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).


Open article in different language:  DE  |  FR  |  IT
Art. 64 Approved registries and data to be entered

1 For an au­thor­ised clin­ic­al tri­al, the spon­sor must re­gister the data spe­cified in An­nex 5 num­ber 1:

a.
in a primary re­gistry47 re­cog­nised by the World Health Or­gan­iz­a­tion (WHO); or
b.
in the re­gistry of the U.S. Na­tion­al Lib­rary of Medi­cine48.

2 The spon­sor shall ad­di­tion­ally enter the data spe­cified in An­nex 5 num­ber 2 in the sup­ple­ment­ary fed­er­al data­base, us­ing a Swiss na­tion­al lan­guage.

3 The data must be entered in the form au­thor­ised by the re­spons­ible eth­ics com­mit­tee.

47 The re­gis­tries can be con­sul­ted at: www.who.int > Pro­grammes and pro­jects > Clin­ic­al Tri­als – In­ter­na­tion­al Re­gistry Plat­form.

48 The re­gistry can be con­sul­ted at: www.clin­ic­al­tri­als.gov

Previous article Show article in the law Next article

Diese Seite ist durch reCAPTCHA geschützt und die Google Datenschutzrichtlinie und Nutzungsbedingungen gelten.

Feedback
Gesetzeskürzel Name
DE FR IT EN
DE FR IT EN
Laden