EudraCT
  Hosted on behalf of the European CommissionEU
Home
EudraCT user manual


Registering a trial and updating its information
EudraCT number, CTA & Login for posting results
CTA & results documentation
Tutorials on posting results
Training
Frequently asked questions
National competent authorities
Statistics and technical documentation
EU Clinical Trials Register
Need Help? Contact us

Previous news

22-06-2020

Update: the below issues have now been solved. EudraCT application is now fully operational for all users.

Users may experience issues when logging in the EudraCT website as a National competent authority or as a sponsor. Fewer functions may be available to users this morning. Our IT is working to resolve it as soon as possible. We apologise for any inconvenience and thank you for your patience.

16-06-2020

EudraCT application maintenance on 22 June 2020

Please note that EudraCT application will be unavailable between 07.00-09.30hrs on Monday, 22 June 2020 due to essential maintenance.

If you have any questions, please contact the IT service desk.

15-06-2020

A new webpage has been introduced to inform sponsors of the steps related to registering a trial in EudraCT and updating its information in EU CTR.

The webpage CTA and results documentation contains useful links related to protocol and results information.

03-06-2020

Computer application maintenance – Sunday 7 June 2020

Essential maintenance work will be carried to EudraCT application as part of EMA’s computer application maintenance work this weekend. As a result, EudraCT will be intermittently unavailable to users between 13:00 – 17:00hrs on Sunday, 7 June 2020.

02-06-2020

The statistics for May 2020 are now available.

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.

27-02-2020

For maintenance purposes, a controlled restart of the EudraCT application will be performed tonight at 2 a.m. CET. The website will be unavailable for 30 minutes. Given the timeframe, we hope that this will affect very few users and we apologise for any inconvenience.

20-02-2020

Update:

The service is re-established. EudraCT application is now fully operational.

Please note that essential maintenance is taking place to EudraCT application today between 11.00-12.00 hours and users may experience intermittent unavailability of the application during this time.

19-02-2020

Update:

The service has been restored. Our IT has resolved the issues that were affecting the reported malfunctions. We apologise for any inconvenience that this may have caused.

In order to resolve the technical issues reported, our IT had to restart the service. EudraCT was not available this morning for a very short period of time. The system is now fully operational.

18-02-2020

Issues with the "Search" function have been reported. A message error is displayed when looking for trials. Our IT is working to resolve this. We apologise for this inconvenience.

14-02-2020

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

31-01-2020

Update - Please note the issue uploading XML in EudraCT CTA module has now been resolved.
Apologies for the inconvenience.

29-01-2020

Dear EudraCT users, Please note there is an issue uploading XML in EudraCT CTA module.
We are working to fix it as soon as possible. Apologies for the inconvenience.

14-01-2020

Update - The issue with EudraCT number, CTA & Login for posting results has now been resolved.

EudraCT number, CTA & Login for posting results is currently offline. Our technical team is working on it and we hope to resolve this issue as soon as possible. We apologise for any inconvenience.        

07-01-2020

Problems have been reported on EudraCT database. These may affect requests for assignment of clinical trials as primary user. They will be solved by the end of today. We apologise for this inconvenience and we kindly ask to re-submit your requests for assignment of clinical trials tomorrow, January 8.

06-01-2020

EudraCT statistics for the month of December 2019 are now available here.

18-12-2019

Due to the high number of users connected, the EudraCT number, CTA & Login for posting results webpage was offline today for 30 minutes.
Our IT promptly intervened and resolved the issue. We apologise for any inconvenience this may have caused.

And

The EMA will be closed from 21/12/2019 to 05/01/2020.

Please note: Requests sent after 20/12/2019 for assignment as a primary user to post results and EudraCT/EU CTR related queries will be processed after the 06/01/2020.

16-12-2019

Essential maintenance to EudraCT Application

EudraCT will be unavailable between 07:30 and 9:000 (CET) on 18 December 2019 due to essential maintenance. We apologise for this inconvenience.

11-12-2019

Users have reported that the webpage “EudraCT number, CTA & Login for posting results” was offline this morning. The issue was resolved as soon as it was reported. We apologise for any inconvenience caused.

10-12-2019

The website EU Clinical Trials Register is experiencing delays. Users are advised to refresh the webpage more than once or to try to open it from a different browser. We are working in order to solve this issue. We thank you very much for your patience.

