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, ser­i­ous ad­verse events oc­cur in par­ti­cipants, the in­vest­ig­at­or must doc­u­ment these in a stand­ard­ised man­ner and no­ti­fy the spon­sor with­in 24 hours after they be­come known. Events which are not to be re­por­ted ac­cord­ing to the pro­tocol are ex­emp­ted.

² In the ab­sence of pro­vi­sions to the con­trary in the pro­tocol, the in­vest­ig­at­or shall no­ti­fy the re­spons­ible eth­ics com­mit­tee of a fatal ser­i­ous ad­verse event oc­cur­ring at a tri­al site in Switzer­land with­in 7 days.

³ In the case of a mul­ti­centre clin­ic­al tri­al, the co­ordin­at­ing in­vest­ig­at­or shall also re­port events as spe­cified in para­graph 2 to the re­spons­ible eth­ics com­mit­tee con­cerned with­in the same peri­od.

⁴ The defin­i­tion of ser­i­ous ad­verse events is gov­erned by the rules of Good Clin­ic­al Prac­tice as spe­cified in An­nex 1 num­ber 2.