79C3C34C52B45572883A05D425EB0F82
Ordinance of 20 September2013 on Clinical Trials inHuman Research (Clinical TrialsOrdinance, ClinO), RS 810.305
https://www.admin.ch/opc/en/classified-compilation/20121176/index.html
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This file was generated: 2020-12-01 07:13:27
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / political affiliation
Searching for indicator party:
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p.000001: a. the person concerned expressly renounces this right when revoking consent; or
p.000001: 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
p.000001: this fact, consented to participate.
p.000001: 3 Persons revoking consent must be offered any follow-up care required to protect their health.
p.000001: Section 4 Liability and Coverage
p.000001: Art. 10 Exemptions from liability
p.000001: 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:
p.000001:
p.000001: a. the administration of an authorised medicinal product used in accordance with the prescribing information;
p.000001: b. the administration of an authorised medicinal product, if this is recognised as standard in guidelines prepared in accordance with internationally
p.000001: accepted quality criteria;
p.000001: c. the employment of a medical device bearing a conformity marking and used in accordance with the instructions;
p.000001: d. the use of some other health-related intervention which is recognised as standard in guidelines prepared in accordance with internationally accepted
p.000001: quality criteria.
p.000001: 2Also exempt from liability under Article 19 paragraph 1 HRA shall be any person who proves that the extent of the damage is no greater than would be
p.000001: expected in the current state of scientific knowledge and:
p.000001:
p.000001: a. comparable damage could also have occurred if the injured party had undergone standard therapy for the disease; or
p.000001: b. in the case of acutely life-threatening diseases for which no standard therapy exists.
p.000001:
p.000001: Art. 11 Extension of the limitation period
p.000001: The limitation period for compensation claims in respect of damage:
p.000001:
p.000001: a. attributable to the use of ionising radiation is governed by Article 40 of the Radiological Protection Act of 22 March 19911;
p.000001: b. attributable to the use of genetically modified organisms is governed by Article 32 of the Gene Technology Act of 21 March 20032.
p.000001: 1 SR 814.50
p.000001: 2 SR 814.91
p.000001:
p.000001: Art. 12 Exemptions from liability coverage requirements
p.000001: Exempt from liability coverage requirements are:
p.000001:
p.000001: a. damage exempt from liability in accordance with Article 10;
p.000001: 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
p.000001: collection of health-related personal data which entail only minimal risks and burdens.
p.000001:
p.000001: Art. 13 Requirements for liability coverage
p.000001: 1 The liability coverage requirements can be fulfilled:
p.000001:
p.000001: a. by taking out insurance; or
p.000001: b. by providing security of equivalent value.
p.000001: 2 The policy value shall be set in accordance with Annex 2.
p.000001: 3 The liability coverage must cover damage occurring up to ten years after the completion of the clinical trial.
p.000001:
p.000001: Art. 14 Protection of the injured party
p.000001: 1 Cancellation of the insurance policy by the insurance company is not permissible after the occurrence of the insured event.
p.000001: 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
p.000001: raised on the basis of the insurance policy or the Insurance Policies Act of 2 April 19081.
p.000001: 3 If the insurance company is subject to action under paragraph 2, it shall have a right of recourse against the insured party.
p.000001: 4 Paragraphs 1–3 apply mutatis mutandis if security of equivalent value is provided in accordance with Article 13 paragraph 1 letter b.
p.000001:
p.000001: 1
p.000001: SR 221.229.1
p.000001:
p.000001:
p.000001: Section 5 Clinical Trials in Emergency Situations
p.000001: Art. 15 Post hoc consent
p.000001: 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:
p.000001:
p.000001: a. the consent of the person concerned can be obtained post hoc as soon as possible;
p.000001: 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
p.000001: required in accordance with Articles 22 and 23 HRA;
p.000001: 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
p.000001: obtained as soon as possible, if no statement of wishes formulated in a state of capacity is available.
p.000001: 2 The procedure for obtaining post hoc consent must be defined in the protocol.
p.000001:
p.000001: Art. 16 Death of the person
...
p.000004: 1.1 Basic form, including a summary of the protocol in the national language of the trial site and reasons for the requested categorisation;
p.000004: 1.2 protocol;
p.000004: 1.3 case report form (CRF);
p.000004: 1.4 information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or advertisements;
p.000004: 1.5 other documents issued to participants;
p.000004: 1.6 information on the type and amount of remuneration for participants;
p.000004: 1.7 for clinical trials of medicinal products: the prescribing information;
p.000004: 1.8 for clinical trials of medical devices: the conformity marking, including the intended use and instructions;
p.000004: 1.9 for clinical trials not using proprietary products: proof of compliance with Good Manufacturing Practice and correct labelling of the therapeutic
p.000004: products;
p.000004: 1.10 the investigator’s CV, including evidence of his or her knowledge and experience, and a list of the other persons conducting the clinical trial, indicating
p.000004: their responsibilities and relevant professional knowledge;
p.000004: 1.11 information on the suitability and availability of infrastructure at the trial site;
p.000004: 1.12 information on the secure handling of personal data;
p.000004: 1.13 agreements between the sponsor, or third parties acting on the sponsor’s behalf, and the investigator, in particular with regard to the financing of the
p.000004: clinical trial, remuneration of the investigator and publication;
p.000004: 1.14 certificate of insurance or other proof of coverage for possible damage, including agreements on this matter between the sponsor, or a third party
p.000004: acting on the sponsor’s behalf, and the investigator;
p.000004: 1.15 any decisions or opinions of ethics committees abroad concerning the clinical trial, including any conditions imposed and the reasons given.
p.000004:
p.000004:
p.000004: 2 Application documents for Category B and C clinical trials of therapeutic products and transplant products
p.000004: 2.1 Basic form, including a summary of the protocol in the national language of the trial site and reasons for the requested categorisation;
p.000004: 2.2 protocol;
p.000004: 2.3 case report form (CRF);
p.000004: 2.4 information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or advertisements;
p.000004: 2.5 other documents issued to participants;
p.000004: 2.6 information on the type and amount of remuneration for participants;
p.000004: 2.71 for Category B clinical trials of medicinal products: the prescribing information and the Investigator’s Brochure (IB), giving details of how the use of
p.000004: the product differs from the dosage/indication specified in the prescribing information;
p.000004: 2.8 for Category C clinical trials of medicinal products: the Investigator’s Brochure (IB);
p.000004: 2.9 for Category C clinical trials of medical devices with no assessment of conformity: the documents specified in Annex 4 number 3.4 letter a;
p.000004: 2.10 for Category C clinical trials of medical devices bearing a conformity marking which are not used in accordance with the intended purpose or the
p.000004: instructions: the documents specified in Annex 4 number 3.5 letters a–d;
p.000004: 2.11 the investigator’s CV, including evidence of his or her knowledge and experience, and a list of the other persons conducting the clinical trial, indicating
p.000004: their responsibilities and relevant professional knowledge;
p.000004: 2.12 information on the suitability and availability of infrastructure at the trial site;
p.000004: 2.13 information on the secure handling of personal data;
p.000004: 2.14 agreements between the sponsor, or third parties acting on the sponsor’s behalf, and the investigator, in particular with regard to the financing of the
p.000004: clinical trial, remuneration of the investigator and publication;
p.000004: 2.15 certificate of insurance or other proof of coverage for possible damage, including agreements on this matter between the sponsor, or a third party
p.000004: acting on the sponsor’s behalf, and the investigator;
p.000004: 2.16 for clinical trials of gene therapy: the information specified in Annex 4 number 4;
p.000004: 2.17 any decisions or opinions of ethics committees abroad concerning the clinical trial, including any conditions imposed and the reasons given.
p.000004:
p.000004:
p.000004: 3 Application documents for clinical trials of transplantation and for clinical trials not involving therapeutic products
p.000004: 3.1 Basic form, including a summary of the protocol in the national language of the trial site and reasons for the requested categorisation;
p.000004: 3.2 protocol;
p.000004: 3.3 case report form (CRF);
p.000004: 3.4 information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or advertisements;
p.000004: 3.5 other documents issued to participants;
p.000004: 3.6 information on the type and amount of remuneration for participants;
p.000004: 3.7 for clinical trials of transplantation of human organs, tissues and cells: information on donor information and consent;
p.000004: 3.8 for Category A clinical trials of transplantation of human organs, tissues and cells: in addition to the information specified in number 3.7, information
p.000004: on:
p.000004: a. the origin and quality of the organs, tissues or cells used, and in particular on the tests performed in this connection,
p.000004: b. compliance with duties of care, particularly with regard to the assessment of fitness to donate and mandatory testing, and the subsequent
p.000004: handling of organs, tissue and cells,
p.000004: c. authorisation, if handling of the organs, tissues or cells used is subject to authorisation under the Transplantation Act;
p.000004: 3.9 the investigator’s CV, including evidence of his or her knowledge and experience, and a list of the other persons conducting the clinical trial, indicating
p.000004: their responsibilities and relevant professional knowledge;
p.000004: 3.10 information on the suitability and availability of infrastructure at the trial site;
p.000004: 3.11 information on the secure handling of personal data;
p.000004: 3.12 agreements between the sponsor, or third parties acting on the sponsor’s behalf, and the investigator, in particular with regard to the financing of the
p.000004: clinical trial, remuneration of the investigator and publication;
p.000004: 3.13 certificate of insurance or other proof of coverage for possible damage, including agreements on this matter between the sponsor, or a third party
p.000004: acting on the sponsor’s behalf, and the investigator;
p.000004: 3.14 for clinical trials of transplantation of genetically modified human organs, tissues and cells: the information specified in Annex 4 number 6.7;
p.000004: 3.15 any decisions or opinions of ethics committees abroad concerning the clinical trial, including any conditions imposed and the reasons given.
p.000004:
p.000004:
p.000004: 4 Application documents for the ethics committees concerned in multicentre clinical trials
p.000004: 4.1 Basic form, including a summary of the protocol in the national language of the trial site and reasons for the requested categorisation;
p.000004: 4.2 protocol;
p.000004: 4.3 information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or advertisements, used at
p.000004: the site in question;
p.000004: 4.4 the CV of the investigator responsible at the site in question, including evidence of his or her knowledge and experience, and a list of the other persons
p.000004: conducting the clinical trial at the site in question, indicating their responsibilities and relevant professional knowledge;
p.000004: 4.5 information on the suitability and availability of infrastructure at the trial site in question;
p.000004: 4.6 agreements between the sponsor, or third parties acting on the sponsor’s behalf, and the coordinating investigator and other investigators at the
p.000004: other sites, in particular with regard to the remuneration of the investigator at the site in question;
p.000004: 4.7 certificate of insurance or other proof of coverage for possible damage occurring at the trial site in question, including agreements on this matter
p.000004: between the sponsor, or a third party acting on the sponsor’s behalf, and the investigator.
p.000004: 5 Additional application documents for Category A clinical trials of therapeutic products capable of emitting ionising
p.000004: radiation, and for investigations involving radiation sources
p.000004: 5.1 Details of all relevant radiological protection aspects, and in particular a calculation or estimate of the effective dose, organ doses and any tumour
p.000004: doses;
p.000004: 5.2 the licences required under Article 28 of the Radiological Protection Act of 22 March 19912.
p.000004:
p.000004:
p.000004: 6 Additional application documents for clinical trials which include investigations involving radiation sources and require an
p.000004: opinion from the FOPH in accordance with Article 28 paragraph 2
p.000004: 6.1 Information on the properties of the radiopharmaceutical, and in particular on pharmacokinetics, quality, stability, radiochemical purity and
p.000004: radionuclide purity;
p.000004: 6.2 for authorised radiopharmaceuticals: the prescribing information;
p.000004: 6.3 for non-authorised radiopharmaceuticals: information on the manufacturing and quality control processes for the radiopharmaceutical, the names of
p.000004: the persons responsible for these processes and details of their professional qualifications;
p.000004: 6.4 the names of the persons responsible for the use of the radiopharmaceutical in humans and details of their professional qualifications;
p.000004: 6.5 information specified in the FOPH form for clinical trials of radiopharmaceuticals or radiolabelled compounds3.
p.000004: 1 Correction of 27 Dec. 2013 ( AS 2013 5579).
p.000004: 2 SR 814.50
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Political / vulnerable
Searching for indicator vulnerable:
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p.000001: Art. 24 Application
p.000001: 1 The investigator shall submit to the responsible ethics committee the application documents specified in Annex 3 for review.
p.000001: 2 The ethics committee may request additional information.
p.000001: 3 The sponsor may submit the application instead of the investigator. In this case, the sponsor assumes the obligations of the investigator as specified in Articles
p.000001: 28 and 29 and also the notification and reporting obligations vis-à-vis the responsible ethics committee. The application documents must be co-signed by the
p.000001: investigator.
p.000001:
p.000001: Art. 25 Review areas
p.000001: The responsible ethics committee shall review:
p.000001:
p.000001: a. the completeness of the application;
p.000001: b. the categorisation requested;
p.000001: c. the information intended for registration in accordance with Article 64;
p.000001: d. the protocol with regard to:
p.000001: 1. the scientific relevance of the topic (Art. 5 HRA), the suitability of the chosen scientific methodology and compliance with Good Clinical
p.000001: Practice,
p.000001: 2. the ratio between the likely risks and burdens and the expected benefits (Art. 12 para. 2 HRA),
p.000001: 3. the measures taken to minimise risks and burdens, and for the protection and follow-up of participants (Art. 15 HRA), including
p.000001: precautionary measures in the handling of personal data,
p.000001: 4. the need to involve persons, and in particular persons who are particularly vulnerable (Art. 11 HRA),
p.000001: 5. the criteria for the selection of participants,
p.000001: 6. the proposed procedure for providing information and obtaining consent, including the appropriateness of the period for reflection,
p.000001: 7. the appropriateness of the remuneration for participants,
p.000001: 8. compliance with scientific integrity requirements;
p.000001: e. the completeness of the documentation for recruitment, information and consent, and its comprehensibility, especially with regard to the possible
p.000001: involvement of particularly vulnerable persons;
p.000001: f. the guaranteeing of the right to compensation in the event of damage (Art. 20 HRA);
p.000001: g. the adequacy of the knowledge and experience of the investigator and of the other persons conducting the clinical trial, in relation to the discipline
p.000001: concerned and the conduct of a clinical trial;
p.000001: h. the suitability of the infrastructure at the trial site;
p.000001: i. the financing of the clinical trial and the agreements between the sponsor, third parties and the investigator concerning the allocation of tasks,
p.000001: remuneration and publication;
p.000001: j. for Category A clinical trials of therapeutic products capable of emitting ionising radiation: additionally, compliance with radiological protection
p.000001: legislation and the dose estimation;
p.000001: k. for investigations involving radiation sources1: additionally, compliance with radiological protection legislation and the dose estimation, in cases
p.000001: where an opinion does not have to be sought from the FOPH in accordance with Article 28;
p.000001: l. other areas, where this is necessary to assess the protection of participants.
p.000001: 1 German text amended by Annex 11 No 6 of the Radiological Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 ( AS 2017 4261). This amendment is not relevant to the English
p.000001: text.
p.000001:
p.000001: Art. 26 Procedure and deadlines
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Searching for indicator vulnerability:
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p.000001:
p.000001: The Swiss Federal Council,
p.000001:
p.000001: on the basis of the Human Research Act of 30 September 20111 (HRA), of Article 36 paragraphs 1, 3 and 4 of the Transplantation Act of 8 October 20042
p.000001: (Transplantation Act), and of Article 54 paragraphs 3, 6 and 7 of the Therapeutic Products Act of 15 December 20003 (TPA),
p.000001:
p.000001: ordains:
p.000001:
p.000001:
p.000001: Chapter 1 General Provisions
p.000001: Section 1 Purpose and Definitions
p.000001: Art. 1 Purpose
p.000001: 1 This Ordinance regulates:
p.000001:
p.000001: a. the requirements for the conduct of clinical trials as defined in Article 3 letter l HRA;
p.000001: b. the authorisation and notification procedures for clinical trials;
p.000001: c. the duties and responsibilities of research ethics committees (ethics committees), the Swiss Agency for Therapeutic Products (Agency) and the Federal
p.000001: Office of Public Health (FOPH) in connection with the authorisation and notification procedures;
p.000001: d. the registration of clinical trials and public access to the registry.
p.000001: 2 For clinical trials of xenotransplantation, the Xenotransplantation Ordinance of 16 March 20071 applies.
p.000001:
p.000001: 1
p.000001: SR 810.213
p.000001:
p.000001: Art. 2 Definitions
p.000001: In this Ordinance:
p.000001:
p.000001: a. health-related intervention means a preventive, diagnostic, therapeutic, palliative or rehabilitative measure investigated in a clinical trial;
p.000001: b. minimal risks and burdens means risks and burdens, which, in terms of intensity and quality, and taking into account the vulnerability of the
p.000001: participants and the specific circumstances, will have only a slight and temporary impact on the participants’ health; in particular, minimal risks and
p.000001: burdens may be associated with:
p.000001: 1. surveys and observations,
p.000001: 2. peripheral venous or capillary blood sampling and skin punch biopsies of limited extent,
p.000001: 3. removing or collecting bodily substances without invasive interventions (in particular, saliva, urine and stool samples),
p.000001: 4. taking swabs,
p.000001: 5. magnetic resonance imaging scans without a contrast medium, ultrasound examinations or electrograms,
p.000001: 6. examinations using medical devices bearing conformity markings without a contrast medium, or using authorised medicinal products
p.000001: capable of emitting ionising radiation, provided that the effective dose1 is below 5 mSv per research project and per person concerned;
p.000001: c. sponsor means a person or institution headquartered or represented in Switzerland that takes responsibility for organising a clinical trial, and in
p.000001: particular for the initiation, management and financing of the trial in Switzerland;
p.000001: d. investigator means a person responsible in Switzerland for the conduct of a clinical trial and for the protection of the participants at the trial site; an
p.000001: investigator who takes responsibility for organising a clinical trial in Switzerland is also a sponsor.
