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Frequently Asked Questions (FAQ) - Studies without drugs
Please refer to the following presentation explaining that usability study is no clinical study: http://de.slideshare.net/Banderlin/usability-testing-medical-devices.
Please see here for non-pharmaceutical products: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/gen.... In general, we advise you to contact your national competent authority very early - and you might get great support from ethic committees located at your local/ regional university hospitals etc.
EC does not make big differences here. They clearly say (in the additional template) that they have a very broad definition of CTs - as long as you COLLECT human data (patients/ volunteers). Sure all we are presenting today is applicable for psychological therapy. Whenever a question in the template is not to answer, just write "not applicable".