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Science and Engineering Ethics

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

Principles of good clinical practice (GCP) in clinical research

  • Dorota Switula
Article

Abstract

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.

Keywords

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

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References

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    World Medical Association Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects, version amended by the 48th General Assembly, October 1996.Google Scholar
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    Allen, M.E., VandenBurg, M.J. & Gerlis, L. (1996) Good Clinical Practice in Europe, Investigator’s Handbook, Rostrum Personal Development: 5–6.Google Scholar
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    EC Note for Guidance: Good Clinical Practice for Trials on Medicinal Products in the European Community. III/3976/88-EN Final. Published in: Pharmacology & Toxicology (1990) 67: 361–372.CrossRefGoogle Scholar
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    World Health Organisation (1995) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products, WHO Technical report Series, No. 850: 97–137.Google Scholar

Copyright information

© Opragen Publications 2000

Authors and Affiliations

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

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