p.000001: 1 The correction (replacement of expressions) of 24 April 2018 relates to the French and Italian texts only ( AS 2018 1653).
p.000001:
p.000001:
p.000001: Section 2 Principles
p.000001: Art. 3 Scientific integrity
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Health / Cognitive Impairment
Searching for indicator cognitive:
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p.000001: treatment;
p.000001: d. the consequences of revocation of consent for their subsequent medical treatment, and for further use of the personal data and biological material
p.000001: collected up to this point;
p.000001: e. their right to receive information at any time in response to further questions relating to the clinical trial;
p.000001: f. their right to be informed of results concerning their health, and their right to forgo such information or to designate a person who is to take this
p.000001: decision for them;
p.000001: g. the measures envisaged to cover any damage arising from the clinical trial, including the procedure in the event of a claim;
p.000001: h. the sponsor and the main sources of financing for the clinical trial;
p.000001: i. other points relevant to their decision on participation.
p.000001: 2If the intention exists to make further use for research of biological material sampled or health-related personal data collected in the clinical trial, the persons
p.000001: concerned must also receive information on the points specified in Articles 28–32 of the Human Research Ordinance of 20 September 20131.
p.000001: 3 The information may be provided in stages. It may be additionally presented in a non-textual form.
p.000001: 4 Appropriate measures must be taken to ensure that the persons concerned have understood the essential elements of the information provided.
p.000001:
p.000001: 1 SR 810.301
p.000001:
p.000001: Art. 8 Exceptions to written form
p.000001: 1 In individual cases, information may be provided and consent given in a non—written form if:
p.000001:
p.000001: a. the person concerned, for physical or cognitive reasons, cannot read or cannot write; and
p.000001: b. the investigator furnishes proof of the provision of information and consent, specifically by means of written confirmation by witnesses, or by a
p.000001: recording of verbal consent.
p.000001: 2 In individual cases, the requirement to provide information in written form may be waived if:
p.000001:
p.000001: a. this could only be implemented with disproportionate effort, given the language skills of the person concerned; and
p.000001: b. an independent qualified translator is called in to provide oral information and gives written confirmation thereof.
p.000001:
p.000001: Art. 9 Consequences of revocation of consent
p.000001: 1If consent is revoked, the biological material and health—related personal data of the person concerned must be anonymised after data evaluation has been
p.000001: completed.
p.000001: 2 Anonymisation of the biological material and personal data may be dispensed with if:
p.000001:
p.000001: a. the person concerned expressly renounces this right when revoking consent; or
p.000001: 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
p.000001: this fact, consented to participate.
p.000001: 3 Persons revoking consent must be offered any follow-up care required to protect their health.
p.000001: Section 4 Liability and Coverage
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Health / Drug Usage
Searching for indicator drug:
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p.000004: 6.4 the names of the persons responsible for the use of the radiopharmaceutical in humans and details of their professional qualifications;
p.000004: 6.5 information specified in the FOPH form for clinical trials of radiopharmaceuticals or radiolabelled compounds3.
p.000004: 1 Correction of 27 Dec. 2013 ( AS 2013 5579).
p.000004: 2 SR 814.50
p.000004: 3 This form can be obtained [in French/German] from the Federal Office of Public Health, Radiological Protection Division, CH-3003 Bern; it can also be accessed online at: www.bag.admin.ch
p.000004: > Themen > Strahlung, Radioaktivität und Schall.
p.000004:
p.000004:
p.000004:
p.000004: Annex 4
p.000004: (Art. 31, 34–36, 54, 55)
p.000004:
p.000004:
p.000004: Application documents to be submitted to the Swiss Agency for Therapeutic Products or to the FOPH for the procedure for
p.000004: clinical trials of therapeutic products and transplant products, clinical trials of gene therapy and of genetically modified or
p.000004: pathogenic organisms, and clinical trials of transplantation
p.000004:
p.000004: 1 Application documents for Category B clinical trials of medicinal products and transplant products
p.000004: 1.1 Basic form;
p.000004: 1.2 protocol;
p.000004: 1.3 prescribing information for the medicinal product or transplant product;
p.000004: 1.4 documents on the quality of the medicinal product, only concerning any changes in the composition and manufacturing thereof;
p.000004: 1.5 Investigator’s Brochure (IB), only concerning changes in the administration of the medicinal product;
p.000004: 1.6 proof of compliance with Good Manufacturing Practice (GMP);
p.000004: 1.7 proof of compliance with correct labelling;
p.000004: 1.8 any decisions of foreign drug regulatory authorities concerning the clinical trial, including any conditions imposed and the reasons given;
p.000004: 1.9 information on any applications currently being reviewed by an ethics committee in Switzerland, and on any decisions of ethics committees in
p.000004: Switzerland.
p.000004:
p.000004:
p.000004: 2 Application documents for Category C clinical trials of medicinal products and transplant products
p.000004: 2.1 Basic form;
p.000004: 2.2 protocol;
p.000004: 2.3 documents on the quality of the medicinal product or transplant product;
p.000004: 2.4 Investigator’s Brochure (IB), including information on risk assessment; if the medicinal product under investigation is authorised for the proposed use
p.000004: in a country with a comparable drug regulation system, the relevant prescribing information may be submitted; for clinical trials in which the
p.000004: medicinal product or transplant product under investigation is being used in persons for the first time: in addition, the study reports cited in the IB;
p.000004: 2.5 for trials of transplant products or gene therapy: documents on preclinical and toxicology studies;
p.000004: 2.6 proof of compliance with Good Manufacturing Practice (GMP);
p.000004: 2.7 proof of compliance with correct labelling;
p.000004: 2.8 any decisions of foreign drug regulatory authorities concerning the clinical trial, including any conditions imposed and the reasons given;
p.000004: 2.9 information on any applications currently being reviewed by an ethics committee in Switzerland, and on any decisions of ethics committees in
p.000004: Switzerland.
p.000004:
p.000004:
p.000004: 3 Application documents for Category C clinical trials of medical devices
p.000004: 3.1. Basic form;
p.000004: 3.2 protocol;
p.000004: 3.3 case report form (CRF);
p.000004: 3.4 for clinical trials of a medical device with no conformity marking: the relevant documentation, comprising:
p.000004: a. Investigator’s Brochure (IB), with a compilation of current clinical and non-clinical information on the product under investigation and its
p.000004: components,
p.000004: b. list of the applicable standards for medical devices and description of all deviations,
p.000004: c. documentation of and reasons for any deviations from the standard ISO 14155,
p.000004: d. manufacturer’s statement or release in accordance with Annex VIII to Directive 93/42/EEC1 or Annex 6 to Directive 90/385/EEC2,
p.000004: e. confirmation that documentation is being kept available as specified in Annex VIII to Directive 93/42/EEC or Annex 6 to Directive
p.000004: 90/385/EEC,
p.000004: f. if the sponsor of the clinical trial and the manufacturer of the product are not identical: agreement on risk management between the
p.000004: sponsor and manufacturer;
p.000004: 3.5 for clinical trials of a medical device bearing a conformity marking which is not used in accordance with the intended purpose or the instructions: the
p.000004: relevant documentation, comprising:
...
Health / HIV/AIDS
Searching for indicator HIV:
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p.000001:
p.000001: Art. 66 Responsibility
p.000001: The sponsor is responsible for the accuracy and completeness of the data entered.
p.000001:
p.000001: Art. 67 Portal
p.000001: 1 Public access to information on clinical trials conducted in Switzerland shall be guaranteed by a portal providing access to one or more registries.
p.000001:
p.000001: 2 The portal shall enable in particular:
p.000001:
p.000001: a. linking of data in the supplementary federal database to data in the approved registry, as specified in Article 64 paragraph 1;
p.000001: b. searching for clinical trials by keywords.
p.000001: 3The operation of the portal and of the supplementary federal database shall be guaranteed by the coordination office specified in Article 10 of the HRA
p.000001: Organisation Ordinance of 20 September 20131.
p.000001:
p.000001: 1 SR 810.308
p.000001:
p.000001:
p.000001:
p.000001: Chapter 6 Final Provisions
p.000001: Art. 68 Updating of Annexes
p.000001: The Federal Department of Home Affairs may update Annexes 1–5 in accordance with international or technical developments. It shall undertake updates which
p.000001: may give rise to technical barriers to trade in consultation with the Federal Department of Economic Affairs, Education and Research.
p.000001:
p.000001: Art. 69 Repeal of other legislation
p.000001: The following Ordinances shall be repealed:
p.000001:
p.000001: 1. Ordinance of 14 June 19931 on the Waiver of Professional Confidentiality in Medical Research;
p.000001: 2. Ordinance of 17 October 20012 on Clinical Trials of Therapeutic Products;
p.000001: 3. HIV Studies Ordinance of 30 June 19933.
p.000001: 1 [AS 1993 1983]
p.000001: 2 [AS 2001 3511, 2004 4037 No I 6, 2007 5651 No II 3, 2010 1215 Annex 7 4043, 2012 2777 Annex 5 No 4]
p.000001: 3 [AS 1993 2294]
p.000001:
p.000001: Art. 70 Amendment of other legislation
p.000001: The amendment of other legislation is regulated in Annex 6.
p.000001:
p.000001: Art. 71 Transitional provisions for clinical trials authorised under existing law
p.000001: 1Clinical trials of therapeutic products and transplant products and trials of transplantation which were authorised before 1 January 2014 are considered to be
p.000001: Category C clinical trials.
p.000001:
p.000001: 2 Other authorised clinical trials are considered to be Category B clinical trials.
p.000001: 3On request, the authority which authorised the clinical trial before 1 January 2014 may assign the clinical trial to a different category. In this case, the liability,
p.000001: coverage, notification, reporting and documentation requirements are governed by the new law.
p.000001: 4The responsible ethics committee shall make the decision specified in paragraph 3 according to the simplified procedure specified in Article 6 of the HRA
p.000001: Organisation Ordinance of 20 September 20131.
p.000001:
p.000001: 5 The assessment of significant changes is governed by the new law.
p.000001:
p.000001: 1 SR 810.308
p.000001:
p.000001: Art. 72 Transitional provision for clinical trials not subject to authorisation under existing law
p.000001: The responsible ethics committee shall make a decision on applications concerning clinical trials not subject to authorisation under existing law, submitted in
...
Health / Mentally Disabled
Searching for indicator disability:
(return to top)
p.000001: b. is not recognised as standard as specified in paragraph 1 letter b.
p.000001:
p.000001:
p.000001: Section 2 Authorisation and Notification Procedures for the Responsible Ethics Committee
p.000001: Art. 62 Applicable provisions
p.000001: The provisions which apply mutatis mutandis are:
p.000001:
p.000001: a. for the authorisation procedure for clinical trials, Articles 24–29;
p.000001: b. for the notification of safety and protective measures, Article 37 paragraph 1;
p.000001: c. for notification and reporting upon completion, discontinuation or interruption of a clinical trial, Article 38 paragraphs 1–4;
p.000001: d. for reporting on the safety of participants, Article 43 paragraphs 1 and 2;
p.000001: e. for data retention requirements, Article 45 paragraph 2.
p.000001:
p.000001: Art. 63 Documentation and notification of serious adverse events
p.000001: 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
p.000001: intervention under investigation, the investigator must document them in a standardised manner. In addition, the investigator shall report these events:
p.000001:
p.000001: a. to the sponsor within 24 hours after they become known; and
p.000001: b. to the responsible ethics committee within 15 days.
p.000001: 2 A serious adverse event is defined as any event which:
p.000001:
p.000001: a. requires inpatient treatment not envisaged in the protocol or extends a current hospital stay;
p.000001: b. results in permanent or significant incapacity or disability;
p.000001: c. is life-threatening or results in death; or
p.000001: d. causes a congenital anomaly or birth defect.
p.000001: 3If necessary in order to guarantee participants’ safety and health, further adverse events which must be documented or reported are to be designated in the
p.000001: protocol or at the request of the responsible ethics committee.
p.000001: 4If, in the case of a multicentre clinical trial, serious adverse events occur at one of the trial sites, the coordinating investigator shall also report the events as
p.000001: specified in paragraphs 1 and 3 to the responsible ethics committee concerned, within the same period.1
p.000001:
p.000001: 1 Correction of 27 Dec. 2013 ( AS 2013 5579).
p.000001:
p.000001:
p.000001:
p.000001: Chapter 5 Registration
p.000001: Art. 64 Approved registries and data to be entered
p.000001: 1 For an authorised clinical trial, the sponsor must register the data specified in Annex 5 number 1:
p.000001:
p.000001: a. in a primary registry1 recognised by the World Health Organization (WHO); or
p.000001: b. in the registry of the U.S. National Library of Medicine2.
p.000001: 2 The sponsor shall additionally enter the data specified in Annex 5 number 2 in the supplementary federal database, using a Swiss national language.
p.000001:
p.000001: 3 The data must be entered in the form authorised by the responsible ethics committee.
p.000001:
p.000001: 1 The registries can be consulted at: www.who.int > Programmes and projects > Clinical Trials – International Registry Platform.
p.000001: 2 The registry can be consulted at: www.clinicaltrials.gov
p.000001:
p.000001: Art. 65 Time of registration
...
Health / injured
Searching for indicator injured:
(return to top)
p.000001:
p.000001: a. the person concerned expressly renounces this right when revoking consent; or
p.000001: 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
p.000001: this fact, consented to participate.
p.000001: 3 Persons revoking consent must be offered any follow-up care required to protect their health.
p.000001: Section 4 Liability and Coverage
p.000001: Art. 10 Exemptions from liability
p.000001: 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:
p.000001:
p.000001: a. the administration of an authorised medicinal product used in accordance with the prescribing information;
p.000001: b. the administration of an authorised medicinal product, if this is recognised as standard in guidelines prepared in accordance with internationally
p.000001: accepted quality criteria;
p.000001: c. the employment of a medical device bearing a conformity marking and used in accordance with the instructions;
p.000001: d. the use of some other health-related intervention which is recognised as standard in guidelines prepared in accordance with internationally accepted
p.000001: quality criteria.
p.000001: 2Also exempt from liability under Article 19 paragraph 1 HRA shall be any person who proves that the extent of the damage is no greater than would be
p.000001: expected in the current state of scientific knowledge and:
p.000001:
p.000001: a. comparable damage could also have occurred if the injured party had undergone standard therapy for the disease; or
p.000001: b. in the case of acutely life-threatening diseases for which no standard therapy exists.
p.000001:
p.000001: Art. 11 Extension of the limitation period
p.000001: The limitation period for compensation claims in respect of damage:
p.000001:
p.000001: a. attributable to the use of ionising radiation is governed by Article 40 of the Radiological Protection Act of 22 March 19911;
p.000001: b. attributable to the use of genetically modified organisms is governed by Article 32 of the Gene Technology Act of 21 March 20032.
p.000001: 1 SR 814.50
p.000001: 2 SR 814.91
p.000001:
p.000001: Art. 12 Exemptions from liability coverage requirements
p.000001: Exempt from liability coverage requirements are:
p.000001:
p.000001: a. damage exempt from liability in accordance with Article 10;
p.000001: 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
p.000001: collection of health-related personal data which entail only minimal risks and burdens.
p.000001:
p.000001: Art. 13 Requirements for liability coverage
p.000001: 1 The liability coverage requirements can be fulfilled:
p.000001:
p.000001: a. by taking out insurance; or
p.000001: b. by providing security of equivalent value.
p.000001: 2 The policy value shall be set in accordance with Annex 2.
p.000001: 3 The liability coverage must cover damage occurring up to ten years after the completion of the clinical trial.
p.000001:
p.000001: Art. 14 Protection of the injured party
p.000001: 1 Cancellation of the insurance policy by the insurance company is not permissible after the occurrence of the insured event.
p.000001: 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
p.000001: raised on the basis of the insurance policy or the Insurance Policies Act of 2 April 19081.
p.000001: 3 If the insurance company is subject to action under paragraph 2, it shall have a right of recourse against the insured party.
p.000001: 4 Paragraphs 1–3 apply mutatis mutandis if security of equivalent value is provided in accordance with Article 13 paragraph 1 letter b.
p.000001:
p.000001: 1
p.000001: SR 221.229.1
p.000001:
p.000001:
p.000001: Section 5 Clinical Trials in Emergency Situations
p.000001: Art. 15 Post hoc consent
p.000001: 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:
p.000001:
p.000001: a. the consent of the person concerned can be obtained post hoc as soon as possible;
p.000001: 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
p.000001: required in accordance with Articles 22 and 23 HRA;
p.000001: 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
...
