Navigation for Study Administrators

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

My Studies

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)
  • Deploy your study design across environments (see details here)
  • Create and manage Environments (see details here)
  • Delete study execution data in development or TST vaults (see details here)

Accessing Manual Deployment Studies

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.

Once you click to open an Environment, Vault automatically opens EDC Tools in the Study Settings tab. You can switch between tabs by clicking the tab’s name in the Navigation panel.

See the table below for details about individual tabs.

You can use the Breadcrumb menu to change Studies while remaining in the current tab, as well as to return to the My Studies page.

To return to the Environments listing, click your Study in the breadcrumb menu. To change Studies, select your Study in the Study section of the breacrumb menu.

Click My Studies to return to the My Studies page.

Environment Details Header

In the right side of the header, Vault shows details about the current Environment.

The badge indicates the Type of environment (Development, Test, Training, Production, or Post-Production Test).

Vault also shows the current version and build number. You can hover over the version number to show the following in a tooltip:

  • Current Casebook Version
  • Study Build Number
  • Name
  • Created On
  • Description

Vault also shows a Locked () or Unlocked () status icon based on the lock status for the Study.

EDC Tools Tabs

The EDC Tools area is divided into tabs based on which task you’re performing. Your assigned Study Role controls the actions you can perform, so you may not have every tab available.

Tab Description Subtabs Related Permissions
Study Settings

Manage certain study-level settings and enable or disable features
  • EDC Tools Tab
  • Edit Study Settings
Study Countries

Create Study Countries to group your sites
  • EDC Tools
  • Manage Study Countries
Sites

Create, lock, and closeout Sites
  • EDC Tools Tab
  • View Study Sites
  • Edit Study Sites
Learning Systems

Assign learning Curriculums to Study Roles (requires the LMS Integration)
  • EDC Tools Tab
  • Manage Learning
Email Group Assignment

Assign Users to Email Groups to receive email notifications sent by Send Email rules
  • EDC Tools Tab
  • Manage Email Group Assignment
Review Plan Assignment*

Assign Review Plans to Sites or Subjects and manage the criteria for automatic assignment

* When using Review Plan Assignment V1 or V2, or when using V3 without the Manage Review Plan Assignment Criteria and Manage Review Plan Manual Assignment permissions
  • EDC Tools Tab
  • Manage Review Plan Assignment
Review Plan Assignment Criteria*

Manage your study’s criteria for automatic review plan assignment

* When using Review Plan Assignment V3
  • EDC Tools Tab
  • Manage Review Plan Assignment Criteria
Manual Review Plan Assignment*

Manually assign Review Plans to Sites or Subjects

* When using Review Plan Assignment V3
  • EDC Tools Tab
  • Manage Review Plan Manual Assignment
FTPs

Create and manage FTP destinations for extract jobs in your Study
  • EDC Tools Tab
  • Manage FTP
Safety Configuration

Manage safety-related settings and map EDC Items to E2B Elements for transmission to a safety system
  • EDC Tools Tab
  • Manage Safety Configuration
Integration Configuration

Manage the configuration and integration mappings for certain integrations
  • EDC Tools Tab
  • View Integration Mappings
  • Edit Integration Mappings
Job History

Check the Status of ongoing jobs and access output and log files
  • EDC Tools Tab
  • Manage Jobs
Job Schedule

Schedule and run jobs in your Study
  • EDC Tools Tab
  • Manage Jobs
Casebook Versions

View casebook versions, assign versions to Sites, and perform retrospective amendments
  • All Versions
  • Casebook Versions by Site
  • Amendment History
  • EDC Tools Tab
  • Manage Amendments
Rules

Review expression criteria and action for rules, as well as run rules as a job
  • Run Rules
  • Error Console
  • EDC Tools Tab
  • Run Rules