Basic↦Ethics and Laws↦Clinical Trials Ordinance↦Ionising Radiation
Was betrifft es? Warum ist das wichtig?
The Human Research Act (HRA) regulates through its ordinances (e.g. ClinO, ClinO-MD) additional requirements for studies using a radiation source.
A radiation source can be combined with a Medicinal Product (ClinO), a Medical Device Product (ClinO-MD), or based on a combination from both products.
The HRA and its ordinances apply to studies with medicinal products capable of emitting ionising radiation, and studies with accompanying examinations involving ionising radiation.
As a SP-INV of studies investigating products capable of emitting ionising radiation, you are required to know and comply with requirements defined in the ClinO/ClinO-MD ordinances.
Was muss ich befolgen?
As a SP-IN, submit an application to the:
- The Ethics Committee (EC) if additional concomitant examinations with ionising radiation measures are performed. Aspects to consider include:
- To inform the EC of a FOPH application. The EC grants approval if the FOPH has no objections.
- The FOPH, for risk-category B and C studies, if the:
- Radiopharmaceutical is applied outside it’s authorization, or has no authorization in Switzerland
- Medical Device is emitting radiation, and is used outside it’s product specification or has no CE-mark.
- Swissmedic, for risk-category B and C studies. For category C studies.
- Swissmedic will seek the opinion of the FOPH, who will review compliance with radiological protection legislation and dose estimation. Swissmedic grants study authorisation if the FOPH has no objections
Submission to Swissmedic (submission) and EC (submission) may be done in parallel. Submission to the second authority must be done within two years after approval of the first authority.
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
References
HumRes: Coordination portal for human research in Switzerland
Swiss Law
ClinO – see in particular articles and annexes
- Art. 11 Extension of the limitation period
- Art. 25 j, k EC review area
- Art. 32 Swissmedic review areas
- Art. 36 Studies of medicinal products emitting ionising radiation
- Art. 36a Accompanying examinations involving ionising radiation
- Annex 3 Application documents to EC
- Annex 4 Application documents to Swissmedic / FOPH
ClinO-MD - see in particular articles and section
- Art. 14 Procedures for accompanying examinations involving ionising radiation
- Art. 18 Studies with devices capable of emitting ionising radiation
RPA – see in particular article
- Art. 28 Mandatory licencing