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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.
(Previous news can be found here)
EudraCT statistics for April 2016 are now available and can be found here.
EudraCT statistics for March 2016 are now available and can be found here.
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.
EudraCT statistics for February 2016 are now available and can be found here.
The presentation and a Q&A documents for the Eudract Results Webinar held on 10 February are now available and can be found here.
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.