|Access to EudraCT|
|EudraPharm EU CTR|
An error has been identified in the software used to load summaries of results into the EU Clinical Trial Register. The problem may affect a subset of results which have been processed outside of the system and reloaded to it. As a consequence, the summary results of clinical trials which have been entered into EudraCT and made public in the EU CTR have been removed from the public domain while they are reviewed and before being returned to the public view. In addition the access for sponsors to enter results or edit existing results has been blocked (and no new accounts are being issued) whilst the underlying software error that gave rise to the problem is resolved. As a consequence if you search for results, you will see the text “Trial results: Removed from public view” in the clinical trial summary. This incident does not affect the “Paediatric studies in scope of Art45 of the Paediatric Regulation”.
In the event of prolonged unavailability of the EudraCT system for posting of clinical trial results, which could affect clinical trial sponsors or PIP addressees ability to meet regulatory reporting timeframes, the sponsors and PIP addressees should:
In the context of the present incident, sponsor accounts to enable them to edit or load summary results in EudraCT were taken off line on 31 July 2015, and therefore the time elapsed from 31 July 2015 until the system is again fully open to sponsors and the public, plus 20 EMA business days, will be added to the original due date in order to determine a new deadline for submission.
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.
(Previous news can be found here)
EudraCT statistics for october are now available and can be viewed here
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.
EudraCT statistics for August and September are now available and can be viewed here.
EudraCT statistics for July are now available and can be viewed here.
Eudra CT statistics for June are now available and can be viewed here.
Eudra CT statistics for April and May are now available and can be viewed here.
Release Notes for EudraCT Version 10.2.0.0 is now available and can be viewed here.
Eudra CT statistics for March are now available and can be viewed here.
Eudra CT statistics for February are now available and can be viewed here.