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

¹ This Or­din­ance reg­u­lates:

a.⁵

the re­quire­ments for the con­duct of:

1.⁶

clin­ic­al tri­als with medi­cin­al products, in­clud­ing com­bin­a­tions un­der Art­icle 2 para­graph 1 let­ters f and g of the Med­ic­al Devices Or­din­ance of 1 Ju­ly 2020 (MedDO)⁷, or trans­plant products,

2.

clin­ic­al tri­als with …⁸ products un­der Art­icle 2a para­graph 2 TPA⁹,

3.

clin­ic­al tri­als of trans­plant­a­tion,

4.

clin­ic­al tri­als that are not clin­ic­al tri­als un­der num­bers 1 to 3;

b.

the au­thor­isa­tion and no­ti­fic­a­tion pro­ced­ures for clin­ic­al tri­als;

c.

the du­ties and re­spons­ib­il­it­ies of re­search eth­ics com­mit­tees (eth­ics com­mit­tees), the Swiss Agency for Thera­peut­ic Products (the Agency) and the Fed­er­al Of­fice of Pub­lic Health (the FOPH) in con­nec­tion with the au­thor­isa­tion and no­ti­fic­a­tion pro­ced­ures;

d.

the re­gis­tra­tion of clin­ic­al tri­als and pub­lic ac­cess to the re­gistry.

² The fol­low­ing ap­ply:

a.¹⁰

for clin­ic­al tri­als with med­ic­al devices un­der Art­icle 1 MedDO und Art­icle 1 of the Or­din­ance of 4 May 2022¹¹ on In Vitro Dia­gnost­ic Med­ic­al Devices: the Or­din­ance of 1 Ju­ly 2020¹² on Clin­ic­al Tri­als with Med­ic­al Devices;

b.

for clin­ic­al tri­als of xeno­trans­plant­a­tion: the Xeno­trans­plant­a­tion Or­din­ance of 16 March 2007¹³ ap­plies.¹⁴