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Ordinance on Clinical Trials with the exception of Clinical Trials of Medical Devices1 (Clinical Trials Ordinance, ClinO)
of 20 September 2013 (Status as of 26 May 2022)
1 Amended by Annex 2 No 2 of the O of 1 July 2020 on Clinical Trials with Medical Devices, in force since 26 May 2021 (AS 2020 3033).
Art. 63Documentation and notification of serious adverse events
1 If, in the course of a clinical trial, serious adverse events occur in participants in Switzerland, and it cannot be excluded that the events are attributable to the intervention under investigation, the investigator must document them in a standardised manner. In addition, the investigator shall report these events:
a.
to the sponsor within 24 hours after they become known; and
b.
to the responsible ethics committee within 15 days.
2 A serious adverse event is defined as any event which:
a.
requires inpatient treatment not envisaged in the protocol or extends a current hospital stay;
b.
results in permanent or significant incapacity or disability;
c.
is life-threatening or results in death; or
d.
causes a congenital anomaly or birth defect.
3 If necessary in order to guarantee participants’ safety and health, further adverse events which must be documented or reported are to be designated in the protocol or at the request of the responsible ethics committee.
4 If, in the case of a multicentre clinical trial, serious adverse events occur at one of the trial sites, the coordinating investigator shall also report the events as specified in paragraphs 1 and 3 to the responsible ethics committee concerned, within the same period.46