes” (Coder Tools > Study Settings)

External coding suggestions can now be used for direct coding via the Set Coding Suggestions API.

Auto-on in Studies created after 24R3 that are using the Clinical Operations - EDC Connection.

Auto-on in Studies created before 24R3 that are using the Clinical Operations - EDC Connection.

Enable the Clinical Operations - EDC Connection (Admin > Connections).

For the Clinical Operations-EDC Connection, EDC Vault Owners are now able to manually trigger a refresh of the integration to re-sync EDC with CTMS data on demand.

Auto-on in Studies created after 24R3 that are using the Clinical Operations - EDC Connection.

Auto-on in Studies created before 24R3 that are using the Clinical Operations - EDC Connection.

Enable the Clinical Operations - EDC Connection (Admin > Connections).

Countries in CTMS and EDC will now be automatically mapped based on the Vault standard country codes. Current manual links will remain intact and will override automatic linking by code. New connections will not require manual linking if both Vaults contain the country codes.

Support

Support

Contact Veeva Support to enable this feature.

This release provides support for increasing the maximum number of lab analytes per form or lab panel from 25 to 35. This change is applied at the vault level upon request.

Auto-on in Studies created after 24R2 that are using Data Model V2

Auto-on in Studies created before 24R2 that are using Data Model V2

Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

We are introducing two new standard reports with item-level information:

-Items Intentionally Left Blank (V3): This report provides a listing of items marked intentionally left blank, filtered by study and grouped by site and subject for Studies on Data Model V2. -Item Reason for Change Report (V3): This report provides a count of items per site per change reason entered by the site for Studies on Data Model V2. It excludes system-managed changed reasons.

Available to Vault Owners to share with other users

Auto-on in Studies created after 24R2 that are using Expression Engine V2

Auto-on in Studies created before 24R2 that are using Expression Engine V2

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

The ‘floating’ parts of the Action Identifiers within User Defined Rules have been relabeled to say “this” and “all” as appropriate per the selected Action and Dynamic Action Scope of the rule.

Auto-on in Studies created after 24R2

Auto-on in Studies created before 24R2

Enable Team Query Restrictions set to “Yes” (Studio > Study Settings),

Enhancements to Query Teams include:

• “Query Team” is added as a filterable column to the Queries grid.

• Users with multiple roles which are part of more than one query team can select the query team when answering or closing a query.

• Reopening a query is reserved for users within the query’s selected Query Team.

• The Query Team tag is moved to the query message header.

Auto-on in Studies created after 24R2 that are using Protocol Deviations

Auto-on in Studies created before 24R2 that are using Protocol Deviations

Enable Protocol Deviations set to “Yes” (Studio > Study Settings), Enable Other Specify - Reason for change set to “Yes” (Studio > Study Settings)

After the initial save of a Protocol Deviation record, subsequent updates will require the user to provide a Reason for Change. The most recent Change Reason for a PD record displays in the System Fields at the bottom of the record and is added to the SYS_PD dataset of the SDE. To support this feature, two new default Change Reasons of type Protocol Deviation have been added in System Tools, and enabled users can add additional change reasons.

Auto-on for all customers utilizing the Clinical Operations - EDC Connection for Visits in Studies created after 24R2.

Auto-on for all customers utilizing the Clinical Operations - EDC Connection for Visits in Studies created before 24R2.

Enable the Clinical Operations - EDC Connection (Admin > Connections) and configure connection to transfer Visit data.

The definition of Event Groups, Event Labels, and Sequences for events in a repeating event group, along with any updates, will now be transferred to CTMS via the ClinOps - EDC Connection.

Available for use in DQS Workbench Studies with Incremental EDC Ingestion created after 24R2, with the exception of the Incomplete Reviews by Subject feature, which does not require incremental ingestion and is available for Studies utilizing Review Listings.

Available for use in DQS Workbench Studies with Incremental EDC Ingestion created before 24R2, with the exception of the Incomplete Reviews by Subject feature, which does not require incremental ingestion and is available for Studies utilizing Review Listings.

