Enablement by Feature Version

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.

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)

Vault CDMS sends Protocol Deviations created or updated in EDC to Vault 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 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.

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.).