For information on CTIS, the Clinical Trials Regulation, and EMA's online training modules for CTIS users, see:
Also on this topic
Handbook for clinical trial sponsors
The CTIS sponsor handbook covers priority topics identified with the help of clinical trial sponsors, with references and links to further supporting materials.
It is aimed at pharmaceutical companies, contract research organisations (CROs), small and medium-sized enterprises (SMEs), academic sponsors and other organisations working on clinical trials.
EMA regularly updates the handbook.
Clinical Trial Information System (CTIS) - Sponsor handbook
Evaluation timelines
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
Clinical Trial Information System (CTIS) evaluation timelines
Additional reference materials for CTIS users
Reference materials are available below to help users work with CTIS.
European Union Member State Public Holidays Recorded in CTIS (year: 2024)
European Union Member State Public Holidays Recorded in CTIS (year: 2023)
Getting started with CTIS: Sponsor quick guide
Principles for Sponsor organisation modelling for CTIS
Clinical Trial Information System (CTIS) - Sponsor user personas
Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modification
Clinical Trial Information System (CTIS) structured data form - Multi trial substantial modification
Clinical Trial Information System (CTIS) structured data form - Notifications
Clinical Trial Information System (CTIS) structured data form - Request for information (RFI)
Clinical Trial Information System (CTIS) structured data form - Annual Safety Report (ASR)
Clinical Trial Information System (CTIS) list values
Clinical Trials Information System (CTIS) - Technical requirements for optimal use
Training and information events
EMA offers live training sessions to provide additional learning opportunities, including bitesize talks, walk-in clinics and webinars.
Recordings and supporting materials become available after each event.
You can look up both past and upcoming events below:
- Clinical Trials Information System (CTIS): Walk-in clinic - March 2024 (12/03/2024)
- Clinical Trials Information System (CTIS): Walk-in clinic - January 2024 (24/01/2024)
- Clinical Trials Information System (CTIS): Walk-in clinic - December 2023 (13/12/2023)
- Clinical Trials Information System (CTIS): Walk-in clinic - November 2023 (15/11/2023)
- Clinical Trials Information System (CTIS): Walk-in clinic - October 2023 (10/10/2023) - Cancelled
- Clinical Trials Information System (CTIS): Walk-in clinic - September 2023 (20/09/2023)
- Clinical Trials Information System (CTIS): Walk-in clinic - August 2023 (23/08/2023) - Cancelled
- Clinical Trials Information System (CTIS): Walk-in clinic - July 2023 (19/07/2023)
- Clinical Trials Information System (CTIS): Walk-in clinic - June 2023 (14/06/2023)
- Clinical Trials Information System (CTIS): Walk-in clinic - May 2023 (17/05/2023)
- Clinical Trials Information System (CTIS): Walk-in clinic - April 2023 (19/04/2023)
- Clinical Trials Information System (CTIS): Walk-in clinic - March 2023 (16/03/2023)
- Clinical Trials Information System (CTIS): Walk-in clinic - January 2023 (18/01/2023)
- Clinical Trials Information System (CTIS): Walk-in clinic - November 2022 (15/11/2022)
- Clinical Trials Information System (CTIS): Walk-in clinic - October 2022 (05/10/2022)
- Clinical Trials Information System (CTIS): Walk-in clinic - September 2022 (20/09/2022)
- Clinical Trials Information System (CTIS): Walk-in clinic - August 2022 (31/08/2022)
- Clinical Trials Information System (CTIS): Walk-in clinic - June 2022 (15/06/2022)
- Clinical Trials Information System (CTIS): Walk-in clinic (02/06/2022)
- Clinical Trials Information System (CTIS): Walk-in clinic - May 2022 (19/05/2022)
- Clinical Trials Information System (CTIS): Walk-in clinic - 5 May 2022 (05/05/2022)
- Clinical Trials Information System (CTIS): Walk-in clinic - April 2022 (22/04/2022)
- Clinical Trials Information System (CTIS): Walk-in clinic (04/04/2022)
- Clinical Trials Information System (CTIS): Walk-in clinic - March 2022 (28/03/2022)
- Clinical Trials Information System (CTIS) bitesize talk: How to submit a transitional trial in CTIS (29/02/2024)
- Clinical Trials Information System (CTIS) bitesize talk: Training materials, CTIS pre-requisites, and updates on transparency rules (29/11/2023)
- Clinical Trials Information System (CTIS) bitesize talk: Part I-only applications and Part II requirements in CTIS (30/08/2023)
- Clinical Trials Information System (CTIS) bitesize talk: How to submit a transitional trial in CTIS (21/06/2023)
- Clinical Trials Information System (CTIS) bitesize talk: IMPD-Q only submission (10/05/2023)
- Clinical Trials Information System (CTIS) bitesize talk: Document and personal data in CTIS (23/02/2023)
- 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) sponsor end user training programme - June 2024 (10-13/06/2024)
- Clinical Trials Information System (CTIS) sponsor end user training programme - April 2024 (8-11/04/2024)
- Clinical Trials Information System (CTIS) sponsor end user training programme - February 2024 (12-15/02/2024)
