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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. 57

1 For no­ti­fic­a­tions and re­port­ing in the case of clin­ic­al tri­als of trans­plant­a­tion, Art­icles 37–41, 43 and 44 ap­ply mu­tatis mutandis.45

2 The ob­lig­a­tions which must be ful­filled un­der these pro­vi­sions vis-à-vis the Agency are to be ful­filled, for clin­ic­al tri­als of trans­plant­a­tion, vis-à-vis the FOPH.

3 For clin­ic­al tri­als of trans­plant­a­tion, the du­ties of the spon­sor and the in­vest­ig­at­or con­cern­ing doc­u­ment­a­tion, trace­ab­il­ity and re­ten­tion of re­cords are gov­erned by Art­icles 34 and 35 of the Trans­plant­a­tion Act.

45 Cor­rec­tion of 27 Dec. 2013 (AS 2013 5579).