Step 9: Create Study Countries & Sites

EDC Tools

Roles


Vault groups your study’s Sites by country using the Study Country object. Study Country joins together Study and Site. In the object hierarchy, Study is the top level, Study Country is the second highest level, and Site is the lowest level object. For example, Study Site “7490” belongs to Study Country “United States”, which belongs to Study “VVT485-301”.

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.

How to Create a Study Country

You can add and edit Study Country records from EDC Tools > Study Countries.

To add a Study Country:

  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.

How to Create a Site

To create a new Site:

  1. From EDC Tools, open the Sites tab.
  2. Click New Site.
    New Site Button

  3. Fill the required fields.
    New Site Dialog

  4. Click Save.

EDC Tools

Roles