Create a study role for all studies

As a global user manager, you may want to a create study role that is available to users for all studies in the application. This allows you to assign study roles consistently to users across all studies in your organization.

When you create a study role at the organization level, it is automatically available to each newly created study in your organization. When a study role of this type is made available in your new study, you can assign it to any user in your study. Newly created study roles, as well as updates to existing study roles at the organization level do not automatically propagate into existing studies.

  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's available in all studies:

  1. On the Home page, along the top, click Global Settings.
  2. Go to 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.
  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.
    • 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.
    The search is performed across all three groups of rights: sponsor, site, and design. If you try to add an unblinding role, you'll get a warning message to confirm that you want to take this action.
  6. Click Save.
    You now can start assigning this study role to users.

    Figure 4-1 How a global user manager creates a study role

    A study role is a collection of permissions