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Frequently Asked Questions (FAQ) - Studies without drugs
You are mainly talking about drug studies. Are there any topics where psychotherapy research is mostly recommended?
Please refer to the following presentation explaining that usability study is no clinical study: http://de.slideshare.net/Banderlin/usability-testing-medical-devices.Schuhe
If the therapy does not involve drugs, does the EMA need to be contacted? Is there another relevant organization which should be contacted?
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.Adidas sneakers
It would be great if there was some mention of clinical trials which do not involve drugs, such as psychological therapy.
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".Jordan Shoes