In Germany there are some special requirements to the use of radioactive substances or ionizing radiation in the context of clinical studies. If you plan to make use of radiation application (e.g. MRT or CT) as part of a study, it is mandatory in Germany to include the responsible authority, the Federal Office for Radiation Protection (BfS). In addition to our extensive services within the scope of scheduling and implementing your studies, we provide advice on how to cope with studies in conjunction with the Radiation Protection Act.
When does the use of radiation applications require notification and authorization?
Procedures, requiring approval and announciation within the context of study-related radiation application, are usually complex and time-consuming. Clinical studies linked to diagnostic radiation applications exceeding the average medical care are notifiable. Approval by the BfS is inevitable if a study incorporates therapeutic measures. Typically, other criteria are decisive when it comes to whether annunciation or approval is required.
To apply at the BfS, the vote of ethics committee must be submitted. The radiation protection regulation is under responsibility of the BfS and hence not audited separately by the ethics committee.
Shorten your application process when conducting clinical trials in Germany
The path through the German notification and approval processes can be long and laborious. We have been able to significantly accelerate these procedures for various sponsors and CROs. This is because, in addition to our many years of experience in conducting various studies with radiation protection relevance, we build on the close and trusting cooperation with a specialist in radiology and correspondingly extensive expertise.
Our service encompasses consultation and verification of your application documents:
- assistance in preparing and investigating documents for initial submission
- investigating applications for amendments
- advice on queries concerning the start of studies
- corrections in general & substantive investigation of applications