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

¹ The spon­sor must re­tain all data re­lat­ing to the clin­ic­al tri­al un­til the ex­piry date of the last batch sup­plied of the medi­cin­al product un­der in­vest­ig­a­tion or of the last product un­der Art­icle 2a para­graph 2 TPA man­u­fac­tured, but at least for ten years after the com­ple­tion or dis­con­tinu­ation of the clin­ic­al tri­al. In the case of products un­der Art­icle 2a para­graph 2 TPA that can be im­planted, the re­ten­tion peri­od amounts to a min­im­um of 15 years.⁴¹

² The in­vest­ig­at­or must re­tain all doc­u­ments re­quired for the iden­ti­fic­a­tion and fol­low-up of par­ti­cipants, and all oth­er ori­gin­al data, for at least ten years after the com­ple­tion or dis­con­tinu­ation of the clin­ic­al tri­al. In the case of products un­der Art­icle 2a para­graph 2 TPA that can be im­planted, the re­ten­tion peri­od amounts to a min­im­um of 15 years.⁴²

³ For clin­ic­al tri­als of trans­plant products and for clin­ic­al tri­als of blood and blood products, the re­ten­tion re­quire­ments are gov­erned by Art­icle 40 para­graph 1 TPA.