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

In this Or­din­ance:

a.

clin­ic­al tri­al means a re­search pro­ject in­volving in­di­vidu­als that pro­spect­ively as­signs them to un­der­go a health-re­lated in­ter­ven­tion in or­der to study its ef­fects on health or on the struc­ture and func­tion of the hu­man body;

b.

health-re­lated in­ter­ven­tion means a pre­vent­ive, dia­gnost­ic, thera­peut­ic, pal­li­at­ive or re­hab­il­it­at­ive meas­ure in­vest­ig­ated in a clin­ic­al tri­al;

c.

min­im­al risks and bur­dens means risks and bur­dens, which, in terms of in­tens­ity and qual­ity, and tak­ing in­to ac­count the vul­ner­ab­il­ity of the par­ti­cipants and the spe­cif­ic cir­cum­stances, will have only a slight and tem­por­ary im­pact on the par­ti­cipants’ health; in par­tic­u­lar, min­im­al risks and bur­dens may be as­so­ci­ated with:

1.

sur­veys and ob­ser­va­tions,

2.

peri­pher­al ven­ous or ca­pil­lary blood sampling and skin punch biopsies of lim­ited ex­tent,

3.

re­mov­ing or col­lect­ing bod­ily sub­stances without in­vas­ive in­ter­ven­tions, in par­tic­u­lar, saliva, ur­ine and stool samples,

4.

tak­ing swabs,

5.

mag­net­ic res­on­ance ima­ging scans without a con­trast me­di­um, ul­tra­sound ex­am­in­a­tions or elec­tro­grams,

6.¹⁶

ex­am­in­a­tions us­ing ion­ising ra­di­ation, provided that the ef­fect­ive dose is be­low 5 mSv per re­search pro­ject and per per­son con­cerned and:

–

the medi­cin­al product used is au­thor­ised or ex­empt from au­thor­isa­tion, or

–

the devices un­der Art­icle 1 MedDO¹⁷ bear con­form­ity mark­ings and no con­trast me­di­um is used;

d.

spon­sor means a per­son or in­sti­tu­tion headquartered or rep­res­en­ted in Switzer­land that takes re­spons­ib­il­ity for or­gan­ising a clin­ic­al tri­al, and in par­tic­u­lar for the ini­ti­ation, man­age­ment and fin­an­cing of the tri­al in Switzer­land;

e.

in­vest­ig­at­ormeans a per­son re­spons­ible in Switzer­land for the con­duct of a clin­ic­al tri­al and for the pro­tec­tion of the par­ti­cipants at the tri­al site; an in­vest­ig­at­or who takes re­spons­ib­il­ity for or­gan­ising a clin­ic­al tri­al in Switzer­land is also a spon­sor.