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

¹ If, in the course of a clin­ic­al tri­al, a sus­pec­ted un­ex­pec­ted ser­i­ous ad­verse re­ac­tion oc­curs in par­ti­cipants, the in­vest­ig­at­or must doc­u­ment this in a stand­ard­ised man­ner and no­ti­fy the spon­sor with­in 24 hours after it be­comes known.

² The in­vest­ig­at­or shall no­ti­fy the re­spons­ible eth­ics com­mit­tee of a fatal sus­pec­ted un­ex­pec­ted ser­i­ous ad­verse re­ac­tion oc­cur­ring in Switzer­land with­in 7 days, and of any oth­er sus­pec­ted un­ex­pec­ted ser­i­ous ad­verse re­ac­tion with­in 15 days.

³ If, in the case of a mul­ti­centre clin­ic­al tri­al, a sus­pec­ted un­ex­pec­ted ser­i­ous ad­verse re­ac­tion oc­curs at one of the tri­al sites, the co­ordin­at­ing in­vest­ig­at­or shall also no­ti­fy the re­spons­ible eth­ics com­mit­tee con­cerned in ac­cord­ance with para­graph 2, with­in the same peri­od.

⁴ For Cat­egory B and C clin­ic­al tri­als, the no­ti­fic­a­tions spe­cified in para­graph 2 shall also be made to the Agency. This ob­lig­a­tion rests on the spon­sor. For Cat­egory A clin­ic­al tri­als, the spon­sor is sub­ject to the no­ti­fic­a­tion re­quire­ments spe­cified in Art­icle 59 para­graphs 1 and 2 TPA.

⁵ The defin­i­tion of a sus­pec­ted un­ex­pec­ted ser­i­ous ad­verse re­ac­tion is gov­erned by the rules of Good Clin­ic­al Prac­tice as spe­cified in An­nex 1 num­ber 2.