New Features in 19R2.4

Simple Listings, Sticky Filters, and more...

Release Date: November 1, 2019

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We are pleased to bring you the following new features in this week's release. See a summary of feature enablement for this release below. Information on developer features (REST API) is in the Developer Portal.

Data Entry

Features in this section are changes to the Data Entry tab, a working area for investigators and clinical research coordinators to enter study execution data.

Sticky Filters in the Data Entry & Review Tabs

When a user filters records on any listing page in the Data Entry or Review tabs, those filters now remain selected throughout the Vault login session. If a user navigates away from the listing and returns to it, Vault applies those remembered filters and will continue to do so until the user logs out of Vault. This saves users the time of applying the same filter repeatedly when working in Vault.

Use Case

Users save time because they no longer have to reselect their filters each time they open a page.

Enablement

These changes apply automatically with no additional configuration required.

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Data Review

Features in this section are changes to the Review tab, a working area for clinical research associates and data managers, or to review functionality within the Data Entry tab.

Enhancements to Review Status Propagation Removal

Because SDV and DMR status is no longer propagated above the Item record, we’ve added the following fields to the Form Operational Summary object to support reporting and SDV and DMR status without aggregating data:

• SDV Completed and DMR Completed: This field is set to true (Yes) when all Items that had the SDV or DMR mode set to Required have SDV or DMR completed.
• SDV Completion Date and DMR Completion Date: The date and time when SDV or DMR was completed for all required items. If there are no items requiring review on the Form, this field remains blank.
• SDV Required Item Exists and DMR Required Item Exists: This field is set to True (Yes) if any Items on the Form have the Required requirement mode for SDV or DMR.
• SDV Last Activity and DMR Last Activity: The date and time of the most recent SDV or DMR status change on any Item on the Form.

Use Case

These changes support easier reporting about SDV and DMR status at the Form level.

Enablement

These data model changes apply automatically, but the removal of SDV and DMR propagation only applies to Studies created after the 19R2.3 release (for limited release vaults) or the 19R3 release (for general release vaults).

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Vault Coder

The following are new features for the Vault Coder application, the Vault CDMS solution for clinical coding.

Reconstitute Code Requests Job

After a study designer finishes updating coding configuration for a Form with existing Code Requests, a lead data manager can use the new Reconstitute Code Requests job to apply those configuration changes to those Code Requests.

The Reconstitute Code Requests job checks each Code Request and verifies that it references the latest configuration as defined in Studio. If it doesn’t, then the job updates the Code Request. Otherwise, the job skips that Code Request, not making any changes. As part of this process, if the values for Verbatim and other coding properties, such as Indication or Route, are updated, then any assigned code is cleared and the request’s Coding Status is set to Updated.

As part of this enhancement, we reduced the scope of the Autocoding and Suggestions job to no longer perform these reconstitution activities. That job now only autocodes and generates suggestions.

Use Case

This enhancement allows an organization to apply configuration changes to existing Code Requests, instead of starting “this point forward”. Reducing the scope of the Autocoding and Suggestions job makes this job more performant, scalable, and transparent.

Enablement

The Reconstitute Code Requests job is available automatically in EDC Tools > Jobs.

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Reports & Dashboards

The following are new features for reports and dashboards in Vault CDMS.

Renamed the Queries Leading to Data Changes Report

With this release, we renamed the Queries Leading to Data Changes report as Standard Template: Queries Leading to Data Changes.

Enablement

This change applies automatically with no additional configuration required.

Allow Administrator Users to Schedule Reports

With this release, permissions have been added to allow Lead Data Managers, Clinical Coding Administrators, and any custom Study Role with the Schedule Report functional permission to have the ability to schedule and run flash reports.

Use Case

This enhancement allows these users to extract operational data from Vault CDMS on a recurring schedule.

Enablement

This change applies automatically with no additional configuration required. These users must schedule flash reports to use them.

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Assessments

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

Enablement Change: Clinical Assessments

With this release, we updated the enablement of Clinical Assessments from “Support” to “By Study Build” in vaults where Role by Study is enabled. This update means that the configuration options for Assessments display automatically in Studio and EDC Tools (when Role by Study is enabled), but an organization must create Assessment Definitions and assign them to Study Roles before they become available to assessment editors.

Contact Veeva Support to enable the Role by Study feature in your vault.

Enablement

The options to configure Assessments are now automatically available in Studio and EDC Tools, but an Assessment must be configured before it is available to end users.

