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 FOPH be­fore be­ing im­ple­men­ted. Ex­empt from this re­quire­ment are meas­ures which have to be taken im­me­di­ately in or­der to pro­tect the par­ti­cipants.

² The spon­sor must sub­mit to the FOPH any ap­plic­a­tion doc­u­ments spe­cified in An­nex 4 which are af­fected by the modi­fic­a­tion. At the same time, the spon­sor shall provide in­form­a­tion on the reas­ons for the modi­fic­a­tion.

³ The fol­low­ing are con­sidered to be sub­stan­tial modi­fic­a­tions:

a.

modi­fic­a­tions due to new sci­entif­ic know­ledge, based in par­tic­u­lar on new pre­clin­ic­al or clin­ic­al data, which af­fects the as­sess­ment of the safety of the or­gans, tis­sues or cells used;

b.

modi­fic­a­tions re­lat­ing to the ori­gin, the tests to be per­formed or the stor­age of the or­gans, tis­sues or cells used;

c.¹²⁵

in the case of clin­ic­al tri­als of the trans­plant­a­tion of em­bryon­ic or foet­al tis­sues and cells: modi­fic­a­tions which may af­fect the safety of the par­ti­cipants; or

d.¹²⁶

the ex­ten­sion of a dead­line in ac­cord­ance with Art­icles 23a and 50; in the ap­plic­a­tion to the FOPH, the spon­sor shall in­dic­ate wheth­er the ap­plic­a­tion doc­u­ments are still up-to-date, par­tic­u­larly with re­gard to ques­tions of the ori­gin, safety and qual­ity of the or­gans, tis­sues or cells used; if this is not the case, the spon­sor shall sub­mit up­dated ap­plic­a­tion doc­u­ments.

⁴ …¹²⁷

⁵ The FOPH shall reach a de­cision with­in 30 days of re­ceipt of the com­plete set of ap­plic­a­tion doc­u­ments af­fected by the modi­fic­a­tion. Art­icle 33 ap­plies mu­tatis mutandis.

⁶ Oth­er modi­fic­a­tions which af­fect doc­u­ments sub­mit­ted to the FOPH must be no­ti­fied to the FOPH as quickly as pos­sible.