1. In Germany, a clinical trial must be approved by BfArM (German Federal Institute for Drugs and Medical Devices). In Austria, trials involving drugs or medical devices must be approved by BASG (Austrian Federal Office for Safety in Health Care) or AGES (Austrian Medicines and Medical Devices Agency).
  2. Before a trial can commence, the trial protocol must be submitted to an ethics committee for review.
  3. The ethics committee reviews the patient information for completeness and comprehensibility. Furthermore, the committee assesses whether all legal guidelines have been adhered to and whether the expected benefit in comparison to possible adverse reactions is justifiable.
  4. The responsible principal investigator must be able to prove that he or she has sufficient experience in the conduct of clinical trials.
  5. The patient files of all trial participants will be reviewed by independent, trained persons (monitoring).
  6. In Austria, the Federal Office for Safety in Health Care (BASG) may inspect or review the trial at any time.