1

Main menu

The main menu lists the categories of tasks for IRT.

The picture above shows the full list of menus. You see only those menus that your role allows you to access.

2

Menu pane

When you select from the main menu, the functions associated with that menu are listed in the menu pane. Select a function from the menu pane to open the page where you can perform the task.

Home —Opens the Home page (dashboard).

Subjects —Perform all subject transactions on the visit schedule, correct subject information, and unblind subjects (if permitted by your role).

Supplies —Manage depot inventory, perform order transactions, perform end-of-study reconciliation, and complete similar tasks.

Study ()—Monitor study limits, approve randomization and drug schedules, set up email notifications, set up regions and countries, manage users for the study, and complete similar tasks.

Sites ( )—Upload and manage sites for the study (for example, activate a site).

Reports ()—Monitor the study through reports and create custom reports.

Approvals —View and approve requests for approval that are assigned to your role.

Configuration —Authorize and configure subject data edits and rollbacks for each type of transaction; set up roles and permissions, and set up approvals, out-of-visit windows, and Do Not Dispense (DND) dates for the study. (Typically available only to IRT administrators.)

Admin —Perform various testing and support tasks, view the audit history, and manage custom menu items. (Typically available only to IRT administrators.)

3

Task list

The tasks display a list of subject, drug order, and depot tasks that require attention.

Pending approvals are listed in the Subject Task List.

For more information, see Viewing a task alert.

4

Trend charts

These charts show up-to-the-minute trends for:

• Enrollment: Total subjects by transactions (screening, screen failed, randomized, early termination, and completed) and by date. You can filter the data to limit the results by region, country, and site.
• Depot inventory: Inventory levels by drug supply type. You can filter the data to limit the results to a specific depot.

5

User profile

This area shows:

• Your name (as set up on the Contact Information page).
• The site you are currently associated with, if applicable (for site and depot users).
• The role you are assigned in IRT.

6

Toolbar

The toolbar, available from any page in the application, provides these options:

—Opens the Home page (dashboard).

—Opens the list of studies to which you have access.

—Opens the Oracle Help Center (OHC) page for this release where you can access the entire IRT documentation set.

—Logs you out of IRT.