05-12-2019

Users have reported that the webpage “EudraCT number, CTA & Login for posting results” is currently offline. Our technical team is working on it. We hope to be able to resolve this issue soon and we apologise for this inconvenience. Update: The issue was resolved at 13:30 CET.

EudraCT statistics for the month of November 2019 are now available here.

28-11-2019

A new version of the Clinical Trial Application form was launched, as referred in EudraLex. Updates regard the footnotes section. This does not have an impact on the clinical trial application form that is created through this website, since footnotes are not included in it.

26-11-2019

Need help? Contact us! has been updated with more useful information

And

The FAQs have been updated and can be found here.

20-11-2019

We are currently experiencing technical issues with the EU CTR website. Trials which should be in public domain are currently not being shown. Our technical teams are working on it. We apologise for any inconvenience. Update: the issue was resolved on 22-11-2019

14-11-2019

The EMA Service Desk is temporarily unavailable. The EMA is working to fix the issue as quickly as possible. We apologise for any inconvenience. The service was restored in the afternoon of 14.11.2019.

04-11-2019

EudraCT statistics for the month of October 2019 are now available here.

30-10-2019

We are experiencing some technical issues in the EudraCT Secure website. This issue may affect search, entering data and XML uploads. We apologise for any inconvenience this has caused.

16-10-2019

Essential maintenance to EudraCT Application

The EudraCT application will be unavailable between 8:00 and 9:00 on Thursday, 17 October, due to essential maintenance. For any questions, please contact the EMA Service Desk.

03-10-2019

Essential maintenance to EudraCT Application

EudraCT application will be unavailable due to essential maintenance activities as follows:

  • Friday, 4th October 2019 between 07.00-09.00hrs
  • Wednesday, 9th October 2019 between 18.00-20.00hrs

If you have any questions, please contact the IT Service Desk.

03-10-2019

EudraCT statistics for the month of September 2019 are now available here.

30-09-2019

Technical issued with EudraCT Resolved

The earlier issues with EudraCT affecting the upload of XML files have now been resolved.

25-09-2019

Technical issues with EudraCT

Currently there is a known issue with uploading XML files. We are working to resolve this as quickly as possible.
Thank you for your patience. If you have any questions, please contact the EMA service desk.

16-09-2019

Weekend maintenance to most EMA computer applications during the weekend of 21st – 22nd September 2019.

Users should be aware that due to essential maintenance work on Oracle databases, most of EMA’s computer applications will experience downtime between the hours of 18.00 on Friday, 20 September and 06.00 on Monday, 23 September 2019.

If you have any questions, please contact the IT service desk

29-08-2019

EudraCT CTA - 10.3.1.0- Release notes are now available here.

22-08-2019

New updates on the EudraCT website:

06-08-2019

An amended template for requesting assignment for results is now available, and can be found here.

05-08-2019

EudraCT statistics for the month of July 2019 are now available here.

26-07-2019

As of 26 July 2019, a new process for registering a new/development substance in EudraCT will be in place. This means instead of creating development substances directly in xEVMPD, Sponsors of CT will need to request them in advance if they want to submit a clinical trial application in EudraCT, or an Investigational Medicinal Product in XEVMPD.

Requests will need to be made using the EMA Service desk portal. If you are already registered, open your request here:
https://servicedesk.ema.europa.eu/jira/servicedesk/customer/portals

If you are not registered, register using the EMA Service desk portal:
https://register.ema.europa.eu/identityiq/login.jsf?prompt=true

In the request you must attach:

This is not a new process but is now extended to the registration of substances for clinical trials.
Note that this process can take 4 working days, so users need to take the SLA into consideration when planning the submission of their applications.

03-07-2019

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

02-07-2019

EudraCT statistics for the month of June 2019 are now available here.

12-06-2019

EudraCT statistics for the month of May 2019 are now available here.

02-05-2019

EudraCT statistics for the month of April 2019 are now available here.

02-04-2019

EudraCT statistics for the month of March 2019 are now available here.

18-03-2019

EudraCT statistics for the month of February 2019 are now available here.

And

The FAQs have been update and can be found here.

20-02-2019

How to convert EudraCT v7 to V8 is now available and can be found here

15-02-2019

From 15 February 2019 Sponsors/MAH/Third country data providers who wish to assign Clinical Trials to other parties are invited to use the CT result request PDF form. The PDF form will replace the letter format, and its use will be mandated from 1 March 2019. There will be a transition period from 15 to 28 February during which the “letter format” will still be accepted. While the process remains the same the introduction of the form is expected to improve user experience and the processing of requests.

