Study Design Process Overview

You can use EDC Studio to design and amend your study. In Studio, you can create both object definitions and your study’s schedule in a simple, drag and drop design interface.

Prerequisites

Before you can begin designing your study, you must first create a Study Master and an environment to contain your design. See details in Creating a New Study.

Creating Design Definition Records

A design definition object record is a record that Vault copies into an “execution” object record during casebook creation. For example, Vault creates a copy of your Event Definition record as an Event, or visit, record for each casebook. To design your study, you’ll need to create definition records for every component of your study’s design, including events, forms, units, and more.

Learn how to create design definitions.

Build the Study Schedule & Forms

Once you’ve created your design definitions, you can combine them to create your study schedule. Your study schedule defines the order of Event Groups, Events, and Forms in your Study, in the order they appear on the casebook schedule for data entry users.

Studio includes an easy, drag-and-drop interface for you to build your schedule within Studio > Schedule.

Learn how to build a schedule.

Create Rules

You can create data validation rules by using the rules engine to validate data in Vault EDC. Vault can then perform certain tasks based on the evaluation of the rule:

• Create a data validation query once a user leaves the field.
• Display Event Groups, Events, and Forms in a Study based on entered data.
• Conditionally enable and disable certain Items and Item Groups based on entered data.
• Derive values to automatically populate Items based on other entered data.

At a minimum, you must use Add Event Group to surface any Event Groups after the first Event Group in a Study.

Learn how to create rules.

Validate & Publish

Once the initial version of your design is complete, you can validate and publish it. This makes the study available for a deployment administrator to deploy it to a testing environment.

During publishing validation, Vault checks for any issues in your study’s design that may cause errors during casebook creation or data collection. Learn more about what Vault checks for here.

After your study design passes validation, you can publish it.

Learn how to validate and publish your design.

Study Update Restrictions

After you publish the initial version of your Casebook Definition, Vault prevents you from making certain changes in any later versions you may create. If you were to make these changes, it could cause errors during the casebook amendment process.

See Study Update Restrictions for a list of disallowed changes and available workarounds.