EMA Clinical Trial Information System Webinar: Dynamic Demo of Sponsor Workspace
This webinar provides a demonstration of the current status of the Clinical Trials Information System (CTIS) which is currently under development, combining presentations and discussions on the underlying principles and concepts with demonstrations of specific functionalities.
After a brief introduction and overview of CTIS, the workspace functionalities that are specifically designed for use by clinical trial sponsors, including commercial and non-commercial (academic) sponsors will be demonstrated.
Following, the user roles, their hierarchy, and related permissions as well as access policies of users will be presented and how to manage these in the system. Functionalities for creating and managing a clinical trial application in CTIS will be outlined, and some practical advice as to how the system will be able to support users to manage their daily work and workload planning will be shared.
Presentations will be provided by system experts complemented by pre-recorded demonstrations of the system, and rounded up in a live Q&A.
• Brief introduction to the Clinical Trials Information System (CTIS)
• Access management
• Sponsor user management – principles and concepts
• Role matrix - principles, concepts and sponsor roles
• CTIS Sponsor workspace
o General overview
o Sponsor user administration in CTIS
o Clinical Trial Application management step by step
o Tools for user workload overview and management
• Preparations for CTIS Go-Live
• Current status and future master trainer involvement
Who should attend?
Clinical trial sponsor staff representing commercial sponsors such as pharmaceutical companies and CROs, SMEs, non-commercial sponsors including academia, research institutions. CTIS Stakeholder associations representatives. Expert trainers with an interest in the area of Clinical Trials.
Fergus Sweeney, PhD • Head of Clinical Studies and Manufacturing Task Force
European Medicines Agency, Netherlands