Training is available from the European Medicines Agency (EMA) on how to use the Clinical Trials Information System (CTIS) ahead of its planned launch. EMA’s training resources are tailored for clinical trial sponsors and staff of the European Union (EU) Member States, European Commission and other organisations who will use the system.
The training materials aim to help users comply with their obligations under the Clinical Trial Regulation (Regulation (EU) No 536/2014), which apply once the CTIS goes live.
More information on the CTIS and the Clinical Trial Regulation is available on Clinical Trial Regulation.
- Introduction to CTIS
- Common functionalities for all registered users
- Authority workspace
- Sponsor workspace
- Virtual training sessions
- Master trainers
Each module contains a brief summary of the topics it covers and learning materials. These consist of e-Learning courses, quick guides, infographics, videos, frequently asked questions (FAQs) and instructor guides.
The learning materials are accessible via links unless they are not yet available. EMA will add new modules and materials throughout 2021. It advises stakeholders to regularly check this page for updates.
To support micro, small and medium-sized enterprises (SMEs) and non-commercial sponsors in academia, EMA is organising tailored virtual training sessions.
Additional training opportunities on specific sponsor roles (e.g. administrator, preparer and submitter) will be planned later in 2021.
EMA also intends to gather feedback on user training needs and expectations to enhance its training offer.