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

¹ Con­sent must be signed by hand or giv­en in elec­tron­ic form.

² The de­clar­a­tion of con­sent must:

a.

be dated; and

b.

be read­able dur­ing the en­tire re­quired re­ten­tion peri­od.

³ Con­sent giv­en in elec­tron­ic form is per­miss­ible provided that:

a.

it has been gran­ted us­ing a meth­od which un­equi­voc­ally iden­ti­fies the per­son con­cerned;

b.

the chosen meth­od pre­vents an over­hasty de­cision;

c.

it is pro­tec­ted against modi­fic­a­tion in ac­cord­ance with the state of the art;

d.

it is de­scribed in the ap­plic­a­tion doc­u­ments how the re­quire­ments spe­cified in let­ters a–c are met.

⁴ The per­son con­cerned can choose to re­ceive a copy of the in­form­a­tion doc­u­ments and the de­clar­a­tion of con­sent either on pa­per or in elec­tron­ic form.