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 health-related interventional studies.
In these studies, participants are assigned to a health-related intervention, which is evaluated based on its effect on health, bodily structure, and/or function.
Interventional studies include any preventative, diagnostic, therapeutic, palliative, or rehabilitative measure based on the use of:
- 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)
- Transplantation and transplant products
- In vitro diagnostic Medical Devices (MD) or products
- Gene therapy and genetically modified organisms (GMO) and pathogenic organisms
- Studies involving ionising radiation
- Other clinical studies
In addition, the ordinance regulates:
- EC/RA / FOPH authorisation and reporting procedures
- EC/RA / FOPH duties and responsibilities
- Study registration and public access
What do I need to do?
When performing studies involving human beings, you are required to know and comply with the HRA act, including its ordinances.
The Clinical Trial Ordinance provides:
- Applicable articles and chapters according to study type (e.g. interventions with the use of a MP, MP in combination with a MD, transplantation or transplant products, or “other clinical trials”)
- Definitions on how to risk categorise a study (e.g. A, B, or C with A having the lowest- and C the highest risk)
- Criteria needed for EC, Swissmedic, and FOPH submission
Read the ClinO ordinance 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 CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
KOFAM: Coordination portal for human research – see in particular
- Online wizard for risk categorisation
FEDLEX – law is available online under number
- 810.305 ClinO
ClinO – see in particular articles
- Art. 1 Purpose
- Art. 2 Definitions
- Art.19 Categorisation of MP studies
- Art. 20 Categorisation of studies of in vitro diagnostic MD and products
- Art. 21 Categorisation of studies of transplant products: refer to Art. 19
- Art. 22 Categorisation of studies with genetically modified or pathogenic organisms: refer to Art. 19
- Art. 49 Categorisation of transplantation studies
- Art. 61 Categorisation of other clinical studies