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.

More information on the CTIS and the Clinical Trial Regulation is available on Clinical Trial Regulation.

Overview

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:

Introduction to CTIS

Common functionalities for all registered users

Authority workspace

Sponsor workspace

Virtual training sessions

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:

Online training materials are also available on using EMA's Organisation Management Service (OMS) and Referentials Management Service (RMS), which are relevant for industry users of CTIS:

Master trainers

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.

A programme for Master trainers for sponsors in pharmaceutical companies, including contract research organisations (CROs) takes place in 2021. The application call closed in February 2021.

How useful was this page?

Add your rating
Average
23 ratings
3 ratings
1 rating