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Ordinance on Clinical Trials with the exception of Clinical Trials of Medical Devices1 (Clinical Trials Ordinance, ClinO)
of 20 September 2013 (Status as of 26 May 2022)
1 Amended by 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).
Art. 5Rules of Good Clinical Practice
1 Clinical trials must be conducted in accordance with the rules of Good Clinical Practice, as specified in Annex 1 number 2.
2 A clinical trial covered by Chapter 4 may be conducted in accordance with other rules which are recognised in the specialty in question, provided that the protection of participants and data quality and security are guaranteed.
3 The measures and precautions required in accordance with the rules of Good Clinical Practice must be adapted to the extent of the risks to which participants are exposed. Depending on the extent of these risks, there may be certain deviations from the rules of Good Clinical Practice. Any deviations must be recorded in the protocol. The protection of the participants and data quality and security must be guaranteed in all cases.