What does THAT mean?  Good Clinical Practice glossary series

This series will review and elaborate on the glossary terms listed in the Good Clinical Practice (GCP) Guidance adopted by the United States Food and Drug Administration (US FDA) for conducting clinical trials.


First, we’ll look at the GCP guidance itself.                                            

The International Conference of Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) develops regulatory guidelines to achieve their mission to “ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner”.  They also apply to biologics and medical devices.

Good Clinical Practice (GCP) guidelines are a set of ethical and quality standards developed by the ICH to harmonize clinical trial practices in the European Union, Japan, the United States, Australia, Canada, the Nordic countries, and the World Health Organization (WHO). They address designing, conducting, recording, and reporting of human clinical studies for regulatory submissions, and aim to protect the rights, safety, and well-being of study participants under the ethical principles of the Declaration of Helsinki.


What are the thirteen principles of the ICH GCP?

The principles of GCP include the requirements that study sponsors ensure that ethics of human subject research are upheld, the benefits of the clinical trial outweigh the risks, there is sound scientific evidence to support the trial, systems are in place to ensure accurate data collection and interpretation, and confidentiality and compliance can be maintained.

  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 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 be adequate to 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)/independent ethics committee (IEC) approval/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, of 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 tasks.
  9. Freely given informed consent should be obtained from every 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 requirements.
  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.
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