Health / patients in emergency situations
Searching for indicator emergency situation:
(return to top)
p.000001: 1 The liability coverage requirements can be fulfilled:
p.000001:
p.000001: a. by taking out insurance; or
p.000001: b. by providing security of equivalent value.
p.000001: 2 The policy value shall be set in accordance with Annex 2.
p.000001: 3 The liability coverage must cover damage occurring up to ten years after the completion of the clinical trial.
p.000001:
p.000001: Art. 14 Protection of the injured party
p.000001: 1 Cancellation of the insurance policy by the insurance company is not permissible after the occurrence of the insured event.
p.000001: 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
p.000001: raised on the basis of the insurance policy or the Insurance Policies Act of 2 April 19081.
p.000001: 3 If the insurance company is subject to action under paragraph 2, it shall have a right of recourse against the insured party.
p.000001: 4 Paragraphs 1–3 apply mutatis mutandis if security of equivalent value is provided in accordance with Article 13 paragraph 1 letter b.
p.000001:
p.000001: 1
p.000001: SR 221.229.1
p.000001:
p.000001:
p.000001: Section 5 Clinical Trials in Emergency Situations
p.000001: Art. 15 Post hoc consent
p.000001: 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:
p.000001:
p.000001: a. the consent of the person concerned can be obtained post hoc as soon as possible;
p.000001: 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
p.000001: required in accordance with Articles 22 and 23 HRA;
p.000001: 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
p.000001: obtained as soon as possible, if no statement of wishes formulated in a state of capacity is available.
p.000001: 2 The procedure for obtaining post hoc consent must be defined in the protocol.
p.000001:
p.000001: Art. 16 Death of the person
p.000001: 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
p.000001: 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
p.000001: the use of such material and health-related data for research purposes.
p.000001: 2In 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.
p.000001: Consent is governed by Article 8 of the Transplantation Act.
p.000001:
p.000001: Art. 17 Handling of biological material and health-related personal data
p.000001: 1The biological material sampled and the health-related personal data collected during a clinical trial in an emergency situation may only be evaluated when
p.000001: consent has been obtained in accordance with Article 15 or 16.
p.000001: 2 In exceptional cases, the biological material and the health-related personal data may be evaluated before consent has been obtained if:
p.000001:
p.000001: a. the biological material is only utilisable for a limited period; or
p.000001: b. this is necessary for the sake of the participants’ safety and health.
p.000001: 3If 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
p.000001: destroyed.
p.000001:
p.000001: 4If 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
p.000001: data, the use thereof in the clinical trial is permissible in spite of refusal of consent. The biological material and the health-related personal data must be
p.000001: anonymised without delay. The right to dissent of the person concerned is reserved.
p.000001: 5If it is foreseeable that material or data may be evaluated before consent has been obtained, in accordance with paragraph 2, or used in spite of refusal of
p.000001: consent, in accordance with paragraph 4, this must be stated in the protocol.
p.000001:
p.000001:
p.000001: Section 6 Storage of Health-Related Personal Data and Biological Material
p.000001: Art. 18
p.000001: 1 Any person who stores health-related personal data in connection with a clinical trial must take appropriate operational and organisational measures to protect
p.000001: it, and in particular:
p.000001:
p.000001: a. restrict the handling of the health-related personal data to those persons who require this data to fulfil their duties;
p.000001: b. prevent unauthorised or accidental disclosure, alteration, deletion and copying of the health-related personal data;
p.000001: c. document all processing operations which are essential to ensure traceability.
p.000001: 2 Any person who stores biological material in connection with a clinical trial must, in particular:
p.000001:
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000001: v Additional informations
p.000001:
p.000001: 810.305 expand all | article overview | collapse all | P
p.000001:
p.000001:
p.000001: English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
p.000001:
p.000001:
p.000001: Ordinance on Clinical Trials in Human Research
p.000001: (Clinical Trials Ordinance, ClinO)
p.000001: of 20 September 2013 (Status as of 24 April 2018)
p.000001:
p.000001: The Swiss Federal Council,
p.000001:
p.000001: on the basis of the Human Research Act of 30 September 20111 (HRA), of Article 36 paragraphs 1, 3 and 4 of the Transplantation Act of 8 October 20042
p.000001: (Transplantation Act), and of Article 54 paragraphs 3, 6 and 7 of the Therapeutic Products Act of 15 December 20003 (TPA),
p.000001:
p.000001: ordains:
p.000001:
p.000001:
p.000001: Chapter 1 General Provisions
p.000001: Section 1 Purpose and Definitions
p.000001: Art. 1 Purpose
p.000001: 1 This Ordinance regulates:
p.000001:
p.000001: a. the requirements for the conduct of clinical trials as defined in Article 3 letter l HRA;
p.000001: b. the authorisation and notification procedures for clinical trials;
p.000001: c. the duties and responsibilities of research ethics committees (ethics committees), the Swiss Agency for Therapeutic Products (Agency) and the Federal
p.000001: Office of Public Health (FOPH) in connection with the authorisation and notification procedures;
p.000001: d. the registration of clinical trials and public access to the registry.
p.000001: 2 For clinical trials of xenotransplantation, the Xenotransplantation Ordinance of 16 March 20071 applies.
p.000001:
p.000001: 1
p.000001: SR 810.213
p.000001:
p.000001: Art. 2 Definitions
p.000001: In this Ordinance:
p.000001:
p.000001: a. health-related intervention means a preventive, diagnostic, therapeutic, palliative or rehabilitative measure investigated in a clinical trial;
p.000001: b. minimal risks and burdens means risks and burdens, which, in terms of intensity and quality, and taking into account the vulnerability of the
p.000001: participants and the specific circumstances, will have only a slight and temporary impact on the participants’ health; in particular, minimal risks and
p.000001: burdens may be associated with:
p.000001: 1. surveys and observations,
p.000001: 2. peripheral venous or capillary blood sampling and skin punch biopsies of limited extent,
p.000001: 3. removing or collecting bodily substances without invasive interventions (in particular, saliva, urine and stool samples),
p.000001: 4. taking swabs,
p.000001: 5. magnetic resonance imaging scans without a contrast medium, ultrasound examinations or electrograms,
p.000001: 6. examinations using medical devices bearing conformity markings without a contrast medium, or using authorised medicinal products
p.000001: capable of emitting ionising radiation, provided that the effective dose1 is below 5 mSv per research project and per person concerned;
p.000001: c. sponsor means a person or institution headquartered or represented in Switzerland that takes responsibility for organising a clinical trial, and in
p.000001: particular for the initiation, management and financing of the trial in Switzerland;
...
p.000001:
p.000001: a. in a primary registry1 recognised by the World Health Organization (WHO); or
p.000001: b. in the registry of the U.S. National Library of Medicine2.
p.000001: 2 The sponsor shall additionally enter the data specified in Annex 5 number 2 in the supplementary federal database, using a Swiss national language.
p.000001:
p.000001: 3 The data must be entered in the form authorised by the responsible ethics committee.
p.000001:
p.000001: 1 The registries can be consulted at: www.who.int > Programmes and projects > Clinical Trials – International Registry Platform.
p.000001: 2 The registry can be consulted at: www.clinicaltrials.gov
p.000001:
p.000001: Art. 65 Time of registration
p.000001: 1 The registration specified in Article 64 must be performed before the clinical trial is conducted, subject to the provisions of paragraph 2.
p.000001:
p.000001: 2 Clinical trials in which the medicinal product under investigation is being administered to adult persons for the first time (Phase I clinical trials) must be
p.000001: registered no later than one year after the completion of the clinical trial.
p.000001:
p.000001: 3The sponsor must update the data entered in accordance with the requirements of the registry in question, as specified in Article 64 paragraph 1, but at least
p.000001: once a year.
p.000001:
p.000001: Art. 66 Responsibility
p.000001: The sponsor is responsible for the accuracy and completeness of the data entered.
p.000001:
p.000001: Art. 67 Portal
p.000001: 1 Public access to information on clinical trials conducted in Switzerland shall be guaranteed by a portal providing access to one or more registries.
p.000001:
p.000001: 2 The portal shall enable in particular:
p.000001:
p.000001: a. linking of data in the supplementary federal database to data in the approved registry, as specified in Article 64 paragraph 1;
p.000001: b. searching for clinical trials by keywords.
p.000001: 3The operation of the portal and of the supplementary federal database shall be guaranteed by the coordination office specified in Article 10 of the HRA
p.000001: Organisation Ordinance of 20 September 20131.
p.000001:
p.000001: 1 SR 810.308
p.000001:
p.000001:
p.000001:
p.000001: Chapter 6 Final Provisions
p.000001: Art. 68 Updating of Annexes
p.000001: The Federal Department of Home Affairs may update Annexes 1–5 in accordance with international or technical developments. It shall undertake updates which
p.000001: may give rise to technical barriers to trade in consultation with the Federal Department of Economic Affairs, Education and Research.
p.000001:
p.000001: Art. 69 Repeal of other legislation
p.000001: The following Ordinances shall be repealed:
p.000001:
p.000001: 1. Ordinance of 14 June 19931 on the Waiver of Professional Confidentiality in Medical Research;
p.000001: 2. Ordinance of 17 October 20012 on Clinical Trials of Therapeutic Products;
p.000001: 3. HIV Studies Ordinance of 30 June 19933.
p.000001: 1 [AS 1993 1983]
p.000001: 2 [AS 2001 3511, 2004 4037 No I 6, 2007 5651 No II 3, 2010 1215 Annex 7 4043, 2012 2777 Annex 5 No 4]
p.000001: 3 [AS 1993 2294]
p.000001:
p.000001: Art. 70 Amendment of other legislation
p.000001: The amendment of other legislation is regulated in Annex 6.
p.000001:
...
Searching for indicator access to information:
(return to top)
p.000001: Chapter 5 Registration
p.000001: Art. 64 Approved registries and data to be entered
p.000001: 1 For an authorised clinical trial, the sponsor must register the data specified in Annex 5 number 1:
p.000001:
p.000001: a. in a primary registry1 recognised by the World Health Organization (WHO); or
p.000001: b. in the registry of the U.S. National Library of Medicine2.
p.000001: 2 The sponsor shall additionally enter the data specified in Annex 5 number 2 in the supplementary federal database, using a Swiss national language.
p.000001:
p.000001: 3 The data must be entered in the form authorised by the responsible ethics committee.
p.000001:
p.000001: 1 The registries can be consulted at: www.who.int > Programmes and projects > Clinical Trials – International Registry Platform.
p.000001: 2 The registry can be consulted at: www.clinicaltrials.gov
p.000001:
p.000001: Art. 65 Time of registration
p.000001: 1 The registration specified in Article 64 must be performed before the clinical trial is conducted, subject to the provisions of paragraph 2.
p.000001:
p.000001: 2 Clinical trials in which the medicinal product under investigation is being administered to adult persons for the first time (Phase I clinical trials) must be
p.000001: registered no later than one year after the completion of the clinical trial.
p.000001:
p.000001: 3The sponsor must update the data entered in accordance with the requirements of the registry in question, as specified in Article 64 paragraph 1, but at least
p.000001: once a year.
p.000001:
p.000001: Art. 66 Responsibility
p.000001: The sponsor is responsible for the accuracy and completeness of the data entered.
p.000001:
p.000001: Art. 67 Portal
p.000001: 1 Public access to information on clinical trials conducted in Switzerland shall be guaranteed by a portal providing access to one or more registries.
p.000001:
p.000001: 2 The portal shall enable in particular:
p.000001:
p.000001: a. linking of data in the supplementary federal database to data in the approved registry, as specified in Article 64 paragraph 1;
p.000001: b. searching for clinical trials by keywords.
p.000001: 3The operation of the portal and of the supplementary federal database shall be guaranteed by the coordination office specified in Article 10 of the HRA
p.000001: Organisation Ordinance of 20 September 20131.
p.000001:
p.000001: 1 SR 810.308
p.000001:
p.000001:
p.000001:
p.000001: Chapter 6 Final Provisions
p.000001: Art. 68 Updating of Annexes
p.000001: The Federal Department of Home Affairs may update Annexes 1–5 in accordance with international or technical developments. It shall undertake updates which
p.000001: may give rise to technical barriers to trade in consultation with the Federal Department of Economic Affairs, Education and Research.
p.000001:
p.000001: Art. 69 Repeal of other legislation
p.000001: The following Ordinances shall be repealed:
p.000001:
p.000001: 1. Ordinance of 14 June 19931 on the Waiver of Professional Confidentiality in Medical Research;
p.000001: 2. Ordinance of 17 October 20012 on Clinical Trials of Therapeutic Products;
p.000001: 3. HIV Studies Ordinance of 30 June 19933.
p.000001: 1 [AS 1993 1983]
p.000001: 2 [AS 2001 3511, 2004 4037 No I 6, 2007 5651 No II 3, 2010 1215 Annex 7 4043, 2012 2777 Annex 5 No 4]
p.000001: 3 [AS 1993 2294]
p.000001:
p.000001: Art. 70 Amendment of other legislation
...
Social / Child
Searching for indicator children:
(return to top)
p.000001:
p.000001: Art. 14 Protection of the injured party
p.000001: 1 Cancellation of the insurance policy by the insurance company is not permissible after the occurrence of the insured event.
p.000001: 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
p.000001: raised on the basis of the insurance policy or the Insurance Policies Act of 2 April 19081.
p.000001: 3 If the insurance company is subject to action under paragraph 2, it shall have a right of recourse against the insured party.
p.000001: 4 Paragraphs 1–3 apply mutatis mutandis if security of equivalent value is provided in accordance with Article 13 paragraph 1 letter b.
p.000001:
p.000001: 1
p.000001: SR 221.229.1
p.000001:
p.000001:
p.000001: Section 5 Clinical Trials in Emergency Situations
p.000001: Art. 15 Post hoc consent
p.000001: 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:
p.000001:
p.000001: a. the consent of the person concerned can be obtained post hoc as soon as possible;
p.000001: 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
p.000001: required in accordance with Articles 22 and 23 HRA;
p.000001: 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
p.000001: obtained as soon as possible, if no statement of wishes formulated in a state of capacity is available.
p.000001: 2 The procedure for obtaining post hoc consent must be defined in the protocol.
p.000001:
p.000001: Art. 16 Death of the person
p.000001: 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
p.000001: 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
p.000001: the use of such material and health-related data for research purposes.
p.000001: 2In 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.
p.000001: Consent is governed by Article 8 of the Transplantation Act.
p.000001:
p.000001: Art. 17 Handling of biological material and health-related personal data
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000001: CC 810.305 Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance; ClinO) DE FR IT RM EN
p.000001:
p.000001:
p.000001:
p.000001: The federal Council m S
p.000001:
p.000001:
p.000001: > Sub-navigation
p.000001:
p.000001:
p.000001:
p.000001: v Additional informations
p.000001:
p.000001: 810.305 expand all | article overview | collapse all | P
p.000001:
p.000001:
p.000001: English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
p.000001:
p.000001:
p.000001: Ordinance on Clinical Trials in Human Research
p.000001: (Clinical Trials Ordinance, ClinO)
p.000001: of 20 September 2013 (Status as of 24 April 2018)
p.000001:
p.000001: The Swiss Federal Council,
p.000001:
p.000001: on the basis of the Human Research Act of 30 September 20111 (HRA), of Article 36 paragraphs 1, 3 and 4 of the Transplantation Act of 8 October 20042
p.000001: (Transplantation Act), and of Article 54 paragraphs 3, 6 and 7 of the Therapeutic Products Act of 15 December 20003 (TPA),
p.000001:
p.000001: ordains:
p.000001:
p.000001:
p.000001: Chapter 1 General Provisions
p.000001: Section 1 Purpose and Definitions
p.000001: Art. 1 Purpose
p.000001: 1 This Ordinance regulates:
p.000001:
p.000001: a. the requirements for the conduct of clinical trials as defined in Article 3 letter l HRA;
p.000001: b. the authorisation and notification procedures for clinical trials;
p.000001: c. the duties and responsibilities of research ethics committees (ethics committees), the Swiss Agency for Therapeutic Products (Agency) and the Federal
p.000001: Office of Public Health (FOPH) in connection with the authorisation and notification procedures;
p.000001: d. the registration of clinical trials and public access to the registry.
p.000001: 2 For clinical trials of xenotransplantation, the Xenotransplantation Ordinance of 16 March 20071 applies.
p.000001:
p.000001: 1
p.000001: SR 810.213
p.000001:
p.000001: Art. 2 Definitions
p.000001: In this Ordinance:
p.000001:
...
p.000001: g. the measures envisaged to cover any damage arising from the clinical trial, including the procedure in the event of a claim;
p.000001: h. the sponsor and the main sources of financing for the clinical trial;
p.000001: i. other points relevant to their decision on participation.
p.000001: 2If the intention exists to make further use for research of biological material sampled or health-related personal data collected in the clinical trial, the persons
p.000001: concerned must also receive information on the points specified in Articles 28–32 of the Human Research Ordinance of 20 September 20131.
p.000001: 3 The information may be provided in stages. It may be additionally presented in a non-textual form.
p.000001: 4 Appropriate measures must be taken to ensure that the persons concerned have understood the essential elements of the information provided.