Enable Incremental EDC Ingestion set to “Yes” (Studio > Study Settings). For the Incomplete Reviews by Subject feature turn Review Enable on in Listing Properties (Listings > Properties).

The Clean Patient Tracker now includes counts by Subject of Incomplete Reviews, Overdue Forms, and In-Progress Log Forms.

Incomplete Reviews are counted in the definition of a Clean Subject.

Users can download Subject, Event, and Form Progress Reports from the Clean Patient Tracker.

Support in Studies created after 24R1 that are using Data Model V2

Support in Studies created before 24R1 that are using Data Model V2

Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

With this release we are introducing two new standard reports with item level information:

• Items Intentionally Left Blank: This report provides a listing of items marked intentionally left blank, filtered by study and grouped by site and subject.
• Item Reason for Change Report: This report provides a count of items per site per change reason entered by the site. It excludes system-managed changed reasons.

Support in Studies created after 24R1 that are using Data Model V2

Support in Studies created before 24R1 that are using Data Model V2

Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

This feature provides users the ability to import data from a CSV file into Forms in EDC. In Studio, designers can create Import Definitions to map columns from their CSV file to Items on a selected Form. These import definitions are part of the study’s design and are included in the deployment package. This feature adds the Data Loader tab, where users can import files into a Study with a chosen Import Definition. Upon import, Vault creates instances of the Form and populates the form’s Items with data from the CSV file.

Once this feature is enabled in your vault, you must enable it in individual Studies using the Enable Data Loader setting in Studio.

Auto-on in Studies created after 23R2 that are using Data Model V2

Auto-on in Studies created before 23R2 that are using Data Model V2

Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

In the Review tab, Data Managers can create snapshots of clinical data for analysis during study milestones. Snapshots are a filtered subset of data that can be used over the course of the study. From the snapshot, users can view data that is ready for lock or freeze, that is already locked or frozen, or that is not yet ready (due to open queries, pending SDV, etc.). Using the snapshot, DMs & CRAs can perform lock/unlock and freeze/unfreeze actions across multiple casebooks in bulk.

Auto-on in Studies created after 23R2 that have Mask Blinded Data enabled

Auto-on in Studies created after 23R2 that have Mask Blinded Data enabled

Mask Blinded Data set to Enabled (Workbench > Configurations)

Organizations can define conditions where data can selectively be unblinded in the system.

Auto-on in Studies created after 23R2 that are using Review State Rollup V2

Auto-on in Studies created before 23R2 that are using Review State Rollup V2

Presence of a Review State Definition record for item__v

We’ve added various columns to the following listing jobs. These changes will be available when accessing listings from Review, EDC Tools, and Reports. Event Progress Listing changes:

• New columns to count the number of submitted forms where SDV & DMR are required Subject Progress Listing changes:
• New columns to count the number of forms where SDV is required and completed
• New columns to count the number of forms where DMR is required and completed We’ve also enabled the Study Progress Listings in the Reports tab feature for all Vaults. Users will still need to schedule listing jobs to populate the corresponding listing reports in the Reports tab. Finally, we relabeled the columns in the Study Summary Metrics report to include “Forms”.

Auto-on in Studies created after 23R2 that are in domains using the My Vaults Page

Auto-on in Studies created before 23R2 that are in domains using the My Vaults Page

Enablement of the My Vaults Page feature for the domain. Contact Veeva Support.

From System Tools, an administrator can define the Sponsor for a Study, which then shows in the Sponsor column of the My Vaults page. This supports CRO users who have access to multiple sponsor vaults.

Auto-on in Studies created after 23R1

Auto-on in Studies created before 23R1 that are using Expression Engine V2

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

Rules containing a @PreviousEvent identifier can now be configured to sort by Schedule order.

Auto-on in Studies created after 22R3

Auto-on in Studies created before 22R3 that are using Rules V2

Rules Version set to “2” (Admin > Business Admin > Study Configuration)

Users can now reference the previous value of an identifier in a rule based on the previous Event in the Casebook, sorted by Event Date.

