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) which commenced from 1 May 2004. Clinical trials which are conducted outside the EU/EEA are included if they form part of a paediatric investigation plan (PIP) or if they are marketing authorisation holder sponsored, and involve the use in the paediatric population of a medicinal product covered by an EU marketing authorisation.
In addition to the above trials, the register also provides information about older paediatric trials in respect of products covered by an EU marketing authorisation.
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 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 .
The details in the protocol related information include:
The details of the information of the summary results for a trial include:
The EU Clinical Trials Register website does not:
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.
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 conducted outside of the European Union and the European Economic Area is supplied by the company or organisation responsible.
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.
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.
EU Clinical Trials Register version 2.0