Ordinance
on Clinical Trials
with the exception of
Clinical Trials of Medical Devices¹
(Clinical Trials Ordinance, ClinO)

¹ In the case of ac­com­pa­ny­ing ex­am­in­a­tions in­volving ion­ising ra­di­ation, the in­vest­ig­at­or shall sub­mit to the re­spons­ible eth­ics com­mit­tee the ad­di­tion­al ap­plic­a­tion doc­u­ments spe­cified in An­nex 3 num­ber 5. Sub­ject to the pro­vi­sions of para­graphs 2–6, the ap­prov­al pro­ced­ure is gov­erned by Art­icles 24–27 and 29.

² The in­vest­ig­at­or shall ad­di­tion­ally sub­mit to the FOPH the ap­plic­a­tion doc­u­ments spe­cified in An­nex 3 num­ber 6 if:

a.

a ra­dio­phar­ma­ceut­ic­al em­ployed is not used in ac­cord­ance with the au­thor­isa­tion or is not au­thor­ised in Switzer­land;

b.

a med­ic­al device em­ployed which is cap­able of emit­ting ion­ising ra­di­ation:

1.

is not used in ac­cord­ance with the in­struc­tions for use, or

2.

does not bear a con­form­ity mark­ing in ac­cord­ance with Art­icle 13 MedDO⁸²; or

c.

some oth­er ra­dio­act­ive source is used.

³ If ad­di­tion­al doc­u­ment­a­tion has to be sub­mit­ted in ac­cord­ance with para­graph 2, the in­vest­ig­at­or shall in­form the eth­ics com­mit­tee ac­cord­ingly.

⁴ The FOPH shall, with­in a reas­on­able peri­od, de­liv­er an opin­ion for the eth­ics com­mit­tee on com­pli­ance with ra­di­olo­gic­al pro­tec­tion le­gis­la­tion and on the dose es­tim­a­tion.

⁵ The eth­ics com­mit­tee shall grant ap­prov­al if:

a.

the re­quire­ments covered by Art­icle 25 are met; and

b.

after dis­cus­sion of the opin­ion spe­cified in para­graph 4, there are no re­main­ing ob­jec­tions to the clin­ic­al tri­al.

⁶ It shall reach a de­cision with­in 45 days after ac­know­ledge­ment of re­ceipt of the form­ally cor­rect ap­plic­a­tion doc­u­ments. It shall in­form the FOPH of its de­cision.