NLRadiotherapy object
Use of radiation or radioactive compounds - Specific requirements
Yes
Applicable legal framework
1. German X-ray Ordinance- Deutsche Roentgenverordnung/ RöV
2. Radiation Protection Ordinance -Strahlenschutzverordnung/ StrSchV
Additional Information
The 2 ordinances apply if radioactive compounds are used in a clinical trial.
For clinical trials involving the use of X-Rays an approval from the Federal Office for Radiation Protection- BfS (Bundesamt für Strahlenschutz) is required according to section 28 RöV (X-Ray Ordinance)