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.
Similar content being viewed by others
References
Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181–182, (1949) U.S. Government Printing Office, Washington, D.C.
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.
Allen, M.E., VandenBurg, M.J. & Gerlis, L. (1996) Good Clinical Practice in Europe, Investigator’s Handbook, Rostrum Personal Development: 5–6.
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.
World Health Organisation (1995) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products, WHO Technical report Series, No. 850: 97–137.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Switula, D. Principles of good clinical practice (GCP) in clinical research. SCI ENG ETHICS 6, 71–77 (2000). https://doi.org/10.1007/s11948-000-0025-z
Received:
Revised:
Accepted:
Issue Date:
DOI: https://doi.org/10.1007/s11948-000-0025-z