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 assigned to the Study Creator global 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 single study user
  A study user administrator or a product administrator assigned to the Study Creator or Global User Manager global roles can modify a study user at any time. The details that can be edited are the effective dates (which govern study access), the assigned study roles, and the site and depot assignments.
• Edit multiple study users
  As an Oracle Clinical One Platform user administrator, you can apply updates to multiple study users simultaneously on the Users tab.
• Add and edit multiple study users using templates
  User administrators can use the Create Users and Update Existing Users templates to add new users and update existing ones simultaneously.
• Delete a study user
  You can delete 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.