Managing a Study in EDC Tools
Vault EDC includes a study administration tool within Tools > EDC Tools. You can perform study administration tasks from the EDC Tools area, such as scheduling recurring jobs or controlling user access. Performing tasks and viewing data in a single location saves you time. Tasks in this area apply at the study- and site-level, instead of at the casebook-level or lower, such as those tasks in the Actions menu or task bar.
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.
Once you’ve opened EDC Tools, Vault displays a list of all Studies that you have permission to view. You can click into a Study to access the administrative tools for that Study.
From here, you can also:
- Lock or unlock a Study (see details here)
- Delete study execution data in development or UAT vaults (see details here)
EDC Tools Tabs
The EDC Tools area is divided into tabs based on which task you’re performing. If the Role by Study feature is enabled in your vault, which tabs you can see depends on your Application Role.
In the Casebook Versions tab, you can manage your casebook versions site-by-site:
You can view a list of all existing data validation rules in your study from the Query Rules tab. Clinical programmers create data validation rules during study design. Vault uses these rules to create system-generated queries. From this tab, you can view details about each rule, as well as activate or inactivate individual rules. See Managing Query Rules in EDC Tools for details.
You can view a job history for that study from the Jobs tab. From the Jobs tab, you can also add and schedule jobs for Vault to initiate. See Managing Jobs in EDC Tools for details.
Email Group Assignment
In the Email Group Assignment tab, you can assign users to Email Groups for Send Email rules. Note that this tab is only available if your organization is using Role by Study and the automated deployment model. See Assigning Users to Email Groups for details.
From the Users tab, you can view a list of all Vault users in your Study. You can also add existing Vault EDC users to your Study. See Managing User Access in Vault EDC for details.
From the Sites tab, you can view a list of all Study Sites within your Study. You can create new sites, view details and an audit trail for each of your existing sites, as well as lock and unlock individual sites. See Managing Sites in EDC Tools for details.
From the Study Countries tab, you can view a list of all Study Countries within your Study. You can also create and delete new Study Countries. See Managing Study Countries in EDC Tools for details.
From the FTPs tab, you can create and manage FTP Connections to export data to. See Connecting to an FTP Server from EDC Tools for details.
Review Plan Assignment
From EDC Tools > Review Plan Assignment, you can assign Review Plans to individual Sites in your Study. You can also define how Vault applies those assignments to your Sites and whether site personnel can override the assignment. See Assigning Review Plans to Sites for details.
In the Assessments tab, you can assign Study Roles to Assessment Definitions. This determines which roles can view and perform clinical review assessments in your Study. Note that this tab is only available if Role by Study is enabled in your vault. Learn more in Assessments Administration.
In the Learning Systems tab, you can assign training curricula from Veeva Learning to Study Roles. Users must complete their assigned training before they can access the study. Note that this tab is only available in Studies where the Veeva Learning Integration_ _is enabled. Learn more in Using the Veeva Learning Integration.
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. Only users with the Vault Owner security profile or the CDMS User Administrator application role and User Administration security profiles can use EDC Tools > Users. 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||Execute Query Rules||
Ability to execute query rules via the Query Rules job in EDC Tools
|Functional Permission||Manage Amendments||
Ability to initiate subject transfers, retrospective amendments, and prospective casebook amendments, from EDC Tools
|Functional Permission||Manage FTP||
Ability to create and edit FTP Connections in EDC Tools
|Functional Permission||Manage Jobs||
Ability to create, edit, and delete scheduled jobs
|Functional Permission||Manage Study Countries||
Ability to create and edit Study Countries in EDC Tools
|Functional Permission||Manage Study Lock||
Ability to lock and unlock Studies and Sites from EDC Tools
|Functional Permission||Manage Study Sites||
Ability to create and edit Sites from EDC Tools
|Functional Permission||Manage Users||
Ability to create and edit Users and their access
|Functional Permission||Manage Learning||
Ability to assign learning system Curriculums to Study Roles from EDC Tools
|Functional Permission||Manage Review Plan Assignments||
Ability to access EDC Tools > Review Plan Assignments and update the study- and site-level templates
|Functional Permission||Manage Email Group Assignment||
Ability to assign users to an Email Group from EDC Tools > Email Group Assignment
If your Study contains restricted data, you must have the Restricted Data Access permission to view it.
Learn more about Study Roles.
To access the EDC Tools area, you must have the EDC: Study Tools: Access permission. The Vault Owner and EDC Lead Data Manager security profiles, have this permission by default.