Roles in user management
There are different roles involved in user management when it comes to clinical studies in Oracle Clinical One Platform. These roles are differentiated according to their responsibilities and the level of access they have. However, for some studies, one person can assume multiple roles and perform different tasks associated to different roles.
Customer Delegated Administrator (CDA)
The CDA is created by an Oracle business operations representative in Oracle Life Sciences Identity and Access Management Service (IAMS). Typically there are two CDAs, which are the first Oracle Life Sciences users for an organization.
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To be able to create user accounts, CDAs must complete a series of Account creation prerequisites. These only need to be completed once.Additionally, the CDA must add the first global user in Oracle Clinical One Platform as the product administrator. Typically, this first user is added as a Global User Manager so that they can add and manage other product administrators as global users to perform different tasks. See Create product administrator accounts.
Product administrators
Product administrators are global users in Oracle Clinical One Platform that perform administrative tasks for the entire organization. The first product administrator is typically added by a CDA with the Global User Manager role. Global user managers then take over from CDAs on the task to create other global users and assign them with the appropriate global roles to perform different tasks. See Add a global user in Oracle Clinical One Platform and Roles for global users in Oracle Clinical One Platform and Oracle Clinical One Digital Gateway.
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Oracle Clinical One Platform provides you with predefined study role templates for the different types of users a study may need. Each has a combination of permissions needed to perform tasks typically associated with the given role. The use of template roles is not recommended, but these can be used as the base of custom study roles. These can be created at the global level (to be used in all studies in the entire organization) and at the study level.In terms of user management, besides managing global users and study roles, product administrators are responsible to add the first user of a study to act as study user administrator. Global users with the Global User Manager or Study Creator roles can add users to a study. However, study creators are the only global users who can assign study users with roles for the study design mode at the study level. This means they are the only ones capable to add study user administrators, which are typically the first study users added to further manage users at the study level. See Create study user accounts.
Study user administrator
A study user administrator is a study level user that is assigned with the User Administrator role, which includes the necessary permissions to Add and Administer Study Users and Create Study Roles. This user is typically the first user added to the study, so it must be added by a product administrator. An user administrator is then responsible to add other users to the study and assign them with the appropriate study roles. See Add a user to a study in Oracle Clinical One Platform.
A study user administrator is also responsible of creating and managing study-level study roles. This includes specifying data classifications that control access to view or edit specific types of questions in the study. See Create a study role at the study level and Specify data classifications for a study role.
User administrators are also responsible of site and depot assignment, which dictate to which sites or depots the user has access to. However, user administrators can only assign other users to the sites and depots for which they have access to. This task is part of the process to create study users. Ultimately, it is up to you and your study's needs to decide on what roles to assign and to which sites or depots a given user must have access to; however, we recomment you to review Best practices for role, site, and depot assignment.
Parent topic: Account basics