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 noncommercial (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.

Key Topics
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
General overview
Sponsor user administration in CTIS
Clinical Trial Application management step by step
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

More information can be found at the EMA website

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