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

¹ Once a year, the in­vest­ig­at­or shall present to the re­spons­ible eth­ics com­mit­tee a list of events and de­fi­cien­cies in the product un­der Art­icle 2a para­graph 2 TPA un­der in­vest­ig­a­tion and ad­verse re­ac­tions as spe­cified in Art­icles 40–42 and, on this basis, shall sub­mit a re­port on their sever­ity and caus­al re­la­tion­ship to the in­ter­ven­tion, and on the safety of par­ti­cipants (an­nu­al safety re­port, ASR).³⁷

² In the case of clin­ic­al tri­als also con­duc­ted abroad ac­cord­ing to the same pro­tocol, the events and de­fi­cien­cies in the product un­der Art­icle 2a para­graph 2 TPA un­der in­vest­ig­a­tion and ad­verse re­ac­tions oc­cur­ring abroad must also be in­cluded in the list and the re­port.³⁸

³ For Cat­egory B and C clin­ic­al tri­als, re­ports as spe­cified in para­graphs 1 and 2 must also be sub­mit­ted to the Agency. This ob­lig­a­tion rests on the spon­sor.