Concept↦Ethics and Laws↦Study Categorisation↦Risk Categories
What is it? Why is it important?
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
What do I need to do?
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.
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
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