Clinical Trials Ordinance (ClinO)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Section 1 General Provisions
Art. 49 Categorisation
1 A clinical trial of the transplantation of human organs, tissues and cells comes under Category A if the transplantation to be investigated is recognised as standard in guidelines prepared in accordance with internationally accepted quality criteria. 2 A clinical trial of the transplantation of human organs, tissues and cells comes under Category C if the transplantation to be investigated is not recognised as standard as specified in paragraph 1. 3 Clinical trials of the transplantation of embryonic and foetal tissues and cells come under Category C.
Art. 50 Information and coordination in approval procedures and deadline for submission to the second authority responsible for approval
1 The investigator and the sponsor may simultaneously submit applications to the responsible ethics committee and to the FOPH. 1bis For Category C clinical trials, the application must be submitted to the second authority within two years after approval has been granted by the first authority. 1ter At the request of the approval holder, the first authority may extend the deadline specified in paragraph 1bis. Such a request constitutes a substantial modification to the clinical trial. 1quater If the deadline specified in paragraph 1bis or the deadline extended in accordance with paragraph 1ter is exceeded, or if a request for a deadline extension in accordance with paragraph 1ter is rejected, then the approval granted shall lapse. 2 The responsible ethics committee and the FOPH shall inform each other about matters relating to the review areas specified both in Article 25 and in Article 53, and shall coordinate their assessments.
Art. 50 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 1bis — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 1ter — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 1quater — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Section 2 Procedure before the Responsible Ethics
Art. 51
For the procedure for the approval of clinical trials of transplantation by the responsible ethics committee, Articles 23a–27, 29 and 36a apply mutatis mutandis.
Art. 51 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Section 3 Procedure before the FOPH
Art. 52 Exemption from mandatory approval
Category A clinical trials are exempted from the requirement for approval from the FOPH specified in Article 36 paragraph 1 of the Transplantation Act.
Art. 53 Review areas
For clinical trials of transplantation, the FOPH shall review: a. the completeness of the application; b. the origin of the organs, tissues or cells used in the clinical trial; c. compliance with the requirements of the transplantation legislation, particularly with regard to the duties of care in the handling of organs, tissues and cells, and the allocation of organs; d. the availability of the authorisations required in accordance with the Transplantation Act; e. other areas, where this is necessary to assess the safety and quality of the organs, tissues or cells used.
Art. 54 Approval procedure
1 The sponsor shall submit to the FOPH the application documents specified in Annex 4 for review. 2 The FOPH may request additional information. 3 For the procedure and deadlines, Article 33 applies mutatis mutandis.
Art. 55 Modifications
1 Substantial modifications to an approved clinical trial must be approved by the FOPH before being implemented. Exempt from this requirement are measures which have to be taken immediately in order to protect the participants. 2 The sponsor must submit to the FOPH any application documents specified in Annex 4 which are affected by the modification. At the same time, the sponsor shall provide information on the reasons for the modification. 3 The following are considered to be substantial modifications: a. modifications due to new scientific knowledge, based in particular on new preclinical or clinical data, which affects the assessment of the safety of the organs, tissues or cells used; b. modifications relating to the origin, the tests to be performed or the storage of the organs, tissues or cells used; c. in the case of clinical trials of the transplantation of embryonic or foetal tissues and cells: modifications which may affect the safety of the participants; or d. the extension
Para. 3 let. c — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 3 let. d — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 4 — Repealed by No I of the O of 7 June 2024, with effect from 1 Nov. 2024 (AS 2024 322).
Art. 56 Special provisions for clinical trials of the transplantation of embryonic or foetal tissues and cells
1 The FOPH shall grant approval if, in addition to Article 53, the requirements specified in Article 34 of the Transplantation Ordinance of 16 March 2007 are met. 2 It shall grant approval within 60 days or, in the case of substantial modifications, within 30 days after receipt of the complete application documents. 3 For clinical trials of the transplantation of embryonic or foetal tissues and cells, Articles 35, 36 and 38 of the Transplantation Ordinance additionally apply.
Para. 1 — SR 810.211
Section 4 Notifications and Reporting
Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 57 Applicable provisions
1 For documentation, notifications and reporting in the case of clinical trials of transplantation, Articles 37–39, 44 and 44a apply mutatis mutandis. 2 The obligations which must be fulfilled under these provisions vis-à-vis Swissmedic are to be fulfilled, for clinical trials of transplantation, vis-à-vis the FOPH. 3 For clinical trials of transplantation, the duties of the sponsor and the investigator concerning documentation, traceability and retention of records are governed by Articles 34 and 35 of the Transplantation Act.
Art. 57 — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 1 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 57a Reporting of serious adverse events
1 If, in the course of a clinical trial, serious adverse events occur in participants, the investigator must document these in a standardised manner and report them to the sponsor within 24 hours after they become known. Events which are not to be reported according to the protocol are exempted. 2 The investigator shall report a serious adverse event with life-threatening or fatal consequences occurring in Switzerland to the responsible ethics committee within 7 days, and any other serious adverse event within 15 days. 3 If, in the case of a multicentre clinical trial, a serious adverse event occurs at one of the trial sites in Switzerland, the coordinating investigator shall also report it to the ethics committee concerned in accordance with paragraph 2, within the same period. 4 For Category C clinical trials, the reports specified in paragraph 2 shall also be made to the FOPH. This obligation rests on the sponsor. 5 The requirements specified in paragraphs 1–4 are also applicable if
Art. 57a — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 57b Reporting on the safety of participants
1 Once a year, the investigator shall present to the responsible ethics committee a list of events as specified in Article 57a. On this basis, the investigator shall submit a report on their severity and causal relationship to the intervention, and on the safety of participants, and shall inform the ethics committee about the general progress of the clinical trial. 2 In the case of clinical trials also conducted abroad according to the same protocol, the events occurring abroad must also be included in the list and the report. 3 For Category C clinical trials, reports as specified in paragraphs 1 and 2 must also be submitted to the FOPH. This obligation rests on the sponsor.
Art. 57b — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Section 5 Inspections and Official Measures
Art. 58 FOPH inspections
1 The FOPH may carry out inspections at any time and inspect all documents and data relating to a clinical trial of transplantation. It may request the cantonal authorities or third parties to carry out inspections. 2 Other powers and duties of cooperation are governed by Article 63 paragraphs 2 and 3 and Article 64 of the Transplantation Act.
Art. 59 Official measures
1 The FOPH may revoke or suspend the approval granted or make the continuation of the clinical trial subject to additional conditions, particularly if: a. it has reason to assume that the requirements are no longer met, the documents specified in Article 54 have been modified without due notification having been made, or the trial is not being conducted in accordance with these documents; b. such measures are necessitated by new information concerning safety or the scientific basis. 2 For the coordination of measures and the exchange of information between the FOPH, the responsible ethics committee and other competent cantonal authorities, Article 48 applies mutatis mutandis.