Your Easy Guide to Clinical Studies

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.  

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.

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