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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.

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.