Managing Study Countries in EDC Tools

You can use the Study Countries tab in EDC Tools to manage the countries within your Study.

Prerequisites

Required Permissions

Users with the standard CDMS Lead Data Manager application role and a Security Profile that grants access to the EDC Tools can perform the actions described above by default. If your vault uses custom Application Roles, your role must have the following permissions:

Type Permission Label Controls
Standard Tab EDC Tools Tab

Ability to access the EDC Tools tab
Functional Permission Manage Study Countries

Ability to create and edit Study Countries in EDC Tools

If your Study contains restricted data, you must have the Restricted Data Access permission to view it.

Learn more about Study Roles.

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

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. The screenshot below is an example of version 1.

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.

Study Countries in Vault EDC

Vault groups your Study Sites by country using the Study Country object. Study Country joins together Study and Study Site.

In the object hierarchy, Study is the top level, Study Country is the second highest level, and Study Site is the lowest level object. For example, Study Site “7490” belongs to Study Country “United States,” which belongs to Study “VVT485-301.”

You can create new Country records as needed from Admin > Business Admin.

How to Add Study Countries

You can add and edit Study Country records from EDC Tools > Study Countries or when creating a new Study Site.

To add a Study Country from EDC Tools:

  1. Navigate to EDC Tools > Study Countries. Study Countries

  2. Click Manage Study Countries. Manage Study Countries button

  3. In the Add Study Countries dialog, use the Arrow buttons to add Countries in the left column into the right, Study Countries column. Add Study Country Dialog

  4. When finished, click Save. Vault creates a new Study Country object record for each country you added. You can now reference those countries when creating new Study Sites.

Deleting Study Countries

You can easily delete Study Country records from EDC Tools > Study Countries. Note that you cannot delete a Study Country if an existing Study Site references that Study Country.

To delete a Study Country:

  1. Navigate to EDC Tools > Study Countries.
  2. Scroll to the Study Country record you want to delete.
  3. From the Actions menu, choose Delete.