What is it? Why is it important?
Based on given criteria, the HRA ordinances (ClinO, ClinO-MD, HRO) assign studies to different risk-categories. The aim of study risk categorisation is to ensure that study participants are protected from anticipated study risks.
- Either category A, B, or C
- Given different risk levels with category A studies presenting the lowest and category C presenting the highest risk.
Based on the risk-category, different requirements apply, such as:
- Documents required for Ethics Committee (EC) / Regulatory Authority (e.g. Swissmedic) submission
- Study relevant templates (e.g. study protocol, PIS / ICF)
- Approval procedures (e.g. risk-category B and C studies must in addition to EC also seek Swissmedic approval)
- Study insurance (e.g. higher risk studies require more extensive coverage)
- Safety reporting (e.g. is more extensive for high risk studies)
- Extent of study monitoring (e.g. is more extensive for high risk studies)
What do I need to do?
As a SP-INV, define the risk-category of your study:
- Consider the aim of your study and your study design (e.g. new drug, placebo controlled), including the type of data or biological material that needs to be collected
- Check the HRA ordinances, which outline the conditions that must be met for each category (i.e.. ClinO, ClinO-MD, HRO)
- Use the KOFAM online tool, which helps you to determine the risk-category of your study
- If still in doubt, submit your questions to your responsible EC through BASEC. They can provide useful advice
The risk-category for your study will be reviewed and approved 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
Swissethics – see in particular
- BASEC: the portal for EC submission
KOFAM: Coordination portal for human research – see in particular
- Online wizard for risk categorisation
ClinO – see in particular articles
- 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