1

Determine which roles should be associated with the users of your study, and which tasks each user performs.

N/A

The tasks are mapped to specific functions in IRT, and permissions to access these functions are associated with the roles.

This process is a collaborative effort between Oracle and the sponsor, which is completed during the design phase of the study.

2

Assign users to a role in the User Guide

Study ()

User Upload

When the user list for the study is uploaded into IRT, the role for each user must be defined.

3

Set up the roles in IRT

Configuration

Manage Roles

Each role in the study is mapped to a role in IRT.

If necessary, you can create new roles to supplement the standard roles.

4

Assign permissions to the roles

Configuration

Manage Permissions

These permissions restrict access to the subject information and functions of IRT.

5

Test access to make sure the roles and permissions are set up correctly.

N/A

The sponsor tests access to make sure roles and permissions for each role are set up correctly.