Clinical Trials Information System (CTIS): online training modules

EMA provides an online modular training programme to help clinical trial sponsors, national competent authorities, ethics committees, European Commission and EMA staff use the Clinical Trials Information System (CTIS). The programme contains modules and audience-targeted materials covering all clinical trial lifecycle stages, from submission through authorisation to supervision. 
HumanClinical trials

EMA is updating the CTIS training modules to reflect the end of the transition period enabling clinical trial sponsors to comply with the Clinical Trials Regulation. Please consider as outdated any information in the training modules that mentions the transition period or the transitional trials.

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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