- Clinical Trials Information System (CTIS) sponsor end user training programme - December 2023 (11-14/12/2023)
- Clinical Trials Information System (CTIS) sponsor end user training programme - November 2023 (10-13/10/2023)
- Clinical Trials Information System (CTIS) sponsor end user training programme - September 2023 (19-22/09/2023)
- Clinical Trials Information System (CTIS) sponsor end user training programme - June 2023 (27-30/06/2023)
- Clinical Trials Information System (CTIS) sponsor end user training programme - May 2023 (02-05/05/2023)
- Clinical Trials Information System (CTIS) sponsor end user training programme - February 2023 (07-10/02/2023)
- Clinical Trials Information System (CTIS) sponsor end user training programme - November 2022 (07-10/11/2022)
- Clinical Trials Information System (CTIS) sponsor end user training programme - September 2022 (20-23/09/2022)
- Clinical Trials Information System (CTIS) sponsor end user training programme - June 2022 (20-23/06/2022)
- Clinical Trials Information System (CTIS) sponsor end user training programme - May 2022 (10-13/05/2022)
- Clinical Trials Information System (CTIS) sponsor end user training programme - April 2022 (05-08/04/2022)
- Clinical Trials Information System (CTIS) sponsor end user training programme - March 2022 (01-04/03/2022)
- Clinical Trials Information System (CTIS) sponsor end user training programme - February 2022 (15-18/02/2022)
- Clinical Trials Information System (CTIS) sponsor end user training programme - January 2022 (24-27/01/2022)
- Organisation Management System (OMS) Trouble Shooting Session for CTIS users - November 2022 (24/11/2022)
- Organisation Management System (OMS) Trouble Shooting Session for CTIS users - October 2022 (19/10/2022)
- Organisation Management System (OMS) Trouble Shooting Session for CTIS users - September 2022 (22/09/2022)
- Organisation Management System (OMS) Trouble Shooting Session for CTIS users - July 2022 (21/07/2022)
- Organisation Management System (OMS) Trouble Shooting Session for CTIS users - June 2022 (30/06/2022)
- SME and academia Clinical Trials Information System (CTIS) two-part training webinar - Day 2 (04/03/2021)
- SME and academia Clinical Trials Information System (CTIS) two-part training webinar - Day 1 (22/02/2021)
- Webinar for small and medium-sized enterprises (SMEs) and academia on the Clinical Trials Regulation and the Clinical Trials Information System (CTIS) (29/11/2021)
- Clinical Trials Information System Webinar: Last Year of Transition (25/03/2024)
- Clinical Trials Information System (CTIS): Information day (17/10/2023)
- Clinical Trials Information System Webinar: Second Year of Transition (04/07/2023)
- Clinical Trials Information System (CTIS): Readiness for mandatory use of the Clinical Trials Regulation from 31 January 2023 (20/01/2023)
- Clinical Trials Information System (CTIS) Webinar - 9 months on and going forward - November 2022 (16/11/2022)
- Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS (29/07/2021)
- Clinical Trials Information System (CTIS) webinar: Six months of CTIS and looking forward (01/07/2021)
- Clinical Trials Information System (CTIS): Virtual information day (26/01/2021)
- Clinical Trials Information System (CTIS) demonstration for stakeholders (20/01/2022)
- EMA Clinical Trial Information System (CTIS) webinar: dynamic demo of sponsor workspace (21/09/2020)
Master trainers
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) took 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.
Dissemination guidelines for training materials: CTIS training programme
Protection of personal data and commercially confidential information
Guidance is available for CTIS users on the protection of personal data and commercially confidential information while using CTIS.
This aims to assist sponsors and authorities in fulfilling the transparency obligations set out in the Clinical Trials Regulation.
The guidance is based on the outcome of a public consultation concluded in 2022. It will apply until the revised CTIS transparency rules are implemented, which is expected in the second quarter of 2024.
The European Commission, EMA and the Heads of Medicines Agency (HMA) have also prepared a questions and answers document on data protection.
Both documents can be found on the Accelerating Clinical Trials in the EU website, at the link listed below.
For more information, see:
- Clinical Trials Information System: Processing of personal data
- Development of the Clinical Trials Information System: Transparency requirements
- Accelerating Clinical Trials in the EU (ACT EU): Implementation of the Clinical Trials Regulation
Documents on ACT EU website:
- Guidance on transparency rules in CTIS
- Annex I - Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS)
- Annex II Annex II to the guidance document of protection of personal data and commercially confidential information while using CTIS
- Q&A on the protection of commercially confidential information and personal data while using CTIS
- User guide: Revised CTIS transparency rules, Interim period & Historical trials