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What's changed

Now only users who are created in Oracle Clinical One Platform as global users with the Study Creator role can assign users to the following Study Design roles and revoke the assignment of the roles from users:

  • Designer Role - Sponsor
  • Designer Role - Blinded
  • View Design-Sponsor
  • User Manager Role - Sponsor

Who sees the change:

  • Sponsor or CRO users who create users, such as clinical supply managers, study managers, and clinical research associates.
  • Study designers who create users.

Why

There were no restrictions on who could assign the following Study Design roles to users:

  • Designer Role - Sponsor
  • Designer Role - Blinded
  • View Design-Sponsor
  • User Manager Role - Sponsor