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.

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.

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.

Casebook Versions

In the Casebook Versions tab, you can manage your casebook versions site-by-site:

  • View a list of all active Casebook Definition versions within your Study (All Versions)
    All Versions in EDC Tools > Casebook Versions

  • View a summary of which casebook versions your sites are using, initiate amendments, and transfer subjects (Active Versions by Site subtab)
    Active Versions by Site in EDC Tools > Casebook Versions

  • View a list of all previous amendments in your Study (Amendment History) Amendment History in EDC Tools > Casebook Versions

Query Rules

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.

Query Rules in EDC Tools

Jobs

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.

Jobs in EDC Tools

Users

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.

Users in EDC Tools

Sites

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.

Sites in EDC Tools

Study Countries

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.

Study Countries in EDC Tools

FTPs

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.

FTPs in EDC Tools

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.

Review Plan Assignments in EDC Tools

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:

Type Permission Label Controls
Functional Permission 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 Review Plan Assignments

Ability to access EDC Tools > Review Plan Assignments and update the study- and site-level templates

Learn more about Study Roles.

Profile Permissions

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.