Templates and documents for notifications to the Ethics Committee
In addition to the templates you find here, the website of the Swiss Clinical Trial Organisation (SCTO) also provides information and guidelines for safety reporting. SCTO is the central cooperation platform for patient-oriented clinical research in Switzerland. It is an independent organisation funded in 2009 as a joint initiative of the Swiss National Science Foundation and the Swiss Academy of Medical Sciences.
Template for the notification of serious events (SE) to the ethics committees for research projects not involving clinical trials (HRO)
Template for the notification of serious adverse events (SAE) to the ethics committees for clinical trials (ClinO)
Template for the notification of serious adverse events (SAE) and device deficiencies to the ethics committees for clinical investigations with medical devices.
Template from Swissmedic requires Adobe Acrobat Reader. Download the template first, if it does not open directlty in the Browser.
European reporting form for the notification of serious adverse events (SAE) to the ethics committees for conformity-related multi-centre clinical trials with medical devices in sub-categories C1 and C2 that are also being conducted abroad (art. 33 lit. 3 ClinO-MD)
Completion instructions of the reporting form MDGC 2020-10/2 are given in chapter 10 of the European guidance document MDCG 2020-10/1 (link).
Do not use this reporting form to notify SAEs occurring in Switzerland if the clinical trial is only conducted in Switzerland.
Template for the notification of serious adverse events (SAE) and device deficiencies to the ethics committees for IVD devices clinical performance studies.
Template from Swissmedic requires Adobe Acrobat Reader. Download the template first, if it does not open directlty in the Browser.
Template for writing an 'Annual Safety Report' for 'Investigator initiated trials' (IITs) according to ClinO / ClinO-MD
Notification of significant changes and other changes to the ethics committee for clinical trials (ClinO) and for research projects not involving clinical trials (HRO)
Notification of significant changes and other changes to the ethics committee for clinical trials (ClinO-MD)
Notification and reporting to the ethics committee for clinical trials (ClinO) and for research projects (HRO).
Notification and reporting to the ethics committee and to Swissmedic for clinical trials of medical devices (ClinO-MD)
Absence of the investigator for an extended period of time? How should this be handled?
Protokollverletzung, Änderungen des Protokolls und Sicherheitsmassnahmen
Template for the notification of completion or discontinuation of the clinical trial or of the research project to the Ethics Committee
Template for writing a clinical study report of clinical trial conducted under Chapter 4 Other clinical trials, of the Clinical Trial Ordinance (ClinO).
Do not use this template to notify the completion or discontinuation of the clinical trial or of the research project.
Do not use this template for writing a clinical study report of a clinical trial with a medicinal product. Guidance how to write such a study report is given in ICH-E3 guideline «Structure and Content of Clinical Study Reports».