Basic↦Ethics and Laws↦Clinical Trials Ordinance↦Aim
What is it? Why is it important?
The Human Research Act (HRA) regulates through its Clinical Trials Ordinance (ClinO) requirements needed for the conduct of human interventional studies, with the exception of clinical trials of Medical Devices (ClinO-MD).
In these studies, participants are prospectively assigned to one or more interventions, which are evaluated based on its effect on health, bodily structure, and/or function.
The ordinance regulates studies with:
- Medicinal products (MP)
- Medicinal products in combination with medical devices (e.g. non-separable combinations of MP and device and where the MP assumes a primary function such as an insulin pump)
- Transplant products
- Transplantation
- Gene therapy and genetically modified organisms and pathogenic organisms
- Products capable of emitting radiation
- Other clinical studies
More
In addition, the ordinance regulates:
- Ethics Committee (EC) / RA (e.g. Swissmedic) / Federal Office of Public Health (FOPH) authorisation and reporting procedures
- EC/RA/ FOPH duties and responsibilities
- Study registration and public access to information on clinical trials in Switzerland
What do I need to do?
As a SP-INV and Site-INV performing studies involving human beings, you are required to know and comply with the HRA act and its ordinances.
The Clinical Trial Ordinance:
- Is divided into chapters and articles based on study type(e.g. interventions with the use of a MP, or transplant products, or transplantation, or “other clinical trials”)
- Defines risk-categories based on expected study risks (e.g. A, B, or C with A having the lowest and C the highest risk)
- Lists Ethics Committee (EC), RA (e.g Swissmedic), and Federal Office of Public Health (FOPH) submission requirements
Read ClinO and based on your study:
- Familiarise yourself with the organisation of the various chapters and sections
- Focus on the articles that are relevant to your study. Tag them in order to ensure compliance
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
References
HumRes: Coordination portal for human research in Switzerland
Swiss Law
ClinO – see in particular articles and annexes
- Art. 1 Purpose
- Art. 2 Definitions
- Art.19 Categorisation of MP studies and transplant products
- Art. 22 Categorisation of studies with gene therapy, genetically modified or pathogenic organisms: refer to Art. 19
- Art. 49 Categorisation of transplantation studies
- Art. 61 Categorisation of other clinical studies
- Annex 3 Application documents to EC
- Annex 4 Application documents to Swissmedic / FOPH