The course “Introduction to CTIS” provides a practical overview of the Clinical Trials Information System and its role in the European clinical trial regulatory framework. It is designed for professionals involved in clinical trial submissions, regulatory operations, clinical operations, project management, and related functions who need to understand how clinical trials are submitted, assessed, and managed under the EU Clinical Trials Regulation.
The course begins with a general recap of the EU Clinical Trials Regulation and the implementation of CTIS as the legally binding system for clinical trial activities in the EU and EEA. Participants will learn about the purpose of CTIS, its key functionalities, and its role in harmonizing clinical trial authorization processes across Member States.
The training also covers the clinical trial lifecycle under the EU CTR, including initial clinical trial applications, substantial modifications, additional Member State procedures, notifications, safety-related updates, and study closure activities. Special attention is given to CTIS user management, including role-based access, sponsor workspace responsibilities, administrator roles, and operational permissions.
Participants will also explore CTIS notifications, examples of substantial modifications, frequent issues identified during assessments, and best practices for planning a successful submission strategy. The course highlights the importance of strong documentation control, cross-functional collaboration, timely responses to Requests for Information, transparency planning, redaction, and quality control.
By the end of the course, participants will understand the key principles of CTIS and EU CTR operations and will be better prepared to support compliant and efficient clinical trial submissions.
AI tools were used to support the technical production and editing of the course. All substantive content, including the script and educational materials, was prepared by the SME.
