Study roles in Oracle Clinical One Platform

Study roles represent a collection of permissions that, when assigned, let users perform their tasks in the system in an efficient manner, without compromising the study blind.

Oracle Clinical One Platform provides a list of template study roles available for your entire orgnaization. Template study roles already contain the standard combinations of permissions for each type of user that must be created in a study. However it is not recommended to assign template roles to users, as these don't have any data classification assignment and cannot be modified.

As a user administrator, you can leverage the existing study role templates using them as a starting point to create custom study roles. By creating a copy of a template study role, you have a new study role with a specific combination of permissions which you can modify at any time, even when already assigned to study users. Working with custom study roles allows you to add or remove permissions and data classifications as required.

What are my documentation resources to create the best study roles for my users?

To ensure that you make the best decision when it comes to your user management strategy, we have prepared a complete list of useful documentation resources. See a list of all resources below.

Resource	Description
Study role examples	This section includes a complete list of the available template study roles and the combination of permissions for each.
Descriptions of permissions in Oracle Clinical One Platform	This section describes all permissions available in Oracle Clinical One Platform and their scope. Use this to identify which permissions to include in (or remove from) a given study role to enable or disable different functionality or to provide or deny access to unblinding data.
Best practices for study role, site, and depot assignments	Besides permissions and study roles, site and depot assignments are also a key part of the user provisioning process. We offer you clear guidelines and best practices for how to assign users to every type of site and depot in every study mode.
Step-by-step instructions to create and manage roles in Oracle Clinical One Platform	Learn how to create study user accounts and assign the appropriate roles to users.

• Roles for study designers
  Learn more about the responsibilities and the roles of a study designer.
• Roles for blinded study users
  Learn more about the roles and responsibilities of a blinded study user, such as a CRA or a data manager.
• Roles for unblinded study users
  Learn more about the roles and responsibilities of an unblinded study user, such as a clinical supply manager or statistician.
• Roles for site users
  Learn more about the roles and responsibilities of a site user.
• Best practices for role, site, and depot assignment
  Users with different responsibilities require different roles. For example, some users need the ability to add users to a study. Some need to only add to add site and depot users.