Radiation Protection Requirements for Clinical Trials with Ionising Radiation in Germany (BfArM)

Legal Framework

Clinical trials involving ionising radiation in Germany are subject to the Radiation Protection Act (Strahlenschutzgesetz – StrlSchG) and the Radiation Protection Ordinance (Strahlenschutzverordnung – StrlSchV). These laws implement EU Basic Safety Standards (Directive 2013/59/Euratom) and set strict requirements for the protection of trial participants, personnel, and the environment. BfArM is the competent federal authority for radiation protection in medicinal product trials. Radiation Protection Act - BfArM

Scope of Application

Radiation protection rules apply to clinical trials that:

• Use radioactive substances (e.g., radiopharmaceuticals for diagnostics or therapy).
• Involve exposure to ionising radiation from external sources (e.g., X-ray, CT in trial procedures).
• Include therapeutic nuclear medicine applications.

Non-ionising radiation (e.g., MRI, ultrasound) is not covered under these provisions.

Key Requirements

Justification and Dose Optimisation

• Every exposure must be justified: the benefit must outweigh the radiation risk.
• Dose optimisation (ALARA principle) is mandatory – doses must be as low as reasonably achievable.
• Individual justification and optimisation plans are required for each participant.

Risk-Benefit Evaluation

• Trial protocols must include detailed radiation risk assessment.
• Ethics committees and BfArM evaluate the radiation-related risk-benefit balance.
• Special consideration for vulnerable populations (e.g., children, pregnant women).

Authorisation and Notification

• Trials with radioactive substances require a radiation protection authorisation from BfArM (or state authorities in some cases).
• Use of radiation-emitting devices in trials may require notification or permit.
• Substantial changes affecting radiation exposure must be reported.

Radiation Protection Measures

• Qualified radiation protection experts must be involved.
• Dosimetry monitoring and recording of individual doses.
• Emergency preparedness and contingency plans.

BfArM Responsibilities

• Assesses and authorises radiation-related aspects of clinical trial applications.
• Provides guidance on StrlSchG/StrlSchV compliance for trial sponsors.
• Monitors compliance through inspections and documentation review.
• Coordinates with ethics committees, state authorities, and the Paul-Ehrlich-Institut (PEI) for certain biologicals.

Practical Guidance for Sponsors

• Integrate radiation protection data early in the trial protocol and CTIS application.
• Consult BfArM prior to submission for complex trials involving radiation.
• Ensure dosimetry and justification documentation meets German requirements.

These requirements ensure that the use of ionising radiation in clinical research in Germany adheres to the highest standards of radiation safety while enabling scientifically valuable trials. Radiation Protection Act - BfArM