Vault EDC for Randomization Managers

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

Configuring Randomization in Studio

Before you can start randomizing subjects in the Data Entry tab, you must configure Randomization settings in Studio.

Enrollment

The Enrollment tab allows you to view a list of subjects as they are randomized or become candidates for Randomization. This tab specifies Subject Status,...

Kits/Devices

The Kits and Devices tabs display Kit/Device records that have been entered by Sites in the Data Entry tab after a subject has been randomized.

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Randomization Lists

In the Randomization Lists tab, you can generate and upload your own Randomization list using the provided template. Your template is based on the configuration...

Randomization Settings

To access Randomization Settings, you must select a study from the landing page after clicking on the Randomization module. Randomization Settings allow you to choose...

Randomizing in Data Entry

Once your Randomization tab and Randomization settings in Studio have been configured, you can randomize a subject in the Data Entry tab.

Stratification

With the Stratification tab, you can choose up to five Strata Variables per study to generate Strata Groups for Randomization.

Unmasked Data

This tab provides a listing of all unmasked data and is only accessible via an explicit permission. The following data can be masked in the...

Using the Randomization Module

Randomization provides a way to randomly allocate study treatment, thereby ensuring unbiased data for statistical analysis within and across subject groups. Through the Randomization module,...