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

¹ The in­vest­ig­at­or shall, with­in 7 days, no­ti­fy the re­spons­ible eth­ics com­mit­tee of the fol­low­ing:

a.

ser­i­ous ad­verse events which oc­cur in par­ti­cipants in Switzer­land in the course of a Cat­egory C clin­ic­al tri­al of products un­der Art­icle 2a para­graph 2 TPA and where it can­not be ex­cluded that the events are at­trib­ut­able:

1.

to the product un­der in­vest­ig­a­tion, or

2.

to an in­ter­ven­tion un­der­taken in the clin­ic­al tri­al;

b.

de­fi­cien­cies in the product un­der Art­icle 2a para­graph 2 TPA un­der in­vest­ig­a­tion that could have led to ser­i­ous ad­verse events if suit­able ac­tion had not been taken, in­ter­ven­tion had not been made, or cir­cum­stances had been less for­tu­nate.

² If, in the case of a mul­ti­centre clin­ic­al tri­al at one of the tri­al sites, ser­i­ous ad­verse events or de­fi­cien­cies oc­cur de­fi­cien­cies in the product un­der Art­icle 2a para­graph 2 TPA un­der in­vest­ig­a­tion, the co­ordin­at­ing in­vest­ig­at­or shall also no­ti­fy the re­spons­ible eth­ics com­mit­tee con­cerned.

³ For a Cat­egory C clin­ic­al tri­al, the no­ti­fic­a­tions spe­cified in para­graph 1 shall also be made to the Agency. This ob­lig­a­tion rests on the spon­sor. In ad­di­tion, the spon­sor shall no­ti­fy the Agency of any events oc­cur­ring or de­fi­cien­cies in the product un­der Art­icle 2a para­graph 2 TPA un­der in­vest­ig­a­tion ob­served abroad. In the case of a Cat­egory A clin­ic­al tri­al, the spon­sor is sub­ject to the re­port­ing re­quire­ments spe­cified in Art­icle 15 para­graph 1 MedDO³⁵ in its ver­sion of 1 Janu­ary 2002³⁶ in ap­plic­a­tion of Art­icle 103 para­graph 2 MedDO.

⁴ The defin­i­tion of ser­i­ous ad­verse events and de­fi­cien­cies in products un­der Art­icle 2a para­graph 2 TPA is gov­erned by the rules of Good Clin­ic­al Prac­tice as spe­cified in An­nex 1.