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The European Medicines Agency has launched a new version of the European Clinical Trials Database (EudraCT). This new version, EudraCT V9, marks the initial step of a process through which summary clinical trial results will be made publicly available through the EU Clinical Trials Register (EU CTR).
EudraCT already contains protocol-related information submitted by sponsors for interventional clinical trials conducted in European Economic Area countries and/or in third countries, when the clinical trial is part of an agreed Paediatric Investigation Plan (PIP). As of today, clinical-trial sponsors are encouraged to register on the EudraCT website to start uploading summary results. Results posted by sponsors in EudraCT will start to become publicly available once the Agency has launched the complementary new version of the EU CTR towards the end of the year. The content and level of detail of the summary results is set out in a European Commission guideline and in its technical guidance.
This initial release of EudraCT will be followed by further updates to the system in 2014 which will provide improved functionalities for sponsors and EU regulatory authorities. With the launch of these further iterations of EudraCT by mid-2014, the modalities and timing of posting of result-related information as described in the EC guideline will apply, and sponsors will then be required to post result-related information.
The Agency supports international standardisation of data requirements for clinical trial registration. EudraCT’s data requirements are already substantially aligned with those of ClinicalTrials.gov and the Agency works closely with the National Institutes of Health (NIH) of the United States, which operate ClinicalTrials.gov and with stakeholders to progress this objective.
The Agency will make the data descriptions and technical specifications available to enable stakeholders to build systems that can generate structured data sets and upload them electronically into EudraCT.