Auto-on in Studies created after 22R3

Auto-on in Studies created before 22R3 that are using Global Versionless Labs and Data Model V2

Labs Version set to “Global” (Admin > Business Admin > Study Configuration), Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

Users can use “>” and “<” when entering Lab data.

Auto-on in Studies created after 22R3

Auto-on in Studies created before 22R3 that are using Global Versionless Labs

Labs Version set to “Global” (Admin > Business Admin > Study Configuration)

Lab Units and Codelists are now visible in the following grids: Repeating Form Grid, Form Linking Grid, and Item Linking Selection Dialog.

Auto-on in Studies created after 22R3

Auto-on in Studies created before 22R3 that are using Expression Engine V2

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

With this release, rules containing Form and Item links will allow references to fully-qualified identifiers outside of the linked identifiers.

Auto-on in Studies created after 25R3

By Study Build in Studies created before 25R3 that have Data Model V2 enabled

Data Entry Version set to “2” (Admin > Business Admin > Study Configuration)

This feature allows users to select from pre-generated responses when answering queries and is available to users who have Query Teams enabled.

Support in Studies created after 22R3 that are using Data Model V2

Support in Studies created before 22R3 that are using Data Model V2

Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

Principal Investigators can apply their signatures to forms and event dates that have open queries.

By Study Build in Studies created after 22R3 that are using Data Model V2

By Study Build in Studies created before 22R3 that are using Data Model V2

Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

Principal Investigators will now have the ability to sign multiple casebooks at once rather than signing one individual casebook at a time. This feature added the Signature History page to the Data Entry tab.

Auto-on in Studies created after 22R2 that are using Data Model V2

Support in Studies created before 22R2 that are using Data Model V2

Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

Local Labs Unit and Codelists are now versionless, and Lab Forms point to Lab module for Units and Codelists instead of Studio. This enhancement exposes translated values in the Audit Trail for both lab and non-lab forms. Existing Studies must undergo a migration process in Business Admin to move to this new model. Vault CDMS Utilities does not support the new Global Versionless Local Labs.

Auto-on in Studies created after 22R2 that are using Data Model V2

Auto-on in Studies created before 22R2 that are using Data Model V2

Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

When the legal reason of a signature definition is changed in Studio, the system will invalidate the eSignature for any objects where this signature was applied. For Data Model 2 studies, the audit trail will now include an entry when the signature was invalidated due to a change in attestation statement. This functionality is already available for DM1 studies.

Auto-on in Studies created after 22R2 that are using Data Model V2

Auto-on in Studies created before 22R2 that are using Data Model V2

Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

Study data, like execution data and restricted data if applicable, can be copied from Production by users with the Copy Study Data to PPT permission. Does not include CDB or custom object data. Data copied to the Post Production Test (PPT) environment cannot be merged; subsequent Copy Study Data actions will first remove any existing data.

Auto-on in Studies created after 22R2

Auto-on in Studies created before 22R2 that are using Review Rollup V2

Presence of a Review State Definition record for item__v

The Additive Review Listing will provide CRAs and data managers with a report on items additively reviewed in the study. It will include a summary report to give a high-level view of items additively reviewed by sites. Additionally, it will include a detailed report at the item or event-date level, which will include the user who performed the additive review, the datetime when the item or event date was reviewed and the additive reason why.

Auto-on in Studies created after 22R1 that are using Expression Engine V2

Auto-on in Studies created before 22R1 that are using Expression Engine V2

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

Vault now supports the following functions for use with rules: Median, NetWorkdays, and Workday. IsBlank now supports aggregate identifiers (arrays). Users can now reference the following attributes in rule expressions: unit__v (Item), translated_unit__v (Item), change_reason__v (Item), and subject_name__v (Casebook). When creating a rule, Vault no longer requires the selection of a Form in the Rule Details panel for rules that don’t require binding to a Form, such as rules only looking at Event Dates. Vault only requires the selection of a Form when the rule expression or action contains @Form identifiers or the rule uses the Override Review Plan, Set Item Value, or Send Email rule action types.

