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

For clin­ic­al tri­als of trans­plant­a­tion, the FOPH shall re­view:

a.

the com­plete­ness of the ap­plic­a­tion;

b.

the ori­gin of the or­gans, tis­sues or cells used in the clin­ic­al tri­al;

c.

com­pli­ance with the re­quire­ments of the trans­plant­a­tion le­gis­la­tion, par­tic­u­larly with re­gard to the du­ties of care in the hand­ling of or­gans, tis­sues and cells, and the al­loc­a­tion of or­gans;

d.

the avail­ab­il­ity of the au­thor­isa­tions re­quired in ac­cord­ance with the Trans­plant­a­tion Act;

e.

oth­er areas, where this is ne­ces­sary to as­sess the safety and qual­ity of the or­gans, tis­sues or cells used.