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 in Switzer­land, and it can­not be ex­cluded that the events are at­trib­ut­able to the in­ter­ven­tion un­der in­vest­ig­a­tion, the in­vest­ig­at­or must doc­u­ment them in a stand­ard­ised man­ner. In ad­di­tion, the in­vest­ig­at­or shall re­port these events:

a.

to the spon­sor with­in 24 hours after they be­come known; and

b.

to the re­spons­ible eth­ics com­mit­tee with­in 15 days.

² A ser­i­ous ad­verse event is defined as any event which:

a.

re­quires in­pa­tient treat­ment not en­vis­aged in the pro­tocol or ex­tends a cur­rent hos­pit­al stay;

b.

res­ults in per­man­ent or sig­ni­fic­ant in­ca­pa­city or dis­ab­il­ity;

c.

is life-threat­en­ing or res­ults in death; or

d.

causes a con­gen­it­al an­om­aly or birth de­fect.

³ If ne­ces­sary in or­der to guar­an­tee par­ti­cipants’ safety and health, fur­ther ad­verse events which must be doc­u­mented or re­por­ted are to be des­ig­nated in the pro­tocol or at the re­quest of the re­spons­ible eth­ics com­mit­tee.

⁴ If, in the case of a mul­ti­centre clin­ic­al tri­al, ser­i­ous ad­verse events oc­cur at one of the tri­al sites, the co­ordin­at­ing in­vest­ig­at­or shall also re­port the events as spe­cified in para­graphs 1 and 3 to the re­spons­ible eth­ics com­mit­tee con­cerned, with­in the same peri­od.⁴⁶