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

of 20 September 2013 (Status as of 26 May 2022)

1 Amended by Annex 2 No 2 of the O of 1 July 2020 on Clinical Trials with Medical Devices, in force since 26 May 2021 (AS 2020 3033).


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Art. 55 Changes

1 Sig­ni­fic­ant changes to an au­thor­ised clin­ic­al tri­al must be au­thor­ised 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 change. At the same time, the spon­sor shall provide in­form­a­tion on the reas­ons for the change.

3 The fol­low­ing are con­sidered to be sig­ni­fic­ant changes:

a.
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; or
b.
changes re­lat­ing to the ori­gin, the tests to be per­formed or the stor­age of the or­gans, tis­sues or cells used.

4 Also con­sidered sig­ni­fic­ant in the case of clin­ic­al tri­als of the trans­plant­a­tion of em­bryon­ic or foet­al tis­sues and cells are changes which may af­fect the safety of the par­ti­cipants.

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

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

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