New Features 17R3.4: Mark Field as Intentionally Left Blank and more...

Release Date: Feb 9, 2018


We are pleased to bring you the following new features in this week’s release. See details about each feature’s enablement below.

EDC

The sort of for the Study, Site, and Subject parts of the Breadcrumb navigation will align with the default sort of the Study, Site, and Casebook listing pages. This feature will help ensure a consistent navigation experienced for EDC users.

Mark Field as Intentionally Left Blank

This feature allows users to mark an Item as intentionally left blank at the field level if the value was not collected or not available. In the Intentionally Left Blank dialog, Vault prompts users to select a reason for why the data was not collected. Marking a field Intentionally Left Blank also prevents Vault from generating any system queries against that field. Learn more about marking an Item as Intentionally Left Blank.

Display Subject Casebook Version

Users can now view the current casebook version that a Subject is on by hovering over the Information icon next to the subject name in the casebook header.

Audit Trail Enhancements for Item History

In this release, we refined the audit trail display for Items, or Item History, to make viewing and following an Item record’s progression easier to interpret in the audit trail. In the previous release, Vault created a separate audit entry for any field item field updates even if they were part of the same transaction. The display for item audits will now combine multiple item audit records into one display row instead of multiple rows making it easier to follow the changes. For example, when item value is changed and there is an accompanying change reason both value change and change reason will be displayed in a single row in the audit.

Skip Item (Item Groups)

Clinical programmers can create a data validation rule using the Skip Item action type to conditionally enable and disable Item Groups. These rules use a single identifier for the dependent Item Group, instead of a list of dependent Items. Like the existing skip Item behavior, Vault EDC conditionally enables and disables all Item fields in the dependent Item Group, based on the user’s entry into the controlling Item field. This feature eases the creation of this rule type for clinical programmers, as well as decreasing opportunities for error. Learn more about designing rules to skip Item Groups.

Design Tab Persistence

Studio users can now open multiple form designs in Design view and switch between Design and Browse views without the system closing the tabs. This is a general usability enhancement that was implemented to simplify the user experience when making study updates.

Date Mask Update

The date mask stores the configuration of unknown date values for an item. This update consists of the following changes:

  1. Vault now stores the date mask in the Item Definition object, using the Mask field. Previously, Vault stored this setting in the Rule Definition object.
  2. Vault checks against the item definition’s Mask field value when determining whether or not to show the Unknown checkbox.
  3. Vault no longer creates mask-type rules.

In existing vaults, date mask settings will be migrated from the Rule Definition to the Item Definition automatically.

Codelist Versioning

Vault now versions a study’s Codelist Definitions with the Casebook Definition version, like the other definition objects in the study design. This includes both the Codelist Definition and the Codelist Item Definition. The relationship between the Codelist Definition and the Codelist Item Definition is now tied to the Casebook Definition version. With codelists being versioned, clinical programmers can save time by copying codelists for reuse instead of creating new object records. 

Export Skipped Items Summary

When exporting a Casebook Definition, Studio users now receive a summary of objects that Vault was not able to export. This summary is a CSV report, including information about the object that Vault skipped. In this release, Vault skips exporting rules that do not have valid identifiers to objects in the study design.

Set Names for Casebook Versions

When creating a new Casebook Definition version, Studio users can now set a descriptive, unique name for each version. This Name is visible alongside the version number in Study Tools > Casebook Versions. If a Studio user chooses not to set a Name, Vault automatically names the version with the Version Number. Data managers can now more easily identify casebook versions in Study Tools, without having to reference Admin > Business Admin or confirm changes version by version with a clinical programmer.

Admin: Study Tools Access Controlled by Permissions

Access to the Study Tools area is now controlled by the EDC > Study Tools > Access permission. By default, the standard EDC Lead Data Manager security profile has this permission. The Study Tools area of Vault EDC involves more advanced study administration tasks, including operations like reviewing and running query rules in batch, activating specific sites with specific casebook definitions, and viewing jobs. Controlling access to the Study Tools area with a permission eases user management in Vault EDC.

