The online training modules are all available on this page. EMA regularly updates and enhances its training materials. 

Please consult the documents below for:

  • a full catalogue of available training modules, organised by clinical trial lifecycle stage;
  • the latest new or updated training materials;
  • technical system requirements for the best experience with using CTIS. 

Guide to CTIS training material catalogue

Reference Number: Version 1.3 – August 2024

English (EN) (1.19 MB - PDF)

First published: Last updated:
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CTIS Training materials - Latest updates

Reference Number: Version 1.2 February 2023

English (EN) (499.06 KB - PDF)

First published: Last updated:
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Clinical Trials Information System (CTIS) - Technical requirements for optimal use

Reference Number: EMA/121913/2022 - version 1.00

English (EN) (100.55 KB - PDF)

First published:
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Users can provide feedback to help EMA enhance its CTIS training materials, by completing a short survey, at any time:

Introduction to CTIS

Module 01Introduction to the Clinical Trials Regulation (Regulation (EU) No 536/2014)
Target audience(s)
  • Authorities of EU Member States
  • European Commission
  • Sponsors
  • Market authorisation applicants and holders
  • Members of the public
Topics covered
Learning materials

Module 02High-level overview of CTIS workspaces and common system functionalities
Target audience(s)
  • Authorities of EU Member States
  • European Commission
  • Sponsors
  • Market authorisation applicants and holders
  • Members of the public
Topics covered
  • What CTIS is
  • The two individual secure workspaces (i.e. authority and sponsor) in CTIS and their functionalities
  • The public website which will allow members of the public to access detailed information on all clinical trials conducted in the EU, in all official EU languages
  • The databases and the systems that feed CTIS with data
  • CTIS functionalities common to the main user categories, namely sponsors, Member States and the European Commission 
  • Goals of the public website and what information members of the public will be able to access
Learning materials

Module 10Create, submit and withdraw a clinical trial
Target audience(s)
  • Sponsors
Topics covered
  • The different types of clinical trial applications and non-substantial modifications
  • Process for creating, submitting and cancelling an initial clinical trial application 
  • Process for withdrawing an initial clinical trial application
  • Key differences in creating, submitting or withdrawing an initial clinical trial application and other types of applications
  • Evaluation process for a clinical trial application
Learning materials

 

Module 11Respond to requests for information received during the evaluation of a clinical trial application
Target audience(s)
  • Sponsors
Topics covered
  • Phases and associated timelines for the evaluation of a clinical trial application
  • What a request for information (RFI) is and the different types of RFIs that can be sent by a concerned Member State during the evaluation of a clinical trial application
  • How to search and view an RFI during the evaluation of a clinical trial application
  • How to create and submit an RFI response, including changes to an existing application
  • Roles and permissions involved in the management of an RFI
Learning materials

Module 05Manage a clinical trial through CTIS
Target audience(s)
  • Sponsors
Topics covered
  • Responsibilities of sponsors, from the submission of a clinical trial application to the submission of  the summary of results
  • Use of notifications
  • Processes for ad-hoc assessments and corrective measures
  • How to address requests for information (RFIs)
  • How to prepare and submit clinical trial results
Learning materials

Module 18How to create and submit an annual safety report and respond to related requests for information
Target audience(s)
  • Sponsors
Topics covered
  • What an annual safety report (ASR) is and when a sponsor can create one
  • Phases and associated timelines for the assessment of an ASR
  • How to create, cancel, and submit an ASR
  • How to respond to requests for information received during the evaluation of an ASR
  • How to search, view, and download and an ASR
  • Roles and permissions involved in the ASR process
Learning materials

Module 13Clinical study reports submissions
Target audience(s)
  • Marketing authorisation applicants
  • Sponsors
Topics covered
  • What the clinical study report (CSR) is
  • How to prepare and submit a CSR
  • How to view, download, update and withdraw a CSR
  • Roles and permissions involved in managing a CSR
Learning materials

Module 09Search, view and download information on clinical trials and clinical trial applications
Target audience(s)
  • Sponsors
Topics covered
  • How to search for a clinical trial or a clinical trial application
  • Information displayed while navigating through a clinical trial or a clinical trial application
  • How to download information and associated documents
  • Which user roles can access and download information on a specific clinical trial or clinical trial application
Learning materials

Module 19CTIS for SMEs and academia
Target audience(s)
  • Sponsors (SMEs and academia)
Topics covered
  • Steps of main processes related to the Sponsors activities in CTIS and the roles and permissions involved
  • CTIS main functionalities for the sponsor workspace
  • How to search, view, and download a CT and a CTA
  • How to submit the different types of clinical trial applications and non-substantial modifications
  • How to create and submit an RFI response, including changes to an existing application
  • How to manage a CT
  • How to submit an ASR and how to respond to related RFIs
Learning materials

Common functionalities for all registered users

Module 03User access management
Target audience(s)
  • Authorities of EU Member States
  • Sponsors
  • European Commission
  • Market authorisation applicants and holders
Topics covered
  • The process of self-registration of a user in identity and access management (IAM) 
  • How to log into CTIS and access the landing page
  • High-level understanding of user roles and permissions
  • The user profile management functionality
Learning materials

Module 07Management of registered users and role matrix
Target audience(s)
  • Authorities of EU Member States
  • Sponsors
  • European Commission
  • Market authorisation applicants and holders
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 12Data 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 04Support with workload management
Target audience(s)
  • Authorities of EU Member States
  • Sponsors
  • European Commission
  • Market authorisation applicants and holders
Topics covered
  • How the main system functionalities work in the authority workspace
  • How the main system functionalities work in the sponsor workspace
  • Efficient workload management using workspace functionalities
  • Use of the 'tasks' functionality in the authority workspace
  • Use of the 'requests for information (RFI) list' functionality in the sponsor 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

Module 23Transitional trials 
Target audience(s)
  • Sponsors
  • Member States
Topics covered
  • Remember what a Transitional trial is
  • Understand how to submit a Transitional trial in the sponsor workspace
  • Understand how to evaluate a Transitional trial in the authority workspace
  • Understand how to submit notifications and clinical trial results for a
  • Transitional trial
  • Understand the roles and permissions involved
Learning materials

Authority workspace

Module 06Evaluate 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 08Evaluate 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 17Supervise 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 14Supervise 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 16Supervise 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 20Assess 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 15Search, 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 21Union 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

Searching CTIS as a public user

Module 22Introduction to CTIS for public users
Target audience(s)
  • Public users
Topics covered
  • Remember what the CTIS public website is.
  • Understand how users can search for a Clinical Trial (CT).
  • Understand how to view and download the information displayed in a CT.
  • Understand how to remove information from the public website.
  • Remember how users can view union control reports.
Learning materials

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