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. 60 Scope
This Chapter applies to clinical trials which are neither trials of medicinal products, products under Article 2a paragraph 2 TPA or transplant products nor trials of transplantation.
Art. 61 Categorisation
1 A clinical trial comes under Category A if the intervention investigated: a. entails only minimal risks and burdens; or b. is recognised as standard in guidelines prepared in accordance with internationally accepted quality criteria. 2 A clinical trial comes under Category B if the intervention investigated: a. entails more than minimal risks and burdens; and b. is not recognised as standard as specified in paragraph 1 letter b.
Para. 1 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 2 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Section 2 Approval and Notification Procedures for
Art. 62 Applicable provisions
The provisions which apply mutatis mutandis are: a. for the approval procedure for clinical trials, Articles 24–27, 29 and 36a; abis. for the setting of a time limit for the approval, Article 23a; b. for the notification of safety and protective measures, Article 37 paragraph 1; c. for the notification of the first visit of the first participant and for notification and reporting upon completion, premature termination, interruption or resumption of a clinical trial, Article 38 paragraphs 1–4; d. for reporting on the safety of participants, Article 43 paragraphs 1 and 2; dbis. for notification and reporting in the case of accompanying examinations involving ionising radiation, Article 44; e. for data retention requirements, Article 45 paragraph 2.
let. a — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). let. abis — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). let. c — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). let. dbis — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 63 Documentation and reporting of serious adverse events
1 If, in the course of a clinical trial, serious adverse events occur in participants in Switzerland, and it cannot be excluded that the events are attributable to the intervention under investigation, the investigator must document them in a standardised manner. In addition, the investigator shall report these events: a. to the sponsor within 24 hours after they become known; and b. to the responsible ethics committee within 15 days. 2 A serious adverse event is defined as any event which: a. requires inpatient treatment not envisaged in the protocol or extends a current hospital stay; b. results in permanent or significant incapacity or disability; c. is life-threatening or results in death; or d. causes a congenital anomaly or birth defect. 3 If necessary, in order to guarantee participants’ safety and health, further adverse events which must be documented or reported are to be designated in the protocol or at the request of the responsible ethics committee. 4 If, in the case of a
Para. 4 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).