Inactivate Assessment Questions

Study designers can mark assessment questions as Inactive. During assessment creation, Vault now only creates assessment questions in the Active status. Any questions that are Inactive are not added to new assessments. If a study designer later reactivates a question, that question is not added to any existing Assessments unless assessment editor resets the Assessment. Similarly, if a study designer inactivates a question, that question is not removed from existing Assessment until those assessments are reset.

Use Case

Study designers can make mid-stream changes to an Assessment Definition.

Enablement

This feature applies automatically to all existing and future Assessments.

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Study Design & Configuration

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

Set Subject Status with Rules

Study designers can use the new Set Subject Status rule action to create rules updating the Status of a Subject. They can also set the status change’s date to a specific item value or event date.

Use Case

The ability to set subject statuses with rules reduces the amount of custom SDK configuration required for studies and empowers organizations to use subject status more effectively.

Enablement

The Set Subject Status rule action is available automatically, but rules must be created using this action before it applies to existing Studies.

Send Emails with Rules

With this release, Vault CDMS now supports sending email notifications to users when certain conditions are met using the new Send Email rule action. Study designers can create a Send Email rule to send an email to a set group of users when the rule evaluates as true. For example, a rule can send an email to a group of users upon the creation of an adverse event. The group of users (Email Group) and email message template are tied to a rule expression that determines when an email should be sent to the group.

In this release, rule configuration for Send Email rules must be performed primarily in Admin > Business Admin.

Use Case

The ability to control email notifications with rules reduces the amount of custom SDK configuration required for studies.

Enablement

The Send Email rule action is available automatically, but configuration must be performed in Admin > Business Admin for those rules to be usable. rules must be created using this action before it applies to existing Studies.

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Study Administration

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

Import & Export Users for both Manual & Automated Deployments

With this release, we returned the ability to import and export Users in EDC Tools > Users.

As part of this change, importing and exporting Users is now supported in Studies using the automated deployment model. For these Studies, a user administrator can include the Study Environment column in their CSV file to indicate which environments a User should have access to.

Use Case

User administrators can now easily add users in bulk by importing them into a study.

Enablement

This change applies automatically with no additional configuration required.

Core Listings

Lead data managers can use the new Data Listing job to generate core data listings in their Studies. The Data Listing job exports clinical data for selected Sites and Forms as a ZIP file, which includes a CSV file for each Form. The CSV files lists Item values, the form’s completion date, and more.

Lead data managers can run and schedule this job from within EDC Tools > Jobs.

Use Case

This feature provides EDC Tools users an easy way to extract clinical data from within Vault, instead of requesting such an extract from Veeva Services.

Enablement

The Data Listing job type is available automatically in EDC Tools with no additional configuration required. EDC Tools users can begin running Data Listing jobs right away.

Enablement Change: Prospective Amendments

With this release, we updated the enablement of the Prospective Amendments feature to Support. This feature is now disabled in all existing vaults. Organizations must contact Veeva Services to enable this feature.

Enablement

This enablement change applies automatically to all CDMS application vaults.

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Deployments

Features in this section are enhancements to deployment functionality in Vault CDMS.

Automated Deployment Enhancements

With this release, we made the following minor enhancements to automated deployments:

• Vault now prevents users from changing an environment’s type from Admin > Business Admin.
• The Study Label value must now be unique within a vault.
• The CDMS Study Designer study role no longer has access to the Data Entry tab.

Use Case

These enhancements prevent issues during study deployments.

Enablement

These changes apply automatically in studies using the automated deployment model.

Lock Study for Automated Deployments

With this release, deployment administrators can now lock study environments from EDC Tools > Deployments. When a study environment is locked, lead data managers cannot perform actions that change data from within EDC Tools (such as an amendment or initiating a Query Rules job). Data entry and monitoring users can see collected data, but they cannot perform any create, update, or delete actions. This includes adding new Casebooks, entering or modifying data, and opening, answering, and closing queries.

Use Case

Locking an environment can be used during a study for mid-stream stopping points, or it can be used to close an environment when data collection is complete for the Study.

Enablement

This feature is automatically available in Studies using the automated deployment model, with no additional configuration required.

Hotfix & Merge for Automated Deployments

With this release, organizations can utilize a second development-type study environment to make a change to their study, without deploying any in progress changes that exist on their primary development environment. For example, an organization could use this process to add a new Codelist Item to a Codelist while they are building out a new Form in their other development environment. Then, they can deploy a version with the new Codelist Item before they finish with their new Form.

