What is it? Why is it important?
Based on given criteria, the HRA ordinances (ClinO. CinO-MD, HRO) assign studies to different risk categories. The aim of study 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 having the lowest and category C having the highest risk.
Based on the risk category, different requirements apply, such as:
- Documents required for EC/RA submission
- Study relevant templates (e.g. study protocol, PIS / ICF)
- Approval procedures
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 (e.g. ClinO, HRO, ClinO-MD)
- 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 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, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
Swissethics – see in particular
- BASEC: the portal for EC submission
KOFAM: Coordination portal for human research – see in particular – see in particular
- Online wizard for risk categorisation
FEDLEX – laws are available online under numbers
- 810.301 HRO
- 810.305 ClinO
- 810.306 ClinO-MD
ClinO – see in particular articles
- 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
ClinO-MD – see in particular article
- Art. 6 Categorisation of clinical trials
HRO – see in particular article
- Art. 7 Categorisation