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 Purpose and Definitions
Art. 1 Purpose
1 This Ordinance regulates: a. the requirements for the conduct of: 1. clinical trials of medicinal products, including combinations under Article 2 paragraph 1 letters f and g of the Medical Devices Ordinance of 1 July 2020 (MedDO), or transplant products, 2. clinical trials of… products under Article 2a paragraph 2 TPA, 3. clinical trials of transplantation, 4. clinical trials that are not clinical trials under numbers 1 to 3; b. the approval and notification procedures for clinical trials; c. the duties and responsibilities of research ethics committees (ethics committees), the Swiss Agency for Therapeutic Products (Swissmedic) and the Federal Office of Public Health (the FOPH) in connection with the approval and notification procedures; d. the registration of clinical trials and public access to the register. 2 The conduct of the following clinical trials is not covered by this Ordinance: a. clinical trials of medical devices under Article 1 MedDO and Article 1 of the Ordinance of
Para. 1 let. a — Amended by Annex 2 No 2 of the O of 1 July 2020 on Clinical Trials of Medical Devices, in force since 26 May 2021 (AS 2020 3033). Para. 1 let. a let. 1 — Amended by Annex No 2 of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281). Para. 1 let. a let. 1 — SR 812.213 Para. 1 let. a let. 2 — Term removed by Annex 2 No 2 of the O of 4 May 2022, with effect from 26 May 2022 (AS 2022 294). This change has been made throughout the text. Para. 1 let. a let. 2 — Term in accor
Art. 2 Definitions
In this Ordinance: a. clinical trial means a research project involving individuals that prospectively assigns them to undergo one or more interventions in order to study the effects thereof on health or on the structure and function of the human body; b. intervention means any measure to which the participant is subjected and whose effects on this person are to be investigated; c. minimal risks and burdens mean risks and burdens, which, in terms of intensity and quality, and taking into account the vulnerability of the participants and the specific circumstances, will have only a slight and temporary impact on the participants’ health; in particular, minimal risks and burdens may be associated with: 1. surveys and observations, 2. peripheral venous or capillary blood sampling and skin punch biopsies of limited extent, 3. removing or collecting bodily substances without invasive interventions, in particular, saliva, urine and stool samples, 4. taking swabs, 5. magnetic resonance imagin
Art. 2 — Amended by Annex 2 No 2 of the O of 1 July 2020 on Clinical Trials on Medical Devices, in force since 26 May 2021 (AS 2020 3033). let. a — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). let. b — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). let. c let. 6 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). let. c let. 6 — SR 812.213 let. f — Inserted by No I of the O of 7 June 2024,
Section 2 Principles
Art. 3 Scientific integrity
1 The sponsor and the investigator, and the other persons involved in the clinical trial, shall maintain scientific integrity. In particular, it is prohibited: a. to falsify, fabricate or suppress research results; b. to fail to disclose conflicts of interest at the planning stage, in the approval procedure, or when conducting or publishing research; c. to impede or prevent research activities without good reason; d. to prevent or sanction the exposure of scientific misconduct. 2 The code of conduct for scientific integrity, issued by the Swiss Academies of Arts and Sciences, as specified in Annex 1 number 1, is applicable. In justified cases, other recognised scientific integrity guidelines of equivalent standing may be used.
Para. 2 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 4 Scientific quality
The sponsor and the investigator of a clinical trial shall ensure scientific quality. In particular: a. they shall define a research question based on the current state of scientific knowledge; b. they shall use an appropriate scientific methodology; and c. they shall ensure the availability of the resources required for the clinical trial and provide the necessary infrastructure.
Art. 4a Inclusion of relevant groups of persons
1 The sponsor and the investigator must ensure that the criteria for the selection of participants and the trial design permit appropriate representation of the groups of persons that are relevant for answering the scientific question; in particular, they shall take into account the sex ratio and age groups. 2 The exclusion or deliberate underrepresentation of relevant groups of persons must be declared and justified in the application documents.
