What is it? Why is it important?
A radiation source can be combined with a Medicinal Product (ClinO), a Medical Device (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 altogether
What do I need to do?
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 the compliance with:
- Radiological protection legislations
- The dose estimation
EC, FOPH, and Swissmedic submission must be done in parallel as they coordinate their assessments.
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