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News update

An error has been identified in the software used to load summaries of results into the EU Clinical Trial Register (EU CTR). The problem may affect a subset of results which have been processed outside of the system and reloaded. As a precautionary measure, all summary results of clinical trials in EU CTR are currently being reviewed. During the review, the summary results will be temporarily unavailable, and you will see the text “Trial results: Removed from public view” when you click on the clinical trial summary in EU CTR. The summary results will be gradually made available for public access again, once the information has been reviewed and verified.

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. 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.

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EU Clinical Trials Register version 2.1


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Patients’ and Consumers’ Organisations’ contact information PDF document

Healthcare Professionals’ Organisations contact information PDF document

Sponsors' contact information PDF document

EU Clinical Trials Register Service Desk: euctr@ema.europa.eu
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