Clinical Trials Information System (CTIS): online modular training programme

Introduction to CTIS
Common functionalities for all registered users
Authority workspace
Sponsor workspace
Searching CTIS as a public user

EMA is delivering an online modular training programme to help clinical trial sponsors, national competent authorities, ethics committees, European Commission and EMA staff prepare for using the Clinical Trials Information System (CTIS). The training programme consists of several modules, covering the full lifecycle of clinical trial submission, authorisation and supervision.

EMA's online training modules are available on this page.

An overview of available and planned training modules is available in the guide below. The guide outlines the various life-cycle stages of a clinical trial and the relevant training modules in each stage. It also covers the preparatory steps needed to use CTIS, such as user registration.

Each module contains a brief summary of the topics it covers with learning materials included. These consist of e-learning courses, quick guides, step-by-step guides, infographics, videos, frequently asked questions (FAQs) and instructor guides.

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Guide to CTIS training material catalogue (PDF/1.19 MB)

First published: 23/06/2021
Last updated: 07/02/2022
Version 1.1

Update: EMA regularly updates these training modules. You can find an overview of the modules that contain new or recently updated materials in the document below.

EMA updates this document regularly.

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CTIS Training materials - Latest updates (PDF/514.23 KB)

First published: 31/05/2021
Last updated: 21/02/2023
Version 1.2 February 2023

For optimal use of CTIS, please consult our system requirements and recommendations.

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Clinical Trials Information System (CTIS) - Technical requirements for optimal use (PDF/100.55 KB)

First published: 03/03/2022
EMA/121913/2022 - version 1.00

Users can provide feedback to help EMA enhance its CTIS training materials, by completing a short survey. There is no deadline to provide feedback:

Provide feedback on EMA’s CTIS training materials

Introduction to CTIS

Module 01	Introduction 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	Objective, scope, need for change and benefits of the Regulation Key changes and new elements of the Regulation Transition period from Directive 2001/20/EC to Regulation (EU) No 536/2014
Learning materials	e-learning course (use Chrome browser) Infographic Instructor's guide Frequently asked questions (FAQs)

Module 02	High-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	e-learning course (use Chrome browser) Quick guide Instructor's guide Frequently asked questions (FAQs) Supporting materials: Guide on CTIS common features List of acronyms Quick guide: Fill in the blanks exercise Videos: CTIS technical environment CTIS common functionalities, Part A CTIS common functionalities, Part B CTIS specific functionalities CTIS public website

Common functionalities for all registered users

Module 03	User 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	Quick guide Quick guide (OMS) CTTM03 - Step-by-step guide (Create organisations locally in CTIS) Instructor's guide Frequently asked questions (FAQs) Videos: CTIS password recovery and User profile functionalities

Module 07	Management 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	e-learning course (use Chrome browser) Instructor's guide Step-by-step guide (high-level CTIS administrator) Frequently asked questions (FAQs) Supporting materials: Roles and permissions matrix summary - Authority Workspace Member States Business Processes and Roles Roles and permissions matrix summary - Sponsors Workspace Sponsors Business Processes and Roles Notices and alerts per role Videos: Creating a clinical trial: Clinical trial centric approach vs organisation centric approach How to request roles and how to assign roles to registered users in CTIS How to amend and revoke roles of registered users in CTIS

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	e-learning course (use Chrome browser) Videos: Data protection in CTIS

Module 04	Support 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	e-learning course (authority workspace) (use Chrome browser) e-learning course (sponsor workspace) (use Chrome browser) Step-by-step guide for authorities Step-by-step guide for sponsors Instructor's guide Frequently asked questions (FAQs) Videos: How to manage the workload in CTIS - Tasks tab (authority workspace) How to manage the workload in CTIS - RFI tab (sponsor workspace) How to manage the workload in CTIS - Timetable

Module 23	Transitional 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	Frequently asked questions (FAQs) Quick Guides Sponsors Member states

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	e-Learning course (use Chrome browser) Step-by-step guide Instructor's guide Frequently asked questions (FAQs) Videos: How to access an initial clinical trial application in CTIS – Reporting Member State selection How to access an initial clinical trial application in CTIS – Validation - Document considerations How to access an initial clinical trial application in CTIS – Validation - RFI and issue validation decision

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: Quick guide - Introduction Quick guide - Part I Quick guide - Part II Quick guide - Decision Step-by-step guides: How to evaluate an Additional Member State Concerned clinical trial application How to evaluate a Substantial Modification clinical trial application Instructor's guide Frequently asked questions (FAQs) Supporting materials: Process puzzle Videos: How to assess an initial clinical trial application in CTIS – Part I How to assess an initial clinical trial application in CTIS – Part II How to submit the final decision on the clinical trial application in CTIS (Authority)