Admin: Adding Jobs from Study Tools

Lead Data Managers can now add jobs from the Study Tools area of EDC. After a user adds the job, it appears in the jobs list, with links to download any resulting file outputs and a summary log. Users will still receive a Vault notification email upon job completion. The job types include:

  • Query Rule: This job type runs a query rule in batch, creating and closing queries throughout the study data. A user might run this job after a clinical programmer changes a rule.
  • Data Export: When a  Studio View Definition exists, this job runs the data export to CSV of that view.
  • Detail PDFs:  This job creates detail PDFs (with or without queries) for all subject Casebooks at the selected Site.
  • Targeted SDV: When a targeted SDV Review Plan changes, this job updates the SDV status of existing data to align with the updated Review Plan.

By adding jobs from the Jobs tab, data managers no longer have to leave the Study Tools area to initiate these bulk tasks. Learn more about initiating jobs from Study Tools > Jobs.

Admin: Access Job Output Files & Logs from Study Tools

The Study Tools area now includes a Jobs tab, showing those jobs added from within Study Tools. Once a user adds a job, the listing shows a link to download the Vault job log and, when applicable, the file output of a job, for example, a report on a query rule run about how many queries were created and closed. These logs and files expire when the Vault job expires, and so they are unavailable for download at that time. However, the entry detailing the job being run, including the date and time, who ran it, and the type, remains as a record in the Study.

Admin: Edit Query Rules from Study Tools

Data managers, and other users with permission to access Study Tools, can now review their query rules directly from the Query Rules tab. They can view the rule’s criteria, actions, and summary information about the queries created from the rule. Within the Query Rules tab, they can set the status of a rule to Active or Inactive. When a rule is Inactive, Vault does not create queries based on that rule. Learn more about editing query rules.

Admin: User Listing in Study Tools

Users with the permission to access the Study Tools area can now view a summary listing of users in their Study in the Users tab. The Users tab summarizes the users of the study, their site access, their security profile, and their application role. Lead data managers can now easily review users in their Study from a single view.

Vault Objects

Formula Fields

With formula fields for objects, Admins can automatically populate an object field value based on information already available in their vault. Admins can create new object fields with the Formula field type, select a Return Type for the data, and enter an expression to calculate the field value. Admins can choose Icon, Date, Boolean, Number, or Text as the Return Type. Admins can use date, number, text, yes/no, and picklist fields as the source tokens for a formula field expression. Formula fields on the object record are read-only to all users, regardless of security profile. Vault calculates the formula field’s value at run-time, and so formula fields are not available for searching or filtering.

For example, an Admin can create a formula field of with a date return type called Audit End Date, and define it using an existing Audit Start Date field with the expression, dateAdd({audit_start_date__c}, days (7)). Vault calculates an Audit End Date that is seven (7) days after the Audit Start Date.

Formula field expressions use the standard grammar for formulas in Vault. With this feature we added support for picklist fields and functions in the standard grammar for Formula Fields.  

Record Icons

Icons in object records can easily signify a record status. An Admin may configure a record icon as a type of badge. Admins can configure a Formula-type object field, selecting Icon for the Return Type, to display icons in object records. Admins can write the formula expression so that Vault displays certain icons based on different conditions. Admins can use any of the large set of icons provided in the Expression Editor. Admins can also assign the icon a color using a hex color code. Vault displays the icon on the object record list and detail pages. An Admin can also configure the icon so that it displays in the object record detail page header. Because icons use formula-type fields, they are read-only.

Record Favorites

Users can now favorite object records to view them together easily and quickly, similar to document favorites. To favorite an object record, users can click on the Star icon next to the record in an object record list or detail view to mark a record as a favorite. Users can click the Star icon again on a favorited record to remove it from favorites. All favorited records for an object will be show in a new view called “Favorites”. Favorites are specific to an object and a user.

Jobs on Objects

This feature expands the existing Job Scheduler functionality to support jobs on object records. Admins can schedule jobs for any object that uses a lifecycle. Based on object date fields, Vault can trigger actions to change the lifecycle state of an object record or to send a notification. This expansion provides better feature parity between documents and objects.

Object Create Permission Grants Edit Permission

In past releases, Vault permission sets could include the Create permission for an object without granting the Edit permission for that object. In vaults using Field-Level Security for objects, this configuration was not effective. As of this release, the Edit permission will be granted for any permission sets that include the Create permission. This change affects both existing permission sets and future configurations.