p.000001:
p.000001: 1 SR 810.301
p.000001:
p.000001: Art. 8 Exceptions to written form
p.000001: 1 In individual cases, information may be provided and consent given in a non—written form if:
p.000001:
p.000001: a. the person concerned, for physical or cognitive reasons, cannot read or cannot write; and
p.000001: b. the investigator furnishes proof of the provision of information and consent, specifically by means of written confirmation by witnesses, or by a
p.000001: recording of verbal consent.
p.000001: 2 In individual cases, the requirement to provide information in written form may be waived if:
p.000001:
p.000001: a. this could only be implemented with disproportionate effort, given the language skills of the person concerned; and
p.000001: b. an independent qualified translator is called in to provide oral information and gives written confirmation thereof.
p.000001:
p.000001: Art. 9 Consequences of revocation of consent
p.000001: 1If consent is revoked, the biological material and health—related personal data of the person concerned must be anonymised after data evaluation has been
p.000001: completed.
p.000001: 2 Anonymisation of the biological material and personal data may be dispensed with if:
p.000001:
p.000001: a. the person concerned expressly renounces this right when revoking consent; or
p.000001: 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
p.000001: this fact, consented to participate.
p.000001: 3 Persons revoking consent must be offered any follow-up care required to protect their health.
p.000001: Section 4 Liability and Coverage
p.000001: Art. 10 Exemptions from liability
p.000001: 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:
p.000001:
p.000001: a. the administration of an authorised medicinal product used in accordance with the prescribing information;
p.000001: b. the administration of an authorised medicinal product, if this is recognised as standard in guidelines prepared in accordance with internationally
p.000001: accepted quality criteria;
...
p.000001: 2 A serious adverse event is defined as any event which:
p.000001:
p.000001: a. requires inpatient treatment not envisaged in the protocol or extends a current hospital stay;
p.000001: b. results in permanent or significant incapacity or disability;
p.000001: c. is life-threatening or results in death; or
p.000001: d. causes a congenital anomaly or birth defect.
p.000001: 3If necessary in order to guarantee participants’ safety and health, further adverse events which must be documented or reported are to be designated in the
p.000001: protocol or at the request of the responsible ethics committee.
p.000001: 4If, in the case of a multicentre clinical trial, serious adverse events occur at one of the trial sites, the coordinating investigator shall also report the events as
p.000001: specified in paragraphs 1 and 3 to the responsible ethics committee concerned, within the same period.1
p.000001:
p.000001: 1 Correction of 27 Dec. 2013 ( AS 2013 5579).
p.000001:
p.000001:
p.000001:
p.000001: Chapter 5 Registration
p.000001: Art. 64 Approved registries and data to be entered
p.000001: 1 For an authorised clinical trial, the sponsor must register the data specified in Annex 5 number 1:
p.000001:
p.000001: a. in a primary registry1 recognised by the World Health Organization (WHO); or
p.000001: b. in the registry of the U.S. National Library of Medicine2.
p.000001: 2 The sponsor shall additionally enter the data specified in Annex 5 number 2 in the supplementary federal database, using a Swiss national language.
p.000001:
p.000001: 3 The data must be entered in the form authorised by the responsible ethics committee.
p.000001:
p.000001: 1 The registries can be consulted at: www.who.int > Programmes and projects > Clinical Trials – International Registry Platform.
p.000001: 2 The registry can be consulted at: www.clinicaltrials.gov
p.000001:
p.000001: Art. 65 Time of registration
p.000001: 1 The registration specified in Article 64 must be performed before the clinical trial is conducted, subject to the provisions of paragraph 2.
p.000001:
p.000001: 2 Clinical trials in which the medicinal product under investigation is being administered to adult persons for the first time (Phase I clinical trials) must be
p.000001: registered no later than one year after the completion of the clinical trial.
p.000001:
p.000001: 3The sponsor must update the data entered in accordance with the requirements of the registry in question, as specified in Article 64 paragraph 1, but at least
p.000001: once a year.
p.000001:
p.000001: Art. 66 Responsibility
p.000001: The sponsor is responsible for the accuracy and completeness of the data entered.
p.000001:
p.000001: Art. 67 Portal
p.000001: 1 Public access to information on clinical trials conducted in Switzerland shall be guaranteed by a portal providing access to one or more registries.
p.000001:
p.000001: 2 The portal shall enable in particular:
p.000001:
p.000001: a. linking of data in the supplementary federal database to data in the approved registry, as specified in Article 64 paragraph 1;
p.000001: b. searching for clinical trials by keywords.
...
p.000004: Guidance www.ec.europa.eu/growth/ > Sectors > Medical devices > Guidance.
p.000004: 8 The Classification can be obtained against payment or consulted free of charge at the Federal Office of Public Health, CH-3003 Bern; it can also be accessed online at: www.who.int > Health
p.000004: topics > Classifications of disease.
p.000004:
p.000004:
p.000004:
p.000004: Annex 2
p.000004: (Art. 13)
p.000004:
p.000004:
p.000004: Policy values for liability coverage
p.000004: 1. For Category A clinical trials where any measures for the collection of health-related personal data or the sampling of biological material entail more
p.000004: than only minimal risks and burdens, the policy value shall be at least:
p.000004: a. per person: 250 000 Swiss francs;
p.000004: b for damage to property: 20 000 Swiss francs;
p.000004: c. for the entire clinical trial: 3 million Swiss francs.
p.000004: 2. For other clinical trials, the policy value shall be at least:
p.000004: a. per person: 1 million Swiss francs;
p.000004: b. for damage to property: 50 000 Swiss francs;
p.000004: c. for the entire clinical trial: 10 million Swiss francs.
p.000004:
p.000004:
p.000004: Annex 3
p.000004: (Art. 24, 27–29)
p.000004:
p.000004:
p.000004: Application documents to be submitted to the responsible ethics committee for the procedure for clinical trials
p.000004:
p.000004: 1 Application documents for Category A clinical trials of therapeutic products and transplant products
p.000004: 1.1 Basic form, including a summary of the protocol in the national language of the trial site and reasons for the requested categorisation;
p.000004: 1.2 protocol;
p.000004: 1.3 case report form (CRF);
p.000004: 1.4 information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or advertisements;
p.000004: 1.5 other documents issued to participants;
p.000004: 1.6 information on the type and amount of remuneration for participants;
p.000004: 1.7 for clinical trials of medicinal products: the prescribing information;
p.000004: 1.8 for clinical trials of medical devices: the conformity marking, including the intended use and instructions;
p.000004: 1.9 for clinical trials not using proprietary products: proof of compliance with Good Manufacturing Practice and correct labelling of the therapeutic
p.000004: products;
p.000004: 1.10 the investigator’s CV, including evidence of his or her knowledge and experience, and a list of the other persons conducting the clinical trial, indicating
p.000004: their responsibilities and relevant professional knowledge;
p.000004: 1.11 information on the suitability and availability of infrastructure at the trial site;
p.000004: 1.12 information on the secure handling of personal data;
p.000004: 1.13 agreements between the sponsor, or third parties acting on the sponsor’s behalf, and the investigator, in particular with regard to the financing of the
p.000004: clinical trial, remuneration of the investigator and publication;
p.000004: 1.14 certificate of insurance or other proof of coverage for possible damage, including agreements on this matter between the sponsor, or a third party
p.000004: acting on the sponsor’s behalf, and the investigator;
p.000004: 1.15 any decisions or opinions of ethics committees abroad concerning the clinical trial, including any conditions imposed and the reasons given.
p.000004:
p.000004:
p.000004: 2 Application documents for Category B and C clinical trials of therapeutic products and transplant products
p.000004: 2.1 Basic form, including a summary of the protocol in the national language of the trial site and reasons for the requested categorisation;
p.000004: 2.2 protocol;
p.000004: 2.3 case report form (CRF);
p.000004: 2.4 information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or advertisements;
p.000004: 2.5 other documents issued to participants;
p.000004: 2.6 information on the type and amount of remuneration for participants;
p.000004: 2.71 for Category B clinical trials of medicinal products: the prescribing information and the Investigator’s Brochure (IB), giving details of how the use of
p.000004: the product differs from the dosage/indication specified in the prescribing information;
p.000004: 2.8 for Category C clinical trials of medicinal products: the Investigator’s Brochure (IB);
p.000004: 2.9 for Category C clinical trials of medical devices with no assessment of conformity: the documents specified in Annex 4 number 3.4 letter a;
p.000004: 2.10 for Category C clinical trials of medical devices bearing a conformity marking which are not used in accordance with the intended purpose or the
p.000004: instructions: the documents specified in Annex 4 number 3.5 letters a–d;
p.000004: 2.11 the investigator’s CV, including evidence of his or her knowledge and experience, and a list of the other persons conducting the clinical trial, indicating
p.000004: their responsibilities and relevant professional knowledge;
p.000004: 2.12 information on the suitability and availability of infrastructure at the trial site;
p.000004: 2.13 information on the secure handling of personal data;
p.000004: 2.14 agreements between the sponsor, or third parties acting on the sponsor’s behalf, and the investigator, in particular with regard to the financing of the
p.000004: clinical trial, remuneration of the investigator and publication;
p.000004: 2.15 certificate of insurance or other proof of coverage for possible damage, including agreements on this matter between the sponsor, or a third party
p.000004: acting on the sponsor’s behalf, and the investigator;
p.000004: 2.16 for clinical trials of gene therapy: the information specified in Annex 4 number 4;
p.000004: 2.17 any decisions or opinions of ethics committees abroad concerning the clinical trial, including any conditions imposed and the reasons given.
p.000004:
p.000004:
p.000004: 3 Application documents for clinical trials of transplantation and for clinical trials not involving therapeutic products
p.000004: 3.1 Basic form, including a summary of the protocol in the national language of the trial site and reasons for the requested categorisation;
p.000004: 3.2 protocol;
p.000004: 3.3 case report form (CRF);
p.000004: 3.4 information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or advertisements;
p.000004: 3.5 other documents issued to participants;
p.000004: 3.6 information on the type and amount of remuneration for participants;
p.000004: 3.7 for clinical trials of transplantation of human organs, tissues and cells: information on donor information and consent;
p.000004: 3.8 for Category A clinical trials of transplantation of human organs, tissues and cells: in addition to the information specified in number 3.7, information
p.000004: on:
p.000004: a. the origin and quality of the organs, tissues or cells used, and in particular on the tests performed in this connection,
p.000004: b. compliance with duties of care, particularly with regard to the assessment of fitness to donate and mandatory testing, and the subsequent
p.000004: handling of organs, tissue and cells,
p.000004: c. authorisation, if handling of the organs, tissues or cells used is subject to authorisation under the Transplantation Act;
p.000004: 3.9 the investigator’s CV, including evidence of his or her knowledge and experience, and a list of the other persons conducting the clinical trial, indicating
p.000004: their responsibilities and relevant professional knowledge;
p.000004: 3.10 information on the suitability and availability of infrastructure at the trial site;
p.000004: 3.11 information on the secure handling of personal data;
p.000004: 3.12 agreements between the sponsor, or third parties acting on the sponsor’s behalf, and the investigator, in particular with regard to the financing of the
p.000004: clinical trial, remuneration of the investigator and publication;
p.000004: 3.13 certificate of insurance or other proof of coverage for possible damage, including agreements on this matter between the sponsor, or a third party
p.000004: acting on the sponsor’s behalf, and the investigator;
p.000004: 3.14 for clinical trials of transplantation of genetically modified human organs, tissues and cells: the information specified in Annex 4 number 6.7;
p.000004: 3.15 any decisions or opinions of ethics committees abroad concerning the clinical trial, including any conditions imposed and the reasons given.
p.000004:
p.000004:
p.000004: 4 Application documents for the ethics committees concerned in multicentre clinical trials
p.000004: 4.1 Basic form, including a summary of the protocol in the national language of the trial site and reasons for the requested categorisation;
p.000004: 4.2 protocol;
p.000004: 4.3 information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or advertisements, used at
p.000004: the site in question;
p.000004: 4.4 the CV of the investigator responsible at the site in question, including evidence of his or her knowledge and experience, and a list of the other persons
p.000004: conducting the clinical trial at the site in question, indicating their responsibilities and relevant professional knowledge;
p.000004: 4.5 information on the suitability and availability of infrastructure at the trial site in question;
p.000004: 4.6 agreements between the sponsor, or third parties acting on the sponsor’s behalf, and the coordinating investigator and other investigators at the
p.000004: other sites, in particular with regard to the remuneration of the investigator at the site in question;
p.000004: 4.7 certificate of insurance or other proof of coverage for possible damage occurring at the trial site in question, including agreements on this matter
p.000004: between the sponsor, or a third party acting on the sponsor’s behalf, and the investigator.
p.000004: 5 Additional application documents for Category A clinical trials of therapeutic products capable of emitting ionising
p.000004: radiation, and for investigations involving radiation sources
p.000004: 5.1 Details of all relevant radiological protection aspects, and in particular a calculation or estimate of the effective dose, organ doses and any tumour
p.000004: doses;
...
p.000004: 6.9 information on any applications currently being reviewed by an ethics committee in Switzerland, and on any decisions of ethics committees in
p.000004: Switzerland.
p.000004: 1 Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ L 169, 12.7.1993, p. 1; last amended by Directive 2007/47/EC, OJ L 247, 21.9.2007, p. 21.
p.000004: 2 Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, OJ L 189, 20.7.1990, p. 17; last amended
p.000004: by Directive 2007/47/EC, OJ L 247, 21.9.2007, p. 21.
p.000004: 3 SR 814.50
p.000004: 4 German text amended by Annex 11 No 6 of the Radiological Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 ( AS 2017 4261).
p.000004: 5 This form can be obtained [in French/German] from the Federal Office of Public Health, Radiological Protection Division, CH-3003 Bern; it can also be accessed online at: www.bag.admin.ch
p.000004: > Themen > Strahlung, Radioaktivität und Schall.
p.000004:
p.000004:
p.000004:
p.000004: Annex 5
p.000004: (Art. 64)
p.000004:
p.000004:
p.000004: Content of registration
p.000004:
p.000004: 1 Data to be entered in a registry
p.000004: The data specified in Version 1.2.1 of the WHO Trial Registration Data Set 1 must be entered in a registry as specified in Article 64 paragraph 1.
p.000004:
p.000004:
p.000004: 2 Data to be entered in the supplementary database
p.000004: In the supplementary database specified in Article 64 paragraph 2, the following data must be entered in a Swiss national language:
p.000004:
p.000004: a. the name of the registry specified in Article 64 paragraph 1 in which the data was entered, together with the time of registration and the
p.000004: identification number issued by the registry;
p.000004: b. the title of the clinical trial and a summary of the study protocol in lay—friendly language;
p.000004: c. the health-related intervention being studied;
p.000004: d. the disease or condition being studied;
p.000004: e. eligibility and exclusion criteria;
p.000004: f. trial sites.
p.000004: 1 The Trial Registration Data Set can be consulted free of charge at the Federal Office of Public Health, CH-3003 Bern; it can also be accessed online at: www.who.int > Programmes and
p.000004: projects > Clinical Trials – International Registry Platform > Registry Network.
p.000004:
p.000004:
p.000004:
p.000004: Annex 6
p.000004: (Art. 70)
p.000004:
p.000004:
p.000004: Amendment of other legislation
p.000004: The following Ordinances shall be amended as follows:
p.000004:
p.000001: 1
p.000001:
p.000001:
p.000001: 1 The amendments may be consulted under AS 2013 3407.
p.000001:
p.000001: AS 2013 3407
p.000001:
p.000001: 1 SR 810.30 2 SR 810.21 3 SR 812.21
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: ^ Back to top
p.000001:
p.000001:
p.000001: Additional informations
p.000001:
p.000001: This text is in force.
p.000001:
p.000001: Decision 20 September 2013
p.000001:
p.000001: In force 1 January 2014
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: All versions of this law
p.000001:
p.000001: 26.05.2021
p.000001:
p.000001: 24.04.2018 PDF
p.000001:
p.000001: 01.01.2018
p.000001:
p.000001: 26.11.2017
p.000001:
p.000001: 01.05.2017
p.000001:
p.000001: 01.01.2014
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: All editions of this law
p.000001:
p.000001: 01.01.2014
...
