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.

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 typically takes part 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. See Template study roles.

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. See Manage study roles.

For more details on the available permissions, to identify which to include in (or remove from) a given study role, see Descriptions of permissions in Oracle Clinical One Platform.

Browse the different types of study roles available in Oracle Clinical One Platform:

• Roles for Study Design mode
  Learn more about the roles that can be assigned to users for the Design mode of a study.
• Roles for blinded study team 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 team 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.