Vault EDC for Study Designers

Users with the Design security profile and the CDMS Study Designer application role can use Vault EDC Studio to design their studies.

The topics below will help Study Designers, and users in similar roles, get started using Vault EDC:

About Studio

Vault EDC contains a study design and management interface, EDC Studio, to enhance the experience of clinical programmers as they design their studies. Using Studio,...

Configuring Assessments

Medical monitors and other users in similar roles can perform clinical assessments from within Vault EDC. Before a user can perform a clinical assessment, you...

Working with Casebook Versions in Studio

When you need to make changes to your study, for example, due to a study amendment or issue, you can use Vault EDC’s casebook versioning...

Comparing Casebook Versions in Studio

You can run a report to show the differences between two Casebook Definitions or two Casebook Definition versions. This illustrates added, removed, and changed design...

Configuring Cycles (Repeating Event Groups)

Vault EDC supports repeating Event Groups, which you can use to implement cycles in your study design. Each new repeating Event Group is a sequence....

Configuring Repeating Forms & Item Groups

Vault EDC supports repeating Forms and Item Groups, which you can use to collect the same set of data multiple times within a single Event....

Creating a Study Master in Studio

Before your organization can begin building your Study, you must first create a Study Master and the appropriate Study Environments. The Study Master is an...

CDMS Design Properties Reference

The CDMS Design Properties reference lists all available design properties for study objects, including Review Plans, Assessments, and Views.

Designing a Study in Studio

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...

Enabling Forms for Coding

You can easily identify coding Forms and configure them in Studio for clinical coders to code form data within Vault Coder.

Navigation in Studio

Vault EDC contains a study design and management interface, EDC Studio, to enhance the experience of clinical programmers as they design their studies. Using Studio,...

Using the Properties Panel

In EDC Studio, you can use the Properties panel to manage your object definitions. The fields available in the Properties panel depend on which type...

Publishing Validation Errors & Warnings

See the information below for help troubleshooting errors and warnings that occur when validating a casebook version:

Creating a Review Plan

With Targeted SDV (Source Data Verification) and DMR (Data Management Review), you can define SDV or DMR requirements for a subject in a Review Plan....

Rule Design Properties

In EDC Studio, you can use the Properties panel to manage your object definitions. The fields available in the Properties panel depend on which type...

Defining Rules in Studio (V1)

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...

Creating Rules in Studio

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...

Building a Study Schedule

From Studio > Schedule, you can drag and drop object definitions from the Components panel onto the Design palette to design your study schedule and...

Managing Study Settings

After creating your Study, you can update various study-level settings related to data collection in your study from Studio > Settings. Note that your selections...

Configuring Reasons for Change

You can specify the options for any dialog that uses a Reason for Change. Vault EDC stores these values in the Change Reason Configuration object...

Configuring Signature Definitions in Business Admin

In order for your Investigators to provide eSignatures, you must configure a Signature Definition object record related to your Study.

Creating a Review Plan in Business Admin

With Targeted SDV (Source Data Verification) and DMR (Data Management Review), you can define SDV or DMR requirements for a subject in a Review Plan....

Creating Study Specifications

With Vault EDC Studio, you can easily generate study documentation at any point in the design process. In the current release, there are three types...

Creating Design Definitions for Study Objects

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...

About Templates & Object Reuse

When designing a study in EDC Studio, you can use templates or existing Study definition objects.

Defining Default Units & Conversions

Vault EDC uses whichever Unit Definition Item  you select as the default for that particular unit. For all other Unit Definition Items  in that unit,...

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...

Upgrading a Study from Manual to Automatic Deployments

If your Study meets certain requirements, your organization can choose to upgrade your study from manual (pre-19R3) to automatic (post-19R3) deployments.

Clinical Data Transformation & Extraction

Vault EDC supports not only the collection of clinical data, but also the transformation and extraction of that data into a usable format. Vault EDC...

Common View Configuration Details

This article contains explanations about some common View Definition configurations. With the “Mapping Adverse Events” example, you can see an overview of an end-to-end view...

Creating Views in Studio

From Studio, you can create View Definitions, which Vault EDC uses alongside the Data Export job to export Study data into a readable CSV format....

Managing Views in Studio

View Sets are a method of preparing clinical data for export from Vault EDC. Vault EDC uses Views and View Sets alongside the Data Export...

Vault CDMS Formula Reference (V2)

You can create formulas to accomplish a variety of tasks in Vault. Vault uses an Excel™-like formula language, including functions and operators that allow you...