Concept↦Ethics and Laws↦Study Categorisation↦Risk Categories
Was betrifft es? Warum ist das wichtig?
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
Mehr
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)
Was muss ich befolgen?
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.
Wo kann ich Hilfe anfordern?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), 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