Create a study role at the study level

You can create a study role that 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 is part of that study.

  1. From the Home page, Open the study's settings.
  2. Navigate to the Study Roles tab.
  3. You can either:
    • Copy an existing study role by selecting it from the list and then, from the Manage Study Role drop-down, select Copy.

      Tip:

      You can copy and customize template study roles as well as retired study roles. Remember template study roles should not be assigned to users.
    • 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 is for members of the study team at either the sponsor or CRO.
      • Select Site if the role is for site users.
      • Select Design if the role is for the study design mode.
    • 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. For more information on the available permissions see Descriptions of permissions in Oracle Clinical One Platform.
  6. Click Save.
    You now can start assigning this study role to users.
    A study role is a collection of permissions