By Study Build in Studies created after 22R1 that are using Form Linking V2

By Study Build in Studies created before 22R1 that are using Form Linking V2

Form Linking Version set to “2” (Admin > Business Admin > Study Configuration)

This feature allows site users to indicate if a linked Concomitant Medication is just a concomitant medication or if it’s suspected to have caused an SAE (by using Item to Form Linking between the ConMed and AE forms). CDMS then records that in the Safety Case and transmits it to the safety system in the E2B XML package. Any administered study drug in the XML is then marked as interacting. Safety Link tracks this relationship and generates follow-ups as required. Safety Link now evaluates Link creation dates in addition to Form submit dates, and it stores the last date of this set in the E2B ID C.1.5 “Date of Most Recent Information in This Report”.

Study Feature Flag in Studies created after 22R1 that are using Form Linking V2

Study Feature Flag in Studies created before 22R1 that are using Form Linking V2

Form Linking Version set to “2” (Admin > Business Admin > Study Configuration)

Linked forms and their data will display in a new visible group below the form data. The process for linking a form to another form remains the same, but the data entry user no longer has to navigate to another tab to add, edit or view a link. Instead, they can perform these actions while remaining on the same page as the form data.

By Study Build in Studies created after 22R1 that are using Data Model V2

By Study Build in Studies created before 22R1 that are using Data Model V2

Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

With this feature, data entry users can now link an individual item to another form. In Studio, there is a new item type, called Form Link, which study builders can add to a form. When a Form Link item is added to a form, the study builder can set up to five Display Items, which are items from the linked form that display within the link item.

By Study Build in Studies created after 22R1 that are using Review State Rollup V2

By Study Build in Studies created before 22R1 that are using Review State Rollup V2

Presence of a Review State Definition record for item__v

Additive Review allows review users to perform additional SDV and DMR tasks, with a recorded reason, on Event Dates and Items that are set to Not Required on the subject’s assigned Review Plan.

Auto-on in Studies created after 22R1 that are using Data Model V2

Auto-on in Studies created before 22R1 that are using Data Model V2

Data Model Version set to “2” (Admin > Business Admin > Study Configuration)

Study designers can now define a custom query message to use when opening a query based on a comparison rule (rule defined using the Date Comparison Configurator in Studio > Rules > Comparison Rules).

By Study Build in Studies created after 21R3

By Study Build in Studies created before 21R3 that are using Expression Engine V2

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

Study designers can create Subject Groups, which are used for dividing Subjects into arms and cohorts. Subjects are assigned groups via rules. This feature adds casebook variables for Arm, Cohort, and Substudy. Vault displays the subject’s assigned group in EDC.

By Study Build in Studies created after 21R3

By Study Build in Studies created before 21R3 that are using Expression Engine V2

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

Studio now supports using [-1] (previous) and [+1] (next) to indicate that an identifier should resolve to the previous or next value of that identifier, for repeating Event Groups, Forms, and Item Groups.

By Study Build in Studies created after 21R3

By Study Build in Studies created before 21R3 that are using Expression Engine V2

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

With this release, we added the following functions for use with aggregate identifiers: IsAnyBlank, Count, CountIf, NoBlanks, AllEqual, and GetAllMatches.

By Study Build in Studies created after 21R3

By Study Build in Studies created before 21R3 that are using Expression Engine V2

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

For Send Email rules, Vault now supports the has_value_changed__v attribute on the Item identifier. This attribute returns true if the value of the identified Item has changed since the previous form submission. Vault now supports the submit_counter__v attribute on @Form identifiers and fully-qualified form identifiers. This attribute returns the number of times the identified Form has been submitted. Vault now supports the previous_submit_value__v attribute on fully-qualified item identifiers. Vault now supports the intentionally_left_blank__v and change_reason__v attributes on fullyqualified identifiers. The intentionally_left_blank__v attribute returns true if the identifier was marked as intentionally left blank. The change_reason__v attribute returns the Change Reason applied to the most recent modification of the identifier.

Auto-on in Studies created after 21R3

Auto-on in Studies created before 21R3 that are using Rules V2

Rules Version set to “2” (Admin > Business Admin > Study Configuration)

Studio users can configure the progressive display of multiple Items or Item Groups from a single dialog on the controlling Item. Vault now also indicates whether an Item is the controlling Item and displays both controlling and dependent definitions in the Properties panel.

