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

¹ Any per­son who stores health-re­lated per­son­al data in con­nec­tion with a clin­ic­al tri­al must take ap­pro­pri­ate op­er­a­tion­al and or­gan­isa­tion­al meas­ures to pro­tect it, and in par­tic­u­lar:

a.

re­strict the hand­ling of the health-re­lated per­son­al data to those per­sons who re­quire this data to ful­fil their du­ties;

b.

pre­vent un­au­thor­ised or ac­ci­dent­al dis­clos­ure, al­ter­a­tion, de­le­tion and copy­ing of the health-re­lated per­son­al data;

c.

doc­u­ment all pro­cessing op­er­a­tions which are es­sen­tial to en­sure trace­ab­il­ity.

² Any per­son who stores bio­lo­gic­al ma­ter­i­al in con­nec­tion with a clin­ic­al tri­al must, in par­tic­u­lar:

a.

com­ply with the prin­ciples set out in para­graph 1 mu­tatis mutandis;

b.⁴⁹

en­sure that the tech­nic­al re­quire­ments are met for ap­pro­pri­ate stor­age of the bio­lo­gic­al ma­ter­i­al; here, na­tion­ally and in­ter­na­tion­ally re­cog­nised guidelines must be con­sul­ted;

c.

make re­sources re­quired for stor­age avail­able.