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

¹ The co­ordin­at­ing in­vest­ig­at­or shall sub­mit the ap­plic­a­tion for mul­ti­centre clin­ic­al tri­als to the lead com­mit­tee in ac­cord­ance with Art­icle 47 para­graph 2 HRA. The spon­sor may sub­mit the ap­plic­a­tion in­stead of the co­ordin­at­ing in­vest­ig­at­or; Art­icle 24 para­graph 3 ap­plies mu­tatis mutandis.

² The co­ordin­at­ing in­vest­ig­at­or is the per­son re­spons­ible in Switzer­land for co­ordin­a­tion of the in­vest­ig­at­ors re­spons­ible at the in­di­vidu­al tri­al sites.

³ The lead com­mit­tee shall ac­know­ledge re­ceipt of the ap­plic­a­tion with­in 7 days and at the same time no­ti­fy the co­ordin­at­ing in­vest­ig­at­or wheth­er the ap­plic­a­tion doc­u­ments are form­ally in or­der.

⁴ At the re­quest of the lead com­mit­tee, the co­ordin­at­ing in­vest­ig­at­or shall sub­mit the re­quired num­ber of cop­ies of the ap­plic­a­tion doc­u­ments spe­cified in An­nex 3 to the eth­ics com­mit­tees re­spons­ible at the oth­er tri­al sites (eth­ics com­mit­tees con­cerned). These shall re­view the loc­al con­di­tions and in­form the lead com­mit­tee of their as­sess­ment with­in 15 days.

⁵ The lead com­mit­tee shall reach a de­cision with­in 45 days of ac­know­ledge­ment of re­ceipt of the form­ally cor­rect ap­plic­a­tion. It shall in­form the eth­ics com­mit­tees con­cerned of its de­cision and the Agency in the case of Cat­egory B and C clin­ic­al tri­als.