Clinical Trials Ordinance (ClinO)
Amended by No I of the O of 7 June 2024, in force since 1 March 2025 (AS 2024 322).
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 64 Registration and data to be entered
1 The sponsor must register and publish an authorised clinical trial by entering the data specified in Annex 5 number 1: a. in a primary registry recognised by the World Health Organization (WHO); or b. in the registry of the U.S. National Library of Medicine. 2 The sponsor shall additionally enter the data specified in Annex 5 numbers 2.1–2.9, using the Swiss national languages in which recruitment is planned, in the cantonal information system specified in Article 56a HRA. 2bis For Phase I clinical trials in which the medicinal product under investigation is administered exclusively to adults, the data specified in Annex 5 number 3.1 may initially be excluded from entry in accordance with paragraphs 1, 2 and 4; it must however be entered and automatically published at the latest within the period specified in Annex 5 number 3.2. 3 The data must be entered in the version approved by the responsible ethics committee. It must be regularly updated. 4 Registration and entry in accordance
Amended by No I of the O of 7 June 2024, in force since 1 March 2025 (AS 2024 322). Amended by No I of the O of 7 June 2024, in force since 1 March 2025 (AS 2024 322). The registries can be consulted at: www.who.int/ > Programmes and projects > Clinical Trials – International Registry Platform. The registry can be consulted at: www.clinicaltrials.gov . Amended by No I of the O of 7 June 2024, in force since 1 March 2025 (AS 2024 322). Inserted by No I of the O of 7 June 2024, in force since 1 Ma
Art. 66 Responsibility
The sponsor is responsible for the accuracy and completeness of the data entered.
Art. 67 Portal
1 The FOPH shall operate a portal ensuring public access to information on clinical trials conducted in Switzerland via online access to one or more registries. 2 The portal shall enable in particular the linking of data to be entered under Articles 64 and 65a, as well as Articles 41 and 42 ClinO-MD, and the publication of this and other data from the cantonal information system as specified in Annex 5.
Art. 67 — Amended by No I of the O of 7 June 2024, in force since 1 March 2025 (AS 2024 322). Para. 2 — SR 810.306