Clinical Trials Information System (CTIS): training programme
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.
EMA’s training programme is mainly composed of online training modules.
EMA’s online training modules are available on this page. Each module identifies a target audience but all modules are available to any interested user.
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.
Users can provide feedback to help EMA enhance its CTIS training materials, by completing a short survey. There is no deadline to provide feedback:
The Agency is also offering virtual training sessions in classroom format, to provide additional learning opportunities.
These are particularly aimed at clinical trial sponsors representing SMEs and non-commercial sponsors in academia.
For more information on each training session, including supporting materials, see:
- SME and academia Clinical Trials Information System (CTIS) two-part training webinar - Day 2 (04/03/2021)
- SME and academia Clinical Trials Information System (CTIS) two-part training webinar - Day 1 (22/02/2021)
EMA is working closely with master trainers, a core group of users who will train and support other users in their organisations in preparing to work with the CTIS.
Master trainers from the national competent authorities and ethics committees of each EU Member State have been working with EMA since October 2020.
EMA is setting up a network of master trainers for sponsors in pharmaceutical companies, including contract research organisations (CROs). For more information and to apply to participate, see Application for CTIS master trainers' programme.