Vault Admin in Studies created after 20R2 (see notes)

Work with your Veeva Services representative to upgrade your study’s data model to version 2

Data Model Version set to “2.0” (Admin > Business Admin > Study Configuration)

Vault now tracks the “Last Signed Date”, which is updated to the current date and time each any time the “Sign” status field is updated to “Yes”. To view this field in a report, the column must be added to a custom report

Vault automatically begins using this field to track signature dates, but a Vault Administrator must create a custom report to expose this field to report users.

By Study Build in Studies created after 21R3

By Study Build in Studies created before 21R3 that are using Expression Engine V2

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

For each error listed in the Error Console, users can now view the associated rule’s syntax and the entire error message in the Error Details dialog. They can also download the list of errors as a CSV file.

Auto-on in Studies created after 21R3

Auto-on in Studies created before 21R3 that are using Review Rollup V2

Presence of a Review State Definition record for item__v

Users can see the SDV or DMR review status when review is completed but then the requirement mode is set to No Review.

Auto-on in Studies created after 21R3

Auto-on in Studies created before 21R3 that are using Review Plan Assignment V1 or later

Review Plan Assignment Version set to “1”, “2”, or “3” (Admin > Business Admin > Study Configuration)

Users with permission to view SDV and DMR in the Review tab can now see which Review Plan is assigned as well as Form Review Plan overrides.

Auto-on in Studies created after 21R2 that are using _Protocol Deviations

Auto-on in Studies created before 21R2 that are using Protocol Deviations

Enable Protocol Deviations set to “Yes” (Studio > Study Settings)

Users can now filter the Protocol Deviation list by Study.

Auto-on in Studies created after 21R2 that are using _Protocol Deviations

Auto-on in Studies created before 21R2 that are using Protocol Deviations

Enable Protocol Deviations set to “Yes” (Studio > Study Settings)

Veeva EDC sends Protocol Deviations created or updated in EDC to Veeva CTMS via the CTMS connection.

Auto-on in Studies created after 21R2 that are using automatic deployments

Auto-on in Studies created before 21R2 that are using automatic deployments

Enablement of the Automatic Deployment feature for the Study

Study designers with access to multiple vaults can now copy records from one vault to another using Copy From Study.

By Study Build in Studies created after 21R2

By Study Build in Studies created after 21R2 that are using Expression Engine V2

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

Users can access the Name of the currently assigned Review Plan in a rule expression using @Casebook.current_sdv_plan__v and @Casebook.current_dmr_plan__v.

By Study Build in Studies created after 21R2 that have Data Model V2 enabled

By Study Build in Studies created before 21R2 that have Data Model V2 enabled

Data Entry Version set to “2” (Admin > Business Admin > Study Configuration)

Study Designers now have the ability to configure a repeating item group to appear in Data Entry in an Editable Grid format. Editable Grids allow for site users to efficiently enter data in a tabular, spreadsheet-like, format.

By Study Build in Studies created after 21R2 that have Query Team Restrictions enabled

By Study Build in Studies created before 21R2 that have Query Team Restrictions enabled

Enable Query Team Restrictions set to Yes (Studio > Settings)

Study Designers can choose to set the Query Team assigned to system-generated queries.

By Study Build in Studies created after 21R2

By Study Build in Studies created before 21R2 that are using Expression Engine V2

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

Study designers can now specify if an identifier should return an array of values, instead of distinct values. For the repeating parts of an identifier, they can use an asterisk (*) instead of a number inside the brackets to indicate that all instances of repetition should be considered in the value of the identifier. These identifiers can be referenced in the new aggregate functions.

By Study Build in Studies created after 21R2

By Study Build in Studies created before 21R2 that are using Expression Engine V2

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

Study designers can mark query-type Rules as having “delayed execution”, meaning that after a Form is submitted, the rule enters a queue for processing, instead of processing immediately after form submission.

