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EudraCT user manual


Registering a trial and updating its information
EudraCT number, CTA & Login for posting results
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Tutorials on posting results
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Welcome to the EudraCT public home page

EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) is the European database for all interventional clinical trials on medicinal products authorized in the European Union (EEA) and outside the EU/EEA if they are part of a Paediatric Investigation Plan (PIP) from 1 May 2004 onwards. It has been established in accordance with Directive 2001/20/EC. Protocol and results information on interventional clinical trials are made publicly available through the European Union Clinical Trials Register since September 2011.

In order to navigate through the present website, it is strongly encouraged to refer to the EudraCT user manual.

Sponsors are reminded that, whenever possible, the contact point specified in section B.5.6 of the Clinical Trial Application should give functional information rather than details of one "person", in order to avoid the need for update and maintenance of these contact details.

Sponsors’ representatives are recommended to prepare and post clinical trials results as explained in the Tutorials on posting results webpage.

Requirements to provide results for authorised clinical trials: Joint Letter by the European Commission, EMA and HMA

Brexit preparednessJoint Technical Notice to Sponsors by the European Commission, EMA and HMA and Notice to stakeholders of 7 May 2020

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What's New

Sponsors of clinical trials on COVID-19 are requested to include the term "COVID-19" in the title of their trial (section A.3 of the CTA). Sponsors are also reminded of the importance of timely reporting of SAEs (Serious Adverse Events) and of SUSARs (Suspected Unexpected Serious Adverse Reactions) to the competent authorities, in order to protect the safety of the participants. In addition, we encourage sponsors of COVID-19 trials to post the relevant results as soon as it is feasible, also before the deadline.

29-07-2022

A considerable amount of clinical trials are currently marked as "ongoing" in the EudraCT database. In view of the upcoming transition of trials to CTIS, sponsors are encouraged to verify whether the correct status of their trials is reported on EU CTR. An end of trial form needs to be submitted to National Competent Authorities for the trials that should be marked as “completed” or “prematurely ended”. In addition, sponsors are requested to post results of these trials as per European Commission guideline 2012/C 302/03: to know how to post results visit Tutorials on posting results. For questions, refer to Contact us.

30-06-2022

Following the issuing of the Joint Letter by the European Commission, EMA and HMA, National Competent Authorities and European Medicines Agency have sent reminders to sponsors who were not compliant with the European Commission guideline on results posting. Thanks to these reminders, the percentage of posted results substantially increased. However, for some trials the reminders were not successful: detailed lists of these trials can be found here.

03-03-2022

Following the European Commission's Guidance on results postings, the European Medicines Agency and National Competent Authorities sent rounds of notifications in order to remind sponsors of their responsibilities as regards posting clinical trial results in EudraCT. In an attempt to reach sponsors who have not uploaded results yet, round of reminders are now being sent to email addresses stored not only in EudraCT, but also in other databases, such as the EMA Eudra Common Directory (results user roles list), EudraVigilance, SPOR and Art. 57 database.

The EMA recommends all sponsors to verify if their trials comply with the Guidance on results postings through looking for their sponsor name in EU CTR. To learn how to post results visit Tutorials on posting results.

 

Previous news can be found here

 

For the UK, as of 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.


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