Social / Property Ownership
Searching for indicator home:
(return to top)
p.000001:
p.000001: Art. 65 Time of registration
p.000001: 1 The registration specified in Article 64 must be performed before the clinical trial is conducted, subject to the provisions of paragraph 2.
p.000001:
p.000001: 2 Clinical trials in which the medicinal product under investigation is being administered to adult persons for the first time (Phase I clinical trials) must be
p.000001: registered no later than one year after the completion of the clinical trial.
p.000001:
p.000001: 3The sponsor must update the data entered in accordance with the requirements of the registry in question, as specified in Article 64 paragraph 1, but at least
p.000001: once a year.
p.000001:
p.000001: Art. 66 Responsibility
p.000001: The sponsor is responsible for the accuracy and completeness of the data entered.
p.000001:
p.000001: Art. 67 Portal
p.000001: 1 Public access to information on clinical trials conducted in Switzerland shall be guaranteed by a portal providing access to one or more registries.
p.000001:
p.000001: 2 The portal shall enable in particular:
p.000001:
p.000001: a. linking of data in the supplementary federal database to data in the approved registry, as specified in Article 64 paragraph 1;
p.000001: b. searching for clinical trials by keywords.
p.000001: 3The operation of the portal and of the supplementary federal database shall be guaranteed by the coordination office specified in Article 10 of the HRA
p.000001: Organisation Ordinance of 20 September 20131.
p.000001:
p.000001: 1 SR 810.308
p.000001:
p.000001:
p.000001:
p.000001: Chapter 6 Final Provisions
p.000001: Art. 68 Updating of Annexes
p.000001: The Federal Department of Home Affairs may update Annexes 1–5 in accordance with international or technical developments. It shall undertake updates which
p.000001: may give rise to technical barriers to trade in consultation with the Federal Department of Economic Affairs, Education and Research.
p.000001:
p.000001: Art. 69 Repeal of other legislation
p.000001: The following Ordinances shall be repealed:
p.000001:
p.000001: 1. Ordinance of 14 June 19931 on the Waiver of Professional Confidentiality in Medical Research;
p.000001: 2. Ordinance of 17 October 20012 on Clinical Trials of Therapeutic Products;
p.000001: 3. HIV Studies Ordinance of 30 June 19933.
p.000001: 1 [AS 1993 1983]
p.000001: 2 [AS 2001 3511, 2004 4037 No I 6, 2007 5651 No II 3, 2010 1215 Annex 7 4043, 2012 2777 Annex 5 No 4]
p.000001: 3 [AS 1993 2294]
p.000001:
p.000001: Art. 70 Amendment of other legislation
p.000001: The amendment of other legislation is regulated in Annex 6.
p.000001:
p.000001: Art. 71 Transitional provisions for clinical trials authorised under existing law
p.000001: 1Clinical trials of therapeutic products and transplant products and trials of transplantation which were authorised before 1 January 2014 are considered to be
p.000001: Category C clinical trials.
p.000001:
p.000001: 2 Other authorised clinical trials are considered to be Category B clinical trials.
p.000001: 3On request, the authority which authorised the clinical trial before 1 January 2014 may assign the clinical trial to a different category. In this case, the liability,
p.000001: coverage, notification, reporting and documentation requirements are governed by the new law.
...
Searching for indicator property:
(return to top)
p.000003: products > Efficacy Guidelines.
p.000004: 4
p.000004: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ L 169, 12.7.1993, p. 1; last amended by Directive 2007/47/EC, OJ L 247, 21.9.2007, p. 21.
p.000004: 5 Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, OJ L 189, 20.7.1990, p. 17; last amended
p.000004: by Directive 2007/47/EC, OJ L 247, 21.9.2007, p. 21.
p.000004: 6 This standard can be consulted free of charge at the Federal Office of Public Health, CH—3003 Bern and at the Swiss Agency for Therapeutic Products, CH-3003 Bern. It can also be purchased
p.000004: from the Swiss Association for Standardisation, Sulzerallee 70, 8404 Winterthur; www.snv.ch.
p.000004: 7 These Guidelines can be consulted free of charge at the Federal Office of Public Health, CH-3003 Bern, or accessed online at: www.ec.europa.eu/growth/ > Sectors > Medical devices >
p.000004: Guidance www.ec.europa.eu/growth/ > Sectors > Medical devices > Guidance.
p.000004: 8 The Classification can be obtained against payment or consulted free of charge at the Federal Office of Public Health, CH-3003 Bern; it can also be accessed online at: www.who.int > Health
p.000004: topics > Classifications of disease.
p.000004:
p.000004:
p.000004:
p.000004: Annex 2
p.000004: (Art. 13)
p.000004:
p.000004:
p.000004: Policy values for liability coverage
p.000004: 1. For Category A clinical trials where any measures for the collection of health-related personal data or the sampling of biological material entail more
p.000004: than only minimal risks and burdens, the policy value shall be at least:
p.000004: a. per person: 250 000 Swiss francs;
p.000004: b for damage to property: 20 000 Swiss francs;
p.000004: c. for the entire clinical trial: 3 million Swiss francs.
p.000004: 2. For other clinical trials, the policy value shall be at least:
p.000004: a. per person: 1 million Swiss francs;
p.000004: b. for damage to property: 50 000 Swiss francs;
p.000004: c. for the entire clinical trial: 10 million Swiss francs.
p.000004:
p.000004:
p.000004: Annex 3
p.000004: (Art. 24, 27–29)
p.000004:
p.000004:
p.000004: Application documents to be submitted to the responsible ethics committee for the procedure for clinical trials
p.000004:
p.000004: 1 Application documents for Category A clinical trials of therapeutic products and transplant products
p.000004: 1.1 Basic form, including a summary of the protocol in the national language of the trial site and reasons for the requested categorisation;
p.000004: 1.2 protocol;
p.000004: 1.3 case report form (CRF);
p.000004: 1.4 information sheet and informed consent form, and recruitment documents, in particular the wording of announcements or advertisements;
p.000004: 1.5 other documents issued to participants;
p.000004: 1.6 information on the type and amount of remuneration for participants;
p.000004: 1.7 for clinical trials of medicinal products: the prescribing information;
p.000004: 1.8 for clinical trials of medical devices: the conformity marking, including the intended use and instructions;
p.000004: 1.9 for clinical trials not using proprietary products: proof of compliance with Good Manufacturing Practice and correct labelling of the therapeutic
p.000004: products;
p.000004: 1.10 the investigator’s CV, including evidence of his or her knowledge and experience, and a list of the other persons conducting the clinical trial, indicating
p.000004: their responsibilities and relevant professional knowledge;
p.000004: 1.11 information on the suitability and availability of infrastructure at the trial site;
...
Social / education
Searching for indicator education:
(return to top)
p.000001: registered no later than one year after the completion of the clinical trial.
p.000001:
p.000001: 3The sponsor must update the data entered in accordance with the requirements of the registry in question, as specified in Article 64 paragraph 1, but at least
p.000001: once a year.
p.000001:
p.000001: Art. 66 Responsibility
p.000001: The sponsor is responsible for the accuracy and completeness of the data entered.
p.000001:
p.000001: Art. 67 Portal
p.000001: 1 Public access to information on clinical trials conducted in Switzerland shall be guaranteed by a portal providing access to one or more registries.
p.000001:
p.000001: 2 The portal shall enable in particular:
p.000001:
p.000001: a. linking of data in the supplementary federal database to data in the approved registry, as specified in Article 64 paragraph 1;
p.000001: b. searching for clinical trials by keywords.
p.000001: 3The operation of the portal and of the supplementary federal database shall be guaranteed by the coordination office specified in Article 10 of the HRA
p.000001: Organisation Ordinance of 20 September 20131.
p.000001:
p.000001: 1 SR 810.308
p.000001:
p.000001:
p.000001:
p.000001: Chapter 6 Final Provisions
p.000001: Art. 68 Updating of Annexes
p.000001: The Federal Department of Home Affairs may update Annexes 1–5 in accordance with international or technical developments. It shall undertake updates which
p.000001: may give rise to technical barriers to trade in consultation with the Federal Department of Economic Affairs, Education and Research.
p.000001:
p.000001: Art. 69 Repeal of other legislation
p.000001: The following Ordinances shall be repealed:
p.000001:
p.000001: 1. Ordinance of 14 June 19931 on the Waiver of Professional Confidentiality in Medical Research;
p.000001: 2. Ordinance of 17 October 20012 on Clinical Trials of Therapeutic Products;
p.000001: 3. HIV Studies Ordinance of 30 June 19933.
p.000001: 1 [AS 1993 1983]
p.000001: 2 [AS 2001 3511, 2004 4037 No I 6, 2007 5651 No II 3, 2010 1215 Annex 7 4043, 2012 2777 Annex 5 No 4]
p.000001: 3 [AS 1993 2294]
p.000001:
p.000001: Art. 70 Amendment of other legislation
p.000001: The amendment of other legislation is regulated in Annex 6.
p.000001:
p.000001: Art. 71 Transitional provisions for clinical trials authorised under existing law
p.000001: 1Clinical trials of therapeutic products and transplant products and trials of transplantation which were authorised before 1 January 2014 are considered to be
p.000001: Category C clinical trials.
p.000001:
p.000001: 2 Other authorised clinical trials are considered to be Category B clinical trials.
p.000001: 3On request, the authority which authorised the clinical trial before 1 January 2014 may assign the clinical trial to a different category. In this case, the liability,
p.000001: coverage, notification, reporting and documentation requirements are governed by the new law.
p.000001: 4The responsible ethics committee shall make the decision specified in paragraph 3 according to the simplified procedure specified in Article 6 of the HRA
p.000001: Organisation Ordinance of 20 September 20131.
p.000001:
p.000001: 5 The assessment of significant changes is governed by the new law.
p.000001:
p.000001: 1 SR 810.308
p.000001:
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000001: 6. the proposed procedure for providing information and obtaining consent, including the appropriateness of the period for reflection,
p.000001: 7. the appropriateness of the remuneration for participants,
p.000001: 8. compliance with scientific integrity requirements;
p.000001: e. the completeness of the documentation for recruitment, information and consent, and its comprehensibility, especially with regard to the possible
p.000001: involvement of particularly vulnerable persons;
p.000001: f. the guaranteeing of the right to compensation in the event of damage (Art. 20 HRA);
p.000001: g. the adequacy of the knowledge and experience of the investigator and of the other persons conducting the clinical trial, in relation to the discipline
p.000001: concerned and the conduct of a clinical trial;
p.000001: h. the suitability of the infrastructure at the trial site;
p.000001: i. the financing of the clinical trial and the agreements between the sponsor, third parties and the investigator concerning the allocation of tasks,
p.000001: remuneration and publication;
p.000001: j. for Category A clinical trials of therapeutic products capable of emitting ionising radiation: additionally, compliance with radiological protection
p.000001: legislation and the dose estimation;
p.000001: k. for investigations involving radiation sources1: additionally, compliance with radiological protection legislation and the dose estimation, in cases
p.000001: where an opinion does not have to be sought from the FOPH in accordance with Article 28;
p.000001: l. other areas, where this is necessary to assess the protection of participants.
p.000001: 1 German text amended by Annex 11 No 6 of the Radiological Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 ( AS 2017 4261). This amendment is not relevant to the English
p.000001: text.
p.000001:
p.000001: Art. 26 Procedure and deadlines
p.000001: 1The ethics committee shall acknowledge receipt of the application within 7 days and notify the investigator of any formal deficiencies in the application
p.000001: documents.
p.000001: 2 It shall reach a decision within 30 days of acknowledgement of receipt of the formally correct application documents.
p.000001: 3 If the ethics committee requests additional information in accordance with Article 24 paragraph 2, the clock shall be stopped until this information has been
p.000001: received.
p.000001: 4 It shall inform the Agency of its decision in the case of Category B and C clinical trials.
p.000001:
p.000001: Art. 27 Multicentre clinical trials
p.000001: 1The coordinating investigator shall submit the application for multicentre clinical trials to the lead committee in accordance with Article 47 paragraph 2 HRA.
p.000001: The sponsor may submit the application instead of the coordinating investigator; Article 24 paragraph 3 applies mutatis mutandis.
p.000001: 2 The coordinating investigator is the person responsible in Switzerland for coordination of the investigators responsible at the individual trial sites.
...
p.000001: 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
p.000001: of their assessment within 15 days.
p.000001: 5The lead committee shall reach a decision within 45 days of acknowledgement of receipt of the formally correct application. It shall inform the ethics
p.000001: committees concerned of its decision and the Agency in the case of Category B and C clinical trials.
p.000001:
p.000001: Art. 28 Procedure for investigations involving radiation sources
p.000001: 1 In the case of investigations involving radiation sources, the investigator shall additionally submit to the responsible ethics committee the documents specified
p.000001: in Annex 3 number 5. Subject to the provisions of the following paragraphs, the authorisation procedure is governed by Articles 24–27 and 29.
p.000001: 2 The investigator shall additionally submit to the FOPH the application documents specified in Annex 3 number 6, informing the ethics committee at the same
p.000001: time, if the effective dose per person, taking the uncertainty factor into account, is more than 5 mSv per year and:
p.000001:
p.000001: a. a radiopharmaceutical is used which is not authorised in Switzerland;
p.000001: b. a radiopharmaceutical is used which is authorised in Switzerland, and the intervention in question is not a routine nuclear medicine examination; or
p.000001: c. some other radioactive source1 is used.
p.000001: 3 The FOPH shall deliver an opinion for the ethics committee on compliance with radiological protection legislation and on the dose estimation.
p.000001: 4 The ethics committee shall grant authorisation if:
p.000001:
p.000001: a. the requirements covered by Article 25 are met; and
p.000001: b. the FOPH has raised no objections to the clinical trial.
p.000001: 5 It shall reach a decision within 45 days of acknowledgement of receipt of the formally correct application documents. It shall inform the FOPH of its decision.
p.000001:
p.000001: 1 German text amended by Annex 11 No 6 of the Radiological Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 ( AS 2017 4261).
p.000001:
p.000001: Art. 29 Changes
p.000001: 1Significant changes to an authorised clinical trial must be authorised by the ethics committee before being implemented. Exempt from this requirement are
p.000001: measures which have to be taken immediately in order to protect the participants.
p.000001: 2 The investigator shall submit to the ethics committee any application documents specified in Annex 3 which are affected by the change. At the same time, the
p.000001: investigator shall provide information on the reasons for the change.
p.000001: 3 The following are considered to be significant changes:
p.000001:
p.000001: a. changes affecting the participants’ safety and health, or their rights and obligations;
...
p.000001: specified in Annex 4 number 4 must be submitted to the Agency.
p.000001: 2 Before granting authorisation, the Agency shall seek opinions from the Swiss Expert Committee for Biosafety (SECB), the Federal Office for the Environment
p.000001: (FOEN) and the FOPH.
p.000001: 3In addition to the areas specified in Article 32, it shall review whether the quality and biological safety of the product are guaranteed with regard to the
p.000001: participants and to human health and the environment.
p.000001:
p.000001: 4 It shall grant authorisation if:
p.000001:
p.000001: a. the SECB has confirmed the quality and biological safety of the product with regard to the participants and to human health and the environment;
p.000001: and
p.000001: b. no objections to the clinical trial have been raised by the FOPH or by the FOEN, based on the assessment of the environmental data.
p.000001: 5The Agency shall grant authorisation within 60 days of acknowledgement of receipt of the formally correct application documents. The Agency shall inform the
p.000001: competent federal and cantonal authorities of its decision.
p.000001: 6 Authorisations shall remain valid for the duration of the clinical trial, but for no longer than five years after they are granted.
p.000001: 7 The Agency, the FOPH and the FOEN shall jointly issue guidelines on assessment of risks to human health and the environment.
p.000001:
p.000001: Art. 36 Clinical trials of therapeutic products capable of emitting ionising radiation
p.000001: 1For Category B and C clinical trials of therapeutic products capable of emitting ionising radiation, the documents specified in Annex 4 number 5 must
p.000001: additionally be submitted to the Agency.
p.000001: 2 In the case of Category C clinical trials, the Agency shall seek an opinion from the FOPH before granting authorisation. The FOPH shall review compliance with
p.000001: radiological protection legislation and the dose estimation.
p.000001: 3 The Agency shall grant authorisation if:
p.000001:
p.000001: a. the requirements covered by Article 32 are met; and
p.000001: b. the FOPH has raised no objections to the clinical trial.
p.000001: 4The Agency shall reach a decision on Category C clinical trials within 60 days of acknowledgement of receipt of the formally correct application documents. It
p.000001: shall inform the FOPH of its decision.
p.000001: 5 In the case of Category C clinical trials, it shall transmit to the FOPH directly after receipt:
p.000001:
p.000001: a. the final report specified in Article 38 paragraph 3 including all information of relevance for radiological protection, and in particular a retrospective
p.000001: participant dose estimation, unless stipulations to the contrary have been made by the FOPH;
p.000001: b. the reports specified in Article 41 paragraph 2 and Article 42 paragraph 1.
p.000001:
p.000001:
p.000001: Section 5 Notifications and Reporting
p.000001: Art. 37 Notification of safety and protective measures
p.000001: 1If immediate safety and protective measures have to be taken during the conduct of a clinical trial, the investigator shall notify the ethics committee of these
p.000001: measures, and of the circumstances necessitating them, within 7 days.
p.000001: 2 In the case of clinical trials of medical devices, this notification shall be made within 2 days.
p.000001: 3 For Category B and C clinical trials, the notifications specified in paragraphs 1 and 2 shall be made to the Agency. This obligation rests on the sponsor.
p.000001:
...
p.000002: Art. 44 1Assessment, notification and reporting on the use of radiation sources
p.000002: 1In clinical trials involving therapeutic products capable of emitting ionising radiation, and in investigations using radiation sources, the investigator shall assess
p.000002: compliance with the dose guidance value in accordance with Article 45 of the Radiological Protection Ordinance of 26 April 20172.
p.000002: 2If the permitted dose guidance value is exceeded at any time, the investigator shall notify the responsible ethics committee within seven working days of it
p.000002: becoming known.
p.000002: 3In the case of Category B and C clinical trials with therapeutic products that emit ionising radiation, notification in accordance with paragraph 2 must also be
p.000002: given to the Agency. This obligation rests on the sponsor.
p.000002: 4 The responsible ethics committee and the Agency may obtain specialist advice from the FOPH in order to assess the dose calculation or the dose estimation and
p.000002: to decide what further measures are required.
p.000002: 5 Within a year of the completion or discontinuation of a clinical trial which included investigations involving radioactive sources, the investigator shall submit to
p.000002: the FOPH a final report including all information of relevance for radiological protection, and in particular a retrospective participant dose estimation.
p.000002: 6 The reporting requirements in accordance with paragraph 5 do not apply in the case of routine nuclear medicine examinations involving authorised
p.000002: radiopharmaceuticals.
p.000002: 7 Within the framework of the opinion delivered in accordance with Article 28, or on request, the FOPH may specify further exemptions from the reporting
p.000002: requirements in accordance with paragraph 5.
p.000002:
p.000002: 1 Amended by Annex 11 No 6 of the Radiological Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 ( AS 2017 4261).
p.000002: 2 SR 814.501
p.000002:
p.000002: Art. 45 Data retention requirements
p.000002: 1 The sponsor must retain all data relating to the clinical trial until the expiry date of the last batch supplied of the medicinal product investigated or of the last
p.000002: medical device manufactured, but at least for ten years after the completion or discontinuation of the clinical trial. In the case of implantable medical devices, the
p.000002: retention period shall be at least 15 years.
p.000002: 2The investigator must retain all documents required for the identification and follow-up of participants, and all other original data, for at least ten years after the
p.000002: completion or discontinuation of the clinical trial. In the case of implantable medical devices, the retention period shall be at least 15 years.
p.000002: 3For clinical trials of transplant products and for clinical trials of blood and blood products, the retention requirements are governed by Article 40 paragraph 1
p.000002: TPA.
p.000002:
p.000002:
p.000002: Section 6 Inspections and Official Measures
p.000002: Art. 46 Agency inspections
p.000002: 1 The Agency is entitled to inspect all clinical trials of therapeutic products and transplant products.
p.000002: 2If the Agency carries out inspections, it shall inform in advance the responsible ethics committee and other competent cantonal and federal authorities. They
p.000002: may participate in the inspection.
