Roles and permissions
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 a defined by a list of actions that users can perform in CTIS. Up to 18 sponsor user roles are foreseen for in CTIS. The profile of a user can be built with a combination of 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 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 module 7 of the CTIS training programme. See also the link to summary of roles and role permissions.
The EMA guidebook Principles for Sponsor Organisation Modelling for CTIS outlines key principles and considerations when deciding on user access, roles and responsibilities in CTIS. It also describes examples of sponsor organisation models for different kinds of clinical trials, and how sponsors can make best use of CTIS.