New Features in 21R1.4

JDrug, Study Data Extract Enhancements, and more...

Release Date: June 25, 2021

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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.

CDMS

Features in this section are changes that apply to all application areas of Vault CDMS.

Pop-Up Window Support for CDMS SSO Authentication

Vault CDMS now supports pop-up windows for SSO authentication with SAML Profile configurations, in addition to the iFrame support introduced in 21R1. For Vaults configured with the pop-up window, users will authenticate with their credentials in a separate pop-up window, instead of within the current browser tab.

Customers using IE11 with SSO enabled must enable the SAML eSignature feature.

Randomization Users: Customers who use Randomization on IE11 with SSO must enable the SAML eSignatures feature to access certain Randomization features.

Use Case

The system now provides more flexibility in SAML Profile configurations for authentication occurring within Vault CDMS.

Enablement

A Vault Owner must select the Authenticate SAML eSignatures in a pop-up window rather than an iFrame checkbox on the SAML Profile to enable the pop-up flow. SAML Profiles without this checkbox selected will continue to operate within an iFrame.

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Clinical Coding

The following are new features for Coder, the clinical coding area for Vault Coder.

JDrug

Vault Coder now offers JDrug to code and autocode Japanese medications.

To code in Japanese, Vault Coder searches the Dictionary using several Japanese scripts, specifically Kanji, Hiragana, and Katakana. Coders may also search the Dictionary with an English phrase and view Japanese results. Vault supports both full-width and half-width Japanese and English search phrases.

Vault Coder now also offers the ability to display JDrug coding in all Listings and Extracts.

Use Case

Japanese language studies are more holistically supported in CDMS.

Enablement

Coder Administrators must select a JDrug dictionary when assigning one to a Form in Coder Tools.

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Study Design & Configuration

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

Change Vault Login to Vault Selector for Diff Reports

With this release, users no longer have to log in to a remote vault to run a comparison report. This process will provide users with the same list of vaults that they have access to at the Vault level and will accommodate SSO users.

Use Case

This feature allows SSO users to run a comparison report across vaults without having to use a non-SSO account.

Enablement

This change applies automatically.

Access Current Review Plan in a Rule Expression

Study designers can now access the Review Plans currently assigned to a Subject in a rule expression by using two new @Casebook attributes: current_sdv_plan__v and current_dmr_plan__v.

Use Case

This feature allows more granular control of override review plan rules by allowing study designers to check if a subject is on a specific review plan before deciding if the review plan needs to be overridden.

Enablement

These attributes are automatically available for Studies using version 2 of the expression grammar.

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Study Administration

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

Study Data Extract Enhancements

With this release, multiple enhancements have been made to the Study Data Extract job, including the addition of new columns to clinical datasets, supporting custom objects information extraction, and additional configuration options in the SDE dialog UI and FTP connection dialog. The new features are listed below:

• Add Data Type to Key columns and Length column in Definitions File
  • Populates the data type (such as text, integer) for all columns in the Definitions file for SAS and CSV exports and adds a Length column to CSV exports
• New checkboxes in the SDE dialog UI for:
  • Using External ID instead of Item Definition Names in clinical datasets
  • Split Datetime columns into two columns: Date and Time
• Add a FORMILB column
  • Adds a FORMILB column for intentionally left blank forms in clinical datasets
• Add a LINKEDTO column for form linking datasets
  • Adds a column to show how many forms are linked to that dataset and includes some of the item data within those linked forms
• Users can choose a Zip File Name for SDE export
  • Allows users to enter a custom zip file name instead of a system-generated one
• Choose FTP directory path where SDE files will be placed
  • Allows users to specify a directory path they want the SDE files to go to - they are allowed up to three directories within the path
• Add subject status dates to SYS_SUB
  • The SYS_SUB dataset now contains columns for all subject status change dates. Those dates get set through rules when the subject status gets updated.
• Export Custom Object files in the SDE
  • Allows users to add records to a custom object configurator object in Business Admin, and the SDE will export those custom objects into files based upon the records.

Use Case

This feature allows users to include more options for their exports.

Enablement

These enhancements are available to all users that can run or schedule the Study Data Extract job. Extracting custom object data requires a study-by-study configuration in Business Admin to define which custom objects need to be extracted for which study.

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Clinical DataBase (CDB)

The following are new features for the CDB application, the Vault CDMS solution for data cleaning and reporting.

CQL Improvements

This feature introduces a new form modifier: ALIGN and UNALIGN. Prior to this release, when a Form or Item Group was repeating, CQL only returned joined data for the matching instances. Now, CQL returns the joined data across all matching sequences. For example, when showing information from a Demographics form and a repeating Adverse Event form, CQL now returns the data from the Demographics form in the rows returned for all Adverse Event form instances for a subject. This is “aligned”. The default behavior is UNALIGN, and so this doesn’t need to be specified.

Enablement

These changes apply automatically.

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Integrations

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

Send Protocol Deviations to Vault CTMS

With this release, Protocol Deviations created in Vault CDMS can be configured to flow into Vault CTMS via the Spark Connection. Once configured, creating or updating a Protocol Deviation in CDMS (either programmatically or manually) triggers an action in CTMS to either update or create the matching Protocol Deviation in CTMS. Protocol deviation data only flows one direction (into CTMS) with the Spark Connection. Any updates made in CTMS don’t transfer back into CDMS.

Use Case

Protocol Deviation records created in CDMS can now flow automatically into CTMS for a centralized location for managing Protocol Deviations.

Enablement

This feature requires a Vault CTMS Connection. Categories, Subcategories, and Severities must be configured within CTMS and mapped to the corresponding CDMS records to enable the transfer.

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Feature Enablement Summary

Feature Name	Configuration	Dependencies	Day 1 Impact to Primary Users	Users with Day 1 Visibility
CDMS
Pop-Up Window Support for CDMS SSO Authentication	Vault Admin
Clinical Coding
JDrug	Coder Tools			Coder Administrator
Study Administration
Study Design & Configuration
Change Vault Login to Vault Selector for Diff Reports				Librarians Study Administrators Study Designers
Access Current Review Plan in a Rule Expression	Studio	Expression Grammar v2		Study Designers Librarians
Vault CDB
Integrations
Send Protocol Deviations to Vault CTMS		Vault CTMS Connection & Protocol Deviations		Study Administrators

Enablement Legend

• Configuration: This field lists the location(s) where configuration for this feature occurs, for example, "Studio" or "EDC Tools". "Support" indicates that this feature must be enabled by Veeva Support, and "Vault Admin" indicates that configuration must be performed by a Vault Owner in the vault's Admin area.
• Dependencies: This field lists any dependencies required to use this feature, for example, Labs or Expression Engine V2. The other columns assume that the dependencies are enabled/in use.
• Day 1 Impact to Primary Users: This feature is visible and available to one or more primary user teams (Site Users, Clinical Team, and Coders) on day 1. Otherwise, this feature is either only visible to study designers or administrator users, it requires configuration before it is visible to primary users.
• Users with Day 1 Visibility: This feature is visible to these users on day 1 if no configuration occurs.