Version 11.0 of the Questions & Answers Document in Eudralex Volume 10: Clinical Trials - Chapter V has been published.
In the latest version, two new Q&As have been added:
1.7. Question: Is a study addressing the time of surgery a clinical trial, if patients receive otherwise standard treatment with medicines?
Answer: This is a case by case decision and it depends from whether the object of the study is one of those listed in Article 2(a) of Directive 2001/20/EC. If this is not the case, the study is not a clinical trial. The sponsor has the responsibility to provide clear information on the object of the study.
4.1. Question: Can the National Competent Authority or the Ethics Committee oblige the sponsor to report all suspected expected serious adverse reactions (in addition to the suspected unexpected serious adverse reactions, as per Article 17(1)(a)(b) of Directive 2001/20/EC)?
Answer: Yes. The authorisation/favourable opinion may be made conditional upon such requirement. However, suspected expected serious adverse reactions are not SUSARS and shall not be reported as such.
The complete document can be found here: Eudralex Volume 10, Chapter V, Q&A Document, Version 11.0