English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Section 1 Documentation and Reporting of Events an
Art. 32 Documentation of adverse events
1 The sponsor must document the following adverse events that occur during a clinical trial in a standardised form: a. adverse events of all types identified in the clinical trial plan as being critical to the evaluation of the results of that clinical trial; b. any serious adverse events: c. any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate; d. any new findings in relation to any documented event as specified in letters a–c. 2 The sponsor shall provide Swissmedic and the competent ethics committee with the documentation specified in paragraph 1 on request. 3 The definitions of adverse events and device deficiencies are based: a. for devices in accordance with the MedDO: on Article 2 points 57–59 EU-MDR; b. for devices in accordance with the IvDO: on Article 2 points 60–62 EU-IVDR.
Para. 3 let. a — SR 812.213 Para. 3 let. a — See the footnote to Art. 4 para. 1 let. a. Para. 3 let. b — SR 812.219 Para. 3 let. b — See the footnote to Art. 2a para. 3. Para. 3 let. b — Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294).
Art. 33 Reporting of serious adverse events
1 For sub-category A2 performance studies and category C clinical trials, the sponsor shall report without delay to the competent ethics committee: any serious adverse event that has a causal relationship with the device to be investigated, the comparator or the investigation procedure, or where such causal relationship is reasonably possible; any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate; any new findings in relation to any event referred to in points a and b. 2 For category C clinical trials, the reports specified in paragraph 1 shall also be submitted to Swissmedic. 3 For conformity-related clinical trials in sub-categories C1 and C2 that are also being conducted abroad, the sponsor shall also notify Swissmedic and the competent ethics committee without delay of all events, device deficiencies and findings as specified in paragraph 1 which arise fr
Art. 33 — Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294). Para. 7 — SR 812.213 Para. 7 — SR 812.219
Art. 34 Notification of safety and protective measures
1 If safety and protective measures have to be implemented without delay during the course of a clinical trial, the sponsor shall notify these measures and the circumstances that necessitated them to the ethics committee within two days. 1bis For clinical trials that are also being conducted or are also due to be conducted in EU or EEA states, the sponsor shall also notify the ethics committee within two days of all imposed or voluntary safety and protective measures that are being implemented in EU or EEA states and the circumstances that necessitated them. 2 The sponsor must notify any clinical trial that is terminated prematurely or interrupted for reasons of safety in accordance with Article 36 paragraph 4. 3 For category C clinical trials, the notifications specified in paragraphs 1 and 1bis must also be made to Swissmedic. 4 For conformity-related performance studies in sub-category A2 and clinical trials in sub-categories C1 and C2, the sponsor shall, within 2 days, also provide
Para. 1bis — Inserted by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281). Para. 3 — Amended by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281). Para. 4 — Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294).
Section 2 Reporting on the Safety of Participants
Art. 35 Annual reporting on the safety of participants
1 Once a year, the sponsor shall submit to the competent ethics committee a list of the serious adverse events and device deficiencies in accordance with Article 33 and provide it with a report on their severity, causal relationship with the device and the intervention, as well as on the safety of the participants. The sponsor shall inform the ethics committee about the general progress of the clinical trial. 2 For category C clinical trials that are also being conducted abroad, the list and report must also include adverse events and device deficiencies that occurred abroad. 2bis For category C clinical trials that are also being conducted in, or are also due to be conducted in, EU or EEA states, the report in accordance with paragraph 2 must include the status of the clinical trial in the states in question.
Para. 1 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 323). Para. 2bis — Inserted by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).
Art. 36 Notification of the completion, premature termination and interruption of a clinical trial
1 The sponsor shall notify the ethics committee of the completion of the clinical trial in Switzerland within 15 days. 2 Unless otherwise specified in the clinical trial plan, the completion of the clinical trial is deemed to be the last visit of the last participant. 3 The sponsor shall notify the ethics committee of the premature termination or interruption of the clinical trial within 15 days. The notification must set out the reasons for the premature termination or interruption. 4 If the trial is terminated prematurely or interrupted for reasons of safety, the following shall apply: a. The notification must be made within 24 hours. b. The notification must also be made to those contracting states in which the clinical trial is being conducted or is due to be conducted. 4bis For clinical trials that are also being conducted in EU or EEA states, the sponsor must also notify the ethics committee of any premature termination or interruption of the trial in EU or EEA states within 24 h
Para. 4bis — Inserted by Annex No 1 of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).
Art. 37 Final report
1 The sponsor shall submit to the ethics committee a final report for clinical investigations in accordance with Section 2.8 of Chapter I and Section 7 of Chapter III of Annex XV to EU-MDR and for performance studies in accordance with Part A Section 2.3.3 of Annex XIII to EU-IVDR: a. within one year of the completion of the clinical trial; b. within three months of the clinical trial being terminated prematurely or interrupted. 2 If scientific reasons prevent compliance with the reporting deadline specified in paragraph 1 letter a, the sponsor must submit the report as soon as it is available. The clinical trial plan must specify when the final report is to be submitted and provide reasons. 3 A summary in easily understandable terms must be included with the final report.
Para. 1 — See the footnote to Art. 4 para. 1 let. a. Para. 1 — See the footnote to Art. 2a para. 3. Para. 1 — Amended by No I of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294).
Art. 38 Notification and reporting to Swissmedic
For category C clinical trials, the notifications and reports specified in Articles 35–37 must also be submitted to Swissmedic.
Section 3 Reporting in relation to the Use of Ioni
Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 323).
Art. 39 Assessment, notification and reporting in relation to the use of ionising radiation
1 In clinical trials involving any use of ionising radiation, the investigator shall assess compliance with the dose constraint specified in Article 45 of the Radiological Protection Ordinance of 26 April 2017. 2 If the permitted dose constraint is exceeded at any time, the investigator or sponsor shall notify the competent ethics committee within seven working days of it becoming known. 3 For category C trials of devices that emit ionising radiation, notification in accordance with paragraph 2 must also be made to Swissmedic. 4 The competent ethics committee and Swissmedic may obtain expert advice from the FOPH in order to assess the dose calculation or the dose estimation and to decide what further measures are required. 5 For clinical trials in accordance with paragraph 1, the sponsor shall document in the final report all information of relevance for radiological protection, and in particular the retrospective dose estimation for the participants. 6 The reporting requirements speci
Art. 39 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 323). Para. 1 — SR 814.501 Para. 1 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 323). Para. 2 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 323). Para. 3 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 323). Para. 5 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 323). Para. 6 — SR 8
Art. 40 Data retention requirements
1 The sponsor must retain all data concerning the clinical trial until the expiry date of the last series of devices used in the trial, but for a minimum of ten years following the completion or premature termination of the clinical trial. The retention period for implantable devices is at least 15 years. 2 The investigator must retain all documents required to identify and provide post-trial care to participants, as well as all other original data, for at least ten years after the completion or premature termination of the clinical trial. The retention period for implantable devices is at least 15 years.