Templates and documents for notifications to the Ethics Committee

Notification of serious events (SE)

Template for the notification of serious events (SE) to the ethics committees for research projects not involving clinical trials (HRO)

English
1.2
Serious adverse events (SAE) with medicinal products and other clinical trials

Template for the notification of serious adverse events (SAE) to the ethics committees for clinical trials (ClinO)

English
1.0
Serious adverse events (SAE), medical devices

Template from Swissmedic for the notification of serious adverse events (SAE) and device deficiencies to the ethics committees for clinical trials with medical devices.

Template requires Adobe Acrobat Reader. Download the template first, if it does not open directlty in the Browser.

Deutsch
1.0 26.05.2020
updated: 23.06.2020
Français
1.0 26.05.2020
updated: 23.06.2020
English
1.0 26.05.2020
updated: 23.06.2020
Italiano
1.0 26.05.2020
updated: 23.06.2020
Annual Safety Report

Template for writing an 'Annual Safety Report' for 'Investigator initiated trials' (IITs) according to ClinO

English
1.1
Notification of significant changes and other changes to the ethics committee

Notification of significant changes and other changes to the ethics committee for clinical trials (ClinO) and for research projects not involving clinical trials (HRO)

English
1.4
updated: 27.05.2021
Français
1.4
updated: 27.05.2021

Notification of significant changes and other changes to the ethics committee for clinical trials (ClinO-MD)

English
1.0
updated: 06.05.2021
Notification and reporting to the ethics committee

Notification and reporting to the ethics committee for clinical trials (ClinO) and for research projects (HRO). The leaflet describes also the notification and reporting of SAEs and SUSARs to the Ethics Committee

Deutsch
4.0
updated: 24.05.2021
Français
4.0
updated: 24.05.2021
Italiano
4.0
updated: 24.05.2021
English
4.0
updated: 24.05.2021

Notification and reporting to the ethics committee and to Swissmedic for clinical trials of medical devices (ClinO-MD)

English
1.0
updated: 04.05.2021
Absence of the investigator

Absence of the investigator for an extended period of time? How should this be handled?

Deutsch
1.1
updated: 13.09.2016
Français
1.0
updated: 13.09.2016
Italiano
1.0
updated: 13.09.2016
English
1.0
updated: 13.09.2016
Protocol violations, changes in protocols and safety measures
Deutsch
1.0
updated: 17.05.2016
Français
1.0
updated: 17.05.2016
Italiano
1.0
updated: 17.05.2016
Notification of the completion or discontinuation of the clinical trial or of the research project

Template for the notification of completion or discontinuation of the clinical trial or of the research project to the Ethics Committee

English
3.0
updated: 03.06.2021