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

¹ In clin­ic­al tri­als in­volving medi­cin­al products or products un­der Art­icle 2a para­graph 2 TPA cap­able of emit­ting ion­ising ra­di­ation, and in in­vest­ig­a­tions us­ing ra­di­ation sources, the in­vest­ig­at­or shall as­sess com­pli­ance with the dose guid­ance value in ac­cord­ance with Art­icle 45 of the Ra­di­olo­gic­al Pro­tec­tion Or­din­ance of 26 April 2017⁴⁰.

² If the per­mit­ted dose guid­ance value is ex­ceeded at any time, the in­vest­ig­at­or shall no­ti­fy the re­spons­ible eth­ics com­mit­tee with­in sev­en work­ing days of it be­com­ing known.

³ In the case of Cat­egory B and C clin­ic­al tri­als with medi­cin­al products or products un­der Art­icle 2a para­graph 2 TPA that emit ion­ising ra­di­ation, no­ti­fic­a­tion in ac­cord­ance with para­graph 2 must also be giv­en to the Agency. This ob­lig­a­tion rests on the spon­sor.

⁴ The re­spons­ible eth­ics com­mit­tee and the Agency may ob­tain spe­cial­ist ad­vice from the FOPH in or­der to as­sess the dose cal­cu­la­tion or the dose es­tim­a­tion and to de­cide what fur­ther meas­ures are re­quired.

⁵ With­in a year of the com­ple­tion or dis­con­tinu­ation of a clin­ic­al tri­al which in­cluded in­vest­ig­a­tions in­volving ra­dio­act­ive sources, the in­vest­ig­at­or shall sub­mit to the FOPH a fi­nal re­port in­clud­ing all in­form­a­tion of rel­ev­ance for ra­di­olo­gic­al pro­tec­tion, and in par­tic­u­lar a ret­ro­spect­ive par­ti­cipant dose es­tim­a­tion.

⁶ The re­port­ing re­quire­ments in ac­cord­ance with para­graph 5 do not ap­ply in the case of routine nuc­le­ar medi­cine ex­am­in­a­tions in­volving au­thor­ised ra­dio­phar­ma­ceut­ic­als.

⁷ With­in the frame­work of the opin­ion de­livered in ac­cord­ance with Art­icle 28, or on re­quest, the FOPH may spe­cify fur­ther ex­emp­tions from the re­port­ing re­quire­ments in ac­cord­ance with para­graph 5.