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 investigations and (diagnostic) examinations (e.g. CT scan, X-rays, etc.) using an effective person dose exceeding 5 mSv per year.

 

In addition it applies to radiopharmaceutical products under investigation that:

• Are not authorised in Switzerland
• Are authorised in Switzerland, but where the investigation is not a routine nuclear medical examination, or
• Use another radioactive source is used altogether

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.

 

Aspects to consider:

• The authorization status of the radiopharmaceutical under investigation (e.g. approval status in Switzerland)
• Planned radiation dose and participant exposure
• Required licence for administering radioactive substances to humans
• Completion of the required research application form for FOPH submission

 

Submit an application to:

• The FOPH, if the effective dose per person > 5 mSv per year
• Ethics Committee (EC) who grants authorisation of all studies (e.g. study risk-categories)
• Swissmedic who grants authorisation of category B and C studies

 

The FOPH delivers its opinion to EC with respect to compliance with:

• Radiological protection legislation
• The dose estimation

 

EC, FOPH, and Swissmedic submission must be done in parallel as they coordinate their assessments.

References

KOFAM: Coordination portal for human research – see in particular

• Online wizard for risk categorisation

Swiss Law

ClinO – see in particular articles

• Art. 2, 6 Definition
• Art. 11 Extension of the limitation period
• Art. 25 j, k EC review area
• Art. 28 Procedures for investigations involving radiation sources
• Art. 32 Swissmedic review areas
• Art. 36 Studies of medicinal products emitting ionising radiation

ClinO-MD - see in particular articles and section

• Art. 14 Procedures for investigations involving radiation source
• Art. 18 Studies with devices capable of emitting ionising radiation
• Section 3. Reporting in relation with the use of radiation sources and document retention

RPA – see in particular article

• Art. 28 Mandatory licencing