Art. 4a — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 5 Rules of Good Clinical Practice
1 Clinical trials must be conducted in accordance with the rules of Good Clinical Practice, as specified in Annex 1 number 2. 2 A clinical trial covered by Chapter 4 may be conducted in accordance with other rules which are recognised in the specialty in question, provided that the protection of participants and data quality and security are guaranteed. 3 The measures and precautions required in accordance with the rules of Good Clinical Practice must be adapted to the extent of the risks to which participants are exposed. Depending on the extent of these risks, there may be certain deviations from the rules of Good Clinical Practice. Any deviations must be recorded in the protocol. The protection of the participants and data quality and security must be guaranteed in all cases.
Art. 6 Professional qualifications
1 The clinical trial investigator must: a. be adequately trained in Good Clinical Practice and have the professional knowledge and experience required for the clinical trial; b. be conversant with the legal requirements for clinical trials or be able to ensure compliance by calling in appropriate expertise; and c. have appropriate knowledge and skills in the areas of data security and data protection or be able to ensure compliance by calling in appropriate expertise. 2 In addition, the investigator in a clinical trial of medicinal products, products under Article 2a paragraph 2 TPA or transplantation must be entitled to practise as a physician under his or her own professional responsibility. 3 For clinical trials covered by Chapter 4, a person without medical qualifications may also serve as an investigator, provided that this person is entitled to practise the profession specifically qualifying him or her to conduct the clinical trial under his or her own responsibility. 4 The other
Para. 1 let. c — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 2 — Amended by Annex 2 No 2 of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). Para. 3 — Amended by Annex 2 No 2 of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294).
Section 3 Information, Consent, Communication of R
Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 7 Information
1 In addition to the points specified in Article 16 paragraph 2 HRA, the persons concerned must receive information on: a. possible alternatives to the intervention under investigation, if the clinical trial is expected to offer a direct benefit; b. the effort involved and the obligations arising from participation; c. their right to withhold or to revoke their consent without giving reasons and without suffering any disadvantages in relation to their medical treatment; d. the consequences of revocation of consent for their subsequent medical treatment, and for further use of the personal data and biological material collected up to this point; e. their right to receive information at any time in response to further questions relating to the clinical trial; ebis. the possibility of surplus information arising, and the significance of the discovery of surplus information and the significance of exercising one’s right to know or not to know; f. their right to be informed of results conce
Para. 1 let. ebis — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 1 let. hbis — Inserted by No I of the O of 7 June 2024, in force since 1 March 2025 (AS 2024 322, 582). Para. 2 — SR 810.301 Para. 4 let. b — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 7a Information in cases of genetic testing
1 If, when presymptomatic genetic testing, prenatal genetic testing, or testing for family planning purposes (Art. 3 let. e, g and i of the Federal Act of 15 June 2018 on Human Genetic Testing, HGTA) is conducted, results arise which concern the health of the person concerned, he or she must additionally receive information on the following: a. the purpose, nature and significance of the test; b. the frequency and nature of the disorder to be screened for; c. medical, psychological and social implications of the test; d. the possible significance of the results for the person concerned and for family members, and their right not to know. 2 When presymptomatic testing is conducted (Art. 3 let. e HGTA), the person concerned must additionally be informed about the conditions under which insurance providers may request the disclosure of data from genetic tests performed (Art. 43 and Art. 44 HGTA).
Art. 7a — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). Para. 1 — SR 810.12
Art. 7b Information in cases of prenatal risk assessment
When a prenatal risk assessment is conducted (Art. 3 let. h HGTA) the pregnant woman must additionally be informed about the matters specified in Article 23 HGTA.
