Enablement by Feature Version

This table lists the various features that have a “version” or depend on the version of an earlier feature to be available. For example, in the 19R1 release, we introduced the “Rules Editor & Enhanced Vault Formulas for Rules” feature, which was controlled by the Expression Engine Version. For Expression Engine Version “1”, this feature was unavailable. In Studies created after 19R1, the Expression Engine Version is set to “2”, meaning the feature is automatically enabled for the Study. Later features require version 2 of the Expression Engine to be available. If your Study was created after 19R1, you would then be able to enable such a feature.

For feature rows that have the Automatic Deployment column checked, that means that the feature is only available to Studies using the Automatic Deployment model (introduced in 19R3, any studies created after 19R3 are automatically using the new model). Learn how to upgrade your Study to the Automatic Deployment model.

Enablement Description
Auto-on Automatically activated and no configuration is required before using the feature; note that in some cases, a new feature is dependent on another feature that must be enabled or configured.
Study Feature Flag This feature is available by configuration within the Study Configuration object (or similar). To enable a feature using study configuration, navigate to Admin > Business Admin > Study Configuration and edit the Study Configuration record for your Study.
By Study Build The configuration options for this feature are available automatically in Studio, EDC Tools, Coder Tools, or System Tools, but you must configure them within your Study for those options to apply.
Support On/off option controlled by Support.
Feature Dependencies Added In New Study Enablement Existing Study Enablement Controlled By Automatic Deployments Feature Description Notes
New Attributes, Functions & Usability Enhancements for Rules Expression Engine V2 22R1

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.

Suspected Concomitant Medication Form Linking V2 22R1

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”.

Form Linking UI/UX Enhancements Form Linking V2 22R1

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.

Item to Form Linking Data Model V2 22R1

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.

Additive Review Review State Rollup V2 22R1

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.

Comparison Rules Enhancements (Override Query Message Text) Data Model V2 22R1

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).

Arms & Cohorts Expression Engine V2 21R3

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.

Previous/Next Identifiers for Repeating Event Groups, Forms & Item Groups Expression Engine V2 21R3

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.

New Aggregate Functions Expression Engine V2 21R3

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.

Rule Syntax Enhancements Expression Engine V2 21R3

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.

Progressive Display Enhancements Rules V2 21R3

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.

Last Signed Date Tracking for Reports Data Model V2 21R3

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.

Error Console Enhancements Expression Engine V2 21R3

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.

Display Historical SDV & DMR Status when REquirement Mode is Set to No Review Review State Rollup V2 21R3

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.

Display Assigned Review Plan in the Review Tab Review Plan Assignment V1 & Later 21R3

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.

Protocol Deviation Study Filter Protocol Deviations 21R3

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.

Send Protocol Deviations to Vault CTMS Vault CTMS Connection, Protocol Deviations 21R2

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)

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

Cross Vault Copy -- 21R2

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.

Access Current Review Plan in a Rule Expression Expression Engine V2 21R2

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.

Editable Grids Data Entry V2 21R2

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.

Enhanced System Query Closure Restrictions Query Team Restrictions 21R2

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.

Aggregate Identifiers & Functions Expression Engine V2 21R2

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.

Delayed Execution for Query Rules Expression Engine V2 21R2

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.

Access Data from Linked Forms in Rules Expression Engine V2 21R1

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.

Programmatic Protocol Deviations Expression Engine V2 21R1

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).

Comparison Rule to Check that Dates are Equal (Rule Enhancements) Expression Engine V2 21R1

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.

Add Multiple Event Groups with One Rule (Rule Enhancements) Expression Engine V2 21R1

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.

Restricted Data Data Model V2 20R2

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.

Out of Range Queries on Event Dates Data Model V2 20R2

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.

Freeze/Lock/Sign Propagation Updates Data Model V2 20R2

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.

Changed Handling of Dynamic Form Removal Data Model V2 20R2

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.

Clinical Data Mapping (Views) Data Model V1 18R1

Unavailable in Studies created after 20R2

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.

Enhanced SDV/DMR Review Plans ("Review Plan Assignment V2") -- 20R2

By Study Build in Studies created after 20R2

Not intended for Studies created before 20R2 (see notes)

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.

Data-driven Review Plans Expression Engine V2 20R2

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.

Reference Sequence Number in Rules Expression Engine V2 20R2

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.

Progressive Display Rules V2, Expression Engine V2 20R1

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.

Rule Editor Enhancements Expression Engine V2 20R1

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.

New Functions in the Formula Expression Grammar Expression Engine V2 20R1

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.

Send Email Rules Expression Engine V2 20R1

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.

Prevent Creation of First Instance for Repeating Forms Added by an Add Form or Add Event Rule -- 20R1

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”.

Data Entry Navigation Enhancements ("Data Entry V2") -- 20R1

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.

Enhanced Detail PDFs ("PDF Format V2") -- 19R3

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.

Review Plan Editor Event Date Review 19R2

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.

Event Date Review -- 19R1

Auto-on in Studies created after the 19R1 release

Work with Veeva Support to 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.

Rules Editor & Enhanced Vault Formulas for Rules ("Expression Engine V2") -- 19R1

Auto-on in Studies created after the 19R1 release

Unavailable to Studies created before 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.).