Your Easy Guide to Clinical Studies

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.

 

Categories are:

• 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)

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.

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

• 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