Under the new Clinical Trials Regulation 536/2014/EU, it is now a requirement for the sponsor of a clinical trial to report to the regulatory authorities a serious breach of the Regulation or to the clinical trial protocol (Article 52). A serious breach, in this context, is defined as “a breach likely to affect to a significant degree the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial“. This requirement is currently contained in the legislation of some Member States, such as in the UK (Regulation 29A Medicines for Human Use (Clinical Trials) Regulations 2004/1031), but was not previously included in Directive 2001/20/EC or in ICH GCP (although a sponsor should list all significant protocol non-compliances in the clinical study report). This is, therefore, the first time that there is such a requirement in all EU countries.
Continue Reading Consultation on serious breaches of clinical trial protocol