By Study Build in Studies created after 21R1

By Study Build in Studies created before 21R1 that are using Expression Engine V2

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

Study designers can now reference linked Forms in a rule expression.

By Study Build in Studies created after 21R1 where Protocol Deviations is enabled

By Study Build in Studies created before 21R1 where Protocol Deviations is enabled and Expression Engine V2 is in use

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

Study designers can create a Create Protocol Deviation rule to create a new Protocol Deviation when certain conditions are met.

The Create Protocol Deviation rule action is the only part of the Protocol Deviations feature that requires Expression Engine V2. Studies that aren’t using Expression Engine V2 can use the Protocol Deviations feature without the rule (all manual Protocol Deviations).

By Study Build in Studies created after 21R1

By Study Build in Studies created before 21R1 that are using Expression Engine V2

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

Date comparison rules may now specify that two dates or datetimes are equal.

By Study Build in Studies created after 21R1

By Study Build in Studies created before 21R1 that are using Expression Engine V2

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

Study designers can add multiple Event Groups with a single Add Event Group rule action.

By Study Build in Studies created after 20R2

Work with your Veeva Services representative to upgrade your study’s data model to version 2

Data Model Version set to “2.0” (Admin > Business Admin > Study Configuration)

Study designers can configure certain Form Definitions as restricted. During the course of the study, these Forms will only be visible to unblinded users with permission to view restricted data.

Auto-on in Studies created after 20R2

Work with your Veeva Services representative to upgrade your study’s data model to version 2

Data Model Version set to “2.0” (Admin > Business Admin > Study Configuration)

Studio users can configure the Event Window for an Event so that Vault will create system queries if the Event is outside the window.

Auto-on in Studies created after 20R2

Work with your Veeva Services representative to upgrade your study’s data model to version 2

Data Model Version set to “2.0” (Admin > Business Admin > Study Configuration)

This feature completes the migration of the rest of the Review tasks (e.g. Freeze, Lock and Signature) off of the execution objects (for example, Item, Item Group, Form, Event, and Casebook) and to the Review State objects. The signature status of Forms and Event Dates will be stored on the Signature State object, which will eliminate the need to propagate the signature up and down the execution record hierarchy. This feature also introduced several new standard report templates.

Auto-on in Studies created after 20R2

Work with your Veeva Services representative to upgrade your study’s data model to version 2

Data Model Version set to “2.0” (Admin > Business Admin > Study Configuration)

If a dynamic Form contains data, and the controlling Item is edited in such a way that the Form should be removed, Vault now shows a banner on the Form indicating that it isn’t required. Upon reset, Vault automatically removes the Form from the Casebook.

Support in Studies created before 20R2 (Data Model V1 dependency added in 20R2)

Data Model Version set to “1.0” (Admin > Business Admin > Study Configuration) and Veeva Support enabling the Views feature for the vault

Study designers can create and manage Views, which can display mapped data in CSV or SAS format in an export package generated by the Data Export job.

By Study Build in Studies created after 20R2

Review Plan Assignment Version set to “2” (Admin > Business Admin > Study Configuration)

Source Data Verification will be driven by Subject Status and can be applied to a subset of subjects. You can provide multiple parameters for identifying subjects for verification. For a given Review Task, Review Plan Assignment criteria can be defined by Study Country, Study Site, Subject Status, or any combination of the three. You can also specify a minimum number of subjects or minimum percentage of subjects for assignment.

If you have not deployed the Study to production, you can upgrade to Review Plan Assignment V2 after deleting all study data. If your production environment has at least one subject, you cannot upgrade to Review Plan Assignment V2. To upgrade, delete all study data in the development, UAT, and training environments, then set the Review Plan Assignment field to “2” on the Study Configuration record.

By Study Build in Studies created after 20R2

By Study Build in Studies created before 20R2 that are using Expression Engine V2

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

Studies can use the new Override Review Plan rule action type to assign a chosen Review Plan to a Form based on user-entered data.

By Study Build in Studies created after 20R2

By Study Build in Studies created before 20R2 that are using Expression Engine V2

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

Study designers can reference the Sequence Number of a repeating Event Group, Form, or Item Group in a rule expression or action to only apply to a single instance of the repeating object.

