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

¹ Sub­stan­tial modi­fic­a­tions to an ap­proved clin­ic­al tri­al must be ap­proved 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 modi­fic­a­tion. At the same time, the in­vest­ig­at­or shall provide in­form­a­tion on the reas­ons for the modi­fic­a­tion.

³ The fol­low­ing are con­sidered to be sub­stan­tial modi­fic­a­tions:

a.

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

b.

modi­fic­a­tions to the pro­tocol, and in par­tic­u­lar modi­fic­a­tions 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;

d.

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

e.⁶⁹

the ex­ten­sion of a dead­line in ac­cord­ance with Art­icles 23, 23a and 50; in the ap­plic­a­tion to the eth­ics com­mit­tee, the in­vest­ig­at­or shall in­dic­ate wheth­er the ap­plic­a­tion doc­u­ments are still up-to-date, par­tic­u­larly with re­gard to the sci­entif­ic rel­ev­ance of the ques­tion; if this is not the case, the in­vest­ig­at­or shall sub­mit up­dated ap­plic­a­tion doc­u­ments.

⁴ The eth­ics com­mit­tee shall reach a de­cision on sub­stan­tial modi­fic­a­tions 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 ap­prov­al, the pro­ced­ure is gov­erned by Art­icle 27mu­tatis mutandis.

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