5 Manage users and roles in Oracle Clinical One Platform

  • Access Oracle Clinical One Platform
    To access Oracle Clinical One Platform you must sign in using the web address (URL) specific to your organization.
  • Add a global user in Oracle Clinical One Platform
    Every organization must have at least one global user who can take responsibility of the global level tasks, such as creating studies and adding the first user for them. An organization typically has a limited number of global users.
  • Add a global role to an existing global user
    Every organization must have at least one global user who can take responsibility of the global level tasks. The particular administrative tasks you can perform at the global level for your organization depend on the global roles assignied.
  • Roles for global users in Oracle Clinical One Platform and Oracle Clinical One Digital Gateway
    Global users perform administrative tasks, such as creating studies, adding users to studies, managing integrations, and managing training.
  • Remove a global user in Oracle Clinical One Platform
    You can remove a global user if the user is no longer part of your team or should no longer have access to your organization at the global level.
  • Add a user to a study in Oracle Clinical One Platform
    A product administrator with Study Creator role adds the first user to a study and assigns study roles. The first user in a study is typically an administrator who is responsible for adding other users to the study. This user is called a study user administrator.
  • Edit a study user
    A study user administrator or a product administrator with the Study Creator or Global User Manager roles can modify a study user at any time. The details that can be edited for a study user include: the effective date range for their access, their assigned study roles and their site and depot assignments.
  • Manage study users in bulk
    User administrators can use the user upload template to add new and update existing study users in bulk. In this template you define user details, such as the effective date range for their access, their assigned study roles, and their site, and depot assignments.
  • Remove a study user
    You can remove a user from a study if the user is no longer part of it or if they should no longer have access.
  • Manage study roles
    In Oracle Clinical One Platform you can have study roles created at the global level and at the study level. Global-level study roles are available for the entire organization and can be used in all studies. Study roles at the study level only exist for the particular study in which they were created.
  • Types of study roles in Oracle Clinical One Platform
    Study roles represent a collection of permissions that, when assigned, allow users to perform specific tasks. You must be mindful to create the correct type of study role (Sponsor, Site or Design) and include only the relevant permissions to the role, without compromising the study blind.
  • Best practices for role, site, and depot assignment
    Users with different responsibilities require different assignements. For example, some users need the ability to add users to a study, some others need permissions for study design or study management tasks. Similarly, some users need access to all sites and depots, while some others need access only to specific facilities.
  • Run and download report
    As a global user manager or user administrator, you typically run reports that offer you information on the study roles and users within your study or overall organization.