About the EU Clinical Trials Register

The EU Clinical Trials Register website contains information on interventional clinical trials on medicines which are conducted in the European Union (EU), the European Economic Area (EEA) and clinical trials which are conducted outside the EU/EEA if they form part of a paediatric investigation plan (PIP).

The register website launched on 22 March 2011 enables users to search for information which has been included in the EudraCT database . The EudraCT database is the application used by national competent authorities to enter protocol related data. The result related data are directly provided by the sponsors into EudraCT and published in the register once the sponsors have validated the data.

The register includes information on clinical trials which commenced in the EU/EEA from 1 May 2004, and also includes clinical trials linked to European paediatric drug development.

The EU clinical trials register has been a primary registry in the WHO Registry Network since September 2011 and since that date is a WHO Registry Network data provider. It is available on the WHO International Clinical Trials Registry Platform .

Users are able to:

• view the description of phase II-IV adult clinical trials where the investigator sites are in the EU/EEA
• view the description of any paediatric clinical trial with investigator site in the EU/EEA and any trials which form part of a paediatric investigation plan (PIP) including those where the investigator sites are outside the EU
• view the summary results of clinical trials
• download up to 50 results (per request) in a text file (.txt).

The details in the protocol related information include:

• the design of the trial
• the sponsor
• the investigational medicine (trade name or active substance identification);
• the therapeutic areas
• the status (authorised, ongoing, complete).

The details of the information of the summary results for a trial include:

• the summary results in the form of datasets including
  • trial information
  • subject disposition
  • baseline characteristics
  • endpoints
  • adverse events
  • additional information
• and/or summary attachment(s)

What is not available?

The EU Clinical Trials Register website does not:

• provide information on non-interventional clinical trials of medicines (observational studies on authorised medicines);
• provide information on clinical trials for surgical procedures, medical devices or psychotherapeutic procedures; 
• provide access to the authorisation document from the national medicine regulatory authority or the opinion document from the relevant ethics committee;
• provide information on clinical trials where investigator sites are all outside of the European Union and the European Economic Area. Exception: If such trials are part of an agreed paediatric investigation plan (PIP) then their information is present in EU CTR;
• manage the process for joining any clinical trial published on the website;
• provide navigation and web content in languages other than English.

Legal basis

The EU Clinical Trials Register website was launched to provide the public with information held in the EudraCT database, the application that is used by national competent authorities to enter clinical trial data.  The EudraCT database was established in article 11 of the Clinical Trial Directive 2001/20/EC  [152kB]. Since then changes to the EU pharmaceutical legislation (article 57 of the Regulation (EC) No 726/2004  [207kB] and article 41 of the paediatric Regulation (EC) No 1901/2006  [203kB]) allow that some of the information held in the EudraCT database is made public.

Source of information

The information that appears on the EU clinical trials register website is originally provided by the company or organisation responsible for the clinical trial.  The protocol related information is a component of the sponsor application to a national competent authority for authorisation to conduct a trial.  The information is loaded into the EudraCT database by the national competent authority. The national competent authority adds to this information the authorisation of the clinical trial and the opinion from the relevant ethics committee. The protocol related information on clinical trials that are part of a paediatric investigation plan (PIP) and are conducted outside of the European Union and the European Economic Area is supplied by the company or organisation responsible for the PIP.

The result related information on clinical trials conducted in the EEA and/or outside of the EEA is shown as posted into EudraCT by the sponsor/Marketing Authorisation Holder (MAH)/Paediatric Investigational Plan (PIP) addressee.

The European Medicines Agency (EMA) is not responsible for the completeness or accuracy of this information. In addition, the EMA and NCAs assume no liability for any party's use, or the results of such use, of any part of the database.

Clinical Trials in the European Union

The European Clinical Trials Directive 2001/20/EC  [152kB] was introduced to protect clinical trial participants and to harmonise the supervision of clinical trials in the European Union. The European Union Clinical Trials Directive 2001/20/EC provides a framework which sets out how clinical trials investigating the safety or efficacy of a medicinal product in humans must be conducted. Member States have transposed the requirements of the directive into national laws, regulations and administrative provisions. The approval of clinical trial applications is the responsibility of the member states. Find out more on clinical trials in the European Union (EC website) and information on national medicine regulatory authorities on this website.