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

¹ The clin­ic­al tri­al in­vest­ig­at­or must:

a.

be ad­equately trained in Good Clin­ic­al Prac­tice and have the pro­fes­sion­al know­ledge and ex­per­i­ence re­quired for the clin­ic­al tri­al;

b.

be con­vers­ant with the leg­al re­quire­ments for clin­ic­al tri­als or be able to en­sure com­pli­ance by call­ing in ap­pro­pri­ate ex­pert­ise; and

c.²⁵

have ap­pro­pri­ate know­ledge and skills in the areas of data se­cur­ity and data pro­tec­tion or be able to en­sure com­pli­ance by call­ing in ap­pro­pri­ate ex­pert­ise.

² In ad­di­tion, the in­vest­ig­at­or in a clin­ic­al tri­al of medi­cin­al products, products un­der Art­icle 2a para­graph 2 TPA or trans­plant­a­tion must be en­titled to prac­tise as a phys­i­cian un­der his or her own pro­fes­sion­al re­spons­ib­il­ity.²⁶

³ For clin­ic­al tri­als covered by Chapter 4, a per­son without med­ic­al qual­i­fic­a­tions may also serve as an in­vest­ig­at­or, provided that this per­son is en­titled to prac­tise the pro­fes­sion spe­cific­ally qual­i­fy­ing him or her to con­duct the clin­ic­al tri­al un­der his or her own re­spons­ib­il­ity.²⁷

⁴ The oth­er per­sons con­duct­ing the clin­ic­al tri­al must have the pro­fes­sion­al know­ledge and ex­per­i­ence ap­pro­pri­ate to the activ­it­ies in ques­tion.