...
p.000004: the site in question;
p.000004: 4.4 the CV of the investigator responsible at the site in question, including evidence of his or her knowledge and experience, and a list of the other persons
p.000004: conducting the clinical trial at the site in question, indicating their responsibilities and relevant professional knowledge;
p.000004: 4.5 information on the suitability and availability of infrastructure at the trial site in question;
p.000004: 4.6 agreements between the sponsor, or third parties acting on the sponsor’s behalf, and the coordinating investigator and other investigators at the
p.000004: other sites, in particular with regard to the remuneration of the investigator at the site in question;
p.000004: 4.7 certificate of insurance or other proof of coverage for possible damage occurring at the trial site in question, including agreements on this matter
p.000004: between the sponsor, or a third party acting on the sponsor’s behalf, and the investigator.
p.000004: 5 Additional application documents for Category A clinical trials of therapeutic products capable of emitting ionising
p.000004: radiation, and for investigations involving radiation sources
p.000004: 5.1 Details of all relevant radiological protection aspects, and in particular a calculation or estimate of the effective dose, organ doses and any tumour
p.000004: doses;
p.000004: 5.2 the licences required under Article 28 of the Radiological Protection Act of 22 March 19912.
p.000004:
p.000004:
p.000004: 6 Additional application documents for clinical trials which include investigations involving radiation sources and require an
p.000004: opinion from the FOPH in accordance with Article 28 paragraph 2
p.000004: 6.1 Information on the properties of the radiopharmaceutical, and in particular on pharmacokinetics, quality, stability, radiochemical purity and
p.000004: radionuclide purity;
p.000004: 6.2 for authorised radiopharmaceuticals: the prescribing information;
p.000004: 6.3 for non-authorised radiopharmaceuticals: information on the manufacturing and quality control processes for the radiopharmaceutical, the names of
p.000004: the persons responsible for these processes and details of their professional qualifications;
p.000004: 6.4 the names of the persons responsible for the use of the radiopharmaceutical in humans and details of their professional qualifications;
p.000004: 6.5 information specified in the FOPH form for clinical trials of radiopharmaceuticals or radiolabelled compounds3.
p.000004: 1 Correction of 27 Dec. 2013 ( AS 2013 5579).
p.000004: 2 SR 814.50
p.000004: 3 This form can be obtained [in French/German] from the Federal Office of Public Health, Radiological Protection Division, CH-3003 Bern; it can also be accessed online at: www.bag.admin.ch
p.000004: > Themen > Strahlung, Radioaktivität und Schall.
p.000004:
p.000004:
p.000004:
p.000004: Annex 4
p.000004: (Art. 31, 34–36, 54, 55)
p.000004:
p.000004:
p.000004: Application documents to be submitted to the Swiss Agency for Therapeutic Products or to the FOPH for the procedure for
p.000004: clinical trials of therapeutic products and transplant products, clinical trials of gene therapy and of genetically modified or
p.000004: pathogenic organisms, and clinical trials of transplantation
p.000004:
p.000004: 1 Application documents for Category B clinical trials of medicinal products and transplant products
p.000004: 1.1 Basic form;
p.000004: 1.2 protocol;
...
Economic / Economic/Poverty
Searching for indicator poor:
(return to top)
p.000002: 3For clinical trials of transplant products and for clinical trials of blood and blood products, the retention requirements are governed by Article 40 paragraph 1
p.000002: TPA.
p.000002:
p.000002:
p.000002: Section 6 Inspections and Official Measures
p.000002: Art. 46 Agency inspections
p.000002: 1 The Agency is entitled to inspect all clinical trials of therapeutic products and transplant products.
p.000002: 2If the Agency carries out inspections, it shall inform in advance the responsible ethics committee and other competent cantonal and federal authorities. They
p.000002: may participate in the inspection.
p.000002: 3 The Agency’s powers are governed by Article 43 of the Medicinal Products Authorisation Ordinance of 17 October 20011.
p.000002: 4The Agency may additionally carry out inspections abroad at the sponsor’s expense, if this is necessary to assess the clinical trial conducted in Switzerland. The
p.000002: sponsor must be informed in advance.
p.000002: 5 The Agency shall inform the responsible ethics committee and other competent cantonal and federal authorities of the results of the inspection.
p.000002:
p.000002: 1 SR 812.212.1
p.000002:
p.000002: Art. 47 Official measures of the Agency
p.000002: The Agency may revoke or suspend the authorisation granted or make the continuation of the clinical trial subject to additional conditions, in particular if:
p.000002:
p.000002: a. the safety or health of participants is at risk, particularly as a result of inadequate product safety or manufacturing defects;
p.000002: b. the quality of the data collected is poor;
p.000002: c. the clinical trial is not conducted in accordance with the application documents approved by the Agency or by the ethics committee;
p.000002: d. the authorisation and notification requirements have not been complied with.
p.000002:
p.000002: Art. 48 Coordination and information
p.000002: 1 The responsible ethics committee, the Agency and the other competent cantonal authorities shall coordinate in advance the official measures to be taken.
p.000002: 2The right is reserved to take measures which have to be ordered without delay in order to protect the safety or health of the persons concerned. The ethics
p.000002: committees and the other competent federal and cantonal authorities shall immediately inform each other about such measures.
p.000002:
p.000002:
p.000002: Chapter 3 Authorisation and Notification Procedures for Clinical Trials of the
p.000002: Transplantation of Human Organs, Tissues and Cells
p.000002: Section 1 General Provisions
p.000002: Art. 49 Categorisation
p.000002: 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
p.000002: standard in guidelines prepared in accordance with internationally accepted quality criteria.
p.000002: 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
p.000002: standard as specified in paragraph 1.
p.000002: 3 Clinical trials of the transplantation of embryonic and foetal tissues and cells come under Category C.
p.000002:
p.000002: Art. 50 Information and coordination in authorisation procedures
...
General/Other / Incapacitated
Searching for indicator incapacity:
(return to top)
p.000001:
p.000001: a. entails more than minimal risks and burdens; and
p.000001: b. is not recognised as standard as specified in paragraph 1 letter b.
p.000001:
p.000001:
p.000001: Section 2 Authorisation and Notification Procedures for the Responsible Ethics Committee
p.000001: Art. 62 Applicable provisions
p.000001: The provisions which apply mutatis mutandis are:
p.000001:
p.000001: a. for the authorisation procedure for clinical trials, Articles 24–29;
p.000001: b. for the notification of safety and protective measures, Article 37 paragraph 1;
p.000001: c. for notification and reporting upon completion, discontinuation or interruption of a clinical trial, Article 38 paragraphs 1–4;
p.000001: d. for reporting on the safety of participants, Article 43 paragraphs 1 and 2;
p.000001: e. for data retention requirements, Article 45 paragraph 2.
p.000001:
p.000001: Art. 63 Documentation and notification of serious adverse events
p.000001: 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
p.000001: intervention under investigation, the investigator must document them in a standardised manner. In addition, the investigator shall report these events:
p.000001:
p.000001: a. to the sponsor within 24 hours after they become known; and
p.000001: b. to the responsible ethics committee within 15 days.
p.000001: 2 A serious adverse event is defined as any event which:
p.000001:
p.000001: a. requires inpatient treatment not envisaged in the protocol or extends a current hospital stay;
p.000001: b. results in permanent or significant incapacity or disability;
p.000001: c. is life-threatening or results in death; or
p.000001: d. causes a congenital anomaly or birth defect.
p.000001: 3If necessary in order to guarantee participants’ safety and health, further adverse events which must be documented or reported are to be designated in the
p.000001: protocol or at the request of the responsible ethics committee.
p.000001: 4If, in the case of a multicentre clinical trial, serious adverse events occur at one of the trial sites, the coordinating investigator shall also report the events as
p.000001: specified in paragraphs 1 and 3 to the responsible ethics committee concerned, within the same period.1
p.000001:
p.000001: 1 Correction of 27 Dec. 2013 ( AS 2013 5579).
p.000001:
p.000001:
p.000001:
p.000001: Chapter 5 Registration
p.000001: Art. 64 Approved registries and data to be entered
p.000001: 1 For an authorised clinical trial, the sponsor must register the data specified in Annex 5 number 1:
p.000001:
p.000001: a. in a primary registry1 recognised by the World Health Organization (WHO); or
p.000001: b. in the registry of the U.S. National Library of Medicine2.
p.000001: 2 The sponsor shall additionally enter the data specified in Annex 5 number 2 in the supplementary federal database, using a Swiss national language.
p.000001:
p.000001: 3 The data must be entered in the form authorised by the responsible ethics committee.
p.000001:
p.000001: 1 The registries can be consulted at: www.who.int > Programmes and projects > Clinical Trials – International Registry Platform.
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000001: collection of health-related personal data which entail only minimal risks and burdens.
p.000001:
p.000001: Art. 13 Requirements for liability coverage
p.000001: 1 The liability coverage requirements can be fulfilled:
p.000001:
p.000001: a. by taking out insurance; or
p.000001: b. by providing security of equivalent value.
p.000001: 2 The policy value shall be set in accordance with Annex 2.
p.000001: 3 The liability coverage must cover damage occurring up to ten years after the completion of the clinical trial.
p.000001:
p.000001: Art. 14 Protection of the injured party
p.000001: 1 Cancellation of the insurance policy by the insurance company is not permissible after the occurrence of the insured event.
p.000001: 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
p.000001: raised on the basis of the insurance policy or the Insurance Policies Act of 2 April 19081.
p.000001: 3 If the insurance company is subject to action under paragraph 2, it shall have a right of recourse against the insured party.
p.000001: 4 Paragraphs 1–3 apply mutatis mutandis if security of equivalent value is provided in accordance with Article 13 paragraph 1 letter b.
p.000001:
p.000001: 1
p.000001: SR 221.229.1
p.000001:
p.000001:
p.000001: Section 5 Clinical Trials in Emergency Situations
p.000001: Art. 15 Post hoc consent
p.000001: 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:
p.000001:
p.000001: a. the consent of the person concerned can be obtained post hoc as soon as possible;
p.000001: 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
p.000001: required in accordance with Articles 22 and 23 HRA;
p.000001: 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
p.000001: obtained as soon as possible, if no statement of wishes formulated in a state of capacity is available.
p.000001: 2 The procedure for obtaining post hoc consent must be defined in the protocol.
p.000001:
p.000001: Art. 16 Death of the person
p.000001: 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
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000001: Organisation Ordinance of 20 September 20131.
p.000001:
p.000001: 1 SR 810.308
p.000001:
p.000001:
p.000001:
p.000001: Chapter 6 Final Provisions
p.000001: Art. 68 Updating of Annexes
p.000001: The Federal Department of Home Affairs may update Annexes 1–5 in accordance with international or technical developments. It shall undertake updates which
p.000001: may give rise to technical barriers to trade in consultation with the Federal Department of Economic Affairs, Education and Research.
p.000001:
p.000001: Art. 69 Repeal of other legislation
p.000001: The following Ordinances shall be repealed:
p.000001:
p.000001: 1. Ordinance of 14 June 19931 on the Waiver of Professional Confidentiality in Medical Research;
p.000001: 2. Ordinance of 17 October 20012 on Clinical Trials of Therapeutic Products;
p.000001: 3. HIV Studies Ordinance of 30 June 19933.
p.000001: 1 [AS 1993 1983]
p.000001: 2 [AS 2001 3511, 2004 4037 No I 6, 2007 5651 No II 3, 2010 1215 Annex 7 4043, 2012 2777 Annex 5 No 4]
p.000001: 3 [AS 1993 2294]
p.000001:
p.000001: Art. 70 Amendment of other legislation
p.000001: The amendment of other legislation is regulated in Annex 6.
p.000001:
p.000001: Art. 71 Transitional provisions for clinical trials authorised under existing law
p.000001: 1Clinical trials of therapeutic products and transplant products and trials of transplantation which were authorised before 1 January 2014 are considered to be
p.000001: Category C clinical trials.
p.000001:
p.000001: 2 Other authorised clinical trials are considered to be Category B clinical trials.
p.000001: 3On request, the authority which authorised the clinical trial before 1 January 2014 may assign the clinical trial to a different category. In this case, the liability,
p.000001: coverage, notification, reporting and documentation requirements are governed by the new law.
p.000001: 4The responsible ethics committee shall make the decision specified in paragraph 3 according to the simplified procedure specified in Article 6 of the HRA
p.000001: Organisation Ordinance of 20 September 20131.
p.000001:
p.000001: 5 The assessment of significant changes is governed by the new law.
p.000001:
p.000001: 1 SR 810.308
p.000001:
p.000001: Art. 72 Transitional provision for clinical trials not subject to authorisation under existing law
p.000001: The responsible ethics committee shall make a decision on applications concerning clinical trials not subject to authorisation under existing law, submitted in
p.000001: accordance with Article 67 paragraph 2 HRA, within six months after acknowledgement of receipt of the formally correct application documents.
p.000001:
p.000001: Art. 73 Transitional provision concerning mandatory registration
p.000001: The sponsor of an authorised clinical trial which is not completed within a year after the commencement of the HRA must, within six months, enter the data
p.000001: specified in Annex 5 number 1 in a registry, as specified in Article 64 paragraph 1.
p.000001:
p.000001: Art. 74 Commencement
p.000001: This Ordinance comes into force on 1 January 2014.
p.000001:
p.000001:
p.000001:
p.000001: Annex 11
p.000001: (Art. 3, 5, 19, 39–42)
p.000001: Rules and classifications
p.000001:
p.000001: 1 Guidelines on scientific integrity
...
