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ICH E6 Good Clinical Practice Principles

  1. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical practice (GCP) and applicable regulatory requirement(s).
  2. 2- Clinical trials should be designed and conducted in ways that ensure the rights, safety, and well-being of participants.
  3. Informed consent is an integral feature of the ethical conduct of a trial. Clinical trial participation should be voluntary and based on a consent process that ensures participants are well-informed.
  4. Clinical trials should be subject to objective review by an institutional review board (IRB)/independent ethics committee (IEC).
  5. Clinical trials should be scientifically sound for their intended purpose, and based on robust and current scientific knowledge and approaches.
  6. Clinical trials should be designed and conducted by qualified individuals.
  7. Quality should be built into the scientific and operational design and conduct of clinical trials.
  8. Clinical trial processes, measures, and approaches should be proportionate to the risks to participants and to the reliability of trial results.
  9. Clinical trials should be described in a clear, concise, and operationally feasible protocol
  10. Clinical trials should generate reliable results
  11. – Roles, tasks and responsibilities in clinical trials should be clear and documented appropriately.
  12. Investigational products used in a clinical trial should be manufactured in accordance with applicable Good Manufacturing Practice (GMP) standards and be stored, shipped, and handled in accordance with the product specifications and the trial protocol.