National requirements for the clinical trial application in the The Clinical Trials Information System (part II documents)
Until adoption of a national regulation, the national competent authority in Latvia - State Agency of Medicines (SAM) and ethics committee allow the use of EUDRALEX 10 public forms with a clear identificator of the trial. Please, see specific national requirements here.
The way clinical trials are conducted in the European Union (EU) has changed when the Clinical Trials Regulation (Regulation (EU) No 536/2014) came into application on 31 January 2022. The Regulation harmonizes the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). CTIS contains the centralized EU portal and database for clinical trials foreseen by the Regulation. The European Medicines Agency (EMA) sets up and maintains CTIS, in collaboration with the Member States and the European Commission.
The Regulation repeals the existing EU Clinical Trials Directive (EC) No. 2001/20/EC and national legislation that was put in place to implement the Directive. Regulation will also apply to trials authorized under the previous legislation if they are still ongoing three years after the Regulation has come into operation 31.01.2025.
The authorization and oversight of clinical trials remains the responsibility of Member States, with EMA managing CTIS and supervising content publication on the public website.
Aims and key benefits of the Regulation
The goal of the Clinical Trials Regulation is to create an environment that is favourable to conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information. The Regulation will require:
- consistent rules for conducting clinical trials throughout the EU;
- information on the authorisation, conduct and results of each clinical trial carried out in the EU to be publicly available.
This will increase the efficiency of all trials in Europe with the greatest benefit for those conducted in multiple Member States. It aims to foster innovation and research, while helping avoid unnecessary duplication of clinical trials or repetition of unsuccessful trials.
The key benefits of the Regulation include:
- harmonised electronic submission and assessment process for clinical trials conducted in multiple Member States;
- improved collaboration, information-sharing and decision-making between and within Member States;
- increased transparency of information on clinical trials;
- highest standards of safety for all participants in EU clinical trials.
How the Clinical Trials Information System will work
CTIS will be the single entry point for submitting clinical trial information in the EU, which will be stored in the system. EMA will make information stored in CTIS publicly available subject to transparency rules.
The clinical trial application form and supporting dossier will cover all regulatory and ethics assessments from the Member States concerned. It will also include the public registration of the clinical trial and any subsequent updates.
EMA published the functional specifications for the EU portal and database available through CTIS to be audited in December 2014, following a public consultation:
The system will support the day-to-day business processes of Member States and sponsors throughout the life-cycle of a clinical trial in a user-friendly way.
It will provide regulatory oversight of clinical trials and tools for supervision and monitoring.
It will contain collaboration tools, workflow and document management capabilities, accessible via individual workspaces.
Sponsor workspace
A secure workspace will assist clinical trial sponsors in preparing and compiling data to submit to the system for assessment by Member States. It will allow sponsors to:
- manage users and user roles within their organisations;
- compile clinical trial application dossiers for new and updated trials;
- cross-reference to product documents in other clinical trials;
- upload documents for clinical trial application submission;
- receive alerts and notifications for ongoing trials;
- respond to requests for information and view deadlines;
- search and access clinical trials;
- record clinical trial results.
Authority workspace
A secure workspace will support the activities of Member States and the European Commission in overseeing clinical trials. It will allow Member States to:
- manage users and user roles within their organisations;
- view clinical trial application dossiers;
- manage tasks related to the assessment of clinical trials;
- collaborate within and between Member States;
- receive alerts and notifications for ongoing trials;
- download documents submitted by clinical trial sponsors;
- record inspections of sites and clinical trials.
Public website
Through the website, members of the public can access detailed information on all clinical trials conducted in the EU, in all official EU languages. The website will provide the following features:
- overview of clinical trial statistics;
- advanced search;
- download data and reports;
- site updates and announcements.
Clinical Trials Information System development
CTIS is due to go live on 31 January 2022.
EMA's Management Board endorsed a delivery timeframe in December 2015. However, the system's go-live date was postponed due to technical difficulties with the development of the IT system.
The IT supplier submitted to EMA a revised project plan with improved project management, development and testing processes, resources and increased contingency. EMA also subsequently revised the CTIS project methodology and delivery plan.
Since June 2019, the development of CTIS followed an agile and iterative delivery model, with functionalities delivered in short development cycles. This is based on a revised project plan from the IT supplier, with improved project management, development and testing processes, resources and increased contingency.
Member States and stakeholders are directly engaged in the development of CTIS through nominated ‘product owners’ to ensure their expectations are taken into account. This means that nominated business experts representing user groups from the national competent authorities and ethics committees and from sponsors have an enhanced and continuous opportunity to test, review, select and verify functionalities.
In 2021 EMA is focusing on:
- the findings of a system audit;
- improving usability, quality and stability of the CTIS;
- knowledge transfer to prepare users and their organisations for CTIS.
EMA is working towards go-live, with the plan below.
Training and supporting materials on how to use CTIS are available to help clinical trial sponsors, national competent authorities, ethics committees, European Commission and EMA staff prepare for using CTIS and comply with their obligations under the Clinical Trials Regulation (Regulation (EU) No 536/2014):
- Clinical Trials Information System: training and support
- Clinical Trials Information System (CTIS): online modular training programme
EMA is providing regular progress updates on the development of CTIS to its Management Board. For further details, see the highlights published after the meetings of the Management Board.
EMA and the Member States are fully committed to ensuring the success of this project and its delivery. This remained a priority during EMA's preparation for Brexit and its relocation to Amsterdam.
For more information on the original delivery timeframe, see:
Progress updates
Progress updates are available below on the development of CTIS and its functionalities, rollout of training and user support.
These include the CTIS Highlights newsletter. Editions start from June 2020.
To subscribe to the newsletter, write to ct.communication@ema.europa.eu.
Information source: European Medicines Agency webpage
