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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. 65 Time of registration

1 The re­gis­tra­tion spe­cified in Art­icle 64 must be per­formed be­fore the clin­ic­al tri­al is con­duc­ted, sub­ject to the pro­vi­sions of para­graph 2.

2 Clin­ic­al tri­als in which the medi­cin­al product un­der in­vest­ig­a­tion is be­ing ad­min­istered to adult per­sons for the first time (Phase I clin­ic­al tri­als) must be re­gistered no later than one year after the com­ple­tion of the clin­ic­al tri­al.

3 The spon­sor must up­date the data entered in ac­cord­ance with the re­quire­ments of the re­gistry in ques­tion, as spe­cified in Art­icle 64 para­graph 1, but at least once a year.