The CT result request PDF form is available here and users can refer to the guidance when filling in
the form.

12-12-2018

EudraCT statistics for the month of November 2018 are now available here.

21-11-2018

Release notes - EudraCT v10.4.4.0 are available here

07-11-2018

EudraCT statistics for the month of October 2018 are now available here.

09-10-2018

EudraCT statistics for the month of September 2018 are now available here.

04-09-2018

EudraCT statistics for the month of August 2018 are now available here.

06-08-2018

EudraCT statistics for the month of July 2018 are now available here.

03-07-2018

EudraCT statistics for the month of June 2018 are now available here.

20-06-2018

The issues with uploading EudraCT XML uploads has now been resolved and is now available. We apologise for any inconvenience this may have caused.

19-06-2018

Important:

EudraCT XML uploads are not available; work is ongoing to restore the service.

Sorry for any inconvenience. Please contact 020 3660 7253

04-06-2018

EudraCT statistics for the month of May 2018 are now available here.

02-05-2018

EudraCT statistics for the month of April 2018 are now available here.

03-04-2018

EudraCT statistics for the month of March 2018 are now available here.

06-03-2018

EudraCT statistics for the month of February 2018 are now available here.

01-02-2018

EudraCT statistics for the month of January 2018 are now available. The 2017 statistics have now been archived as a zip file and can be found here.

03-01-2018

EudraCT statistics for the month of December are now available and can be found here.

04-12-2017

EudraCT statistics for the month of November are now available and can be found here.

06-11-2017

EudraCT statistics for the month of October are now available and can be found here.

20-10-2017

EudraCT statistics for the month of September are now available and can be found here.

06-10-2017

Go-live planning of the new EudraVigilance system – scheduled EudraVigilance downtime from 8 to 21 November

The Agency will be releasing the new EudraVigilance system on 22 November. This follows the EMA Management Board announcement in May that the EudraVigilance (Human) system has achieved full functionality. A number of planned tasks and activities are necessary to prepare for the release of the new EudraVigilance system, requiring a downtime period of 10 business days from 8 to 21 November. The scheduled downtime will affect a number of key EudraVigilance functionalities and several other IT systems and business processes. More information on the impacted IT systems, including EudraVigilance, business processes and the alternative arrangements, can be found here.

03-10-2017

'EudraCT Results new release - Version: 10.4.0.0'

On 28th of September a new release of EudraCT has been deployed to fix issues identified and change requests. Detailed information can be found in the Release notes - EudraCT v10.4.0.0 here.

05-09-2017

EudraCT statistics for the month of August are now available and can be found here.

01-08-2017

EudraCT statistics for the month of July are now available and can be found here.

03-07-2017

EudraCT statistics for the month of June are now available and can be found here.

01-06-2017

EudraCT statistics for the month of May are now available and can be found here.

04-05-2017

EudraCT statistics for the month of April are now available and can be found here.

04-04-2017

EudraCT statistics for the month of March are now available and can be found here.

01-03-2017

EudraCT statistics for the month of February are now available and can be found here.

10-2-2017

EudraCT statistics for the month of January are now available and can be found here. The statistics for 2016 have now been archieved (zip file) and can be found on the same page.

05-01-2017

EudraCT statistics for the month of December are now available and can be found here.

05-12-2016

Sponsors/MAH/Third country data providers who wish to request assignment via letter to prepare results should submit an assignment letter. Template instructions are available here.

01-12-2016

The Release notes for EudraCT v10.3.0.0 are available here.

EudraCT statistics for the month of November are now available and can be found here.

11-11-2016

EudraCT statistics for October are now available and can be found here.

04-10-2016

EudraCT statistics for September are now available and can be found here.

05-09-2016

EudraCT statistics for August are now available and can be found here.

12-08-2016

EudraCT statistics for July are now available and can be found here.

12-07-2016

EudraCT statistics for June are now available and can be found here.

24-06-2016

EudraCT is pleased to announce a set of multi-media tutorials for clinical trial results is now available.
These tutorials will aid sponsors in a step-by-step guide to provide results in EudraCT.

We recommend you read the overview on the page before you download and use these tutorials.

Additionally we have added an RSS feed on the Home page to allow you to get any new updates to the site instantly. To subscribe to the RSS here , click on the icon and follow the instructions.

