Concept↦Ethics and Laws↦Study Categorisation↦Risk Categories
What is it? Why is it important?
The HRA ordinances (ClinO, ClinO-MD, HRO) define three possible risk-categories, namely A, B, or C, with category A representing a low risk and category C a high risk. Based on study type, either three, two or no category apply.
- Based on ClinO, risk-categories of the following study types are set as follows:
- Investigational Medicinal Product (IMP) = A, B, C
- A combination of IMP and an Investigational-Medical-Device (IMD) = 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
- Based in ClinO-MD, risk-categories for Medical Device (MD) studies are either:
- A, which are further subdivided into A1 and A2
- C, which are further subdivided into C1, C2 and C3
- Based on HRO, risk categories of research projects are set as follows:
- Projects with patients or healthy volunteers = A, B
- Further-us of health-related personal data (HRpD) and biological material (BM): = none
- Deceased persons, Embryos, and Foetuses = none
More
Risk-categorisation of Medical Device(s) studies
Clinical investigations with MDs:
Category A
- MD to be investigated carries a conformity marking
- MD to be investigated is used in accordance with the instructions for use and
- It is not prohibited to make the device to be investigated available on the market, put it into service or use it in Switzerland
Category A sub-categories
- A1, if the participants do not undergo additional invasive or burdensome procedures compared to the procedures performed under the normal conditions of use of MD to be investigated
- A2, if the participants undergo additional invasive or burdensome procedures compared to the procedures performed under the normal conditions of use of MD to be investigated
Category C
- C1, if MD to be investigated carries a conformity marking, but is not used in accordance with the instructions for use
- C2, if MD to be investigated does not carry a conformity marking or
- C3, if it is prohibited to make MD to be investigated available on the market, put it into service or use it in Switzerland
Medical Device performance studies
Category A:
Sub-category A1, if
- MD to be investigated carries a conformity marking in accordance with Article 12 IvDO
- MD to be investigated is used in accordance with the instructions for use
- it is not prohibited to make MD to be investigated available on the market, put it into service or use it in Switzerland,
- None of the procedures stated in letter b point 2 are used
Sub-category A2, if
- A non-interventional performance study that is not covered by Art. 2a paragraphs 1-3 is involved,
- An interventional performance study in accordance with letter a points 1–3 is involved and
- Surgically invasive procedures are used in order to collect biological material from the participants exclusively for the purpose of the performance study or
- Participants undergo additional invasive or burdensome procedures compared to the procedures performed under the normal conditions of use of MD to be investigated
Category C:
- If an interventional performance study is involved and
- MD to be investigated carries a conformity marking in accordance with Article 12 IvDO, but is not used in accordance with the instructions for use (sub-category C1)
- MD to be investigated does not carry a conformity marking in accordance with Article 12 IvDO (sub-category C2) or
- It is prohibited to make MD to be investigated available on the market, put it into service or use it in Switzerland (sub-category C3)
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-category of your study (e.g. A has the lowest and C the highest risk)
- If still in doubt, submit your questions to the Ethics Committee (EC) through BASEC portal. They can provide you with useful advice
- Upon EC submission, include the defined risk-category of your study and its rational
The EC reviews the defined risk-category of your study, and can decide to change its category to a higher or lower risk level.
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
- Online wizard for risk categorisation
Swiss Law
ClinO – see in particular articles and annex
- 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. 2 Definitions
- Art. 6 Categorisation of clinical investigations
HRO – see in particular article
- Art. 7 Categorisation
IvDO – see in particular
- Art. 14 Classification
Concept ↦ Ethics and Laws ↦ Study Categorisation ↦ Risk Categories