Ordinance
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Art. 6 Professional qualifications
1 The clinical trial investigator must:
2 In addition, the investigator in a clinical trial of medicinal products or transplantation must be entitled to practise the medical profession independently. 3 For clinical trials of in vitro diagnostic medical devices14 and products under Article 2a paragraph 2 TPA and for clinical trials covered by Chapter 4, a person without medical qualifications may also serve as an investigator, provided that this person is entitled to practise independently the profession specifically qualifying him or her to conduct the clinical trial. 4 The other persons conducting the clinical trial must have the professional knowledge and experience appropriate to the activities in question. 14 Term in accordance with Annex 2 No 2 of the O of 1 July 2020 on Clinical Trials with Medical Devices, in force since 26 May 2021 (AS 2020 3033). This change has been made throughout the text. |