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. 38 Notification and reporting upon completion, discontinuation or interruption of a clinical trial

1 The in­vest­ig­at­or shall no­ti­fy the eth­ics com­mit­tee of the com­ple­tion of the clin­ic­al tri­al in Switzer­land with­in 90 days. Com­ple­tion of a clin­ic­al tri­al is marked by the last par­ti­cipant’s fi­nal fol­low-up vis­it, in the ab­sence of pro­vi­sions to the con­trary in the pro­tocol.

2 The in­vest­ig­at­or shall no­ti­fy the eth­ics com­mit­tee of the dis­con­tinu­ation or in­ter­rup­tion of the clin­ic­al tri­al with­in 15 days. In the no­ti­fic­a­tion, the reas­ons for the dis­con­tinu­ation or in­ter­rup­tion shall be stated.

3 The in­vest­ig­at­or shall sub­mit a fi­nal re­port to the eth­ics com­mit­tee with­in a year after com­ple­tion or dis­con­tinu­ation of the clin­ic­al tri­al, un­less a longer peri­od is spe­cified in the pro­tocol.

4 If a mul­ti­centre clin­ic­al tri­al is dis­con­tin­ued or in­ter­rup­ted at one of the tri­al sites, the co­ordin­at­ing in­vest­ig­at­or shall also no­ti­fy the re­spons­ible eth­ics com­mit­tee con­cerned in ac­cord­ance with para­graph 2.

5 For Cat­egory B and C clin­ic­al tri­als, the no­ti­fic­a­tions and re­ports spe­cified in para­graphs 1–3 shall be made to the Agency. These ob­lig­a­tions rest on the spon­sor.

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