swissethics
Schweizerische Ethikkommissionen für die Forschung am Menschen
Commissions d’éthique suisses relative à la recherche sur l'être humain
Commissioni etiche svizzere per la ricerca sull'essere umano
Swiss Ethics Committees on research involving humans
Notification and reporting
to the ethics committee from 1 January 2014
(Author: Zurich CEC [Clinical Ethics Committee])
for clinical trials [Clinical Trials Ordinance; KlinV-ClinO]
Reporting of safety and protective measures
see Article 37 KlinV-ClinO:
Notification to the EC within 7 days
Trials of medical devices: within 2 days
Completion, discontinuation or interruption of the clinical trial
See Article 38 KlinV-ClinO:
Notification of completion to the EC within 90 days
Notification of discontinuation or interruption to the EC within 15 days
Final report to the EC: within one year of completion or discontinuation
Serious adverse events (SAEs) in clinical trials of medicinal products
See Article 40 KlinV-ClinO:
Unless otherwise specified in the protocol, SAEs with fatal consequences within 7 days (to the local
EC for local events, to the responsible EC for all events in Switzerland).
Suspected unexpected serious adverse reactions, SUSARs)
See Article 41 KlinV-ClinO:
SUSARs with fatal consequences within 7 days, other SUSARs within 15 days (to the local EC for
local events, to the responsible EC for all events in Switzerland).
Serious adverse events (SAEs) in clinical trials of medical devices
See Article 42 KlinV-ClinO:
In Category C trials, SAEs where a connection is suspected with the investigational device or
intervention, within 7 days (to the local EC for local events, to the responsible EC for all events in
Switzerland).
Serious adverse events (SAEs) that may be related to the intervention under investigation in other
clinical trials
See Article 63 KlinV-ClinO:
Notification of responsible EC within 15 days.
Reporting on the safety of participants
See Article 43 KlinV-ClinO:
Annual list of global events (Annual Safety Report)
The Annual Safety Report to the responsible EC must also report any changes that do not require
approval (i.e. all changes that are not significant according to Art. 29 KlinV-ClinO).
Notification and reporting
version of 14.03.2014
page 1/2
swissethics
Schweizerische Ethikkommissionen für die Forschung am Menschen
Commissions d’éthique suisses relative à la recherche sur l'être humain
Commissioni etiche svizzere per la ricerca sull'essere umano
Swiss Ethics Committees on research involving humans
Notification and reporting to the ethics committee
from 1 January 2014 for research projects not involving clinical trials [Human
Research Ordinance; HFV-HRO]
Research with human subjects associated with measures for sampling biological material or
the collection of health-related personal data
Safety and protective measures
see Article 20 HFV-HRO:
Notification of the EC within 7 days
Serious events
See Article 21 HFV-HRO
Notification within 7 days (to the local EC for local events, to the responsible EC for all events in
Switzerland).
Completion or discontinuation of a research project
See Article 22 HFV-HRA
Notification of the EC within 90 days
Further use of biological material and health-related personal data for research purposes
See Article 36 of HFV-HRO:
Change of project leader
Prior notification of the EC
Completion or discontinuation of the research project
Notification of the EC within 90 days
Further use of biological material and health-related personal data for research purposes in
the absence of informed consent according to Article 34 HFG [Human Research Act, HRA]
See Article 40 HFV-HRO:
Changes to the information given in the authorisation
Prior notification of the EC
Completion or discontinuation of the research project
Notification of the EC within 90 days
Research on deceased persons (Article 43 HFV-HRO)
See Article 43 HFV-HRO:
Change of project leader
Prior notification of the EC
Research projects involving deceased persons undergoing artificial respiration
Significant changes to the research protocol
Prior notification of the EC
Abschluss oder Abbruch des Forschungsprojekts
Notification of the EC within 90 days
Notification and reporting
version of 14.03.2014
page 2/2