Your Easy Guide to Clinical Studies

The HRA ordinances (ClinO, ClinO-MD, HRO) define three possible risk-categories, namely A, B, or C, with category A resenting a low risk and category C a high risk. Based on study type, either three, two or no category apply.

 

• Based on ClinO, risk-categories of the following study types are set as follows:
  • Investigational Medicinal Product (IMP) = A, B, C
  • A combination of IMP and an Investigational-Medical-Device (IMD) = A, B, C
  • Standardized transplants = A, C
  • Gene therapy, genetically modified or pathogenic organisms = A, B, C
  • Transplantation = A, C
  • Ionising radiation = B,C
  • Other clinical studies = A, B

 

• Based in ClinO-MD, risk-categories for Medical Device (MD) studies are either:
  • A, which are further subdivided into A1 and A2
  • C, which are further subdivided into C1, C2 and C3

 

• Based on HRO, risk categories of research projects are set as follows:
  • Projects with patients or healthy volunteers = A, B
  • Further-us of health-related personal data (HRpD) and biological material (BM): = none
  • Deceased persons, Embryos, and Foetuses = none

As a SP-INV:

• Select the Ordinance (e.g. ClinO, ClinO-MD or HRO) that applies to your study
• Use the KOFAM risk-calculator to support you in defining the risk-category of your study (e.g. A has the lowest and C the highest risk)
• If still in doubt, submit your questions to the Ethics Committee (EC) through BASEC portal. They can provide you with useful advice
• Upon EC submission, include the defined risk-category of your study and its rational

 

The EC reviews the defined risk-category of your study, and can decide to change its category to a higher or lower risk level.

External Links

Swissethics – see in particular

• BASEC: the portal for EC submission

References

KOFAM: Coordination portal for human research – see in particular 

• Online wizard for risk categorisation

Swiss Law

ClinO – see in particular articles and annex

• Art. 19 Categorisation of clinical trials of medicinal products
• Art. 20 Categorisation of clinical trials of products under Article 2a paragraph 2 TPA
• Art. 21 Categorisation of clinical trials of transplant products
• Art. 22 Categorisation of clinical trials of gene therapy and genetically modified or pathogenic organisms
• Art. 49 Categorisation of clinical trials of transplantation of human organs, tissues and cells
• Art. 61 Categorisation of other clinical studies

ClinO-MD – see in particular article

• Art. 6 Categorisation of
• investigations

HRO – see in particular article

• Art. 7 Categorisation

IvDO – see in particular

• Art. 14 Classification