For information on CTIS, the Clinical Trials Regulation, and EMA's online training modules for CTIS users, see: 

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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

Reference Number: EMA/923413/2022 v.4.0

English (EN) (1.61 MB - PDF)

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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

English (EN) (2.06 MB - PDF)

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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)

Reference Number: EMA/525683/2023

English (EN) (199.75 KB - PDF)

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European Union Member State Public Holidays Recorded in CTIS (year: 2025)

Reference Number: EMA/416959/2024

English (EN) (219.03 KB - PDF)

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Getting started with CTIS: Sponsor quick guide

English (EN) (87.43 KB - PDF)

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Principles for Sponsor organisation modelling for CTIS

Reference Number: EMA/527655/2021 Version 2

English (EN) (695.23 KB - PDF)

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Clinical Trial Information System (CTIS) - Sponsor user personas

English (EN) (312.61 KB - PDF)

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Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modification

Reference Number: EMA/343883/2021

English (EN) (929.4 KB - XLSX)

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Clinical Trial Information System (CTIS) structured data form - Multi trial substantial modification

English (EN) (454.98 KB - XLSX)

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Clinical Trial Information System (CTIS) structured data form - Notifications and results

Reference Number: EMA/297654/2021

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Clinical Trial Information System (CTIS) structured data form - Request for information (RFI)

Reference Number: EMA/599358/2021

English (EN) (334.09 KB - XLSX)

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Clinical Trial Information System (CTIS) structured data form - Annual Safety Report (ASR)

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Clinical Trial Information System (CTIS) list values

English (EN) (213.82 KB - XLSX)

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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)

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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: 

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

Reference Number: Version 1.1Summary:

This guide is intended to support instructors in disseminating the training materials prepared for the CTIS training programme. We suggest the trainers to follow a blended learning approach combining asynchronous with synchronous activities for an optimal learning experience of end-users while making efficient use of their time.

English (EN) (480.57 KB - PDF)

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Protection of personal data and commercially confidential information

Information on clinical trials submitted in CTIS is made available on the CTIS public portal, in line with the revised CTIS transparency rules applicable as of June 2024. 

For more information on the revised rules, including a quick user guide and guidance on the protection of personal data and commercially confidential information while using CTIS, see: 

The roles and responsibilities of each party regarding the processing of personal data in CTIS is described by the joint controllership arrangement. For more information, see:

This aims to assist sponsors and authorities in fulfilling the transparency obligations set out in the Clinical Trials Regulation.

All CTIS transparency documents can be found on the Accelerating Clinical Trials in the EU website. For more information, see:

To search for information in CTIS, see:

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