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. 5 Rules of Good Clinical Practice

1 Clin­ic­al tri­als must be con­duc­ted in ac­cord­ance with the rules of Good Clin­ic­al Prac­tice, as spe­cified in An­nex 1 num­ber 2.

2 A clin­ic­al tri­al covered by Chapter 4 may be con­duc­ted in ac­cord­ance with oth­er rules which are re­cog­nised in the spe­cialty in ques­tion, provided that the pro­tec­tion of par­ti­cipants and data qual­ity and se­cur­ity are guar­an­teed.

3 The meas­ures and pre­cau­tions re­quired in ac­cord­ance with the rules of Good Clin­ic­al Prac­tice must be ad­ap­ted to the ex­tent of the risks to which par­ti­cipants are ex­posed. De­pend­ing on the ex­tent of these risks, there may be cer­tain de­vi­ations from the rules of Good Clin­ic­al Prac­tice. Any de­vi­ations must be re­cor­ded in the pro­tocol. The pro­tec­tion of the par­ti­cipants and data qual­ity and se­cur­ity must be guar­an­teed in all cases.

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