Lifecycle & Workflow

Add Participants to Active Object Workflows

Users can now add participants to active object workflows, enabling these users to participate in current tasks and future tasks on the active workflow. If the workflow configuration to constrains participants based on roles, only users currently in those roles will be available to participate in the workflow. Any user with a security profile that includes the Add Participant permission can add users to active workflows.

The object lifecycle Change State of Related Records entry action and Verify State of Related Records entry criteria currently support direct relationships such as parent-child and reference relationships.  In this release, these features now support join relationships as well, both simple and complex joins.  

Reporting

Enhanced Reports Tab

This feature updates the Reports tab to provide customers with the tools they need to organize their reports in Vault and find specific reports faster. Report users will have access to search, a sortable tabular view, filters, and custom views. In addition, reports will have a field for custom tags that users can utilize to easily group reports together in views. Learn more about reporting capabilities.

Administration & Configuration

Locked Objects and Tabs

For customers that use application families but don’t use all applications within the family, Vault will lock standard objects and tabs provided by an application that is not licensed. Locked objects and tabs are hidden from most users, but visible to users with access to the Admin area.

Expose API Usage Logs

This feature adds a new log with information around usage of Vault APIs. Users with the new Admin > Logs > API Usage permission can access these logs via the UI and API. The logs include daily API usage information, including the time, username, sessionId, endpoint, and daily usage limits for every call to the Vault API that day. Logs are available for download in CSV or Logfile format.

New Supported Component Types

The following component types are now supported for Configuration Migration Packages, Vault Compare, and Vault Configuration Report:

  • Saved View (Savedview)
  • Overlay Template (Overlaytemplate)
  • Signature Page Template (Signaturepage)

Users can use these component types to compare configurations between vaults, export definitions to a package, and import and deploy packages to a vault. 

Vault Java SDK

Admin UI for Vault Java SDK

Admins can view lists of custom code deployed to a vault, such as Record Triggers, Actions, and User-Defined Classes. Organizations can develop custom code using the Vault Java SDK. Admins can download the source code file from Admin > Configuration > Vault Java SDK. The list pages are view-only. To inquire about Vault Java SDK solutions, contact Veeva Services.

Feature Enablement Details

Feature Enablement Application
EDC
Breadcrumb Sorting for Study, Site and Subject Auto-On EDC
Mark Field as Intentionally Left Blank Auto-On EDC
Display Subject Casebook Version Auto-On EDC
Audit Trail Display Enhancement for Item History Auto-On EDC
Skip Item (Item Groups) Configuration EDC
Design Tab Persistence Auto-On EDC
Date Mask Update Auto-On EDC
Codelist Versioning Auto-On EDC
Export Skipped Items Summary Auto-On  EDC
Detect Duplicate Objects Auto-On 1 EDC
Set Names for Casebook Versions Auto-On EDC
Admin: Study Tools Access Controlled by Permissions Auto-On EDC
Admin: Adding Jobs from Study Tools Auto-On EDC
Admin: Access Job Output Files & Logs from Study Tools Auto-On EDC
Admin: Edit Query Rules from Study Tools Auto-On EDC
Admin: User Listing in Study Tools Auto-On EDC
Vault Objects
Formula Fields Configuration Platform
Record Icons Configuration Platform
Record Favorites Auto-On Platform
Jobs on Objects Configuration Platform
Object Create Permission Grants Edit Permission Auto-On Platform
Lifecycle & Workflow
Active Object Workflow Management - Add Participants Auto-On Platform
Support Joins for Actions on Related Records Configuration All
Reporting
Enhanced Reports Tab Auto-On All
Administration & Configuration
Locked Objects & Tabs Auto-On Platform
Expose API Usage Logs Auto-On Platform
New Supported Component Types Auto-On Platform
Vault Java SDK
Admin UI for Vault Java SDK  Support Platform
1 Postponed to a later release.

Enablement Legend

See the following explanations for feature enablement options:

Enablement Description
Auto-on Automatically activated and no configuration is required before using the feature; note that in some cases, a new feature is dependent on another feature that must be enabled or configured.
Admin Checkbox Admins must turn on the feature with an Admin checkbox. Note that some “Auto-On” features have a checkbox setting that hides the feature; these will show “Auto-On.”
Configuration Admins must configure the feature (separately from an Admin checkbox) before it is available to use or is active; for example, a Clinical Programmer must create an Item Definition of a certain new Item Type.
Support On/off option controlled by Support.

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