Orphaned Trigger Words
p.000001:
p.000001:
p.000001: Section 2 Principles
p.000001: Art. 3 Scientific integrity
p.000001: 1 The sponsor and the investigator, and the other persons involved in the clinical trial, shall maintain scientific integrity. In particular, it is prohibited:
p.000001:
p.000001: a. to falsify, fabricate or suppress research results;
p.000001: b. to fail to disclose conflicts of interest at the planning stage, in the authorisation procedure, or when conducting or publishing research;
p.000001: c. to impede or prevent research activities without good reason;
p.000001: d. to prevent or sanction the exposure of scientific misconduct.
p.000001: 2The applicable guidelines are the Principles and Procedures for Integrity in Scientific Research issued by the Swiss Academies of Arts and Sciences, as specified in
p.000001: Annex 1 number 1. In justified cases, other recognised scientific integrity guidelines of equivalent standing may be used.
p.000001: Art. 4 Scientific quality
p.000001: The sponsor and the investigator of a clinical trial shall ensure scientific quality. In particular:
p.000001:
p.000001: a. they shall define a research question based on the current state of scientific knowledge;
p.000001: b. they shall use an appropriate scientific methodology; and
p.000001: c. they shall ensure the availability of the resources required for the clinical trial and provide the necessary infrastructure.
p.000001:
p.000001: Art. 5 Rules of Good Clinical Practice
p.000001: 1 Clinical trials must be conducted in accordance with the rules of Good Clinical Practice, as specified in Annex 1 number 2.
p.000001: 2A 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
p.000001: protection of participants and data quality and security are guaranteed.
p.000001: 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
p.000001: 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
p.000001: the protocol. The protection of the participants and data quality and security must be guaranteed in all cases.
p.000001:
p.000001: Art. 6 Professional qualifications
p.000001: 1 The clinical trial investigator must:
p.000001:
p.000001: a. be adequately trained in Good Clinical Practice and have the professional knowledge and experience required for the clinical trial; and
p.000001: b. be conversant with the legal requirements for clinical trials or be able to ensure compliance by calling in appropriate expertise.
p.000001: 2 In addition, the investigator in a clinical trial of medicinal products or transplantation must be entitled to practise the medical profession independently.
p.000001: 3For clinical trials of medical devices and for clinical trials covered by Chapter 4, a person without medical qualifications may also serve as an investigator,
p.000001: provided that this person is entitled to practise independently the profession specifically qualifying him or her to conduct the clinical trial.
p.000001: 4 The other persons conducting the clinical trial must have the professional knowledge and experience appropriate to the activities in question.
p.000001:
p.000001:
p.000001: Section 3 Information, Consent and Revocation
p.000001: Art. 7 Information
p.000001: 1 In addition to the points specified in Article 16 paragraph 2 HRA, the persons concerned must receive information on:
p.000001:
p.000001: a. possible alternatives to the intervention under investigation, if the clinical trial is expected to offer a direct benefit;
p.000001: b. the effort involved and the obligations arising from participation;
p.000001: c. their right to withhold or to revoke their consent without giving reasons and without suffering any disadvantages in relation to their medical
p.000001: treatment;
p.000001: d. the consequences of revocation of consent for their subsequent medical treatment, and for further use of the personal data and biological material
p.000001: collected up to this point;
p.000001: e. their right to receive information at any time in response to further questions relating to the clinical trial;
p.000001: f. their right to be informed of results concerning their health, and their right to forgo such information or to designate a person who is to take this
p.000001: decision for them;
p.000001: g. the measures envisaged to cover any damage arising from the clinical trial, including the procedure in the event of a claim;
p.000001: h. the sponsor and the main sources of financing for the clinical trial;
p.000001: i. other points relevant to their decision on participation.
p.000001: 2If the intention exists to make further use for research of biological material sampled or health-related personal data collected in the clinical trial, the persons
p.000001: concerned must also receive information on the points specified in Articles 28–32 of the Human Research Ordinance of 20 September 20131.
p.000001: 3 The information may be provided in stages. It may be additionally presented in a non-textual form.
p.000001: 4 Appropriate measures must be taken to ensure that the persons concerned have understood the essential elements of the information provided.
p.000001:
p.000001: 1 SR 810.301
p.000001:
p.000001: Art. 8 Exceptions to written form
p.000001: 1 In individual cases, information may be provided and consent given in a non—written form if:
p.000001:
...
p.000001: b. ensure that the technical requirements are met for appropriate storage of the biological material;
p.000001: c. make available the resources required for storage.
p.000001:
p.000001:
p.000001: Chapter 2 Authorisation and Notification Procedures for Clinical Trials of Therapeutic
p.000001: Products and Transplant Products
p.000001: Section 1 General Provisions
p.000001: Art. 19 Categorisation of clinical trials of medicinal products
p.000001: 1 Clinical trials of medicinal products come under Category A if the medicinal product is authorised in Switzerland and its use:
p.000001:
p.000001: a. is in accordance with the prescribing information;
p.000001: b. is in an indication or dosage different from that specified in the prescribing information, but in accordance with the following criteria:
p.000001: 1. the indication is within the same disease group of the International Classification of Diseases (ICD), as specified in Annex 1 number 3,
p.000001: 2. the disease in question is self-limiting and the dosage of the medicinal product is lower than that specified in the prescribing information;
p.000001: or
p.000001: c. is recognised as standard in guidelines prepared in accordance with internationally accepted quality criteria.
p.000001: 2 Clinical trials of medicinal products come under Category B if the medicinal product:
p.000001:
p.000001: a. is authorised in Switzerland; and
p.000001: b. is not used as specified in paragraph 1.
p.000001: 3 They come under Category C if the medicinal product is not authorised in Switzerland.
p.000001: 4 In justified cases, a clinical trial of a medicinal product authorised in Switzerland may be assigned to a different category if this is possible or necessary with
p.000001: regard to medicinal product safety or protection of the participants’ safety and health.
p.000001:
p.000001: Art. 20 Categorisation of clinical trials of medical devices
p.000001: 1 Clinical trials of medical devices come under Category A if:
p.000001:
p.000001: a. the medical device bears a conformity marking; and
p.000001: b. it is used in accordance with the instructions.
p.000001: 2 They come under Category C if:
p.000001:
p.000001: a. the medical device does not have a conformity marking;
p.000001: b. it is not used in accordance with the intended purposes recognised in the conformity assessment and specified in the instructions; or
p.000001: c. use of the medical device is prohibited in Switzerland.
p.000001:
p.000001: Art. 21 Clinical trials of transplant products
p.000001: For clinical trials of transplant products, the provisions of this Ordinance concerning clinical trials of medicinal products applymutatis mutandis.
p.000001:
p.000001: Art. 22 Clinical trials of gene therapy and clinical trials of genetically modified or pathogenic organisms
p.000001: 1 For the purposes of this Ordinance, clinical trials of gene therapy are trials in which genetic information is introduced into somatic cells (somatic gene therapy).
p.000001: 2For the purposes of this Ordinance, clinical trials of genetically modified organisms are trials of medicinal products containing genetically modified organisms as
p.000001: defined in the Release Ordinance of 10 September 20081, and in particular replication-competent viruses.
p.000001: 3For the purposes of this Ordinance, clinical trials of pathogenic organisms are trials of medicinal products containing pathogenic organisms as defined in the
p.000001: Release Ordinance.
p.000001: 4 For clinical trials of gene therapy and for clinical trials of genetically modified or pathogenic organisms, the provisions of this Ordinance concerning clinical trials
p.000001: of medicinal products apply mutatis mutandis.
p.000001:
p.000001: 1
p.000001: SR 814.911
p.000001:
p.000001: Art. 23 Coordination and information in authorisation procedures
p.000001: 1 The investigator and the sponsor may simultaneously submit applications to the responsible ethics committee and to the Agency.
p.000001: 2The responsible ethics committee and the Agency shall inform each other about matters relating to the review areas specified in Article 25 and in Article 32, and
p.000001: shall coordinate their assessments.
p.000001:
p.000001:
p.000001: Section 2 Procedure for the Responsible Ethics Committee
p.000001: Art. 24 Application
p.000001: 1 The investigator shall submit to the responsible ethics committee the application documents specified in Annex 3 for review.
p.000001: 2 The ethics committee may request additional information.
p.000001: 3 The sponsor may submit the application instead of the investigator. In this case, the sponsor assumes the obligations of the investigator as specified in Articles
p.000001: 28 and 29 and also the notification and reporting obligations vis-à-vis the responsible ethics committee. The application documents must be co-signed by the
p.000001: investigator.
p.000001:
p.000001: Art. 25 Review areas
p.000001: The responsible ethics committee shall review:
p.000001:
p.000001: a. the completeness of the application;
p.000001: b. the categorisation requested;
p.000001: c. the information intended for registration in accordance with Article 64;
p.000001: d. the protocol with regard to:
p.000001: 1. the scientific relevance of the topic (Art. 5 HRA), the suitability of the chosen scientific methodology and compliance with Good Clinical
p.000001: Practice,
p.000001: 2. the ratio between the likely risks and burdens and the expected benefits (Art. 12 para. 2 HRA),
...
p.000001:
p.000001: a. the requirements covered by Article 25 are met; and
p.000001: b. the FOPH has raised no objections to the clinical trial.
p.000001: 5 It shall reach a decision within 45 days of acknowledgement of receipt of the formally correct application documents. It shall inform the FOPH of its decision.
p.000001:
p.000001: 1 German text amended by Annex 11 No 6 of the Radiological Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 ( AS 2017 4261).
p.000001:
p.000001: Art. 29 Changes
p.000001: 1Significant changes to an authorised clinical trial must be authorised by the ethics committee before being implemented. Exempt from this requirement are
p.000001: measures which have to be taken immediately in order to protect the participants.
p.000001: 2 The investigator shall submit to the ethics committee any application documents specified in Annex 3 which are affected by the change. At the same time, the
p.000001: investigator shall provide information on the reasons for the change.
p.000001: 3 The following are considered to be significant changes:
p.000001:
p.000001: a. changes affecting the participants’ safety and health, or their rights and obligations;
p.000001: b. changes to the protocol, and in particular changes based on new scientific knowledge which concern the trial design, the method of investigation, the
p.000001: endpoints or the form of statistical analysis;
p.000001: c. a change of trial site, or conducting the clinical trial at an additional site; or
p.000001: d. a change of sponsor, coordinating investigator or investigator responsible at a trial site.
p.000001: 4 The ethics committee shall reach a decision on significant changes within 30 days. Article 26 applies mutatis mutandis.
p.000001: 5If a site at which a clinical trial is to be additionally conducted does not lie within the responsibility of the ethics committee which granted authorisation, the
p.000001: procedure is governed by Article 27 mutatis mutandis.
p.000001: 6 Other changes must be notified to the ethics committee in the annual safety report specified in Article 43.
p.000001:
p.000001:
p.000001: Section 3 Procedure for the Swiss Agency for Therapeutic Products
p.000001: Art. 30 Exemption from mandatory authorisation
p.000001: Category A clinical trials of therapeutic products are exempted from the requirement for authorisation from the Agency as specified in Article 54 paragraph 1
p.000001: TPA.
p.000001:
p.000001: Art. 31 Application
p.000001: 1 The sponsor shall submit to the Agency the application documents specified in Annex 4 for review.
p.000001: 2 The Agency may request additional information.
p.000001:
p.000001: Art. 32 Review areas
p.000001: 1 For clinical trials of medicinal products, the Agency shall review:
p.000001:
p.000001: a. the completeness of the application;
p.000001: b. the safety of the medicinal product, and in particular the preclinical and clinical pharmacology, toxicology, formulation and pharmacokinetics, and the
p.000001: proposed dosage and indication;
p.000001: c. the risk assessment and risk management based on the medicinal product safety data;
p.000001: d. the quality of the medicinal product and compliance with Good Manufacturing Practice (GMP);
p.000001: e. other areas, where this is necessary to assess the safety or quality of the medicinal product.
p.000001: 2 For Category B clinical trials of medicinal products capable of emitting ionising radiation, it shall additionally review compliance with radiological protection
p.000001: legislation and the dose estimation.
p.000001: 3 For clinical trials of medical devices, it shall review:
p.000001:
p.000001: a. the completeness of the application;
p.000001: b. the requirements specified in Article 54 paragraph 4 letter b TPA.
p.000001:
p.000001: Art. 33 Procedure and deadlines
p.000001: 1 The Agency shall acknowledge receipt of the application within 7 days and notify the sponsor of any formal deficiencies in the application documents.
p.000001: 2 It shall reach a decision within 30 days of acknowledgement of receipt of the formally correct application documents.
p.000001: 3 If a therapeutic product is to be used in persons for the first time or manufactured in a new process, this deadline may be extended by a maximum of 30 days.
p.000001: The Agency shall inform the sponsor of the extended deadline.
p.000001: 4 If the Agency requests additional information in accordance with Article 31 paragraph 2, the clock shall be stopped until this information has been received.
p.000001: 5 The Agency shall inform the responsible ethics committee and other competent cantonal authorities of its decision.
p.000001:
p.000001: Art. 34 Changes
p.000001: 1Significant changes to an authorised clinical trial must be authorised by the Agency before being implemented. Exempt from this requirement are measures
p.000001: which have to be taken immediately in order to protect the participants.
p.000001: 2The sponsor must submit to the Agency any application documents specified in Annex 4 which are affected by the change. At the same time, the sponsor shall
p.000001: provide information on the reasons for the change.
p.000001: 3 The following are considered to be significant changes:
p.000001:
p.000001: a. changes to the therapeutic product, or to its administration or use;
p.000001: b. changes based on new preclinical or clinical data which may affect product safety; or
p.000001: c. changes concerning the production of the therapeutic product which may affect product safety.
p.000001: 4The Agency shall reach a decision within 30 days after receipt of the complete application documents affected by the change. Article 33 applies mutatis
p.000001: mutandis.
p.000001: 5 Other changes which affect the documents submitted to the Agency must be notified to the Agency as quickly as possible.
p.000001:
p.000001:
p.000001: Section 4 Special Provisions for Clinical Trials of Gene Therapy, for Clinical Trials of Genetically Modified or Pathogenic
p.000001: Organisms, and for Clinical Trials involving Ionising Radiation
p.000001: Art. 35 Clinical trials of gene therapy and clinical trials of genetically modified or pathogenic organisms
p.000001: 1For Category B and C clinical trials of gene therapy and for clinical trials of genetically modified or pathogenic organisms as defined in Article 22, the documents
p.000001: specified in Annex 4 number 4 must be submitted to the Agency.
p.000001: 2 Before granting authorisation, the Agency shall seek opinions from the Swiss Expert Committee for Biosafety (SECB), the Federal Office for the Environment
p.000001: (FOEN) and the FOPH.
p.000001: 3In addition to the areas specified in Article 32, it shall review whether the quality and biological safety of the product are guaranteed with regard to the
...
p.000001: 3 The Agency shall grant authorisation if:
p.000001:
p.000001: a. the requirements covered by Article 32 are met; and
p.000001: b. the FOPH has raised no objections to the clinical trial.
p.000001: 4The Agency shall reach a decision on Category C clinical trials within 60 days of acknowledgement of receipt of the formally correct application documents. It
p.000001: shall inform the FOPH of its decision.
p.000001: 5 In the case of Category C clinical trials, it shall transmit to the FOPH directly after receipt:
p.000001:
p.000001: a. the final report specified in Article 38 paragraph 3 including all information of relevance for radiological protection, and in particular a retrospective
p.000001: participant dose estimation, unless stipulations to the contrary have been made by the FOPH;
p.000001: b. the reports specified in Article 41 paragraph 2 and Article 42 paragraph 1.
p.000001:
p.000001:
p.000001: Section 5 Notifications and Reporting
p.000001: Art. 37 Notification of safety and protective measures
p.000001: 1If immediate safety and protective measures have to be taken during the conduct of a clinical trial, the investigator shall notify the ethics committee of these
p.000001: measures, and of the circumstances necessitating them, within 7 days.
p.000001: 2 In the case of clinical trials of medical devices, this notification shall be made within 2 days.
p.000001: 3 For Category B and C clinical trials, the notifications specified in paragraphs 1 and 2 shall be made to the Agency. This obligation rests on the sponsor.
p.000001:
p.000001: Art. 38 Notification and reporting upon completion, discontinuation or interruption of a clinical trial
p.000001: 1 The investigator shall notify the ethics committee of the completion of the clinical trial in Switzerland within 90 days. Completion of a clinical trial is marked by
p.000001: the last participant’s final follow-up visit, in the absence of provisions to the contrary in the protocol.
p.000001: 2The investigator shall notify the ethics committee of the discontinuation or interruption of the clinical trial within 15 days. In the notification, the reasons for the
p.000001: discontinuation or interruption shall be stated.
p.000001: 3The investigator shall submit a final report to the ethics committee within a year after completion or discontinuation of the clinical trial, unless a longer period is
p.000001: specified in the protocol.
p.000001: 4If a multicentre clinical trial is discontinued or interrupted at one of the trial sites, the coordinating investigator shall also notify the responsible ethics committee
p.000001: concerned in accordance with paragraph 2.
p.000001: 5 For Category B and C clinical trials, the notifications and reports specified in paragraphs 1–3 shall be made to the Agency. These obligations rest on the sponsor.
p.000001:
p.000001: Art. 39 Documentation of adverse events (AE) in clinical trials of medicinal products
p.000001: 1If, in the course of a Category C clinical trial of medicinal products, adverse events which are not to be classified as serious occur in participants, they must be
p.000001: documented by the investigator in a standardised manner.
p.000001: 2 Adverse events occurring in the course of a Category B clinical trial must be documented in a standardised manner, if this is envisaged in the protocol or was
p.000001: requested by the authorities responsible for authorisation.
p.000001: 3 For Category A clinical trials, there is no obligation to document adverse events.
p.000001: 4 The definition of adverse events is governed by the rules of Good Clinical Practice as specified in Annex 1 number 2.
p.000001:
p.000001: Art. 40 Serious adverse events (SAE) in clinical trials of medicinal products
p.000001: 1If, in the course of a clinical trial, serious adverse events occur in participants, the investigator must document these in a standardised manner and notify the
p.000001: sponsor within 24 hours after they become known. Events which are not to be reported according to the protocol are exempted.
p.000001: 2In the absence of provisions to the contrary in the protocol, the investigator shall notify the responsible ethics committee of a fatal serious adverse event
p.000001: occurring at a trial site in Switzerland within 7 days.
p.000001: 3In the case of a multicentre clinical trial, the coordinating investigator shall also report events as specified in paragraph 2 to the responsible ethics committee
p.000001: concerned within the same period.
p.000001: 4 The definition of serious adverse events is governed by the rules of Good Clinical Practice as specified in Annex 1 number 2.
