Posting of clinical trial summary results to the EudraCT database became mandatory on 21 Jul 2014. These posts will feed into the publicly accessible European Union Clinical Trials Register and thus will be available to the public. For any interventional trial in the EU that ended on or after this date, posting of results is required… read more
What’s in the new EU Clinical Trial Regulation? Part 2: New reporting requirements
Article 52 requires reporting of serious breaches of the regulation or of the protocol. A serious breach is defined in much the same way that it was in the UK legislation: a breach likely to affect to a significant degree the safety and rights of a subject or the reliability and robustness of the data… read more
What’s in the New EU Clinical Trial Regulation? Part 1: Introduction
The Council of the European Union recently approved the new Clinical Trials Regulation with the stated purpose of making the EU a more attractive place to conduct clinical research. Many will remember that in 2001 the Clinical Trials Directive (CTD) was supposed to do the same thing, but the CTD is now widely considered to… read more