Your Easy Guide to Clinical Studies

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

 

• Risk categories of ClinO studies are based on the use of:
  • Drugs (MP) = A, B, C
  • IMP/IMD in combination = 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

 

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

 

• Risk categories of HRO research projects depend on the inclusion of:
  • Patients or healthy volunteers = A, B
  • Reuse of health-related personal data (HRpD) = none
  • Reuse of biological material (BM): = none
  • Deceased persons = none
  • Foetuses and embryos = 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 of your study (e.g. A has the lowest risk and C the highest risk)
• If still in doubt, submit your questions to the EC through BASEC portal. They can provide you with useful advice
• Upon EC submission, include the selected risk category of your study

 

The risk category for your study will be review and approve by EC. If required, the EC will adapt the risk category of your study.

External Links

Swissethics – see in particular

• BASEC: the portal for EC submission

References

KOFAM: Coordination portal for human research – see in particular – see in particular

• Online wizard for risk categorisation

Swiss Law

FEDLEX – laws are available online under numbers

• 810.305 ClinO
• 810.306 ClinO-MD
• 810.301 HRO

ClinO – see in particular articles and annex

• Art. 19 Categorisation of medicinal products
• Art. 20 Categorisation of in vitro diagnostic MD and products
• Art. 21 Categorisation of transplant products
• Art. 22 Categorisation of gene therapy and genetically modified or pathogenic organisms
• Art. 49 Categorisation of transplantation of human organs, tissues and cells
• Art. 61 Categorisation of other clinical studies
• Annex 1 International classification of diseases

ClinO-MD – see in particular article

• Art. 6 Categorisation of clinical trials

HRO – see in particular article

• Art. 7 Categorisation