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

¹ In the case of in­vest­ig­a­tions in­volving ra­di­ation sources, the in­vest­ig­at­or shall ad­di­tion­ally sub­mit to the re­spons­ible eth­ics com­mit­tee the doc­u­ments spe­cified in An­nex 3 num­ber 5. Sub­ject to the pro­vi­sions of the fol­low­ing para­graphs, the au­thor­isa­tion 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, in­form­ing the eth­ics com­mit­tee at the same time, if the ef­fect­ive dose per per­son, tak­ing the un­cer­tainty factor in­to ac­count, is more than 5 mSv per year and:

a.

a ra­dio­phar­ma­ceut­ic­al is used which is not au­thor­ised in Switzer­land;

b.

a ra­dio­phar­ma­ceut­ic­al is used which is au­thor­ised in Switzer­land, and the in­ter­ven­tion in ques­tion is not a routine nuc­le­ar medi­cine ex­am­in­a­tion; or

c.

some oth­er ra­dio­act­ive source³² is used.

³ The FOPH shall de­liv­er an opin­ion for the eth­ics com­mit­tee on com­pli­ance with ra­di­olo­gic­al pro­tec­tion le­gis­la­tion and on the dose es­tim­a­tion.

⁴ The eth­ics com­mit­tee shall grant au­thor­isa­tion if:

a.

the re­quire­ments covered by Art­icle 25 are met; and

b.

the FOPH has raised no ob­jec­tions to the clin­ic­al tri­al.

⁵ It shall reach a de­cision with­in 45 days of ac­know­ledge­ment of re­ceipt of the form­ally cor­rect ap­plic­a­tion doc­u­ments. It shall in­form the FOPH of its de­cision.