Clinical Trials Information System: training and support
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.
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:
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.
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 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.
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European Union Member State Public Holidays Recorded in CTIS (PDF/193.88 KB)
First published: 20/04/2023
EMA/176184/2023 -
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Getting started with CTIS: Sponsor quick guide (PDF/175.08 KB)
First published: 13/12/2021 -
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Principles for Sponsor organisation modelling for CTIS (PDF/695.23 KB)
First published: 13/10/2021
Last updated: 29/10/2021
EMA/527655/2021 Version 2 -
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Clinical Trial Information System (CTIS) - Sponsor user personas (PDF/312.61 KB)
First published: 30/09/2021
Last updated: 11/10/2021 -
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Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modification (XLSX/862.56 KB)
First published: 29/07/2021
Last updated: 13/04/2022 -
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Clinical Trial Information System (CTIS) structured data form - Multi trial substantial modification (XLSX/488.23 KB)
First published: 29/07/2021
Last updated: 16/12/2021 -
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Clinical Trial Information System (CTIS) structured data form - Notifications (XLSX/1009.33 KB)
First published: 29/07/2021
Last updated: 16/12/2021 -
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Clinical Trial Information System (CTIS) structured data form - Request for information (RFI) (XLSX/372.1 KB)
First published: 16/12/2021 -
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Clinical Trial Information System (CTIS) structured data form - Annual Safety Report (ASR) (XLSX/571.1 KB)
First published: 16/12/2021 -
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Clinical Trial Information System (CTIS) list values (XLSX/213.82 KB)
First published: 16/12/2021 -
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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
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.
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
- Clinical Trials Information System (CTIS): Readiness for mandatory use of the Clinical Trials Regulation from 31 January 2023
- Clinical Trials Information System (CTIS): Walk-in clinic - January 2023
- Clinical Trials Information System (CTIS): Walk-in clinic - February 2023
- Clinical Trials Information System (CTIS) bitesize talk: Document and personal data in CTIS
- Clinical Trials Information System (CTIS) sponsor end user training programme - February 2023
- Clinical Trials Information System (CTIS): Walk-in clinic - March 2023
- Clinical Trials Information System (CTIS): Walk-in clinic - April 2023
- Clinical Trials Information System (CTIS): Walk-in clinic - May 2023
- Clinical Trials Information System (CTIS) bitesize talk: IMPD-Q only submission
- Clinical Trials Information System (CTIS) sponsor end user training programme - May 2023
- Clinical Trials Information System (CTIS): Walk-in clinic - June 2023
- Clinical Trials Information System (CTIS) sponsor end user training programme - June 2023
- Clinical Trials Information System (CTIS): Walk-in clinic - July 2023
- Clinical Trials Information System (CTIS): Walk-in clinic - August 2023
- Clinical Trials Information System (CTIS): Walk-in clinic - September 2023
- Clinical Trials Information System (CTIS): Walk-in clinic - October 2023
- Clinical Trials Information System (CTIS): Walk-in clinic - November 2023
- Clinical Trials Information System (CTIS) Webinar - 9 months on and going forward - November 2022
- Clinical Trials Information System (CTIS): Walk-in clinic - December 2023
2022
- SME and academia Clinical Trials Information System (CTIS) two-part training webinar - Day 1 (22/02/2021, aimed at clinical trial sponsors representing SMEs and non-commercial sponsors in academia)
- SME and academia Clinical Trials Information System (CTIS) two-part training webinar - Day 2 (04/03/2021, aimed at clinical trial sponsors representing SMEs and non-commercial sponsors in academia)
- Webinar for small and medium-sized enterprises (SMEs) and academia on the Clinical Trials Regulation and the Clinical Trials Information System (CTIS)
- Clinical Trials Information System (CTIS) sponsor end user training programme - May 2022
- Clinical Trials Information System (CTIS) sponsor end user training programme - June 2022
- Clinical Trials Information System (CTIS): Walk-in clinic - March 2022
- Clinical Trials Information System (CTIS): Walk-in clinic - April 2022
- Clinical Trials Information System (CTIS): Walk-in clinic - 5 May 2022
- Clinical Trials Information System (CTIS): Walk-in clinic - May 2022
- Clinical Trials Information System (CTIS): Walk-in clinic - June 2022
- Clinical Trials Information System (CTIS): Walk-in clinic - August 2022
- Clinical Trials Information System (CTIS): Walk-in clinic - September 2022
- Clinical Trials Information System (CTIS): Walk-in clinic - October 2022
- Clinical Trials Information System (CTIS): Walk-in clinic - November 2022
- Organisation Management System (OMS) Trouble Shooting Session for CTIS users - June 2022
- Organisation Management System (OMS) Trouble Shooting Session for CTIS users - July 2022
- Organisation Management System (OMS) Trouble Shooting Session for CTIS users - September 2022
- Organisation Management System (OMS) Trouble Shooting Session for CTIS users - October 2022
- Organisation Management System (OMS) Trouble Shooting Session for CTIS users - November 2022
- Clinical Trials Information System (CTIS) webinar: Six months of CTIS and looking forward
- Clinical Trials Information System (CTIS) sponsor end user training programme - September 2022
- Clinical Trials Information System (CTIS) sponsor end user training programme - November 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:
- Introduction to OMS services and activities - industry webinar (03/02/2021)
- Introduction to RMS services and activities - industry webinar (04/02/2021)
Furthermore, EMA organises information events on CTIS, open to all audiences:
- Clinical Trials Information System (CTIS) bitesize talk: Annual safety report (ASR) (15/12/2022)
- Clinical Trials Information System (CTIS) bitesize talk: Notifications - Part 2 (23/11/2022)
- Clinical Trials Information System (CTIS) bitesize talk: Notifications - Part 1 (28/09/2022)
- Clinical Trials Information System (CTIS) bitesize talk: Deferral rules and Public website (20/07/2022)
- Clinical Trials Information System (CTIS) bitesize talk: Transitional trials and additional Member State concerned (MSC) application (23/06/2022)
- Clinical Trials Information System (CTIS) bitesize talk: Modifications (31/05/2022)
- Clinical Trials Information System (CTIS) bitesize talk: Requests for information (28/04/2022)
- Clinical Trials Information System (CTIS) bitesize talk: Initial clinical trial application (23/03/2022)
- Clinical Trials Information System (CTIS) bitesize talk: User access and role management (24/02/2022)
- Clinical Trials Information System (CTIS) demonstration for stakeholders (20/01/2022)
- Clinical Trials Information System (CTIS): Virtual information day (26/10/2021)
- Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS (29/07/2021)
- EMA Clinical Trial Information System (CTIS) webinar: dynamic demo of sponsor workspace (21/09/2020)
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.
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.
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Interim guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) version 1.0 (PDF/632.6 KB)
First published: 03/05/2023
EMA/212507/2021 -
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Annex - Interim guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) version 1.0 (PDF/355.35 KB)
First published: 03/05/2023
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.