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).
Enablement | Description |
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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 |
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Item 2 Standard Reports | Data Model V2 | 24R1 | 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:
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Sponsor Data Loader | Data Model V2 | 24R1 | 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. |
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Snapshots: Bulk Lock & Freeze | Data Model V2 | 23R2 | 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. |
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Conditional Unblinding | Mask Blinded Data | 23R2 | 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. |
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Study Progress Listing Enhancements | Review State Rollup V2 | 23R2 | 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:
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Show Sponsor in the My Vaults Page | My Vaults Page | 23R2 | 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. |
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Sort @PreviousEvent Rules by Schedule | Expression Engine V2 | 23R1 | 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 |
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Rules: Referencing the Previous Value of an Object with @PreviousEvent | Rules V2 | 22R3 | 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. |
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Labs: Support for Lab Results with Characters "<" & ">" | Global Versionless Labs, Data Model V2 | 22R3 | 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. |
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Global Lab Units & Codelists Display in UI Grids & Detail PDF | Global Versionless Labs | 22R3 | 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. |
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Form & Item Linking Rules Allow References to Fully-qualified Identifiers | Expression Engine V2 | 22R3 | 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. |
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Sign with Open Queries | Data Model V2 | 22R3 | 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. |
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Bulk Casebook Signature | Data Model V2 | 22R3 | 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. |
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Versionless Unit & Codelist Definitions for Labs | Data Model V2 | 22R2 | 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. |
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Audit Trail Enhancement: Add Reason for Invalidated Signatures | Data Model V2 | 22R2 | 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. |
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Amendment Preview: Copy Study Data | Data Model V2 | 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. |
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Additive Review Listing | Review Rollup V2 | 22R2 | 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. |
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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. |
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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”. |
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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. |
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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. |
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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. |
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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). |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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). |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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: |
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. |
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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. |
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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”. |
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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. |
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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. |
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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. |
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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. |
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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.). |