New Features: Skip Item and more...
Release Date: October 4, 2017
We are pleased to bring you the following new features to Vault EDC in this week’s release. See details about each feature’s enablement below.
For a list of fixed issues, see Fixed Issues in the 17R2.2.6 Release.
Icon for Intentionally Left Blank Form
Currently, data entry users can mark an entire Form as Intentionally Left Blank when data is not available. After a user marks a Form as Intentionally Left Blank, other users can now save time and distinguish between a Submitted Form and an Intentionally Left Blank Form with a new status icon for Intentionally Left Blank.
Skip Item (Dynamic Entry)
Based on study design, specific Item controls can be initially disabled until certain criteria are met in controlling Items. For example, a Pregnancy Test Result field remains disabled until a user selects Female for Gender. The disabled fields are visible and displayed to data entry users, but they cannot enter data in the Item until the rule criteria are met. If a user later edits a controlling Item so that rule criteria are no longer valid, the dependent Item remains enabled, and any data or open queries remain enabled as well. Once the data is cleared or the query is closed, and a user submits the Form, the dependent Item is once again disabled. After that, if user edits the Form, dependent Items remain disabled for data entry. This feature saves a great deal of time for both data entry users and monitoring users. When a field is not required or irrelevant based on entered data, data entry users no longer need to mark an Item as not available, and monitoring users no longer need to SDV or SDR irrelevant data.
Availability: In the current release, this area of the application is only available to Veeva Services.
Skip Item Rules
Clinical programmers can build new Rules to enable and disable Items on a Form. By building Rules with the Skip Item action. This feature allows users to conditionally enable Items in EDC for entry based on answers to previous Items. Users can enable or disable multiple Items with a single Rule. This feature supports Skip Item (Dynamic Entry), which saves data entry and monitoring users a great deal of time.
Cross-Form & Cross-Event Data Validation Rules
Clinical programmers can build data validation rules that evaluate data across multiple Forms or Events. Clinical programmers can use identifiers for Items in multiple Item Groups, Forms, and Events in rule expressions. Identifiers must include a full path for specific hierarchies or an implied path for Vault to process the rule. For example, a clinical programmer could build a rule that creates a Query when Systolic and Diastolic Blood Pressure on a Vitals form are higher than in an earlier Event and Form.
Feature Enablement Details
|Icon for Intentionally Left Blank Form||Auto-On||EDC|
|Skip Item (Dynamic Entry)||Configuration||EDC|
|Skip Item Rules||Configuration||EDC|
|Cross-Form & Cross-Event Data Validation Rules||Configuration||EDC|
|Required Items not Displayed with Yellow Background postponed to a later release.|
See the following explanations for feature enablement options:
|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.|