Art. 7b — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). SR 810.12
Art. 7c Form of consent
1 Consent must be signed by hand or given in electronic form. 2 The declaration of consent must: a. be dated; and b. be readable during the entire required retention period. 3 Consent given in electronic form is permissible provided that: a. it has been granted using a method which unequivocally identifies the person concerned; b. the chosen method prevents an overhasty decision; c. it is protected against modification in accordance with the state of the art; d. it is described in the application documents how the requirements specified in letters a–c are met. 4 The person concerned can choose to receive a copy of the information documents and the declaration of consent either on paper or in electronic form.
Art. 7c — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 8 Exceptions to written form
1 In individual cases, information may be provided and consent given in a non‑written form if: a. the person concerned, for physical or cognitive reasons, cannot read or cannot write; and b. the investigator furnishes proof of the provision of information and consent, specifically by means of written confirmation by witnesses, or by a recording of verbal consent. 2 In individual cases, the requirement to provide information in written form may be waived if: a. this could only be implemented with disproportionate effort, given the language skills of the person concerned; and b. an independent qualified translator is called in to provide oral information and gives written confirmation thereof.
Art. 8a Communication of results
1 The right of the persons concerned to receive information as specified in Article 8 paragraph 1 HRA applies to results concerning their health obtained by means of tests meeting current standards of analytical and clinical validity. 2 Results must be communicated to the persons concerned or, where applicable, to their legal representative, designated trusted person or the next of kin (Art. 22–24 HRA) in cases where: a. the results are subject to a legal notification requirement which stipulates or involves informing the person concerned about the result; b. the results may entail a public health measure which stipulates or involves informing the person concerned about the result; c. the results must be noted by the person who is to be informed, in order to protect the life and health of third parties or of the person lacking capacity concerned by the test.
Art. 8a — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 9 Consequences of revocation of consent
1 If consent is revoked, the biological material and health‑related personal data of the person concerned must be anonymised after data evaluation has been completed. 2 Anonymisation of the biological material and personal data may be dispensed with if: a. the person concerned expressly renounces this right when revoking consent; or b. it is established at the beginning of the clinical trial that anonymisation is not possible and the person concerned, having been adequately informed of this fact, consented to participate. 3 Persons revoking consent must be offered any follow-up care required to protect their health.
Section 4 Liability and Coverage
Art. 10 Exemptions from liability
1 Exempt from liability in relation to clinical trials under Article 19 paragraph 1 HRA shall be any person who proves that the damage is attributable to: a. the administration of an authorised medicinal product used in accordance with the prescribing information; b. the administration of an authorised medicinal product, if this is recognised as standard in guidelines prepared in accordance with internationally accepted quality criteria; c. the use of a product under Article 2a paragraph 2 TPA that has been notified under Article 6 paragraph 3 MedDO in its version of 1 January 2002 in application of Article 108 paragraph 1 letter b MedDO and used in accordance with the instructions for use; d. the use of some other intervention which is recognised as standard in guidelines prepared in accordance with internationally accepted quality criteria. 2 Also exempt from liability under Article 19 paragraph 1 HRA shall be any person who proves that comparable damage could also have occurred if t
Para. 1 let. c — Amended by Annex 2 No 2 of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). Para. 1 let. c — SR 812.213 Para. 1 let. c — AS 2001 3487 Para. 1 let. d — 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).
Art. 11 Extension of the limitation period
The limitation period for compensation claims in respect of damage: a. attributable to the use of ionising radiation is governed by Article 40 of the Radiological Protection Act of 22 March 1991; b. attributable to the use of genetically modified organisms is governed by Article 32 of the Gene Technology Act of 21 March 2003.
let. a — German term amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322). This amendment (not relevant to the English text) has been made throughout the Ordinance. let. a — SR 814.50 let. b — SR 814.91
Art. 12 Exemptions from liability coverage requirements
Exempt from liability coverage requirements are: a. damage exempt from liability in accordance with Article 10; b. Category A clinical trials (Art. 19 para. 1, Art. 20 para. 1, Art. 49 para. 1 and Art. 61 para. 1) involving measures for sampling of biological material or collection of health-related personal data which entail only minimal risks and burdens.
