Human regulatory

Clinical Trials Information System: training and support

Table of contents

Training and supporting materials are available from the European Medicines Agency (EMA) on how to use the Clinical Trials Information System (CTIS) ahead of its planned launch in January 2022. 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. 

Resources include:

  • online training modules;
  • a handbook for clinical trial sponsors;
  • reference materials for sponsors and authorities;
  • a master trainer programme;
  • training and information events.

The training and support materials aim to help users comply with their obligations under the Clinical Trials Regulation (Regulation (EU) No 536/2014), which apply once the CTIS goes live.

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

Online training modules

EMA is delivering an extensive online modular training programme for self-study to help clinical trial sponsors, national competent authorities, ethics committees, European Commission and EMA staff prepare for using CTIS.

The online training modules cover the various stages of a clinical trial as well as the preparatory steps needed to use CTIS, such as user registration. EMA is adding new modules and materials throughout 2021, as they become available.

More information: 

Handbook for clinical trial sponsors

Guidance is available to help clinical trial sponsors prepare for using CTIS in the handbook below.

It covers priority topics identified with the help of clinical trial sponsors, with reference and links to further supporting materials. EMA will be updating this CTIS sponsor handbook with further priority topics as needed.

The handbook is aimed at pharmaceutical companies, contract research organisations (CROs), small and medium-sized enterprises (SMEs), academic sponsors and other organisations working on clinical trials. 

Evaluation timelines

This document is for CTIS sponsor and authority users and includes:

  • an overview of timelines and deadlines for tasks and actions across the Clinical Trial Application process
  • an explanation of the dynamic character of the workflow - earlier completion of a task (before its deadline) might cause recalculation of the deadline of subsequent or relevant tasks, changing effectively their initially projected deadlines

Reference materials for clinical trial sponsors

Reference materials to assist sponsors in using CTIS are available below. These include materials to help sponsors set up their processes in the system as well as practical guidance on how to work in CTIS.

The reference materials cover:

  • A one-pager quickguide for sponsors on getting started with CTIS.
  • Sponsor organisation models and business processes for using CTIS, with guidance on how sponsors can set up user access, responsibilities and roles. 
  • A description of typical user groups (user personas) which can be used to decide which user roles within CTIS should be assigned to individuals.
  • Guidance on the data fields that clinical trial sponsors will need to fill in CTIS when submitting a clinical trial application or managing a clinical trial is available below. 

EMA will be adding additional reference materials throughout 2021.

Reference materials for authorities

Reference material to assist authorities (such as national competent authorities and ethics committees) is available below. These include materials to help authorities prepare for working in the system. 

Available reference material: 

  • A description of typical user groups (user personas) which can be used to decide which user roles within CTIS should be assigned to individuals. 

EMA will be adding additional reference materials throughout 2021.

Training and information events

EMA is also offering training sessions in classroom format, to provide additional learning opportunities. 

For more information on each training session, including supporting materials, see:

2023

2022 

Online training materials are also available on using EMA'sOrganisation Management Service (OMS) andReferentials Management Service (RMS), including the below webinars, targeted at industry users of CTIS:

Furthermore, EMA organises information events on CTIS, open to all audiences:

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 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. 

Guidance is available on training techniques and materials to support master trainers, or anyone responsible for rolling out the CTIS training programme.

Protection of personal data and commercially confidential information

Update: Interim guidance is available for CTIS users on the protection of personal data and commercially confidential information while using CTIS.   

This is meant to assist sponsors and authorities in fulfilling the transparency obligations set out in the Clinical Trials Regulation.

A public consultation on this guidance concluded in 2022.

The European Commission, EMA and the Heads of Medicines Agency (HMA) prepared a questions and answers document on data protection.

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