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EudraCT user manual

EudraCT number, CTA & Login for 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’ 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

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What's New

IMPORTANT UPDATE for sponsors creating Clinical Trial Application(s) on coronavirus COVID-19 disease: please include the term "COVID-19" in the title of your trial (section A.3 of the CTA), in order for it to be approved. Thank you.

04-05-2020

EudraCT statistics for the month of April 2020 are now available here.

17-04-2020

Essential maintenance will be carried out on Tuesday 21 April 2020. EudraCT application will be unavailable to users between 18:00 and 22:00 (CET). We apologise for any inconvenience.

06-04-2020

A few sponsors have reported not receiving the automated email confirmation when applying for an EudraCT number: sponsors are advised to take a screenshot of the number, when assigned. In addition, please note that it is not a legal requirement to provide the confirmation email to National Competent Authorities or Ethics Committees. Further information is in question 13 of our FAQ.

03-04-2020

EudraCT statistics for the month of March 2020 are now available here.

24-03-2020

Computer application maintenance weekend 28-29 March 2020

Essential maintenance work will be carried out to all Telematics applications as part of EMA’s computer application maintenance work during the last weekend in March. 

As a result, EudraCT application will be unavailable to users between 18:30hrs on Friday, 27th March and 08:00hrs on Monday, 30th March. Users will not be able to request EudraCT numbers, create Clinical Trial Applications and upload clinical trial results in the system. We apologise for this inconvenience.

05-03-2020

The EMA has actively worked in order to raise awareness among sponsors on the requirements to provide results for authorised clinical trials in EudraCT. Several thousand emails have been sent to sponsors on a regular basis, in order to remind them to comply with the European Commission Guideline 2012/302 03/EC . Thanks to these reminders, the reporting rate significantly increased, especially for non-commercial sponsors, for which trials with results doubled in one year time. The EMA is also closely collaborating with National Competent Authorities on this topic.

01-03-2020

EudraCT statistics for the month of Februry 2020 are now available here.

Previous news can be found here

 

As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period.


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