Human research

Key points in a nutshell

A brief summary of the key points on human research in Switzerland


Applications & procedure

Requirement to obtain authorisation, categorisation and submission of applications

All information on the requirement to obtain authorisation, categorisation and submission of applications is available here:


SNCTP Portal

Search for studies

Search for registered clinical trials in Switzerland.

Categoriser

Online wizard for categorising human research projects

The categoriser provides help in assigning and categorising your research project according to the provisions of the Human Research Act – good preparation for the submission of your application!

Glossary

Human research glossary

The glossary includes all relevant technical terms from the field of human research, along with explanations and further information, in four languages.

Case studies

A selection of real human research projects

The case study module provides a selection of real human research projects, each with a brief summary. The projects can be filtered according to various criteria.

Improvement of the search function of the Swiss clinical trials portal SNCTP

Any clinical trial in Switzerland must be registered and published on the SNCTP online portal. The online portal has been revised in order to facilitate the search for registered clinical trials. Clinical trials can now be found more quickly and more precisely due to more sophisticated search and sort functions. The core element is the multilingual search: search terms can be entered in any of the four Swiss national languages, and the results are displayed in all available languages.

Development of the SNCTP is an ongoing process. It is planned to expand the search function further as part of the next round of improvements in 2017. Users can also make individual comments regarding the portal with the aid of a feedback function.

Direct link to search for clinical trials on the Swiss trials portal SNCTP.

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Amendment to Annex I of the Clinical Trials Ordinance (ClinO) as of 1 May 2017

The international "Guideline for Good Clinical Practice" of the International Harmonisation Conference (the ‘ICH-GCP guideline’) is referred to in the Clinical Trials Ordinance of 20 September 2013 (ClinO) in Annex I, and is therefore immediately applicable in Switzerland to clinical trials of medicinal products and transplant products.

The previous ICH-GCP Guideline of 10 June 1996 was amended by the International Harmonization Conference on 9 November 2016. The aim of these amendments is to improve the management and monitoring of clinical trials by the sponsor. Particular attention is paid to protection of human subjects participating in trials and the integrity of clinical trial data.

Annex I of the Clinical Trials Ordinance refers to the amended ICH-GCP Guideline of 9 November 2016 (‘ICH E6 (R2)’) as of 1 May 2017. As of this date, the amended ICH-GCP Guideline for clinical trials with medicinal products and transplant products is applicable in Switzerland.

Link to ICH E6(R2) Integrated Addendum

Link to ClinO

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