Clinical Trials Information System (CTIS): online training modules for authorities

The European Medicines Agency (EMA) provides an online modular training programme to help national competent authorities, ethics committees and the European Commission use the Clinical Trials Information System (CTIS). The programme contains modules and audience-targeted materials covering the applicable clinical trial lifecycle stages. 
Human Clinical trials

The online training modules are all available on this page. 

EMA regularly updates and enhances its training materials. 

Please consult the documents below if you are a member of a national competent authority, ethics committee or European Commission and need to know how to perform certain processes through CTIS.

For information on the CTIS Sponsor handbook with instructions for sponsor users, see CTIS training and support. 

Guide to CTIS training material catalogue

Reference Number: Version 2 – July 2025

English (EN) (933.21 KB - PDF)

First published: Last updated:
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Please refer to the CTIS sponsor handbook, which covers priority topics identified with the help of clinical trial sponsors. 

For more information, see: Handbook for clinical trial sponsors 

Common functionalities for all registered users

Module 07 Management of registered users and role matrix
Target audience(s)
  • Authorities of EU Member States
  • European Commission
Topics covered
  • The basic principles of user management in CTIS
  • The roles hierarchy and the main categories of permissions and roles available in CTIS
  • The permissions mapped to the roles and their implications to perform actions in CTIS
  • How 'administrators' can manage users through the CTIS user management functionality
  • How business roles can be viewed and managed in the system 
Learning materials

Module 12 Data protection in CTIS
Target audience(s)
  • Authorities of EU Member States
  • European Commission
  • Sponsors
  • Market authorisation applicants and holders
  • Members of the public
Topics covered
  • Basic principles of the EU data protection framework
  • Implications of Regulation (EU) 2018/1725 and the General Data Protection Regulation (GDPR) for all the actors involved in the operation of CTIS
  • Relevant processing activities for each user group and the related responsibilities
  • How CTIS will assure compliance with data protection obligations 
Learning materials

Module 04 Support with workload management
Target audience(s)
  • Authorities of EU Member States
  • European Commission
Topics covered
  • How the main system functionalities work in the authority workspace
  • Use of the 'tasks' functionality in the authority workspace
  • Use of the 'notices & alerts' functionality available in both workspaces
  • Use of the 'timetable' functionality supporting the monitoring of a specific clinical trial application 
Learning materials

Authority workspace

Module 06 Evaluate a clinical trial application: Selection of reporting Member State (RMS) and validation of the clinical trial application
Target audience(s)
  • Authorities of EU Member States
Topics covered
  • The different types of clinical trial applications
  • Common aspects and phases of the different types of clinical trial applications
  • The first steps in the evaluation of an initial application for a multinational trial
Learning materials

Module 08 Evaluate a clinical trial application: Assessment and decision-making
Target audience(s)
  • Authorities of EU Member States
Topics covered
  • Phases and associated timelines for evaluating an initial clinical trial application, including validation, assessment and decision
  • Process and user roles involved in the first part of the assessment of an initial clinical trial application as a reference and as a concerned Member State
  • Process and user roles involved in the second part of the assessment of an initial clinical trial application as a concerned Member State
  • Process and the user roles involved in the decision on authorising an initial clinical trial application
  • Workload functionalities in CTIS that allow users to monitor the tasks during the evaluation of an initial clinical trial application
Learning materials

Quick guides:

Step-by-step guides:

Supporting materials:

Module 17 Supervise a clinical trial: Ad hoc assessment
Target audience(s)
  • Member states
Topics covered
  • Remember what an Ad hoc assessment is and when a MS can create one
  • Understand how to create, cancel, save and share an Ad hoc assessment
  • Understand how to raise a Request for Information, consult with other MSs, and how to complete an Ad hoc assessment
  • Understand how to search, view, download, and update an Ad hoc assessment
  • Understand the roles and permission involved in the Ad hoc assessment process
Learning materials

Module 14 Supervise a Clinical Trial: Corrective measures
Target audience(s)
  • Authorities of EU Member States
Topics covered
  • What a corrective measure is, the situations in which an MSC can create one and the types of corrective measures
  • How to create and cancel a corrective measure
  • How to consult other MSCs on an intended corrective measure
  • How to request the sponsor’s opinion before applying an intended corrective measure
  • How to submit a corrective measure and its implications, and how to update, withdraw and revert an existing one
  • roles and permissions involved in the corrective measure functionality
Learning materials

Module 16 Supervise a clinical trial: Inspection records
Target audience(s)
  • Member states (inspectors)
Topics covered
  • Remember what an inspection record is and when an MSC can create one
  • Understand how to create and submit an Inspection record
  • Understand how to search, view, update and cancel an Inspection record
  • Understand which user roles are involved in the Inspection record process
Learning materials

Module 20 Assess an Annual Safety Report
Target audience(s)
  • Member states
Topics covered
  • Remember what an Annual Safety Report (ASR) is and when a sponsor can create one
  • Remember the phases and associated timelines for the assessment of an ASR
  • Understand how to search, view and download an ASR
  • Understand how to assess an ASR
  • Understand how to request additional information to the sponsor
  • Understand the roles and permissions involved in the ASR process
Learning materials

Module 15 Search, view and download a clinical trial and a clinical trial application
Target audience(s)
  • Member states
Topics covered
  • Remember how users can search for a Clinical trial / Clinical trial application (CT/CTA)
  • Understand how to view the information displayed in a CT and a CTA
  • Understand how to download information and associated documents
  • Understand which user roles can view and download specific CT/CTA information.
Learning materials

Module 21 Union Controls in CTIS
Target audience(s)
  • European Commission
Topics covered
  • Remember what a Union Control is and when a European Commission user can create one.
  • Understand how to create and submit a Union Control report.
  • Understand how to view, download, update and withdraw a Union Control report.
  • Understand the roles and permissions involved in the Union Controls process.
Learning materials

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