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. 25 Review areas

The re­spons­ible eth­ics com­mit­tee shall re­view:

a.
the com­plete­ness of the ap­plic­a­tion;
b.
the cat­egor­isa­tion re­ques­ted;
c.
the in­form­a­tion in­ten­ded for re­gis­tra­tion in ac­cord­ance with Art­icle 64;
d.
the pro­tocol with re­gard to:
1.
the sci­entif­ic rel­ev­ance of the top­ic (Art. 5 HRA), the suit­ab­il­ity of the chosen sci­entif­ic meth­od­o­logy and com­pli­ance with Good Clin­ic­al Prac­tice,
2.
the ra­tio between the likely risks and bur­dens and the ex­pec­ted be­ne­fits (Art. 12 para. 2 HRA),
3.
the meas­ures taken to min­im­ise risks and bur­dens, and for the pro­tec­tion and fol­low-up of par­ti­cipants (Art. 15 HRA), in­clud­ing pre­cau­tion­ary meas­ures in the hand­ling of per­son­al data,
4.
the need to in­volve per­sons, and in par­tic­u­lar per­sons who are par­tic­u­larly vul­ner­able (Art. 11 HRA),
5.
the cri­ter­ia for the se­lec­tion of par­ti­cipants,
6.
the pro­posed pro­ced­ure for provid­ing in­form­a­tion and ob­tain­ing con­sent, in­clud­ing the ap­pro­pri­ate­ness of the peri­od for re­flec­tion,
7.
the ap­pro­pri­ate­ness of the re­mu­ner­a­tion for par­ti­cipants,
8.
com­pli­ance with sci­entif­ic in­teg­rity re­quire­ments;
e.
the com­plete­ness of the doc­u­ment­a­tion for re­cruit­ment, in­form­a­tion and con­sent, and its com­pre­hens­ib­il­ity, es­pe­cially with re­gard to the pos­sible in­volve­ment of par­tic­u­larly vul­ner­able per­sons;
f.
the guar­an­tee­ing of the right to com­pens­a­tion in the event of dam­age (Art. 20 HRA);
g.
the ad­equacy of the know­ledge and ex­per­i­ence of the in­vest­ig­at­or and of the oth­er per­sons con­duct­ing the clin­ic­al tri­al, in re­la­tion to the dis­cip­line con­cerned and the con­duct of a clin­ic­al tri­al;
h.
the suit­ab­il­ity of the in­fra­struc­ture at the tri­al site;
i.
the fin­an­cing of the clin­ic­al tri­al and the agree­ments between the spon­sor, third parties and the in­vest­ig­at­or con­cern­ing the al­loc­a­tion of tasks, re­mu­ner­a­tion and pub­lic­a­tion;
j.
for Cat­egory A clin­ic­al tri­als of medi­cin­al products or products un­der Art­icle 2a para­graph 2 TPA cap­able of emit­ting ion­ising ra­di­ation: ad­di­tion­ally, com­pli­ance with ra­di­olo­gic­al pro­tec­tion le­gis­la­tion and the dose es­tim­a­tion;
k.
for in­vest­ig­a­tions in­volving ra­di­ation sources31: ad­di­tion­ally, com­pli­ance with ra­di­olo­gic­al pro­tec­tion le­gis­la­tion and the dose es­tim­a­tion, in cases where an opin­ion does not have to be sought from the FOPH in ac­cord­ance with Art­icle 28;
l.
oth­er areas, where this is ne­ces­sary to as­sess the pro­tec­tion of par­ti­cipants.

31 Ger­man text amended by An­nex 11 No 6 of the Ra­di­olo­gic­al Pro­tec­tion Or­din­ance of 26 Apr. 2017, in force since 1 Jan. 2018 (AS 2017 4261). This amend­ment is not rel­ev­ant to the Eng­lish text.

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