The hotfix and merge process is as follows:

1. A deployment administrator creates a second development environment from EDC Tools > Deployments and restores that environment from the production environment, using the new environment-level Restore action.
2. A Study Designer makes the necessary design changes, validates, and publishes the new casebook version.
3. The deployment administrator deploys the new version to UAT and production.
4. A Study Designer copies the study design from the new development environment into the original one using Studio’s copy functionality with the new Update with Changes option.

This feature introduces the new Update with Changes option to the Copy Event Groups, Copy Events, and Copy Forms dialogs. This allows a Studio user to overwrite existing values with those values being copied. This process does not delete relationships between objects, it only adds them. Any deletion will need to be performed manually. A Studio user can then compare casebook versions between the source and the destination to understand what changes will occur as part of the copy.

Use Case

This enhancement allows an organization to “park” ongoing changes while managing emergency changes in production, increasing their flexibility in responding to issues. It also improves build efficiency by allowing users to copy objects from standards, libraries, or other Studies.

Enablement

This feature is automatically available in Studies using the automated deployment model, with no additional configuration required.

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Integrations

Features in this section are new integrations with Vault CDMS or enhancements to existing integrations.

Vault CDMS API

With this release, we introduced the Vault CDMS API. Organizations can use the API to support integrations with external systems.

This release includes the following endpoints:

Study API

API Name	Description
Get Studies API	This API allows user to get a list of all studies. If a customer doesn’t know the Study Names used for other APIs, they can use this endpoint to retrieve them. Vault only returns studies the user has permission to access. GET/api/{version}/app/cdm/studies

Casebook API

API Name	Description
Create Casebook API	Create a new Casebook, with first Event Group and Event in the Unplanned status POST/api/{version}/app/cdm/subjects

Event API

API Name	Description
Set Event Dates API	Set the Event Date for an Event POST/api/{version}/app/cdm/events/action/setdate

Form APIs

API Name	Description
Set Item Value API	Set data on a form POST/api/{version}/app/cdm/forms
Submit Form API	Submit a Form. POST/api/{version}/app/cdm/forms
Edit Submitted Form API	Move a submitted Form into edit mode and provide a reason for change. POST/api/{version}/app/cdm/forms

Query APIs

API Name	Description
Retrieve Queries API	Retrieve a list of queries GET/api/{version}/app/cdm/queries
Open Query API	Open a query on an Item or Event Date POST/api/{version}/app/cdm/queries
Answer Query API	Answer a query with message POST/api/{version}/app/cdm/queries/actions/answer
Close Query API	Close a query with an optional message POST/api/{version}/app/cdm/queries/actions/close
Reopen Query API	Reopen a query with a message POST/api/{version}/app/cdm/queries/actions/reopen

User APIs

API Name	Description
Retrieve Users API	Retrieve a list of Users in a Study POST/api/{version}/app/cdm/users
Create User API	Create a new User and assign that User a Study Role for a Study GET/api/{version}/app/cdm/usersmessage

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Feature Enablement Summary

Feature Name	Enablement	Application
Data Entry
Sticky Filters in the Data Entry & Review Tabs	Auto-on	EDC
Data Review
Enhancements to Review Status Propagation Removal	Auto-on * While review status propagation removal only applies to new studies, these data model changes apply in all vaults.	EDC
Vault Coder
Reconstitute Code Requests Job	Auto-on	EDC, Coder
Reports & Dashboards
Renamed the Queries Leading to Data Changes Report	Auto-on	Coder, EDC
Allow Administrator Users to Schedule Reports	Auto-on	EDC, Coder
Assessments
Enablement Change: Clinical Assessments	By Study Build * In vaults where Role by Study is enabled	EDC
Inactivate Assessment Questions	By Study Build	EDC
Study Design & Configuration
Set Subject Status with Rules	By Study Build	EDC
Send Emails with Rules	By Study Build	EDC
Study Administration
Import & Export Users for both Manual & Automated Deployments	Auto-on	EDC
Core Listings	Auto-on	EDC, Coder
Enablement Change: Prospective Amendments	Support	EDC
Deployments
Automated Deployment Enhancements	Auto-on	EDC, Coder
Lock Study for Automated Deployments	Auto-on	EDC, Coder
Hotfix & Merge for Automated Deployments	Auto-on	EDC, Coder
Integrations
Vault CDMS API	Auto-on	EDC, Coder

Enablement Legend