Science and Engineering Ethics

, Volume 6, Issue 1, pp 71–77 | Cite as

Principles of good clinical practice (GCP) in clinical research

  • Dorota Switula


Good Clinical Practice is an international quality standard for conducting trials that involve participation of human subjects. Currently, the most widely accepted international document forming the base for GCP is the ICH Harmonised Tripartite Guideline for GCP, which defines in detail the responsibilities and obligations of parties engaged in clinical research. The purpose of this paper is to analyse how compliance with GCP provides protection of the trial subjects and assures quality and credibility of the data obtained.


Good Clinical Practice (GCP) International Conference on Harmonisation (ICH) investigator sponsor ethies committee 


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Copyright information

© Opragen Publications 2000

Authors and Affiliations

  • Dorota Switula
    • 1
  1. 1.Astra Clinical Research Unit — Central EuropeWarsawPoland

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