Development of the Clinical Trials Information System (2024)

At the same time, EMA launcheda searchable publicwebsite enablinganybody to view information on clinical trials in the EU and EEA contained in the CTIS database.

CTISserves to implement EU pharmaceutical law set out in the Clinical Trials Regulation (Regulation (EU) No 536/2014).

A risk mitigation plan is available to help CTIS userscarry out regular activities within the system in different risk scenarios.

EMA monitors its implementationto ensure:

• early identification, classification and assessment of risks;
• coordinated, rapid and effective response;
• user compliance with the Clinical Trials Regulation.

The Agency published the CTIS risk mitigation plan in February 2023. For its set up, EMA worked togetherwith Members States and the European Commission.

For more information:

• Clinical Trials Regulation
• Clinical Trials Information System
• Clinical Trials website

Revisedtransparency rulesapply as of 18 June 2024 for publishinginformation on clinical trials submitted through CTIS.

The revised rules enable easier accessto clinical trial information and ensure a balance between transparencyand protection of commercially confidential information.

These changesbenefitpatients,healthcare professionals and clinical trial sponsors.

EMA also launched a new version of the CTIS public portal on 18 June 2024.

EMA's Management Board adopted the revised rules in October 2023.

User guide for revised CTIS transparency rules

A quick user guide provides a summary of the revised CTIS transparency rules:

• ACT EU - User guide: Revised CTIS transparency rules, interim period and historical trials

For further details on disclosure rules, protection of personal data and commercially confidential information, see the Accelerating Clinical Trials in the EU (ACT EU) website:

• ACT EU - Guidance on how to approach the protection of personal data and commercially confidential information while using CTIS
• ACT EU - Guidance on how to approach the protection of personal data and commercially confidential information while using CTIS: Annex I
• ACT EU - Questions and answers on the protection of commercially confidential information and personal data while using CTIS

The revised rules were available for public consultationbetween May andJune 2023.

For more information, see:

• Review of transparency rules for the EU Clinical Trials Information System (CTIS)(03/05/2023)
• Accelerating Clinical Trials in the EU (ACT EU): Implementation of the Clinical Trials Regulation
• Clinical Trials Information System: training and support: Protection of personal data and commercially confidential information
• CTIS public portal: search for clinical trials

EMA's CTIS newsflashcontains short updates on system usage, key facts and figures, hints to help users with specific features and links to reference materials, following the launch of CTIS on 31 January 2022.

Toreceive the newsletterdirectly by email, please contactct.newslettersubscriptions@ema.europa.eu.

The ninemost recentissues are available below. For previous issues, see:

• Newsletters

During the development of CTIS, EMA providedregular progress updates to its Management Board. For further details, seeHighlights of EMAManagement Board meetings.

EMA originally published the CTISfunctional specificationsin December 2014, following a public consultation, to be formally audited in line with the Clinical Trials Regulation.

An initial go-live date was published in December 2015 but this date was postponed due to technical difficulties with the development of the IT system.

In March 2019, the IT supplier submitteda revised project plan andEMA revised the CTIS project methodologyand delivery plan.

From June 2019, the development of CTIS followed an agile framework and iterative delivery model, with functionalities delivered in short development cycles and an improved stakeholder engagement model.

In April 2021, EMA's Management Board confirmed that the system met the agreed requirements following an independent audit of CTIS.

On 31 July 2021, the European Commission confirmed 31 January 2022 as the date of entry into application of theClinical Trials Regulationand the go-live of CTIS, by publishing a notice in the Official Journal of the European Union.

EMA worked towardsgo-liveon 31 January 2022by focusing on the following areas:

• Findings of the independentsystem audit
• Improving usability, quality and stability
• Knowledge transfer to prepare users and theirorganisations

More details are available in the documents below.

EMA continues to regularly engagewith external stakeholders on CTIS developmentand change management matters, before and after go-live, under the stakeholder engagement model in place since 2019.

Nominated experts representingnational competent authorities, ethics committees, clinical trial sponsors, healthcare professionals, patients and the general public were able to test, review, select and verify CTIS functionalities.

Duringdevelopment, EMA consulted EU Member States, the European Commission and stakeholders representingclinical-trial sponsors(including micro, small and medium-sized enterprises (SMEs) and academic organisations), healthcare professionals and patient groups on its proposals, including on:

• the draft functional specifications in2014;
• implementing the transparency rules in 2015.

More background information is available in the documents below.

The European Commission publishedguidance documents for public consultation in 2016.For more information, see:

• Risk proportionate approaches in clinical trials
• Summary of Clinical Trial Results for laypersons
• Definition of investigational medicinal products and use of auxiliary medicinal products
• Ethical considerations for clinical trials on medicinal products conducted with minors
• European Commission: Clinical trials - Major developments