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. 4 Scientific quality

The spon­sor and the in­vest­ig­at­or of a clin­ic­al tri­al shall en­sure sci­entif­ic qual­ity. In par­tic­u­lar:

a.
they shall define a re­search ques­tion based on the cur­rent state of sci­entif­ic know­ledge;
b.
they shall use an ap­pro­pri­ate sci­entif­ic meth­od­o­logy; and
c.
they shall en­sure the avail­ab­il­ity of the re­sources re­quired for the clin­ic­al tri­al and provide the ne­ces­sary in­fra­struc­ture.
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