Principles of good clinical practice (GCP) in clinical research.
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.
Astra Clinical Research Unit-Central Europe, ul. Kubickiego 1, 02-954 Warsaw, Poland.
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D002986:Clinical Trials as Topic / Q000592:standards*; D032781:Codes of Ethics; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D017408:Guidelines as Topic; D006801:Humans; D038622:Internationality; D010344:Patient Advocacy; D011785:Quality Assurance, Health Care; D011786:Quality Control; D012106:Research / Q000592:standards*; D012449:Safety