Step 2: Add Users to the Study

EDC Tools

Roles


To perform UAT and training for your Study, you need to add users to your Study in your UAT or training vault. Add only the users you need for UAT and training, instead of your entire roster of users. You’ll add all of your users to your study later in your production environment.

Prerequisites

Before adding users to your Study, you must have created Study Countries and Sites for your study already. See Step 9: Create Study Countries & Sites in the Study Design Stage for details.

Accessing EDC Tools

To access the EDC Tools administration area, click the Tools tab in the primary navigation bar, and then click EDC Tools.

Access EDC Tools from the Tools Tab

By default, once you open EDC Tools, Vault displays a list of automated deployment Studies. You can use the Automatic and Manual radio buttons to switch between these listings. Select Manual to access your manual deployment Studies.

Select Automatic or Manual

For manual deployment Studies, click on the Study to open EDC Tools for that Study. For automatic deployment Studies, click on the Study to open the Deployments page. From here, you can click on an Environment to open EDC Tools for that study environment.

Once you’ve entered the EDC Tools area, select your Study if you have access to more than one Study. To return to the study list, click Back to Study Listing.

About User Access

When you add a user to a Study from EDC Tools > Users, Vault automatically creates EDC Execution User Role object records for each user added, and additional records for each role assignment for that user. This allows users to have access specific to your study. For example, a user may have the Data Manager role in the Deetoza study but only the Auditor (Read Only) role in the Veeofen study.

See Study Access in Vault CDMS for more information about user access control.

Add or Import Users

You can provide users with study access from Tools > EDC Tools > Users in two ways: by adding single users and by importing users in bulk with a CSV file.

Add Users to a Study

You can add individual users to a Study from EDC Tools > Users by clicking + New User and filling the required fields.

Import Users into a Study

You can import users into your Study in bulk using a CSV file. With user import, you can create new user accounts and add existing users (in the current vault) to the study.

See detailed instructions to import users here.

EDC Tools

Roles