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	e-Learning course (use Chrome browser) Step-by-step guide Instructor's guide Frequently asked questions (FAQs) Videos: How to create an Ad hoc assessment - CT selection and assessment details How to create an Ad hoc assessment - Discussion with MSs and create Requests for Information How to update and complete an Ad hoc assessment

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	E-learning course (use Chrome browser) Step-by-step guide Instructor’s guide Frequently asked questions (FAQs) Videos: How to create and cancel a Corrective Measure (Authority) How to submit, update and revert a Corrective Measure (Authority)

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	e-Learning course (use Chrome browser) Step-by-step guide Instructor's guide Frequently asked questions (FAQs) Supporting materials Process puzzle exercise Videos: How to create an inspection record and how to populate the General information section How to populate the Inspections section How to populate the overall inspection outcome and update and cancel an inspection record

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	e-Learning course (use Chrome browser) Step-by-step guide Instructor's guide Frequently asked questions (FAQs) Supporting materials: Process puzzle exercise Videos: Search and view an ASR and saMS selection Circulate draft ASR - AR, create and consolidate consideration Submit ASR RFIs, assess RFI responses, and finalise ASR assessment

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	Step-by-step guide Quick guide Instructor’s guide Frequently asked questions Videos: How to search for a CTs in the authority workspace How to view and download CTs in the authority workspace

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	e-Learning course (use Chrome browser) Step-by-step guide Frequently asked questions (FAQs)

Sponsor workspace

Module 10	Create, 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	e-learning course: initial clinical trial applications (use Chrome browser) e-learning course: other types of clinical trial applications (use Chrome browser) Step-by-step guide Instructor's guide Frequently asked questions (FAQs) Supporting materials: Process puzzle Checklist of required fields per application type Videos: How to submit an initial clinical trial application in CTIS – Fill in the Form and the MSC sections How to submit an initial clinical trial application in CTIS Sponsor workspace – Fill in the Part I section How to submit an initial clinical trial application in CTIS – Fill in the trial details of Part I section How to submit an initial clinical trial application in CTIS – Fill in the Sponsor details of Part I section How to submit an initial clinical trial application in CTIS – Fill in the Product details of Part I section How to submit an initial clinical trial application in CTIS – Fill in the Part II section How to submit a substantial modification in the CTIS Sponsor workspace How to submit an additional Member State concerned application in the CTIS Sponsor workspace

Module 11	Respond 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	e-learning course (use Chrome browser) Step-by-step guide Instructor's guide Frequently asked questions (FAQs) Supporting materials: Process puzzle Videos: How to access and view an RFI in CTIS How to change a Clinical Trial Application as part of an RFI response How to respond to RFI considerations and submit an RFI response

Module 05	Manage 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	e-learning course (use Chrome browser) Step-by-step guide Quick guide Instructor's guide Frequently asked questions (FAQs) Videos: How to manage a clinical trial in CTIS (Sponsors) – Trial and recruitment periods notifications How to manage a clinical trial in the CTIS sponsor workspace – Other notifications

Module 18	How 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	e-learning course (use Chrome browser) Step-by-step guide Instructor’s guide Frequently asked questions (FAQs) Supporting materials: Process puzzle exercise Videos: How to create, cancel or clear, and submit an annual safety report How to search and view an annual safety report (ASR), and respond to requests for information (RFIs) received during the ASR evaluation

Module 13	Clinical 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	Quick guide Step-by-step guide Instructor's guide Frequently asked questions (FAQs)

Module 09	Search, 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	Quick guide Step-by-step guide Instructor's guide Frequently asked questions (FAQs) Videos: How to search for a clinical trial in the CTIS sponsor workspace How to view and download clinical trial information

Module 19	CTIS 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	Quick guide - Introduction Step-by-step guide: User administration

Searching CTIS as a public user

Module 22	Introduction 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	Frequently asked questions (FAQs) Quick guide

Clinical Trials Information System (CTIS): online modular training programme

Table of contents

Guide to CTIS training material catalogue (PDF/1.19 MB)

CTIS Training materials - Latest updates (PDF/514.23 KB)

Clinical Trials Information System (CTIS) - Technical requirements for optimal use (PDF/100.55 KB)

Introduction to CTIS

Common functionalities for all registered users

Authority workspace

Sponsor workspace

Searching CTIS as a public user

Related EU legislation

External links

Related content

Contact point

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