Art. 13 Requirements for liability coverage
1 The liability coverage requirements can be fulfilled: a. by taking out insurance; or b. by providing security of equivalent value. 2 The policy value shall be set in accordance with Annex 2. 3 The liability coverage must cover damage occurring up to 20 years after the completion of the clinical trial.
Para. 3 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 14 Protection of the injured party
1 Cancellation of the insurance policy by the insurance company is not permissible after the occurrence of the insured event. 2 Within the framework of the insurance coverage, the injured party or legal successor has a direct claim against the insurance company. Objections cannot be raised on the basis of the insurance policy or the Insurance Policies Act of 2 April 1908. 3 If the insurance company is subject to action under paragraph 2, it shall have a right of recourse against the insured party. 4 Paragraphs 1–3 apply mutatis mutandis if security of equivalent value is provided in accordance with Article 13 paragraph 1 letter b.
Para. 2 — SR 221.229.1
Section 5 Clinical Trials in Emergency Situations
Art. 15 Post hoc consent
1 The sponsor and the investigator must, when planning or conducting a clinical trial in an emergency situation, take any measures necessary to ensure that: a. the consent of the person concerned can be obtained post hoc as soon as possible; b. in the case of a clinical trial involving children or adolescents, the consent of the legal representative can be obtained as soon as possible, if this is required in accordance with Articles 22 and 23 HRA; c. in the case of a clinical trial involving adults permanently lacking capacity, the consent of the person authorised to act as a representative can be obtained as soon as possible, if no statement of wishes formulated in a state of capacity is available. 2 The procedure for obtaining post hoc consent must be defined in the protocol.
Art. 16 Death of the person
1 If a person who was included in a clinical trial in an emergency situation dies before it has been possible to obtain consent or refusal in accordance with Article 15, the biological material and the health-related personal data collected may only be used if this person has consented, in an advance directive or otherwise, to the use of such material and health-related data for research purposes. 2 In the absence of a statement of wishes as specified in paragraph 1, use is permissible if consent is given by the next of kin or a designated trusted person. Consent is governed by Article 8 of the Transplantation Act.
Art. 17 Handling of biological material and health-related personal data
1 The biological material sampled and the health-related personal data collected during a clinical trial in an emergency situation may only be evaluated when consent has been obtained in accordance with Article 15 or 16. 2 In exceptional cases, the biological material and the health-related personal data may be evaluated before consent has been obtained if: a. the biological material is only utilisable for a limited period; or b. this is necessary for the sake of the participants’ safety and health. 3 If consent to participate in a clinical trial in an emergency situation is withheld post hoc, the biological material and the health-related personal data must be destroyed. 4 If the validity of the clinical trial or its results is compromised in essential respects by the destruction of the biological material and the health-related personal data, the use thereof in the clinical trial is permissible in spite of refusal of consent. The biological material and the health-related personal da
Section 6 Storage of Health-Related Personal Data
Art. 18
1 Any person who stores health-related personal data in connection with a clinical trial must take appropriate operational and organisational measures to protect it, and in particular: a. restrict the handling of the health-related personal data to those persons who require this data to fulfil their duties; b. prevent unauthorised or accidental disclosure, alteration, deletion and copying of the health-related personal data; c. document all processing operations which are essential to ensure traceability. 2 Any person who stores biological material in connection with a clinical trial must, in particular: a. comply with the principles set out in paragraph 1 mutatis mutandis; b. ensure that the technical requirements are met for appropriate storage of the biological material; here, nationally and internationally recognised guidelines must be consulted; c. make resources required for storage available.
Para. 2 let. b — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Section 7 Handling of Genetic Data in connection w
Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).
Art. 18a
In connection with insurance, Articles 42–44 HGTA apply to the handling of genetic data from clinical trials.
SR 810.12