Create a study role for one study

You can create a study role that is available only to users in a single study in the application.

When you create a study role at a study level, it is only available for the specific study where it is created. When a study role of this type is available in your study, you can assign it to any user that will be part of that study.
  1. Follow the steps in Create an Oracle Health Sciences single sign-on to create the Oracle Health Sciences SSO.
  2. Do one of the following:

To create a study role that is available in a single study:

  1. On the Home page, click the study settings button (settings button) for the study you want to edit, and select Open Settings.
  2. Below the study name, click the Study Roles tab.
  3. You can either:
    • Copy an existing study role by selecting an existing study role from the list and then, from the Manage Study Role drop-down, select Copy.
    • Create your own custom study role by clicking Create Study Role.


    If you want to create a study role that is similar to one that you have already retired, you can copy a retired role by selecting the retired study role, and then selecting Copy from the Manage Study Role drop-down.
  4. On the left, fill in the fields:
    • Role Name: Enter a name for the study role. We recommend using a descriptive name so you'll remember the roles that are in the template later.
    • Type: Select Sponsor if the role will be assigned to a member of the study team at either the sponsor or CRO, Site if the role will be assigned to a site user, or Design if the role will be assigned to a study designer.


      If you try to add an unblinding role, you'll get a warning message to help confirm that you want to take this action.
    • Description: This is optional, but you can add a short description of the study role in this field.
  5. On the right, select the permissions to include in the study role.
  6. Click Save.
    You now can start assigning this study role to users.

    Figure 4-2 How a user administrator creates a study role

    A study role is a collection of permissions