By Study Build in Studies created after 20R1

Study Feature Flag in Studies created before 20R1 that are using Expression Engine V2

Rules Version and Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

Study designers can design a form such that data collection items are dynamically displayed or hidden based on user-entered data.

To upgrade to Rules Version 2, a study designer must first remove all Disable-type rules from the study.

Auto-on in Studies created after 20R1

Auto-on in Studies created before 20R1 that are using Expression Engine Version 2

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

Instead of typing in the path for identifiers directly in the Rule Editor, users can search for identifiers and insert them with #define statements. As part of this feature, users can also collapse and expand the Rule Details panel.

Auto-on in Studies created after 20R1

Auto-on in Studies created before 20R1 that are using Expression Engine Version 2

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

This feature introduced the following functions to the expression grammar: Power(), Sum(), Average(), and StartOfDay(). As part of this feature, the Today() function now also accepts an optional timezone parameter.

While the ability to use these functions in rule expressions is controlled by the Expression Engine Version field, the ability to use them in other areas of Vault, such as report filters, is automatically available.

By Study Build in Studies created after 20R1

By Study Build in Studies created before 20R1 that are using Expression Engine Version 2

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

Studio users can create a rule to send an email notification to a group of study users when certain conditions are met. Then, a lead data manager can assign which users receive those email notifications.

Auto-on for Studies created after 20R1

Auto-on in Studies created before 20R1

Dynamic Repeating Form Instance set to “No” (Admin > Business Admin > Study Configuration)

With this release, Vault no longer automatically creates the first instance of a repeating Form if the Form is added by an Add Form or Add Event rule.

For existing Studies that want to continue with the original behavior or adding the first instance, a Vault Administrator can set the Dynamic Repeating Form Instance field on the Study Configuration object to “Yes”.

Auto-on in Studies created after 20R1

Study Feature Flag in Studies created before 20R1

Data Entry Version set to “2” (Admin > Business Admin > Study Configuration)

This feature combines the Casebook Schedule and Form Display pages into a single page to create a better navigational experience for the user. All Events and Forms in the Study Schedule are now displayed next to the Form panel, allowing data entry users to navigate to any Form within any Event. Any activities previously performed by CRAs or DMs (SDV, DMR, Freeze, Lock, etc.) will now need to be performed in the Review tab.

Auto-on in Studies created after 19R3

Study Feature Flag in Studies created before 19R3

PDF Format Version set to “2” (Admin > Business Admin > Study Configuration)

We made the following enhancements to Detail PDFs: each page now includes a table header providing information about the form; the PDF includes bookmarks; if the PDF includes the audit trail, it now has Audit Trail by Visit and an Audit Trail by Form sections with bookmarks; and if the PDF includes queries, it now has a Queries section with a bookmark.

Auto-on in Studies created after the 19R2 release

Auto-on in Studies created before the 19R2 release where Event Date Review is enabled

This feature is made available by the presence of a Review State Definition record for Event Dates.

Studio now includes a specialized Review Plan Editor to easily create and manage Review Plans for a study.

Auto-on in Studies created after the 19R1 release

Work with Veeva Supportto use Event Date Review in Studies created before the 19R1 release.

Presence of a Review State Definition record for Event Dates.

Vault uses Review State Definitions to map Event Dates to an SDV or DMR Review Plan, allow data entry users to provide electronic signatures for Event Dates, and allow data review users to freeze or lock Event Dates. To allow for these types of reviews on Event Dates, you must have one Review State Definition for each Study.

Auto-on in Studies created after the 19R1 release

Expression Engine Version set to “2” (Admin > Business Admin > Study Configuration)

Studio users can access a new rule editor when creating a new rule or accessing an existing one. This feature improves Vault Formula capabilities, usability, and performance. By utilizing new operators, new functions, and new system variables, customers can streamline formulas and perform new calculations.

While the availability of enhanced formulas for Rules is controlled by the Expression Engine Version field, the enhanced formula grammar is automatically available in all other areas that use Vault Formulas (reports, custom object fields, etc.).