Study roles in Oracle Clinical One Platform

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

As a user administrator, you can leverage the existing study role templates that you can use for all studies in your organization.

Starting with a template study role provided by Oracle is the recommended course of action. Template study roles already contain the standard combinations of permissions for each type of user that must be created in a study. If you want to further customize a user's study role and permissions, we recommend you copy the template study role (found available for all studies in your organization) for your single study and then proceed to add or remove permissions for each study role, as needed. This is considered the recommended and safest option for you, as a user administrator.

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	These topics describe the combinations of permissions that are included in the template study roles for every user in a study, from site users to support or integration users.
Descriptions of permissions in Oracle Clinical One Platform	As the title suggests, this chapter contains specific descriptions of each permission that exists in the application. With this reference material, you can better understand the scope of each permission to know exactly what you are assigning to your study users.
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	We have documentation to guide you every step of the way when creating study user accounts and assigning 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.