GCP's guiding principles are:

• the compatibility of the clinical trial with the law, ethical principles and their concretization in the Declaration of Helsinki
• the start of the clinical trial with a minimum of risk and with the least possible burden for the trial subjects and society
• the rights, safety, and well-being of the trial subjects take precedence over the interests of science and society
• the design of the clinical trial must be reasonable in light of the available preclinical and clinical data
• an appropriate, detailed protocol/CIP must be available
• the clinical trial is conducted in accordance with the protocol/CIP previously "approved" by the Ethics Committee
• adequate care of the trial subjects by a qualified physician is ensured
• all participating persons are qualified by education and training for the tasks they are to perform
• the written consent of the subject is obtained after proper informed consent has been obtained
• proper documentation of the clinical trial for the purpose of ensuring and verifying its usefulness is ensured
• confidentiality and data protection regulations for the protection of the trial subjects are observed
• the use of the trial medication is in accordance with the protocol
• the manufacturing, handling and storage of the investigational medicinal product is performed in accordance with the applicable Good Manufacturing Practice (GMP)
• the medical device is used in accordance with the CIP
• a quality management system is in place, which is applied according to the written specifications