In order to perform an action in CTIS, such as preparing, submitting or viewing a clinical trial application, notifications, summary of results and clinical study reports, a user must be assigned with a CTIS user role to obtain appropriate permissions.
User roles are couples to actions that users can perform in CTIS. Users can be assigned different roles , to allow the user to complete various actions in CTIS. Users with administrator roles (high-level administrator, clinical trial administrator) can assign roles to other users, enabling them to perform actions.
In CTIS, there are admin and business roles. The use of admin roles depends on the approach chosen by the user's organisation, as explained in section 1.5 of the CTIS Sponsor Handbook of EMA. The business role are divided in a viewer, preparer and submitter role. Preparers have also the viewer permissions. Submitters have also the viewer and preparer permissions.
More information on the roles and permissions are given in section 1.6 of the CTIS Sponsor Handbook of EMA.