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Analysis

The 13 Principles of Good Clinical Practice (GCP)

Wed, 09/09/2015 - 09:37

GCP is the global standard for conducting research involving human beings. It comprises 13 ethical and scientific quality principles aimed at protecting the safety and well-being of human participants and applies to all clinical investigations, with a particular emphasis on clinical trials of medicinal products and medical devices. It was developed by the regulatory authorities of the EU, Japan, and the US, in a group named the Tripartite International Conference on Harmonization (ICH). The agreement was finalized in 1996, and became effective in 1997. Soon after implementation, the GCP gained international recognition as a benchmark for best practice, becoming a reference for many regulatory agencies around the world while creating local regulations for clinical trials.

  1. Clinical trials should be conducted in accordance with the ethical principles that originate in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirements.
  2. Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
  3. The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
  4. The available nonclinical and clinical information on an investigational product should adequately support the proposed clinical trial.
  5. Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
  6. A trial should be conducted in compliance with the protocol that has received prior Institutional Review Board (IRB) approval, Independent Ethics Committee (IEC) approval or favorable opinion.
  7. The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, a qualified dentist.
  8. Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s).
  9. Freely given informed consent should be obtained from each subject prior to clinical trial participation.
  10. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification.
  11. The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
  12. Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
  13. Systems with procedures that assure the quality of every aspect of the trial should be implemented.