08-06-2016

EudraCT statistics for May are now available and can be found here.

02-05-2016

EudraCT statistics for April 2016 are now available and can be found here.

04-04-2016

EudraCT statistics for March 2016 are now available and can be found here.

08-03-2016

The presentation and a Q&A documents for the Eudract Results Webinars held on 17 February and 24 February are now available and can be found here.

01-03-2016

EudraCT statistics for February 2016 are now available and can be found here.

24-02-2016

The presentation and a Q&A documents for the Eudract Results Webinar held on 10 February are now available and can be found here.

08-02-2016

The presentation and a Q&A documents for the Eudract Results Webinars held on 27 January and 03 February are now available and can be found here.

02-02-2016

EudraCT statistics for December 2015 and January 2016 are now available and can be found here.

01-02-2016

On 1 February 2016, the Agency is launching an online EMA Service Desk portal: https://servicedesk.ema.europa.eu.
It should be used to report an issue, request a service or ask a question about EMA systems.  

The new portal is being introduced to improve the interaction experience and to improve the effectiveness and transparency of support provided. It will be possible to track the status of requests, queries or issues. To benefit from the use of this tool and its functionalities, users will need to be registered.

  • Users that are already registered for an EMA system (excluding Eudravigilance) can use their existing username and password to log in.

  • Users without login credentials can create a new EMA Service Desk account when they first use the portal. The registration is a simple two-step process.

From 1 February, instead of using one of the functional mailboxes listed above, stakeholders should enter queries using the EMA Service Desk portal (https://servicedesk.ema.europa.eu).

Enquiries raised before 1 February 2016

Enquiries that were raised before 1 February 2016 (via email to any of the functional mailboxes listed above) are unaffected. They will be handled using the former process in place, and will not appear on the EMA Service Desk portal. The answer will be provided to the requester by email.

Transition period

During 1 month transitional period until 1 March 2016, both the old mailbox system and the Service Desk portal may be used, however, we strongly recommend the use of the Service Desk portal for all relevant queries. Until 1 March 2016, any requests submitted by email to the functional mailboxes above will be transferred by EMA to the EMA Service Desk portal on the requestor’s behalf. The requestor will receive an email with a reference number for their enquiry. Please see the EMA Service Desk portal presentation.

If the requestor is not already registered for an EMA system (excluding Eudravigilance), they will also receive login credentials for the EMA Service Desk. They will be able to track the status of their requests on the EMA Service Desk.

From 1 March 2016, the functional mailboxes listed above will no longer be used by EMA. An automatic reply will be implemented to direct users to the EMA Service Desk portal.

We trust this new portal will be useful to you. Should you have any question please do not hesitate to contact us.

For technical support, visit the EMA Service Desk portal: https://servicedesk.ema.europa.eu
For urgent technical matters, telephone: +44 (0)20 3660 8520

22-01-2016

The presentation and a Q&A document for the Eudract Results Webinar held 20 January is now available and can be found here.

13-01-2016

The system has been made available on 13 January 2016. The summary results will be gradually made available for public access from that date, once the information has been reviewed and verified. Full access for sponsors has also been restored from that date.

In the context of clinical trial sponsors’ or PIP addressees’ inability to meet regulatory reporting timeframes while the system was offline: The new deadline for submission for all summary results affected by the period that the system was offline will be 13 July 2016, allowing a period of six months from the date of re-opening of the system. Affected results are those whose submission deadline fell due during the period that the system was offline, as well as those whose submission deadline falls within a period of two months from the re-opening date.

In addition, for trials categorised as to be posted ≤ 24 months after finalisation of the programming (see document “Trial results: modalities and timing of posting”), the deadline for submission of summary results will be 21 December 2016, being five months from the current deadline in July 2016.

The issues causing errors in data recording have been fixed. These are described in the release notes (see “timestamp” and “category” issues).  The results presented are correct. However, the issue that causes the order of display of reporting groups and results to differ through the results set has not been addressed. The reporting groups and results themselves are correct; it is only the display order that is affected.

07-01-2016

The Agency will re-open access for sponsors to enter results or edit existing results in EudraCT on 13 January 2016. Existing user accounts are unaffected and registered sponsors will be able to enter results or edit existing results in EudraCT as soon as the system has been re-opened. New sponsors may seek new accounts with immediate effect.

The summary results will be gradually made available for public access from the same date, once the information has been reviewed and verified.

The EudraCT Results Training environment will be made available at the same time as the production system.

In the context of clinical trial sponsors’ or PIP addressees’ inability to meet regulatory reporting timeframes while the system was offline: The new deadline for submission for all summary results affected by the period that the system was offline will be 13 July 2016, allowing a period of six months from the date of re-opening of the system. Affected results are those whose submission deadline fell due during the period that the system was offline, as well as those whose submission deadline falls within a period of two months from the re-opening date.

In addition, for trials categorised as to be posted ≤ 24 months after finalisation of the programming (see document “Trial results: modalities and timing of posting”, the deadline for submission of summary results will be 21 December 2016, being five months from the current deadline in July 2016.

21-12-2015

The Agency has resolved the problems which led to the temporary unavailability of summary results in the EU Clinical Trial Register (EU CTR) and the withdrawal of access for sponsors to enter results or edit existing results. In early January, the Agency will grant access to sponsors to enter results or edit existing results, and the summary results will be gradually made available for public access from the same date.

Sponsors may seek new accounts with immediate effect.

In the context of clinical trial sponsors’ or PIP addressees’ ability to meet regulatory reporting timeframes, the new deadline for submission for all summary results affected by the period that the system was offline will be a date six months from the date of re-opening of the system. Affected results are those whose submission deadline fell due during the period that the system was offline, as well as those whose submission deadline falls within a period of two months from the re-opening date.

In addition, for trials categorised as to be posted ≤ 24 months after finalisation of the programming, the deadline for submission of summary results will be a date five months from the current deadline in July 2016

08-12-2015

EudraCT statistics for November are now available and can be viewed here

13-11-2015

EudraCT statistics for October are now available and can be viewed here

14-10-2015

EMA IT systems unavailable from 20:00 Friday 30 October to 6:00 Tuesday 3 November

All European Medicines Agency (EMA) IT systems will be temporarily unavailable from 20:00 on Friday 30 October to 6:00 on Tuesday 3 November (UK time), due to an essential exercise to test the Agency’s IT recovery capacity in case of a major event.

During this period, it will not be possible to access the EMA public website, www.ema.europa.eu, or any other EMA-hosted website or online application, including EudraCT and the Clinical Trials Register. Normal service will resume on 3 November.

Emails sent to EMA email addresses during this period will be queued and delivered to recipients on 3 November.

The EMA product emergency hotline and phone number for notifying suspected quality defects or product recalls will operate as usual. While the EMA public website is unavailable, a holding page will be displayed with details of these emergency numbers.

We would like to thank you in advance for your patience and cooperation during this essential IT maintenance work.

And

EudraCT statistics for August and September are now available and can be viewed here.

04-08-2015

EudraCT statistics for July are now available and can be viewed here.

03-07-2015

Eudra CT statistics for June are now available and can be viewed here.

01-06-2015

Eudra CT statistics for April and May are now available and can be viewed here.

29-05-2015

Release Notes for EudraCT Version 10.2.0.0 is now available and can be viewed here.

08-04-2015

Eudra CT statistics for March are now available and can be viewed here.

24-03-2015

Eudra CT statistics for February are now available and can be viewed here.

02-03-2015

Eudra CT statistics for January are now available and can be viewed here. Statistics for 2014 are now archived in a zip file and can also be found here

26-01-2015

Eudra CT statistics for December are now available and can be viewed here.

And

Q&A for Dec 16 2014 session and the training session for stakeholders CT results for EudraCT V10 are available and can be found here.

3-12-2014

EudraCT statistics for October and November are now available and can be viewed here

30-10-2014

The EudraCT V10 - Q&A for 19 Sept 2014 session and the training session for stakeholders CT results for EudraCT V10 are available and can be found here

22-08-2014

EMA launches EudraCT result training environment

The EMA launched the EudraCT result training environment 1 August 2014. This application is aimed at representatives of sponsors and sponsor-investigators who want to familiarise themselves and get a better understanding in the preparation and posting of trials results in EudraCT. Further information can be found on the EudraCT result training environment home page.

14-08-2014

EudraCT statistics for July are now available and can be viewed here

01-08-2014

The European Medicines Agency has moved to

30 Churchill Place | Canary Wharf | London E14 5EU | United Kingdom

02-06-2014

The presentation Getting started with EudraCT to prepare and post results has been updated to reflect the additional option of how to request an assignment based on protocol data


EMA