p.000001:
p.000001: Art. 41 Suspected unexpected serious adverse reactions (SUSAR) in clinical trials of medicinal products
p.000001: 1If, in the course of a clinical trial, a suspected unexpected serious adverse reaction occurs in participants, the investigator must document this in a standardised
p.000001: manner and notify the sponsor within 24 hours after it becomes known.
p.000001: 2The investigator shall notify the responsible ethics committee of a fatal suspected unexpected serious adverse reaction occurring in Switzerland within 7 days,
p.000001: and of any other suspected unexpected serious adverse reaction within 15 days.
p.000001: 3If, in the case of a multicentre clinical trial, a suspected unexpected serious adverse reaction occurs at one of the trial sites, the coordinating investigator shall also
p.000001: notify the responsible ethics committee concerned in accordance with paragraph 2, within the same period.
p.000001: 4For Category B and C clinical trials, the notifications specified in paragraph 2 shall also be made to the Agency. This obligation rests on the sponsor. For Category
p.000001: A clinical trials, the sponsor is subject to the notification requirements specified in Article 59 paragraphs 1 and 2 TPA.
p.000001: 5 The definition of a suspected unexpected serious adverse reaction is governed by the rules of Good Clinical Practice as specified in Annex 1 number 2.
p.000001:
p.000001: Art. 42 1Serious adverse events (SAE) in clinical trials of medical devices
p.000001: 1 The investigator shall, within 7 days, notify the responsible ethics committee of the following:
p.000001:
p.000001: a. serious adverse events which occur in participants in Switzerland in the course of a Category C clinical trial of medical devices and where it cannot be
p.000001: excluded that the events are attributable:
p.000001: 1. to the device under investigation, or
p.000001: 2. to an intervention undertaken in the clinical trial;
p.000001: b. device deficiencies that could have led to serious adverse events if suitable action had not been taken, intervention had not been made, or
p.000001: circumstances had been less fortunate.
p.000001: 2If, in the case of a multicentre clinical trial, serious adverse events or device deficiencies occur at one of the trial sites, the coordinating investigator shall also
p.000001: notify the responsible ethics committee concerned.
p.000001: 3 For a Category C clinical trial, the notifications specified in paragraph 1 shall also be made to the Agency. This obligation rests on the sponsor. In addition, the
p.000001: sponsor shall notify the Agency of any events occurring or device deficiencies observed abroad. In the case of a Category A clinical trial, the sponsor is subject to
p.000001: the notification requirements specified in Article 15 paragraph 1 of the Medical Devices Ordinance of 17 October 20012.
p.000001:
p.000001: 4 The definition of serious adverse events and device deficiencies is governed by the rules of Good Clinical Practice as specified in Annex 1 number 2.
p.000001:
p.000001: 1
p.000001: Amended by Annex No 1 of the O of 25 Oct. 2017, in force since 26 Nov. 2017 ( AS 2017 5935).
p.000002: 2
p.000002: SR 812.213
p.000002:
p.000002: Art. 43 Reporting on the safety of participants
p.000002: 1Once a year, the investigator shall present to the responsible ethics committee a list of events, device deficiencies and adverse reactions as specified in Articles
p.000002: 40–42 and, on this basis, shall submit a report on their severity and causal relationship to the intervention, and on the safety of participants (annual safety report,
p.000002: ASR). 1
p.000002: 2 In the case of clinical trials also conducted abroad according to the same protocol, the events, device deficiencies and adverse reactions occurring abroad must
p.000002: also be included in the list and the report.2
p.000002: 3 For Category B and C clinical trials, reports as specified in paragraphs 1 and 2 must also be submitted to the Agency. This obligation rests on the sponsor.
p.000002:
p.000002: 1 Amended by Annex No 1 of the O of 25 Oct. 2017, in force since 26 Nov. 2017 ( AS 2017 5935).
p.000002: 2 Amended by Annex No 1 of the O of 25 Oct. 2017, in force since 26 Nov. 2017 ( AS 2017 5935).
p.000002: Art. 44 1Assessment, notification and reporting on the use of radiation sources
p.000002: 1In clinical trials involving therapeutic products capable of emitting ionising radiation, and in investigations using radiation sources, the investigator shall assess
p.000002: compliance with the dose guidance value in accordance with Article 45 of the Radiological Protection Ordinance of 26 April 20172.
p.000002: 2If the permitted dose guidance value is exceeded at any time, the investigator shall notify the responsible ethics committee within seven working days of it
p.000002: becoming known.
p.000002: 3In the case of Category B and C clinical trials with therapeutic products that emit ionising radiation, notification in accordance with paragraph 2 must also be
p.000002: given to the Agency. This obligation rests on the sponsor.
...
p.000002: d. the authorisation and notification requirements have not been complied with.
p.000002:
p.000002: Art. 48 Coordination and information
p.000002: 1 The responsible ethics committee, the Agency and the other competent cantonal authorities shall coordinate in advance the official measures to be taken.
p.000002: 2The right is reserved to take measures which have to be ordered without delay in order to protect the safety or health of the persons concerned. The ethics
p.000002: committees and the other competent federal and cantonal authorities shall immediately inform each other about such measures.
p.000002:
p.000002:
p.000002: Chapter 3 Authorisation and Notification Procedures for Clinical Trials of the
p.000002: Transplantation of Human Organs, Tissues and Cells
p.000002: Section 1 General Provisions
p.000002: Art. 49 Categorisation
p.000002: 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
p.000002: standard in guidelines prepared in accordance with internationally accepted quality criteria.
p.000002: 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
p.000002: standard as specified in paragraph 1.
p.000002: 3 Clinical trials of the transplantation of embryonic and foetal tissues and cells come under Category C.
p.000002:
p.000002: Art. 50 Information and coordination in authorisation procedures
p.000002: 1 The investigator and the sponsor may simultaneously submit applications to the responsible ethics committee and to the FOPH.
p.000002: 2The 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,
p.000002: and shall coordinate their assessments.
p.000002:
p.000002:
p.000002: Section 2 Procedure for the Responsible Ethics Committee
p.000002: Art. 51
p.000002: For the procedure for the authorisation of clinical trials of transplantation by the responsible ethics committee, Articles 24–29 apply mutatis mutandis.
p.000002:
p.000002:
p.000002: Section 3 Procedure for the FOPH
p.000002: Art. 52 Exemption from mandatory authorisation
p.000002: Category A clinical trials are exempted from the requirement for authorisation from the FOPH specified in Article 36 paragraph 1 of the Transplantation Act.
p.000002:
p.000002: Art. 53 Review areas
p.000002: For clinical trials of transplantation, the FOPH shall review:
p.000002:
p.000002: a. the completeness of the application;
p.000002: b. the origin of the organs, tissues or cells used in the clinical trial;
p.000002: c. compliance with the requirements of the transplantation legislation, particularly with regard to the duties of care in the handling of organs, tissues
p.000002: and cells, and the allocation of organs;
p.000002: d. the availability of the authorisations required in accordance with the Transplantation Act;
p.000002: e. other areas, where this is necessary to assess the safety and quality of the organs, tissues or cells used.
p.000002:
p.000002: Art. 54 Authorisation procedure
p.000002: 1 The sponsor shall submit to the FOPH the application documents specified in Annex 4 for review.
p.000002: 2 The FOPH may request additional information.
p.000002: 3 For the procedure and deadlines, Article 33 applies mutatis mutandis.
p.000002:
p.000002: Art. 55 Changes
p.000002: 1Significant changes to an authorised clinical trial must be authorised by the FOPH before being implemented. Exempt from this requirement are measures
p.000002: which have to be taken immediately in order to protect the participants.
p.000002: 2The sponsor must submit to the FOPH any application documents specified in Annex 4 which are affected by the change. At the same time, the sponsor shall
p.000002: provide information on the reasons for the change.
p.000002: 3 The following are considered to be significant changes:
p.000002:
p.000002: a. new scientific knowledge, based in particular on new preclinical or clinical data, which affects the assessment of the safety of the organs, tissues or
p.000002: cells used; or
p.000002: b. changes relating to the origin, the tests to be performed or the storage of the organs, tissues or cells used.
p.000002: 4 Also considered significant in the case of clinical trials of the transplantation of embryonic or foetal tissues and cells are changes which may affect the safety of
p.000002: the participants.
p.000002: 5The FOPH shall reach a decision within 30 days of receipt of the complete set of application documents affected by the change. Article 33 applies mutatis
p.000002: mutandis.
p.000002: 6 Other changes which affect documents submitted to the FOPH must be notified to the FOPH as quickly as possible.
p.000002:
p.000002: Art. 56 Special provisions for clinical trials of the transplantation of embryonic or foetal tissues and cells
p.000002: 1The FOPH shall grant authorisation if, in addition to Article 53, the requirements specified in Article 34 of the Transplantation Ordinance of 16 March 20071 are
p.000002: met.
p.000002: 2 It shall grant authorisation within 60 days or, in the case of significant changes, within 30 days after receipt of the complete application documents.
p.000002:
p.000002: 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.
p.000002:
p.000002: 1 SR 810.211
p.000002:
p.000002:
p.000002: Section 4 Notifications and Reporting
p.000002: Art. 57
p.000002: 1 For notifications and reporting in the case of clinical trials of transplantation, Articles 37–41, 43 and 44 apply mutatis mutandis.1
p.000002: 2 The obligations which must be fulfilled under these provisions vis-à-vis the Agency are to be fulfilled, for clinical trials of transplantation, vis-à-vis the FOPH.
p.000002: 3For clinical trials of transplantation, the duties of the sponsor and the investigator concerning documentation, traceability and retention of records are
p.000002: governed by Articles 34 and 35 of the Transplantation Act.
p.000002:
p.000001: 1
p.000001: Correction of 27 Dec. 2013 ( AS 2013 5579).
p.000001:
p.000001:
p.000001: Section 5 Inspections and Official Measures
p.000001: Art. 58 FOPH inspections
p.000001: 1The 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
p.000001: authorities or third parties to carry out inspections.
p.000001: 2 Other powers and duties of cooperation are governed by Article 63 paragraphs 2 and 3 and Article 64 of the Transplantation Act.
p.000001:
p.000001: Art. 59 Official measures
p.000001: 1 The FOPH may revoke or suspend the authorisation granted or make the continuation of the clinical trial subject to additional conditions, particularly if:
p.000001:
p.000001: a. it has reason to assume that the requirements are no longer met, the documents specified in Article 54 have been changed without due notification
p.000001: having been made, or the trial is not being conducted in accordance with these documents;
p.000001: b. such measures are necessitated by new information concerning safety or the scientific basis.
p.000001: 2For the coordination of measures and the exchange of information between the FOPH, the responsible ethics committee and other competent cantonal
p.000001: authorities, Article 48 applies mutatis mutandis.
p.000001:
p.000001:
p.000001: Chapter 4 Other Clinical Trials
p.000001: Section 1 General Provisions
p.000001: Art. 60 Scope
p.000001: This Chapter applies to clinical trials which are neither trials of therapeutic products or transplant products nor trials of transplantation.
p.000001:
p.000001: Art. 61 Categorisation
p.000001: 1 A clinical trial comes under Category A if the health-related intervention investigated:
p.000001:
p.000001: a. entails only minimal risks and burdens; or
p.000001: b. is recognised as standard in guidelines prepared in accordance with internationally accepted quality criteria.
p.000001: 2 A clinical trial comes under Category B if the health-related intervention investigated:
p.000001:
p.000001: a. entails more than minimal risks and burdens; and
p.000001: b. is not recognised as standard as specified in paragraph 1 letter b.
p.000001:
p.000001:
p.000001: Section 2 Authorisation and Notification Procedures for the Responsible Ethics Committee
p.000001: Art. 62 Applicable provisions
p.000001: The provisions which apply mutatis mutandis are:
p.000001:
p.000001: a. for the authorisation procedure for clinical trials, Articles 24–29;
p.000001: b. for the notification of safety and protective measures, Article 37 paragraph 1;
p.000001: c. for notification and reporting upon completion, discontinuation or interruption of a clinical trial, Article 38 paragraphs 1–4;
p.000001: d. for reporting on the safety of participants, Article 43 paragraphs 1 and 2;
p.000001: e. for data retention requirements, Article 45 paragraph 2.
p.000001:
p.000001: Art. 63 Documentation and notification of serious adverse events
...
p.000004: Switzerland.
p.000004:
p.000004:
p.000004: 3 Application documents for Category C clinical trials of medical devices
p.000004: 3.1. Basic form;
p.000004: 3.2 protocol;
p.000004: 3.3 case report form (CRF);
p.000004: 3.4 for clinical trials of a medical device with no conformity marking: the relevant documentation, comprising:
p.000004: a. Investigator’s Brochure (IB), with a compilation of current clinical and non-clinical information on the product under investigation and its
p.000004: components,
p.000004: b. list of the applicable standards for medical devices and description of all deviations,
p.000004: c. documentation of and reasons for any deviations from the standard ISO 14155,
p.000004: d. manufacturer’s statement or release in accordance with Annex VIII to Directive 93/42/EEC1 or Annex 6 to Directive 90/385/EEC2,
p.000004: e. confirmation that documentation is being kept available as specified in Annex VIII to Directive 93/42/EEC or Annex 6 to Directive
p.000004: 90/385/EEC,
p.000004: f. if the sponsor of the clinical trial and the manufacturer of the product are not identical: agreement on risk management between the
p.000004: sponsor and manufacturer;
p.000004: 3.5 for clinical trials of a medical device bearing a conformity marking which is not used in accordance with the intended purpose or the instructions: the
p.000004: relevant documentation, comprising:
p.000004: a. information on the conformity of the medical device,
p.000004: b. product information on the medical device,
p.000004: c. risk analysis for the new use and safety measures derived therefrom,
p.000004: d. other elements of the IB concerning the new use,
p.000004: e. list of the applicable standards for medical devices, description of deviations from these standards associated with the new use,
p.000004: f. documentation of and reasons for any deviations from the standard ISO 14155;
p.000004: 3.6 information sheet and informed consent form;
p.000004: 3.7 any decisions of foreign medical device regulatory authorities concerning the clinical trial, including any conditions imposed and the reasons given;
p.000004: 3.8 information on any applications currently being reviewed by an ethics committee in Switzerland, and on any decisions of ethics committees in
p.000004: Switzerland.
p.000004:
p.000004:
p.000004: 4 Additional application documents for Category B and C clinical trials of gene therapy and of genetically modified or
p.000004: pathogenic organisms
p.000004: 4.1 Information on the risks of the investigational product containing genetically modified or pathogenic organisms;
p.000004: 4.2 risk assessment of the conduct of the clinical trial with regard to the protection of human health and the environment;
p.000004: 4.3 a description of the safety measures required for the protection of human and animal health and the environment, and in particular to prevent the
p.000004: release of microorganisms into the environment during and after transplantation, and during transport, storage and disposal.
p.000004:
p.000004:
p.000004: 5 Additional application documents for clinical trials of therapeutic products capable of emitting ionising radiation
p.000004: 5.1 Details of all relevant radiological protection aspects, and in particular a calculation or estimate of the effective dose, organ doses and any tumour
p.000004: doses;
p.000004: 5.2 the licences required under Article 28 of the Radiological Protection Act of 22 March 19913;
p.000004: 5.3 for therapeutic products containing radioactive sources4:
p.000004: a. information on the properties of the radiopharmaceutical, and in particular on pharmacokinetics, quality, stability, radiochemical purity
p.000004: and radionuclide purity,
p.000004: b. for authorised radiopharmaceuticals: the prescribing information,
p.000004: c. for non-authorised radiopharmaceuticals: information on the manufacturing and quality control processes for the radiopharmaceutical,
p.000004: the names of the persons responsible for these processes and details of their professional qualifications,
p.000004: d. the names of the persons responsible for the use of the radiopharmaceutical in humans and details of their professional qualifications,
p.000004: e. information specified in the FOPH form for clinical trials of radiopharmaceuticals or radiolabelled compounds5.
p.000004:
p.000004:
p.000004: 6 Application documents for Category C clinical trials of transplantation of human organs, tissues and cells
p.000004: 6.1 Basic form;
p.000004: 6.2 protocol;
p.000004: 6.3 proof of the origin of the organs, tissues or cells used;
p.000004: 6.4 documents on the quality of the organs, tissues or cells used, and in particular on the tests performed;
p.000004: 6.5 proof of compliance with duties of care, particularly with regard to the assessment of fitness to donate and mandatory testing, and the procedure in
p.000004: the event of reactive test results;
p.000004: 6.6 proof of compliance with correct labelling;
p.000004: 6.7 authorisation, if handling of the organs, tissues or cells used is subject to authorisation;
p.000004: 6.8 any decisions of foreign regulatory authorities concerning the clinical trial, including any conditions imposed and the reasons given;
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| access | Access to Social Goods |
| access to information | Access to information |
| authority | Relationship to Authority |
| children | Child |
| cognitive | Cognitive Impairment |
| disability | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| emergency | Public Emergency |
| emergency situation | patients in emergency situations |
| home | Property Ownership |
| incapacity | Incapacitated |
| injured | injured |
| language | Linguistic Proficiency |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| poor | Economic/Poverty |
| property | Property Ownership |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| home | ['property'] |
| property | ['home'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
Trigger Words
capacity
consent
ethics
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input