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

¹ Sig­ni­fic­ant changes to an au­thor­ised clin­ic­al tri­al must be au­thor­ised by the eth­ics com­mit­tee be­fore be­ing im­ple­men­ted. Ex­empt from this re­quire­ment are meas­ures which have to be taken im­me­di­ately in or­der to pro­tect the par­ti­cipants.

² The in­vest­ig­at­or shall sub­mit to the eth­ics com­mit­tee any ap­plic­a­tion doc­u­ments spe­cified in An­nex 3 which are af­fected by the change. At the same time, the in­vest­ig­at­or shall provide in­form­a­tion on the reas­ons for the change.

³ The fol­low­ing are con­sidered to be sig­ni­fic­ant changes:

a.

changes af­fect­ing the par­ti­cipants’ safety and health, or their rights and ob­lig­a­tions;

b.

changes to the pro­tocol, and in par­tic­u­lar changes based on new sci­entif­ic know­ledge which con­cern the tri­al design, the meth­od of in­vest­ig­a­tion, the en­d­points or the form of stat­ist­ic­al ana­lys­is;

c.

a change of tri­al site, or con­duct­ing the clin­ic­al tri­al at an ad­di­tion­al site; or

d.

a change of spon­sor, co­ordin­at­ing in­vest­ig­at­or or in­vest­ig­at­or re­spons­ible at a tri­al site.

⁴ The eth­ics com­mit­tee shall reach a de­cision on sig­ni­fic­ant changes with­in 30 days. Art­icle 26 ap­plies mu­tatis mutandis.

⁵ If a site at which a clin­ic­al tri­al is to be ad­di­tion­ally con­duc­ted does not lie with­in the re­spons­ib­il­ity of the eth­ics com­mit­tee which gran­ted au­thor­isa­tion, the pro­ced­ure is gov­erned by Art­icle 27mu­tatis mutandis.

⁶ Oth­er changes must be no­ti­fied to the eth­ics com­mit­tee in the an­nu­al safety re­port spe­cified in Art­icle 43.