NLRadiotherapy object
Use of radiation or radioactive compounds - Specific requirements
Yes
Applicable legal framework
Applicable to trials with radioactive substances (in addition):
Strahlenschutzgesetz (StSG); SR 814.50 (2007)
Radiological Protection Act (RPA) (NB: en, non-official translation)
Strahlenschutzverordnung (StSV), SR 814.501 (1994, as amended)
Radiological Protection Ordinance (RPO) (en, non-official translation)
Additional Information
Radioactive substances, with regard to radiological protection for trial participants: The sponsor must submit the trial to the CA, the EC and, in addition, to the Radiological Protection Division of the Federal Office of Public Health (FOPH). Additional application documents for clinical trials of therapeutic products capable of emitting ionising radiation are required and provided in Annex 4(5) KlinV/ClinO.
