Managing Study Countries in EDC Tools
You can use the Study Countries tab in EDC Tools to manage the countries within your Study.
Accessing EDC Tools
To access the EDC Tools administration area, click the Tools tab in the primary navigation bar, and then click EDC Tools.
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.
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:
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:
- Navigate to EDC Tools > Study Countries.
- Scroll to the Study Country record you want to delete.
- From the Actions menu, choose Delete.
Which permissions control your access depends on when your vault was created. If your vault uses the Role by Study feature, see the first section, Role by Study Permissions. If your vault does not use the CDMS Role by Study feature, see the second section, Profile Permissions.
Role by Study 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:
|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.
The actions described above are available by default to users with the Vault Owner, System Administrator, and EDC Lead Data Manager security profiles.
|Security Profile||EDC: Study Tools: Access||Ability to access the EDC Tools area of Vault EDC|
|Security Profile||Objects: Study County: View, Create, Delete||Ability to view, create, and delete Study Country records|
|Security Profile||Objects: County: View, Create||Ability to view and create Country records|