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

¹ Clin­ic­al tri­als of thera­peut­ic products and trans­plant products and tri­als of trans­plant­a­tion which were au­thor­ised be­fore 1 Janu­ary 2014 are con­sidered to be Cat­egory C clin­ic­al tri­als.

² Oth­er au­thor­ised clin­ic­al tri­als are con­sidered to be Cat­egory B clin­ic­al tri­als.

³ On re­quest, the au­thor­ity which au­thor­ised the clin­ic­al tri­al be­fore 1 Janu­ary 2014 may as­sign the clin­ic­al tri­al to a dif­fer­ent cat­egory. In this case, the li­ab­il­ity, cov­er­age, no­ti­fic­a­tion, re­port­ing and doc­u­ment­a­tion re­quire­ments are gov­erned by the new law.

⁴ The re­spons­ible eth­ics com­mit­tee shall make the de­cision spe­cified in para­graph 3 ac­cord­ing to the sim­pli­fied pro­ced­ure spe­cified in Art­icle 6 of the HRA Or­gan­isa­tion Or­din­ance of 20 Septem­ber 2013⁵³.

⁵ The as­sess­ment of sig­ni­fic­ant changes is gov­erned by the new law.