Implementation of CTIS
The way clinical trials are conducted in the EU will undergo a major change when the Clinical Trial Regulation (Regulation (EU) No 536/2014) comes into application. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical TrialsInformation System (CTIS). CTIS will contain the centralised EU portal and database for clinical trials foreseen by the Regulation and will be used by clinical trial sponsors as a single entry point in the EU to obtain approval for clinical trials based on applications and for monitoring clinical trials during their life cycle, including the submission of summary of results.
Clinical Trial Information System (CTIS) Go-live is planned for 31st of January 2022.
Anticipating the needs from the CTIS-users, the European Medicines Agency has developed a training strategy to provide them with the skills, capabilities and knowledge needed to successfully adopt CTIS. A strong online presence of training modules is foreseen for all user groups to ensure equal access for all. Self-training based on e-learning solutions and training materials (user guides, short videos, FAQ sheets, etc.) which will gradually be made available from January 2021 on EMA's website, as well as various live online training sessions.
EMA has published information about the CTIS training programme and training materials for Member States and for clinical trial sponsors on the EMA Corporate website https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trial-regulation/clinical-trials-information-system-ctis-training-programme
Training programmes for CTIS
Due to the high volume of end-users representing Commercial Sponsors, Small to Medium Enterprises (SMEs), and Non-Commercial Sponsors including academia, three main programme streams have been envisaged:
First Stream: Sponsor Master Trainers
This concept is based on the train-the-trainer approach. It aims to provide training in the functionalities of CTIS for all CTIS roles available for sponsors. It is primarily intended for commercial pharmaceutical industry sponsors and Contract Research Organisations (CROs), that are likely to submit several clinical trial applications and have several CTIS users in various organisation models. The programme is offered by EMA with the organisational support of DIA.
For additional information please contact: firstname.lastname@example.org
Second Stream: Small to Medium Enterprises (SMEs) and non-commercial sponsors (e.g., academic sponsors)
This will be done through compact and tailored materials about key CTIS functionalities and dedicated training events.
For additional information please contact: email@example.com
Third Stream: end-users from all sponsor groups
This programme aims to provide training for end-users in their role-specific functionalities (e.g., administrator, preparer, submitter). This stream will be initiated closer to CTIS Go-live in Q4 of 2021.
Training materials for CTIS
The training materials consist at present of e-Learning courses, quick guides, infographics, short video clips demonstrating CTIS functionalities recording, frequently asked questions (FAQs) and instructor guides tailored to sponsors and EU Member States. More training materials will gradually be made available throughout 2021.
Should you have any further questions regarding the programmes or training materials, please contact: firstname.lastname@example.org
Keep up-to-date with CTIS activities
To keep up-to-date on all activities related to CTIS and the new regulation, we recommend that you subscribe to EMA's newsletter: