Access to EudraCT
EudraPharm EU CTR
Protocol documentation
Results documentation
Technical documentation
Training
Statistics
NCA contacts
Links

Update: 13 January 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.

Welcome to the community clinical trial public home page

The European Medicines Agency has launched a new version of the European Clinical Trials Database (EudraCT). This new version, EudraCT V10, marks the final step of a process through which summary clinical trial results will be made publicly available through the EU Clinical Trials Register (EU CTR).

Sponsors’ representatives are recommended to register with EudraCT in order to become results users and before they can log into EudraCT. The registration process is described in the help and is accessed on the login page.


What's New

(Previous news 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 viewed 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