Good Clinical Practice - GCP

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

Last Modification: 20.06.2023 - Contact Person:

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