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).


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Art. 37 Notification of safety and protective measures

1 If im­me­di­ate safety and pro­tect­ive meas­ures have to be taken dur­ing the con­duct of a clin­ic­al tri­al, the in­vest­ig­at­or shall no­ti­fy the eth­ics com­mit­tee of these meas­ures, and of the cir­cum­stances ne­ces­sit­at­ing them, with­in 7 days.

2 In the case of clin­ic­al tri­als of products un­der Art­icle 2a para­graph 2 TPA, this no­ti­fic­a­tion shall be made with­in 2 days.

3 For Cat­egory B and C clin­ic­al tri­als, the no­ti­fic­a­tions spe­cified in para­graphs 1 and 2 shall be made to the Agency. This ob­lig­a­tion rests on the spon­sor.

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